Shingrix
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Shingrix powder and suspension for suspension for injection 
Herpes zoster vaccine (recombinant, adjuvanted) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, one dose (0.5 ml) contains: 
Varicella Zoster Virus1 glycoprotein E antigen2,3    50 micrograms 
 
1 Varicella Zoster Virus = VZV 
2 adjuvanted with AS01B containing: 
 plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 
 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota  
          50 micrograms 
3 glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA 
technology  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Powder and suspension for suspension for injection. 
The powder is white. 
The suspension is an opalescent, colourless to pale brownish liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 
50 years of age or older (see section 5.1). 
 
The use of Shingrix should be in accordance with official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
 
The primary vaccination schedule consists of two doses of 0.5 ml each: an initial dose followed by a 
second dose 2 months later. 
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 
and 6 months after the first dose (see section 5.1). 
 
The need for booster doses following the primary vaccination schedule has not been established (see 
section 5.1). 
 
Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated 
HZ vaccine (see section 5.1). 



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Shingrix is not indicated for prevention of primary varicella infection (chickenpox). 
 
Paediatric population 
 
The safety and efficacy of Shingrix in children and adolescents have not been established. 
No data are available. 
 
Method of administration 
 
For intramuscular injection only, preferably in the deltoid muscle. 
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications   
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Prior to immunisation 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be 
readily available in case of an anaphylactic event following the administration of the vaccine. 
 
As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an 
acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not 
result in the deferral of vaccination. 
 
As with any vaccine, a protective immune response may not be elicited in all vaccinees. 
 
The vaccine is for prophylactic use only and is not intended for treatment of established clinical 
disease. 
 
Do not administer the vaccine intravascularly or intradermally. 
 
Subcutaneous administration is not recommended. 
Maladministration via the subcutaneous route may lead to an increase in transient local reactions.  
 
Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation 
disorder since bleeding may occur following intramuscular administration to these subjects. 
 
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to 
the needle injection. This can be accompanied by several neurological signs such as transient visual 
disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that 
procedures are in place to avoid injury from faints. 
 
There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a 
dose of another HZ vaccine. 
 



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There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail 
individuals including those with multiple comorbidities (see section 5.1). Healthcare professionals 
therefore need to weigh the benefits and risks of HZ vaccination on an individual basis. 
 
Systemic immunosuppressive medications and immunodeficiency 
 
Safety and immunogenicity data on a limited number of immunocompromised subjects with human 
immunodeficiency virus (HIV) or haematopoietic stem cell transplant (HCT) are available (see section 
5.1). The use of Shingrix in subjects with other confirmed or suspected immunosuppressive or 
immunodeficient conditions is under investigation.  
As with other vaccines, an adequate immune response may not be elicited in these individuals. The 
administration of Shingrix to immunocompromised subjects should be based on careful consideration 
of potential benefits and risks. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine,  
23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheria-tetanus-
acellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites. 
 
In three phase III, controlled, open-label clinical studies, adults ≥ 50 years of age were randomised to 
receive 2 doses of Shingrix 2 months apart administered either concomitantly at the first dose or non-
concomitantly with an unadjuvanted inactivated seasonal influenza vaccine (N=828; Zoster-004), a 
PPV23 vaccine (N=865; Zoster-035) or a dTpa vaccine formulated with 0.3 milligrams Al3+ (N=830; 
Zoster-042). The immune responses of the co-administered vaccines were unaffected, with the 
exception of lower geometric mean concentrations (GMCs) for one of the pertussis antigens 
(pertactin) when Shingrix is co-administered with the dTpa vaccine. The clinical relevance of this data 
is not known.  
 
The adverse reactions of fever and shivering were more frequent when PPV23 vaccine is co-
administered with Shingrix. 
 
Concomitant use with other vaccines is not recommended due to lack of data. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct 
or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or 
post-natal development (see section 5.3). 
 
As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy. 
 
Breast-feeding 
 
The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. 
It is unknown whether Shingrix is excreted in human milk. 
 
Fertility 
 
Animal studies do not indicate direct or indirect effects with respect to fertility in males or females 
(see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects of Shingrix on the ability to drive and use machines have been performed. 



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Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days 
following vaccination. Fatigue and malaise may occur following administration (see section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 
3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose; 
3.0% severe/dose) and headache (26.3% overall/dose; 1.9% severe/dose). Most of these reactions were 
not long-lasting (median duration of 2 to 3 days). Reactions reported as severe lasted 1 to 2 days. 
 
The incidence of adverse reactions was higher in subjects aged 50-69 years compared to those aged 
≥70 years, especially for general adverse reactions such as myalgia, fatigue, headache, shivering, fever 
and gastrointestinal symptoms. 
 
Tabulated list of adverse reactions  
 
The safety profile presented below is based on a pooled analysis of data generated in placebo-
controlled clinical studies on 5,887 adults 50-69 years of age and 8,758 adults ≥ 70 years of age. 
Adverse reactions reported during post-marketing surveillance are also tabulated below. 
 
Adverse reactions reported are listed according to the following frequency: 
 
Very common   (≥1/10) 
Common  (≥1/100 to <1/10) 
Uncommon   (≥1/1,000 to <1/100) 
Rare   (≥1/10,000 to <1/1,000) 
Very rare  (<1/10,000) 
 

System Organ Class Frequency Adverse reactions 

Blood and lymphatic system 
disorders 

Uncommon lymphadenopathy 

Immune system disorders Rare hypersensitivity reactions including 
rash, urticaria, angioedema1 

Nervous system disorders Very common headache 

Gastrointestinal disorders Very common gastrointestinal symptoms (including 
nausea, vomiting, diarrhoea and/or 
abdominal pain) 

Musculoskeletal and connective 
tissue disorders 

Very common myalgia 

Uncommon arthralgia 

General disorders and administration 
site conditions 

Very common injection site reactions (such as pain, 
redness, swelling), fatigue, chills, fever 

Common injection site pruritus, malaise 
1Adverse reactions from spontaneous reporting 
 
Reporting of suspected adverse reactions   



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Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties   
 
Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03. 
 
Mechanism of action 
 
By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed 
to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing 
immunity against VZV. 
 
Non-clinical data show that AS01B induces a local and transient activation of the innate immune 
system through specific molecular pathways. This facilitates the recruitment and activation of antigen 
presenting cells carrying gE-derived antigens in the draining lymph node, which in turn leads to the 
generation of gE-specific CD4+ T cells and antibodies. The adjuvant effect of AS01B is the result of 
interactions between MPL and QS-21 formulated in liposomes. 
 
Efficacy of Shingrix 
 
Efficacy against Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) 
 
In two phase III, placebo-controlled, observer-blind efficacy studies of Shingrix: 
- ZOE-50 (Zoster-006): 15,405 adults ≥ 50 years were randomised to receive two doses of either 

Shingrix (N=7,695) or placebo (N=7,710) administered 2 months apart, 
- ZOE-70 (Zoster-022): 13,900 adults ≥ 70 years were randomised to receive two doses of either 

Shingrix (N=6,950) or placebo (N=6,950) administered 2 months apart. 
The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including 
those with multiple comorbidities, although these subjects were not excluded from the studies. 
 
Efficacy results against HZ and PHN observed in the modified Total Vaccinated Cohort (mTVC), i.e. 
excluding adults who did not receive the second dose of vaccine or who had a confirmed diagnosis of 
HZ within one month after the second dose, are presented in Table 1 and Table 2, respectively. 
 
Shingrix significantly decreased the incidence of HZ compared with placebo in subjects ≥ 50 years (6 
vs. 210 cases in ZOE-50) and in subjects ≥ 70 years (25 vs. 284 cases in the pooled analysis of ZOE-
50 and ZOE-70). 
 
Table 1: Shingrix efficacy against HZ  
 

Age 
(years) 

Shingrix Placebo 
Vaccine efficacy 

(%) 
[95% CI] 

Number 
of 

evaluable
subjects 

Number 
of HZ 
cases 

Incidence 
rate per 

1000 
person 
years 

Number 
of 

evaluable 
subjects 

Number 
of HZ 
cases 

Incidence 
rate per 

1000 
person 
years 



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ZOE-50* 

≥ 50 7,344 6 0.3 7,415 210 9.1 97.2 [93.7; 99.0] 
 50-59 3,492 3 0.3 3,525 87 7.8 96.6 [89.6; 99.4] 
≥ 60 3,852 3 0.2 3,890 123 10.2 97.6 [92.7; 99.6] 
 60-69 2,141 2 0.3 2,166 75 10.8 97.4 [90.1; 99.7] 

Pooled ZOE-50 and ZOE-70** 

≥ 70 8,250 25 0.8 8,346 284 9.3 91.3 [86.8; 94.5] 
 70-79 6,468 19 0.8 6,554 216 8.9 91.3 [86.0; 94.9] 
≥ 80 1,782 6 1.0 1,792 68 11.1 91.4 [80.2; 97.0] 
CI  Confidence interval 
* Over a median follow-up period of 3.1 years 
** Over a median follow-up period of 4.0 years 

Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE-
70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group. 

 
Approximately 13,000 subjects with underlying medical conditions, including conditions associated 
with a higher risk of HZ, were enrolled in ZOE-50 and ZOE-70. Post-hoc analysis of efficacy against 
confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic 
obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that 
the vaccine efficacy is aligned with the overall HZ efficacy. 
 
Shingrix significantly decreased the incidence of PHN compared with placebo in adults ≥ 50 years (0 
vs. 18 cases in ZOE-50) and in adults ≥ 70 years (4 vs. 36 cases in the pooled analysis of ZOE-50 and 
ZOE-70). 
 
Table 2: Shingrix efficacy against PHN 
 

Age 
(years) 

Shingrix Placebo 
Vaccine efficacy 

(%) 
[95% CI] 

Number 
of 

evaluable 
subjects 

Number 
of PHN* 
cases 

Incidence 
rate per 

1000 
person 
years 

Number 
of 

evaluable 
subjects 

Number 
of PHN 
cases 

Incidence 
rate per 

1000 
person 
years 

ZOE-50** 

≥ 50 7,340 0 0.0 7,413 18 0.6 100 [77.1; 100] 
 50-59 3,491 0 0.0 3,523 8 0.6 100 [40.8; 100] 
≥ 60 3,849 0 0.0 3,890 10 0.7 100 [55.2; 100] 
 60-69 2,140 0 0.0 2,166 2 0.2 100

§ 

[< 0; 100] 
Pooled ZOE-50 and ZOE-70*** 

≥ 70 8,250 4 0.1 8,346 36 1.2 88.8 [68.7; 97.1] 
 70-79 6,468 2 0.1 6,554 29 1.2 93.0 [72.4; 99.2] 
≥ 80 1,782 2 0.3 1,792 7 1.1 71.2§ 



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[< 0; 97.1] 
* PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or 

appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI) 
CI Confidence interval 
** Over a median follow-up period of 4.1 years 
*** Over a median follow-up period of 4.0 years 

Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and 
ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age 
group. 

§ Not statistically significant 
 
The benefit of Shingrix in the prevention of PHN can be attributed to the effect of the vaccine on the 
prevention of HZ. A further reduction of PHN incidence in subjects with confirmed HZ could not be 
demonstrated due to the limited number of HZ cases in the vaccine group. 
 
In the fourth year after vaccination, the efficacy against HZ was 93.1 % (95% CI: 81.2; 98.2) and 
87.9% (95% CI: 73.3; 95.4) in adults ≥ 50 years and adults ≥ 70 years, respectively. 
The duration of protection beyond 4 years is currently under investigation. 
 
Efficacy against HZ-related complications other than PHN 
 
The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic 
disease, neurologic disease, visceral disease, and stroke. In the pooled analysis of ZOE-50 and ZOE-
70, Shingrix significantly reduced these HZ-related complications by 93.7% (95% CI: 59.5; 99.9) and 
91.6% (95% CI: 43.3; 99.8) in adults ≥ 50 years (1 vs. 16 cases) and adults ≥ 70 years (1 vs. 12 cases), 
respectively. No cases of visceral disease or stroke were reported during these studies. 
 
Effect of Shingrix on HZ-related pain 
 
Overall there was a general trend towards less severe HZ-related pain in subjects vaccinated with 
Shingrix compared to placebo. As a consequence of the high vaccine efficacy against HZ, a low 
number of breakthrough cases were accrued, and it was therefore not possible to draw firm 
conclusions on these study objectives. 
 
In subjects ≥ 70 years with at least one confirmed HZ episode (ZOE-50 and ZOE-70 pooled), Shingrix 
significantly reduced the use and the duration of HZ-related pain medication by 39.0% (95% CI: 11.9; 
63.3) and 50.6% (95% CI: 8.8; 73.2), respectively. The median duration of pain medication use was 
32.0 and 44.0 days in the Shingrix and placebo group, respectively. 
 
In subjects with at least one confirmed HZ episode, Shingrix significantly reduced the maximum 
average pain score versus placebo over the entire HZ episode (mean = 3.9 vs. 5.5, P-value = 0.049 and 
mean = 4.5 vs. 5.6, P-value = 0.043, in subjects ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-50 and 
ZOE-70 pooled), respectively). In addition, in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled), 
Shingrix significantly reduced the maximum worst pain score versus placebo over the entire HZ 
episode (mean = 5.7 vs. 7.0, P-value = 0.032). 
 
The burden-of-illness (BOI) score incorporates the incidence of HZ with the severity and duration of 
acute and chronic HZ-related pain over a 6 month period following rash onset. 
The efficacy in reducing BOI was 98.4% (95% CI: 92.2; 100) in subjects ≥ 50 years (ZOE-50) and 
92.1% (95% CI: 90.4; 93.8) in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled). 
 
Immunogenicity of Shingrix 
 
An immunological correlate of protection has not been established; therefore the level of immune 
response that provides protection against HZ is unknown. 
 
The immune responses to Shingrix were evaluated in a subset of subjects from the phase III efficacy 
studies ZOE-50 [humoral immunity and cell-mediated immunity (CMI)] and ZOE-70 (humoral 



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immunity). Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month 
post-dose 2 when compared to pre-vaccination levels. 
 
The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively. 
 
Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity) 
 

Anti-gE immune response^ 

Age 
group 
(years) 

Month 3* Month 38** 

N GMC (mIU/ml) (95% CI) 

Median fold 
increase of 

concentrations 
vs. pre-

vaccination  
(Q1; Q3) 

N GMC (mIU/ml) (95% CI) 

Median fold 
increase of 

concentrations 
vs. pre-

vaccination 
(Q1; Q3) 

ZOE-50 

≥ 50 1,070 52,376.6 (50,264.1; 54,577.9) 
41.9 

(20.8; 86.9) 967 
11,919.6 

(11,345.6; 12,522.7) 
9.3 

(4.9; 19.5) 
Pooled ZOE-50 and ZOE-70 

≥ 70 742 49,691.5 (47,250.8; 52,258.2) 
34.3 

(16.7; 68.5) 648 
10,507.7 

(9,899.2; 11,153.6) 
7.2 

(3.5; 14.5) 
ATP  According-To-Protocol 
^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent 

assay (gE ELISA) 
* Month 3   = 1 month post-dose 2 
** Month 38 = 3 years post-dose 2 
N Number of evaluable subjects at the specified time point (for the GMC) 
CI Confidence interval 
GMC Geometric Mean Concentration 
Q1; Q3 First and third quartiles 
 
Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for
 immunogenicity) 
 

gE-specific CD4[2+] T cell response^ 

Age 
group 
(years) 

Month 3* Month 38** 

N 
Median 

frequency 
(Q1; Q3) 

 

Median fold 
increase of 

frequency vs. pre-
vaccination 

(Q1; Q3) 

N 
Median 

frequency 
(Q1; Q3) 

Median fold 
increase of 

frequency vs.  
pre-vaccination 

(Q1; Q3) 
ZOE-50 

≥ 50 164 1,844.1 (1,253.6; 2,932.3) 
24.6 

(9.9; 744.2) 152 
738.9 

(355.7; 1,206.5) 
7.9 

(2.7; 31.6) 

≥ 70*** 52 1,494.6 (922.9; 2,067.1) 
33.2 

(10.0; 1,052.0) 46 
480.2 

(196.1; 972.4) 
7.3 

(1.7; 31.6) 
ATP  According-To-Protocol 
^ gE-specific CD4[2+] T cell response = gE-specific CD4+ T cell activity, measured by intracellular 

cytokine staining (ICS) assay  (CD4[2+] T cells = CD4+ T cells expressing at least 2 of 4 selected 
immune markers) 

* Month 3   = 1 month post-dose 2 
** Month 38 = 3 years post-dose 2 
N  Number of evaluable subjects at the specified time point 
Q1; Q3 First and third quartiles 
*** The gE-specific CD4[2+] data in the ≥70 years of age group were generated in ZOE-50 because CD4+ T 

cell activity was not assessed in ZOE-70 



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Data from a phase II, open-label, single group, follow-up clinical study in adults ≥ 60 years (Zoster-
024) indicate that the vaccine-induced immune response (humoral and CMI) persists up to 
approximately 6 years following a 0, 2-month schedule (N= 119). The median anti-gE antibody 
concentration was greater than 7-fold above the baseline pre-vaccination median concentration. The 
median frequency of gE-specific CD4[2+] T cells was greater than 3.7-fold above baseline pre-
vaccination median frequency. 
 
Immunogenicity in subjects receiving 2 doses of Shingrix 6 months apart 
 
Efficacy has not been assessed for the 0, 6-month schedule. 
In a phase III, open-label clinical study (Zoster-026) where 238 adults ≥ 50 years of age were equally 
randomised to receive 2 doses of Shingrix 2 or 6 months apart, the humoral immune response 
following the 0, 6-month schedule was demonstrated to be non-inferior to the response with the 0, 2-
month schedule. The anti-gE GMC at 1 month after the last vaccine dose was 38,153.7 mIU/ml (95% 
CI: 34,205.8; 42,557.3) and 44,376.3 mIU/ml (95% CI: 39,697.0; 49,607.2) following the 0, 6-month 
schedule and the 0, 2-month schedule, respectively. 
 
Subjects with a history of HZ prior to vaccination 
 
Subjects with a history of HZ were excluded from ZOE-50 and ZOE-70. In a phase III, uncontrolled, 
open-label clinical study (Zoster-033), 96 adults ≥ 50 years of age with a physician-documented 
history of HZ received 2 doses of Shingrix 2 months apart. Laboratory confirmation of HZ cases was 
not part of the study procedures. The anti-gE GMC at 1 month after the last vaccine dose was 47,758.7 
mIU/ml (95% CI: 42,258.8; 53,974.4). 
There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period. This is a higher 
recurrence rate than generally reported in observational studies in unvaccinated individuals with a 
history of HZ. (See section 4.4) 
 
Immunocompromised subjects 
 
Two phase I/II clinical studies, Zoster-001 and Zoster-015, were conducted in subjects with 
autologous hematopoietic stem cell transplant or HIV infection. A total of 135 adults, of whom 73 
were ≥50 years of age, received at least one dose of Shingrix, which was shown to be immunogenic 
and well-tolerated. 
 
Immunogenicity in individuals previously vaccinated with live attenuated herpes zoster (HZ) vaccine 
 
In a phase III, open-label, multicentre clinical study (Zoster-048), a 2 dose schedule of Shingrix 2 
months apart was assessed in 215 adults ≥ 65 years of age with a previous history of vaccination with 
live attenuated HZ vaccine ≥ 5 years earlier compared to 215 matched subjects who had never 
received live attenuated HZ vaccine. The immune response to Shingrix was unaffected by prior 
vaccination with live attenuated HZ vaccine. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Shingrix in one or more subsets of the paediatric population in prevention of Varicella Zoster Virus 
reactivation (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 



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Non-clinical data reveal no special hazard for humans based on conventional studies of acute and 
repeated dose toxicity, local tolerance, cardiovascular/respiratory safety pharmacology and toxicity to 
reproduction and development. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients   
 
Powder (gE antigen): 
Sucrose 
Polysorbate 80 
Sodium dihydrogen phosphate dihydrate 
Dipotassium phosphate 
 
Suspension (AS01B Adjuvant System): 
Dioleoyl phosphatidylcholine 
Cholesterol 
Sodium chloride 
Disodium phosphate anhydrous 
Potassium dihydrogen phosphate 
Water for injections 
 
For adjuvant see also section 2. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products.   
 
6.3 Shelf life 
 
3 years 
 
After reconstitution: 
 
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. 
 
From a microbiological point of view, the vaccine should be used immediately. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would normally not be longer than 6 hours at 2°C to 8°C. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
• Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)  
• Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber). 
 
Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 
vials of powder plus 10 vials of suspension. 
 



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Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal and other handling 
 
Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial 
with a blue-green flip-off cap containing the suspension (adjuvant). 
The powder and the suspension must be reconstituted prior to administration. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The powder and suspension should be inspected visually for any foreign particulate matter and/or 
variation of appearance. If either is observed, do not reconstitute the vaccine. 
 
How to prepare Shingrix: 
 
Shingrix must be reconstituted prior to administration. 
 
1. Withdraw the entire contents of the vial containing the suspension into the syringe. 
2. Add the entire contents of the syringe into the vial containing the powder. 
3. Shake gently until the powder is completely dissolved. 
 
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid. 
 
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of appearance. If either is observed, do not administer the vaccine. 
 
After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be 
stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded. 
 
Before administration: 
 
1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe. 
2. Change the needle so that you are using a new needle to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER   
 
GlaxoSmithKline Biologicals S.A. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 

Antigen 
Powder 

Adjuvant 
Suspension 

1 dose (0.5 ml) 



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8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1272/001 
EU/1/18/1272/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 March 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCES AND MANUFACTURER RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SYPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS FOR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 

 



15 

 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer of the biological active substance 

GlaxoSmithKline Biologicals SA 
Parc de la Noire Epine 
20, Avenue Fleming  
1300 Wavre 
BELGIUM 
 
Name and address of the manufacturer responsible for batch release 

GlaxoSmithKline Biologicals SA 
Rue de l’Institut, 89  
1330 Rixensart 
BELGIUM 
 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
• Official batch release 

 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose. 
 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
• Periodic safety update reports 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 
months following authorisation. 
 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 



16 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
1 VIAL AND 1 VIAL 
10 VIALS AND 10 VIALS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Shingrix powder and suspension for suspension for injection 
Herpes zoster vaccine (recombinant, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus 
glycoprotein E adjuvanted with AS01B  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients:  
sucrose 
polysorbate 80 
sodium dihydrogen phosphate dihydrate 
dipotassium phosphate  
dioleoyl phosphatidylcholine 
cholesterol 
sodium chloride 
disodium phosphate anhydrous 
potassium dihydrogen phosphate 
water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and suspension for suspension for injection 
1 vial: powder (antigen) 
1 vial: suspension (adjuvant) 
 
10 vials: powder (antigen) 
10 vials: suspension (adjuvant) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 



20 

1 dose (0.5 ml) 

 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Powder and suspension to be reconstituted before administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1272/001 – 1 vial and 1 vial 
EU/1/18/1272/002 – 10 vials and 10 vials 
 
 
13. BATCH NUMBER 
 
LOT 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

Antigen Adjuvant 



21 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



22 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Antigen for Shingrix 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
Mix with adjuvant 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
LOT 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose 
 
 
6. OTHER 
 
 



23 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH SUSPENSION  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Adjuvant for Shingrix 
 
 
2. METHOD OF ADMINISTRATION 
 
Mix with antigen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
LOT 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (0.5 ml) 
 
 
6. OTHER 
 
 
 



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 



25 

 
Package leaflet: Information for the user 

 
Shingrix powder and suspension for suspension for injection 

Herpes zoster vaccine (recombinant, adjuvanted) 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.  
 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
 effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
1. What Shingrix is and what it is used for  
2. What you need to know before you receive Shingrix  
3. How Shingrix is given 
4. Possible side effects  
5. How to store Shingrix  
6. Contents of the pack and other information 
 
 
1. What Shingrix is and what it is used for 
 
What Shingrix is used for 
Shingrix is a vaccine that helps to protect adults against shingles (herpes zoster) and post-herpetic 
neuralgia (PHN), the long-lasting nerve pain that follows shingles. 
 
Shingrix is given to adults 50 years and above. 
 
Shingrix cannot be used to prevent chickenpox (varicella). 
 
What shingles is 
• Shingles is a rash with blisters that is often painful. It usually occurs in one part of the body and 

can last for several weeks. 
• Shingles is caused by the same virus that causes chickenpox.  
• After you have had chickenpox, the virus that caused it stays in your body in nerve cells. 
• Sometimes, after many years, if your immune system (the body’s natural defences) becomes 

weaker (due to age, an illness or a medicine you are taking), the virus can cause shingles. 
 
Complications related to shingles 
Shingles may lead to complications.  
The most common complication of shingles is: 
• long-lasting nerve pain – called post-herpetic neuralgia or PHN. After the shingles blisters heal, 

you may get pain which can last for months or years and may be severe. 
Other complications of shingles are: 
• scars where the blisters have been. 
• skin infections, weakness, muscle paralysis and loss of hearing or vision – these are less 

common. 
 



26 

How Shingrix works 
Shingrix reminds your body about the virus that causes shingles. This helps your immune system (the 
body’s natural defences) stay prepared to fight the virus and protect you against shingles and its 
complications. 
 
 
2. What you need to know before you receive Shingrix  
 
You should not receive Shingrix if 
• you are allergic (hypersensitive) to the active substances or any of the other ingredients of this 

vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of 
breath and swelling of the face or tongue. 

You should not receive Shingrix if any of the above apply to you. If you are not sure, talk to your 
doctor or pharmacist. 
 
Warnings and precautions 
Talk to your doctor or pharmacist before you receive Shingrix if: 
• you have a severe infection with a high temperature (fever). In these cases, the vaccination may 

have to be postponed until you have recovered. A minor infection such as a cold should not be a 
problem, but talk to your doctor first; 

• you have a bleeding problem or bruise easily. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you 
receive Shingrix. 
 
Fainting can occur before or after any needle injection. Therefore tell the doctor or nurse if you fainted 
with a previous injection. 
 
Shingrix cannot be used as a treatment if you already have shingles or shingles-related complications. 
 
As with all vaccines, Shingrix may not fully protect all people who are vaccinated. 
 
Other medicines and Shingrix 
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other 
medicines, including medicines obtained without a prescription, or have recently received any other 
vaccine. 
 
Shingrix can be given at the same time as other vaccines. A different injection site will be used for 
each vaccine. 
 
You may be more likely to experience fever and/or shivering when 23-valent pneumococcal 
polysaccharide vaccine is given at the same time as Shingrix.  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before you are given this vaccine. 
 
Driving and using machines 
It is not known if Shingrix affects your ability to drive or use machines. However, do not drive or use 
machines if you are feeling unwell. 
 
Shingrix contains sodium and potassium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’.  
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-
free’. 
 
 



27 

3. How Shingrix is given 
 
• Shingrix is given as an injection into a muscle (usually in the upper arm). 
• You will receive 2 injections with an interval of 2 months. If flexibility in the vaccination 

schedule is necessary, the second dose can be administered between 2 and 6 months after the 
first dose. The first injection can be given from the age of 50 years onwards. 

• You will be informed when you should come back for the second dose of Shingrix. 
 
Make sure you finish the complete vaccination course. This will maximise the protection offered by 
Shingrix. 
 
Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster 
vaccine. Speak to your doctor for more information. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
Side effects reported during clinical trials with Shingrix: 
 
Very common (these may occur with more than 1 in 10 doses of the vaccine): 

• headache 
• stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain) 
• muscle pain (myalgia) 
• pain, redness and swelling where the injection is given  
• feeling tired, chills, fever 

 
Common (these may occur with up to 1 in 10 doses of the vaccine): 

• itching where the injection is given (pruritus)  
• generally feeling unwell 

 
Uncommon (these may occur with up to 1 in 100 doses of vaccine) 

• swollen glands in the neck, armpit or groin 
• joint pain 

 
Most of these side effects are mild to moderate in intensity and are not long-lasting. 
 
Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years. 
 
Side effects reported after the marketing of Shingrix: 
 
Rare (these may occur with up to 1 in 1,000 doses of the vaccine) 

• allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which 
may cause difficulty in swallowing or breathing (angioedema) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Shingrix 
 
• Keep this medicine out of the sight and reach of children. 



28 

• Do not use this medicine after the expiry date which is stated on the label and carton. The expiry 
date refers to the last day of that month. 

• Store in a refrigerator (2°C – 8°C). 
• Do not freeze. 
• Store in the original package in order to protect from light. 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 

how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Shingrix contains  
 
• The active substances are:  

 
 After reconstitution, one dose (0.5 ml) contains: 
 Varicella Zoster Virus1 glycoprotein E antigen2    50 micrograms 
 
 1 Varicella Zoster Virus = VZV  
 2 adjuvanted with AS01B containing: 
 plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 
  3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota  
          50 micrograms 

 
The glycoprotein E is a protein present in the Varicella Zoster Virus. This protein is not 
infectious. 
 
The adjuvant (AS01B) is used to improve the body’s response to the vaccine. 

 
• The other ingredients are: 
 

o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium 
phosphate. 

o Suspension: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate 
anhydrous, potassium dihydrogen phosphate and water for injections. 

 
What Shingrix looks like and contents of the pack 
 
• Powder and suspension for suspension for injection. 
• The powder is white. 
• The suspension is an opalescent, colourless to pale brownish liquid. 
 
One pack of Shingrix consists of:  
• Powder for 1 dose in a vial 
• Suspension for 1 dose in a vial 
 
Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 
vials of powder plus 10 vials of suspension. 
 
Not all pack sizes may be marketed 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 



29 

B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: +370 5 264 90 00 
info.lt@gsk.com 

 
България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 
 

 
Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)33 2081100 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 

Ελλάδα 
GlaxoSmithKline Μονοπρόσωπη A.E.B.E 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
GlaxoSmithKline - Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 

Slovenija 
GlaxoSmithKline d.o.o. 



30 

Tel: + 353 (0)1 495 5000 
 

Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 
 

Ísland 
Vistor hf.  
Sími: +354 535 7000  
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel.: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 

 
Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 
 

 
Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: +44 (0)800 221 441 
customercontactuk@gsk.com  
 

  
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website  
 
------------------------------------------------------------------------------------------------------------------------ 
 
The following information is intended for healthcare professionals only: 
 
Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial 
with a blue-green flip-off cap containing the suspension (adjuvant). 
The powder and the suspension must be reconstituted prior to administration. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Antigen 
Powder 

Adjuvant 
Suspension 

1 dose (0.5 ml) 



31 

The powder and suspension should be inspected visually for any foreign particulate matter and/or 
variation of appearance. If either is observed, do not reconstitute the vaccine. 
 
How to prepare Shingrix: 
 
Shingrix must be reconstituted prior to administration. 
 
1. Withdraw the entire contents of the vial containing the suspension into the syringe. 
2. Add the entire contents of the syringe into the vial containing the powder. 
3. Shake gently until the powder is completely dissolved. 
 
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid. 
 
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of appearance. If either is observed, do not administer the vaccine. 
 
After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be 
stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded. 
 
Before administration: 
 
1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe. 
2. Change the needle so that you are using a new needle to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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called post-herpetic neuralgia or phn. after the shingles blisters heal, you may get pain which can last for months or years and may be severe. other complications of shingles are: scars where the blisters have been. skin infections, weakness, muscle paralysis and loss of hearing or vision these are less common. how shingrix works shingrix reminds your body about the virus that causes shingles. this helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications.", 'Entity_Recognition': [{'Text': 'shingrix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'a vaccine', 'Type': 'TREATMENT', 'BeginOffset': 38, 'EndOffset': 47}, {'Text': 'shingles (herpes zoster', 'Type': 'PROBLEM', 'BeginOffset': 85, 'EndOffset': 108}, {'Text': 'post-herpetic neuralgia (phn)', 'Type': 'PROBLEM', 'BeginOffset': 114, 'EndOffset': 143}, {'Text': 'the long-lasting nerve pain', 'Type': 'PROBLEM', 'BeginOffset': 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{'Title': '2. what you need to know before you receive shingrix', 'Section_Content': "you should not receive shingrix if you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6). signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. you should not receive shingrix if any of the above apply to you. if you are not sure, talk to your doctor or pharmacist. warnings and precautions talk to your doctor or pharmacist before you receive shingrix if: you have a severe infection with a high temperature (fever). in these cases, the vaccination may have to be postponed until you have recovered. a minor infection such as a cold should not be a problem, but talk to your doctor first; you have a bleeding problem or bruise easily. if any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive shingrix. fainting can occur before or after any needle injection. therefore tell the doctor or nurse if you fainted with a previous injection. shingrix cannot be used as a treatment if you already have shingles or shingles-related complications. as with all vaccines, shingrix may not fully protect all people who are vaccinated. other medicines and shingrix tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine. shingrix can be given at the same time as other vaccines. a different injection site will be used for each vaccine. you may be more likely to experience fever and/or shivering when 23-valent pneumococcal polysaccharide vaccine is given at the same time as shingrix. pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine. driving and using machines it is not known if shingrix affects your ability to drive or use machines. however, do not drive or use machines if you are feeling unwell. shingrix contains sodium and potassium this medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium- free'. this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium- free'.", 'Entity_Recognition': [{'Text': 'shingrix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 23, 'EndOffset': 31, 'Score': 0.46849730610847473, 'Text': 'shingrix', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.43399253487586975}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 43, 'EndOffset': 51}, {'Id': 11, 'BeginOffset': 53, 'EndOffset': 67, 'Score': 0.7651059627532959, 'Text': 'hypersensitive', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Text': 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{'Title': '3. how shingrix is given', 'Section_Content': ' shingrix is given as an injection into a muscle (usually in the upper arm). you will receive 2 injections with an interval of 2 months. if flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose. the first injection can be given from the age of 50 years onwards. you will be informed when you should come back for the second dose of shingrix. make sure you finish the complete vaccination course. this will maximise the protection offered by shingrix. shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine. speak to your doctor for more information.', 'Entity_Recognition': [{'Text': 'shingrix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 1, 'EndOffset': 9, 'Score': 0.5210036039352417, 'Text': 'shingrix', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.33580082654953003, 'RelationshipScore': 0.9999903440475464, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 4, 'BeginOffset': 25, 'EndOffset': 34, 'Text': 'injection', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 8, 'BeginOffset': 25, 'EndOffset': 34, 'Score': 0.3039190173149109, 'Text': 'injection', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Id': 0, 'BeginOffset': 42, 'EndOffset': 48, 'Score': 0.8562717437744141, 'Text': 'muscle', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 2, 'BeginOffset': 71, 'EndOffset': 74, 'Score': 0.9439243078231812, 'Text': 'arm', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': '2 injections', 'Type': 'TREATMENT', 'BeginOffset': 94, 'EndOffset': 106}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 127, 'EndOffset': 128}, {'Text': 'the vaccination schedule', 'Type': 'TREATMENT', 'BeginOffset': 155, 'EndOffset': 179}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 238, 'EndOffset': 239}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 244, 'EndOffset': 245}, {'Text': 'the first injection', 'Type': 'TREATMENT', 'BeginOffset': 275, 'EndOffset': 294}, {'Id': 7, 'BeginOffset': 324, 'EndOffset': 326, 'Score': 0.999758780002594, 'Text': '50', 'Category': 'PROTECTED_HEALTH_INFORMATION', 'Type': 'AGE', 'Traits': []}, {'Id': 5, 'BeginOffset': 412, 'EndOffset': 420, 'Score': 0.40460142493247986, 'Text': 'shingrix', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the complete vaccination course', 'Type': 'TREATMENT', 'BeginOffset': 443, 'EndOffset': 474}, {'Text': 'a live attenuated herpes zoster vaccine', 'Type': 'TREATMENT', 'BeginOffset': 594, 'EndOffset': 633}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this vaccine can cause side effects, although not everybody gets them. side effects reported during clinical trials with shingrix: very common (these may occur with more than 1 in 10 doses of the vaccine): headache stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain) muscle pain (myalgia) pain, redness and swelling where the injection is given feeling tired, chills, fever common (these may occur with up to 1 in 10 doses of the vaccine): itching where the injection is given (pruritus) generally feeling unwell uncommon (these may occur with up to 1 in 100 doses of vaccine) swollen glands in the neck, armpit or groin joint pain most of these side effects are mild to moderate in intensity and are not long-lasting. adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years. side effects reported after the marketing of shingrix: rare (these may occur with up to 1 in 1,000 doses of the vaccine) allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'shingrix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 32}, {'Id': 12, 'BeginOffset': 43, 'EndOffset': 55, 'Score': 0.9676685929298401, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': 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{'Title': '5. how to store shingrix', 'Section_Content': ' keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the label and carton. the expiry date refers to the last day of that month. store in a refrigerator (2 8). do not freeze. store in the original package in order to protect from light. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what shingrix contains the active substances are: after reconstitution, one dose (0.5 ml) contains: varicella zoster virus1 glycoprotein e antigen2 50 micrograms 1 varicella zoster virus = vzv 2 adjuvanted with as01b containing: plant extract quillaja saponaria molina, fraction 21 (qs-21) 50 micrograms 3-o-desacyl-4'-monophosphoryl lipid a (mpl) from salmonella minnesota 50 micrograms the glycoprotein e is a protein present in the varicella zoster virus. this protein is not infectious. the adjuvant (as01b) is used to improve the body's response to the vaccine. the other ingredients are: o powder: sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate. o suspension: dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate and water for injections. what shingrix looks like and contents of the pack powder and suspension for suspension for injection. the powder is white. the suspension is an opalescent, colourless to pale brownish liquid. one pack of shingrix consists of: powder for 1 dose in a vial suspension for 1 dose in a vial shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension. not all pack sizes may be marketed", 'Entity_Recognition': [{'Text': 'shingrix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 1, 'BeginOffset': 100, 'EndOffset': 147, 'Score': 0.9761801362037659, 'Text': 'varicella zoster virus1 glycoprotein e antigen2', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9403776526451111, 'RelationshipScore': 0.9999958276748657, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 148, 'EndOffset': 161, 'Text': '50 micrograms', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '50', 'Type': 'NUMBER', 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