Episalvan
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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 
 
Episalvan gel  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula 
pendula Roth, Betula pubescens Ehrh. as well as hybrids of both species (equivalent to 
0.5-1.0 g birch bark), corresponding to 72-88 mg betulin. 
 
Extraction solvent: n-Heptane 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Gel. 
Colourless to slightly yellowish, opalescent. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of partial thickness wounds in adults. See section 4.4 and 5.1 with respect to 
type of wounds studied. 
 
4.2 Posology and method of administration 
 
Posology 
The gel should be applied to the wound surface at a thickness of approximately 1 mm 
and covered by sterile wound dressing. The gel should be re-applied at each wound 
dressing change, until the wound is healed, for up to 4 weeks. See section 4.4 with 
respect to wound size and duration of treatment. 
 
Special populations 
 
Renal or hepatic impairment 
 
No formal studies have been conducted with Episalvan in patients with renal or hepatic 
impairment. No dose adjustment or special considerations are anticipated for patients 
with renal or hepatic impairment, see section 5.2. 
 
Elderly 
 
No dose adjustment is required. 
 



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Paediatric population 
 
The safety and efficacy of Episalvan in children and adolescents under 18 years have 
not yet been established. No data are available.  
 
Method of administration 
For cutaneous application.  
Fresh wounds should achieve haemostasis prior to application of Episalvan. If 
necessary, wounds (accidental wounds) should be cleaned according to standard 
procedure, using e.g. wound antiseptic solution, prior to application of Episalvan. 
 
Episalvan is for single use only. Once opened, the product should be used immediately 
and be discarded after use. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to the excipient listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Wound infection 
Episalvan gel is sterile. However, wound infection is an important and serious 
complication that can occur during wound healing. In the case of infection, it is 
recommended to discontinue treatment with Episalvan. Additional standard treatment 
may be required (see section 4.5).  
 
Wound size 
The mean wound size treated with Episalvan in clinical studies in split-thickness skin 
graft donor site wounds was 40.7 cm² (range 8-300 cm²). In the Grade 2a burn wound 
study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).  
 
Duration of use 
There is no information available on clinical use of Episalvan for more than 4 weeks. 
 
Partial thickness burn wounds 
Repeated critical assessment of burn depth and healing progression is needed. Wounds 
that are assessed as unable to heal within an acceptable time frame may need surgical 
measures (e.g., split-thickness skin grafting) to reduce the risk of hypertrophic scarring. 
 
Other wound types 
There is no clinical experience from use of Episalvan for the treatment of chronic 
wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with 
epidermolysis bullosa. 
 
Birch pollen allergy 
Episalvan is safe to use for people who are allergic to birch pollen, as these allergens are 
not present in Episalvan. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. Since the systemic exposure of Episalvan 
following cutaneous application is negligible no interaction with systemic treatments is 
expected. Interactions with topical products have not been investigated in clinical trials. 
Other topical products should not be concomitantly used together with Episalvan but 
rather sequentially or alternatively depending on the clinical need. 
 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
No studies in pregnant women have been conducted.  
 
No effects during pregnancy are anticipated, since systemic exposure to Episalvan is 
negligible. Episalvan can be used during pregnancy. 
 
Breast-feeding 
No data are available to evaluate whether Episalvan is excreted into human milk.  
 
No effects on the breastfed newborn/infant are anticipated since the systemic exposure 
of the breast-feeding woman to Episalvan is negligible. Episalvan can be used during 
breast-feeding, unless the chest area is subject to treatment. 
 
Fertility 
Fertility studies have not been conducted. No effects on human fertility are anticipated, 
since the systemic exposure is negligible.  
 
4.7 Effects on ability to drive and use machines 
 
Episalvan has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently observed adverse reactions were wound complication (in 2.9% of 
patients), pain of skin (2.5%) and pruritus (1.3%). Adverse reactions were 
administration site reactions only. Wound complication adverse reactions such as 
wound infection and wound necrosis are complications of healing of partial thickness 
skin wounds and can be serious. See also section 4.4.  
 
Tabulated list of adverse reactions  
In the following table, adverse reactions are listed by MedDRA system organ class and 
preferred term. Within each frequency grouping, adverse reactions are presented in 
order of decreasing seriousness.  
 
The frequency of adverse reactions is defined as follows: 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), not known (cannot be estimated from the available 
data). 
 
Table 1: Adverse reactions reported in clinical trials 

System organ class Common 
 

Uncommon 
 

Infections and infestations  Wound infection 
Immune system disorders  Hypersensitivity 
Skin and subcutaneous tissue 
disorders 

Pain of skin Dermatitis 

 Pruritus Rash pruritic 
  Purpura 
General disorders and 
administration site conditions 

 Pain 

Injury, poisoning and procedural 
complications 

Wound 
complication* 

 

* Wound complication comprises different kinds of local complications such as post-procedural 
complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound. 



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In addition, there is one case report of contact dermatitis reported from a literature in a 
patient after prolonged use of a topical birch bark extract containing cosmetic product. 
 
Reporting of suspected adverse reactions 
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 
 
Overdosing with Episalvan is unlikely: in patients in which wound sizes >300 cm2 were 
repeatedly treated with Episalvan, no betulin plasma levels could be detected.  
 
No data have been generated to study the effect of accidental ingestion of Episalvan.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers; ATC code: 
D03AX13 . 
 
Mechanism of action and pharmacodynamic effects 
The active substance accelerated re-epithelialization in an in vitro wound scratch assay 
using human primary keratinocytes at the dosage of 1 μg/ml, and in a porcine ex vivo 
wound healing model at the dosage of 10 µg/ml. The precise mechanism of action of the 
active substance in wound healing in humans is not known. 

 
Clinical efficacy and safety 
Three Phase III studies were conducted to assess the efficacy and safety of Episalvan in 
the treatment of partial thickness wounds of the skin: two studies which investigated 
split-thickness skin graft donor site wounds, which included a total of 219 patients (ITT: 
N=217), and one further study in 61 patients with Grade 2a burn wounds (ITT: N=57). 
Patients with deeper burn wounds (Grade 2b) were not included. 
 
The 219 patients with split-thickness skin graft donor site wounds had a mean age of 
53 years; their donor site mean wound size was 81.5 cm2. In the burn wound study with 
61 patients, the mean study wound area was 216 cm2; the total burn injury of these 
patients was larger and affected 5.8% of the total body surface area. 
 
The Phase III studies were blindly evaluated, prospective, intra-individually controlled, 
randomised, multicentre trials. The target wound area of each patient was divided into 
two treatment areas of approximately the same size; the treatment allocation to the two 
halves of the wound (distal vs. proximal) was determined by randomization (in the burn 
trial, two similar wounds could be used). Episalvan plus wound dressing was applied to 
half of the wound area, and the same kind of non-adhesive wound dressing alone was 
applied to the other half as the control in the split-thickness skin graft donor site studies. 
In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and 
fatty gauze dressing were used as control. Application was at each wound dressing 
change every third to fourth day until full wound closure up to 28 days for the split-
thickness skin graft trials, and every other day up to 21 days for the Grade 2a burn trial. 
Photographs of the wound were taken at each visit for the blinded evaluation. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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The primary endpoint for the two split-thickness skin graft trials was the intra-individual 
difference in time to wound closure (at least 95% epithelialisation) based on blinded photo 
evaluations. Median time to wound healing was 14 days. Wound halves treated with 
Episalvan healed faster than the wound halves treated with standard of care (mean 1.1 
days according to primary endpoints, p<0.0001, two-sided paired t-test). 
 
Table 2: Overview of Efficacy Results: Intra-patient difference in time to wound 
closure 

Mean intra-patient difference in  
time to wound closure  
(95% epithelialisation) 

Split-thickness skin graft 
donor site wound studies 

(pooled) 

Grade 2a burn wound 
study 

N = 217 N=57 
Observer-blinded photo 
assessment (blinded read), mean 
expert evaluation 

  

primary blinded read /  
very conservative calculation 
(primary endpoint for STSG 
studies) 

-1.1 days (CI: -1.5, -0.7) 
faster wound closure with 
Episalvan, p<0.0001a 

-1.0 days (CI: -1.4, -0.6) 
faster wound closure 
with Episalvan, 
p<0.0001a 

Intention-to-treat (ITT) data set. 
‘Primary’ vs. ‘secondary’ blinded read: In the primary blinded read evaluation a rigorous quality check was 
implemented to assure blinding of the observers. In consequence a substantial number of photographs were 
excluded and not presented in the primary blinded read because of apparent gel residues. The secondary 
blinded read was conducted with all photographs presented to the blinded observers. 
’Very conservative calculation’ means that the first observation of wound closure was taken as time of 
wound closure. Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable’. If 
wound closure was not observed in a wound half photo series, it was calculated to have occurred one day 
after the last photograph in the series.  
‘Less conservative calculation’ differs from the ‘very conservative calculation’ in one aspect: If wound 
closure was not observed in a wound half photo series, it was calculated to have occurred not one day, but 
approximately 3 days later (the mean time interval between wound dressing changes in the studies). 
CI: 95% confidence interval; MTWDC: mean time to wound dressing change; N: number of patients in the 
analysis set; STSG Split-thickness skin graft 
 
The primary endpoint for the Grade 2a burn wound trial was the percentage of patients 
with earlier healing (at least 95% epithelialisation) based on blinded photo evaluations. 
Median time to wound healing was 7.3 days. Of the patients with a between-treatment 
difference in wound healing (N=35), the percentage of patients who showed earlier 
healing (primary endpoint) of their Episalvan treated wound half (85.7% [95% CI: 
69.7%, 95.2%]) was higher than those who showed earlier healing of their standard of 
care control treated wound half (14.3% [95% CI: 4.8%, 30.3%]) (p < 0.0001, binomial 
test).  
 
In follow-up visits at 3 months and 12 months after the day of surgery or of burn injury 
the treated wound halves were found to be equal in the majority of patients with regard 
to pigmentation, redness, texture and hair growth of the regenerated epidermis. For a 
subset of patients blinded photo-evaluation indicated better results for Episalvan treated 
wound halves compared to standard of care in pigmentation, redness and texture of the 
former wound areas. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of 
studies with Episalvan in one or more subsets of the paediatric population for the 
treatment of skin injuries. See section 4.2 for information on paediatric use. 
 



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5.2 Pharmacokinetic properties 
 
Absorption 
Episalvan gel is administered topically to skin wounds and shows poor absorbtion. 
Based on data from three clinical studies with a total of 280 patients, application of 
Episalvan gel to open wounds did not lead to betulin plasma levels higher than natural 
background-levels originating e.g. from nutritional sources. 
 
Since no biologically relevant levels of betulin were found in patients, no further studies 
related to distribution, biotransformation and elimination were performed. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of 
safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity. 
Repeated dose toxicity and local tolerance have been studied for up to 4 weeks. Toxicity 
studies of longer duration than 4 weeks have not been performed. The active substance 
was not genotoxic in in vitro assays.  
 
Carcinogenicity and reproductive and developmental toxicity studies have not been 
performed. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sunflower oil, refined. 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
4 years. 
 
For single use only. Once opened, the product should be used immediately and be 
discarded after use. 
 
6.4 Special precautions for storage 
 
Store below 30°C. 
 
6.5 Nature and contents of container  
 
White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and 
with a sealing compound in the fold. The tubes are closed with a tamper-evident 
aluminium membrane and fitted with a white polypropylene screw cap. The single-use 
tube is packed in a cardboard box. 
 
Pack size: 1 single-use tube containing 23.4 g gel.  
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 



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7. MARKETING AUTHORISATION HOLDER 
 
Amryt GmbH 
Streiflingsweg 11 
75223 Niefern-Öschelbronn 
Germany  
tel  +49 (0) 7233 9749 - 0 
fax +49 (0) 7233 9749 – 210 
Email: info.de@amrytpharma.com 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1069/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE 

AUTHORISATION 
 
Date of first authorisation: 14 January 2016 
 
 
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. 
  

http://www.ema.europa.eu/


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ANNEX II 

 

A. 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 
 

 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) responsible for batch release 

 

Amryt GmbH 
Streiflingsweg 11 
75223 Niefern-Öschelbronn 
GERMANY 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription. 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports 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 shall submit the first periodic safety update report 
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 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 as the result of an important (pharmacovigilance or risk 
minimisation) milestone being reached.  

  



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



13 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE 
IMMEDIATE PACKAGING 
 
OUTER CARTON and TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Episalvan gel  
 
Birch bark extract 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1g gel contains: 100 mg birch bark extract (as dry extract, refined) from Betula 
pendula/Betula pubescens, corresponding to 72-88 mg betulin. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipient: Sunflower oil. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gel. 
23.4 g 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Cutaneous use. 
Read the package leaflet before use. 
For single-use only. Discard after 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. 
 
 
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 
 
Amryt GmbH 
Streiflingsweg 11 
75223 Niefern-Öschelbronn 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1069/001  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription.  
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Episalvan gel (carton only) 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
< PC: {number}  
SN: {number}  
NN: {number}> 
 
 
  



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



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Package leaflet: Information for the patient 
 

Episalvan gel 
Birch bark extract 

 
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 start using this medicine 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 nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It 

may harm them, even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Episalvan is and what it is used for  
2. What you need to know before you use Episalvan  
3. How to use Episalvan  
4. Possible side effects  
5. How to store Episalvan  
6. Contents of the pack and other information 
 
 
1. What Episalvan is and what it is used for 
 
Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.  
 
It is used in adults for the treatment of skin wounds, resulting for example from grade 
2a burn wounds or from surgical skin graft transplantation. There is no experience of 
the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or 
venous leg ulcers. 
 
 
2. What you need to know before you use Episalvan 
 
Do not use Episalvan 
- if you are allergic to birch bark or any of the other ingredients of this medicine 

(listed in section 6). Episalvan does not contain birch pollen, so it may be used by 
people with birch pollen allergy. 

 
Warnings and precautions  
Talk to your doctor or nurse before using Episalvan. 
 
If you have an infection in the wound additional treatment may be required. Wound 
infection is a serious complication that can occur during the healing process.  
Possible signs of a wound infection are that the wound begins to drain yellow or 
greenish fluid (pus), or that the skin around the wound becomes red, warm, swollen, or 
increasingly painful.  
 
Children and adolescents 
There is insufficient experience of the use of Episalvan in children and adolescents 
under 18 years of age, therefore it should not be used in these patients. 
 



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Other medicines and Episalvan 
Tell your doctor or nurse if you are using, have recently used or might use any other 
medicines. 
 
No studies have been performed to establish whether Episalvan will interact with other 
medicines. However, since the amount of Episalvan absorbed into the body is extremely 
low it is not expected that Episalvan will interact with other medicines.  
 
No data are available on possible interaction between Episalvan and other medicines 
applied to the skin. Do not apply other products to the skin wound area at the same time 
of applying Episalvan.  
 
Pregnancy, breast-feeding and fertility 
No studies have been done on the effects of Episalvan on pregnant women, but since the 
absorption of this medicine into the body is extremely low, the risk to the unborn baby 
is negligible. Episalvan can be used during pregnancy. 
 
It is not known whether Episalvan passes into human breast milk, but since the 
absorption of this medicine into the body is minimal, the risk to the baby is negligible. 
Episalvan can be used during breast-feeding, unless the chest area is being treated. 
 
The effect of Episalvan on fertility has not been studied, but since the absorption of this 
medicine into the body is extremely low, it is not expected to have an effect on your 
fertility. 
 
Driving and using machines 
Your ability to drive and use machines will not be affected by this medicine. 
 
 
3. How to use Episalvan 
 
Always use this medicine exactly as your doctor or nurse has told you. Check with your 
doctor or nurse if you are not sure.  
 
Method of administration 

• If necessary, wounds should be cleansed using a suitable antiseptic solution 
prior to application of Episalvan 

• Episalvan should be applied to the wound surface at a thickness of 
approximately 1 mm and covered by a sterile wound dressing.  

• Re-apply the gel each time the dressing is changed, until the wound is healed. 
• Once the single-use tube has been opened, use the gel immediately and discard 

the tube, even if there’s some left. 
 
Duration of use 
Episalvan should be used until the wound is healed or up to 4 weeks. Your doctor or 
nurse will tell you for how long you should use the gel.  
There is no experience from long-term use of Episalvan for more than 4 weeks. 
 
If you use more Episalvan than you should 
Episalvan is applied to the skin and the absorption into the body is minimal. This makes 
overdose very unlikely, even if applied to large skin areas and for a long period of time. 
 
If you forget to use Episalvan 
Do not use a double dose to make up for a forgotten dose. Apply Episalvan at the next 
planned change of the wound dressing, continuing with your normal routine. 
 



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If you stop using Episalvan 
Episalvan should be used as advised by your doctor or nurse. Do not stop using it 
without consulting your doctor or nurse. If your wound shows no signs of improvement 
over time, talk to your doctor or nurse.  
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets 
them.  
 
The most frequently reported side effects are: 
Common side effects (may affect up to 1 in 10 people): 
- painful skin 
- itching  
- complications in the wound healing process 
 
Other side effects include: 
Uncommon side effects (may affect up to 1 in 100 people): 
- wound infection 
- allergic reaction (hypersensitivity)  
- skin irritation (dermatitis) 
- itchy rash 
- purple coloured rash 
- pain 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. 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 Episalvan 
 
Keep this medicine out of the sight and reach of children. 
Store below 30°C. 
 
Do not use this medicine after the expiry date which is stated on the carton and tube 
after ‘EXP’. The expiry date refers to the last day of that month. 
 
This product is for single use only and once opened, the product should be used 
immediately. Discard the tube after first use. 
 
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 Episalvan contains  
The active substance is a dry extract from birch bark.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


19 

1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula 
pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g 
birch bark), corresponding to 72-88 mg betulin. 
 
Extraction solvent: n-heptane. 
 
The other ingredient is refined sunflower oil.  
 
What Episalvan looks like and contents of the pack 
Episalvan is a colourless to slightly yellowish, opalescent gel. 
 
Episalvan gel is packed in white collapsible aluminium tubes. The tubes are closed with 
a tamper-evident aluminium membrane and fitted with a white polypropylene screw 
cap. The single-use tube is packed in a cardboard box. 
 
Pack size:1 tube of 23.4 g gel. 
 
 
Marketing Authorisation Holder and Manufacturer 
Amryt GmbH 
Streiflingsweg 11 
75223 Niefern-Öschelbronn 
Germany  
tel +49 (0) 7233 9749 - 0 
fax+49 (0) 7233 9749 – 210 
Email: info.de@amrytpharma.com 
 
 
This leaflet was last revised in  
 
 
Detailed information on this medicine is available on the European Medicines Agency 
web site: http://www.ema.europa.eu.  

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. 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
{'Title': '1. what episalvan is and what it is used for', 'Section_Content': 'episalvan gel is a herbal medicinal product which contains dry extract from birch bark. it is used in adults for the treatment of skin wounds, resulting for example from grade 2a burn wounds or from surgical skin graft transplantation. there is no experience of the use of episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.', 'Entity_Recognition': [{'Text': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'episalvan gel', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 13}, {'Text': 'a herbal medicinal product', 'Type': 'TREATMENT', 'BeginOffset': 17, 'EndOffset': 43}, {'Id': 7, 'BeginOffset': 76, 'EndOffset': 86, 'Score': 0.5334528088569641, 'Text': 'birch bark', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 130, 'EndOffset': 141, 'Score': 0.8848314881324768, 'Text': 'skin wounds', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9611278772354126}]}, {'Text': 'grade 2a burn wounds', 'Type': 'PROBLEM', 'BeginOffset': 170, 'EndOffset': 190}, {'Id': 15, 'BeginOffset': 199, 'EndOffset': 234, 'Score': 0.7229485511779785, 'Text': 'surgical skin graft transplantation', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 208, 'EndOffset': 212, 'Score': 0.9645069241523743, 'Text': 'skin', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 8, 'BeginOffset': 273, 'EndOffset': 282, 'Score': 0.9281352758407593, 'Text': 'episalvan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the treatment', 'Type': 'TREATMENT', 'BeginOffset': 287, 'EndOffset': 300}, {'Text': 'chronic wounds', 'Type': 'PROBLEM', 'BeginOffset': 304, 'EndOffset': 318}, {'Id': 13, 'BeginOffset': 325, 'EndOffset': 345, 'Score': 0.6865432858467102, 'Text': 'diabetic foot ulcers', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7453729510307312}], 'Attributes': [{'Type': 'ACUITY', 'Score': 0.9945530891418457, 'RelationshipScore': 0.914243757724762, 'RelationshipType': 'ACUITY', 'Id': 11, 'BeginOffset': 304, 'EndOffset': 311, 'Text': 'chronic', 'Category': 'MEDICAL_CONDITION', 'Traits': []}]}, {'Id': 2, 'BeginOffset': 334, 'EndOffset': 338, 'Score': 0.9727928638458252, 'Text': 'foot', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 14, 'BeginOffset': 349, 'EndOffset': 366, 'Score': 0.8377168774604797, 'Text': 'venous leg ulcers', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.6828181743621826}, {'Name': 'NEGATION', 'Score': 0.7416917681694031}]}, {'Id': 3, 'BeginOffset': 356, 'EndOffset': 359, 'Score': 0.966223418712616, 'Text': 'leg', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}]}
{'Title': '2. what you need to know before you use episalvan', 'Section_Content': 'do not use episalvan - if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6). episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy. warnings and precautions talk to your doctor or nurse before using episalvan. if you have an infection in the wound additional treatment may be required. wound infection is a serious complication that can occur during the healing process. possible signs of a wound infection are that the wound begins to drain yellow or greenish fluid (pus), or that the skin around the wound becomes red, warm, swollen, or increasingly painful. children and adolescents there is insufficient experience of the use of episalvan in children and adolescents under 18 years of age, therefore it should not be used in these patients. other medicines and episalvan tell your doctor or nurse if you are using, have recently used or might use any other medicines. no studies have been performed to establish whether episalvan will interact with other medicines. however, since the amount of episalvan absorbed into the body is extremely low it is not expected that episalvan will interact with other medicines. no data are available on possible interaction between episalvan and other medicines applied to the skin. do not apply other products to the skin wound area at the same time of applying episalvan. pregnancy, breast-feeding and fertility no studies have been done on the effects of episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible. episalvan can be used during pregnancy. it is not known whether episalvan passes into human breast milk, but since the absorption of this medicine into the body is minimal, the risk to the baby is negligible. episalvan can be used during breast-feeding, unless the chest area is being treated. the effect of episalvan on fertility has not been studied, but since the absorption of this medicine into the body is extremely low, it is not expected to have an effect on your fertility. driving and using machines your ability to drive and use machines will not be affected by this medicine.', 'Entity_Recognition': [{'Text': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 8, 'BeginOffset': 11, 'EndOffset': 20, 'Score': 0.8795984983444214, 'Text': 'episalvan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8314077854156494}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 34, 'EndOffset': 42}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 92, 'EndOffset': 105}, {'Id': 9, 'BeginOffset': 129, 'EndOffset': 138, 'Score': 0.7985451817512512, 'Text': 'episalvan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'birch pollen allergy', 'Type': 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fluid', 'Type': 'PROBLEM', 'BeginOffset': 535, 'EndOffset': 559}, {'Id': 28, 'BeginOffset': 561, 'EndOffset': 564, 'Score': 0.6111549139022827, 'Text': 'pus', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.4607401490211487}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9808977246284485, 'RelationshipScore': 0.8516815304756165, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 0, 'BeginOffset': 579, 'EndOffset': 583, 'Text': 'skin', 'Category': 'ANATOMY', 'Traits': []}]}, {'Text': 'the skin', 'Type': 'PROBLEM', 'BeginOffset': 575, 'EndOffset': 583}, {'Text': 'the wound', 'Type': 'PROBLEM', 'BeginOffset': 591, 'EndOffset': 600}, {'Id': 30, 'BeginOffset': 609, 'EndOffset': 612, 'Score': 0.8895502090454102, 'Text': 'red', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7034388780593872}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9808977246284485, 'RelationshipScore': 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[]}, {'Id': 20, 'BeginOffset': 1847, 'EndOffset': 1856, 'Score': 0.9173964262008667, 'Text': 'episalvan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'breast-feeding', 'Type': 'TREATMENT', 'BeginOffset': 1876, 'EndOffset': 1890}, {'Id': 6, 'BeginOffset': 1903, 'EndOffset': 1913, 'Score': 0.5930151343345642, 'Text': 'chest area', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 21, 'BeginOffset': 1946, 'EndOffset': 1955, 'Score': 0.9167733192443848, 'Text': 'episalvan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 2019, 'EndOffset': 2032}, {'Id': 7, 'BeginOffset': 2042, 'EndOffset': 2046, 'Score': 0.6903289556503296, 'Text': 'body', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'your fertility', 'Type': 'PROBLEM', 'BeginOffset': 2105, 'EndOffset': 2119}, {'Text': 'machines', 'Type': 'TREATMENT', 'BeginOffset': 2178, 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{'Title': '3. how to use episalvan', 'Section_Content': "always use this medicine exactly as your doctor or nurse has told you. check with your doctor or nurse if you are not sure. method of administration if necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of episalvan episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing. re-apply the gel each time the dressing is changed, until the wound is healed. once the single-use tube has been opened, use the gel immediately and discard the tube, even if there's some left. duration of use episalvan should be used until the wound is healed or up to 4 weeks. your doctor or nurse will tell you for how long you should use the gel. there is no experience from long-term use of episalvan for more than 4 weeks. if you use more episalvan than you should episalvan is applied to the skin and the absorption into the body is minimal. this makes overdose very unlikely, even if applied to large skin areas and for a long period of time. if you forget to use episalvan do not use a double dose to make up for a forgotten dose. apply episalvan at the next planned change of the wound dressing, continuing with your normal routine. if you stop using episalvan episalvan should be used as advised by your doctor or nurse. do not stop using it without consulting your doctor or nurse. if your wound shows no signs of improvement over time, talk to your doctor or nurse. if you have any further questions on the use of this medicine, ask your doctor or nurse.", 'Entity_Recognition': [{'Text': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Text': 'method of administration', 'Type': 'TREATMENT', 'BeginOffset': 124, 'EndOffset': 148}, {'Id': 11, 'BeginOffset': 163, 'EndOffset': 169, 'Score': 0.7210688591003418, 'Text': 'wounds', 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. the most frequently reported side effects are: common side effects (may affect up to 1 in 10 people): - painful skin - itching - complications in the wound healing process other side effects include: uncommon side effects (may affect up to 1 in 100 people): - wound infection - allergic reaction (hypersensitivity) - skin irritation (dermatitis) - itchy rash - purple coloured rash - pain reporting of side effects if you get any side effects, talk to your doctor or nurse. 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': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 3, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9670836329460144, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7197489142417908}]}, {'Id': 4, 'BeginOffset': 121, 'EndOffset': 133, 'Score': 0.9533642530441284, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7761372923851013}]}, {'Text': 'common side effects', 'Type': 'PROBLEM', 'BeginOffset': 139, 'EndOffset': 158}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 177, 'EndOffset': 178}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 182, 'EndOffset': 184}, {'Id': 7, 'BeginOffset': 204, 'EndOffset': 218, 'Score': 0.5161846876144409, 'Text': 'skin - 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{'Title': '5. how to store episalvan', 'Section_Content': "keep this medicine out of the sight and reach of children. store below 30. do not use this medicine after the expiry date which is stated on the carton and tube after 'exp'. the expiry date refers to the last day of that month. this product is for single use only and once opened, the product should be used immediately. discard the tube after first use. 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': [{'Text': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '30.', 'Type': 'NUMBER', 'BeginOffset': 71, 'EndOffset': 74}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 86, 'EndOffset': 99}, {'Text': 'the tube', 'Type': 'TREATMENT', 'BeginOffset': 329, 'EndOffset': 337}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what episalvan contains the active substance is a dry extract from birch bark. 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from betula pendula, betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin. extraction solvent: n-heptane. the other ingredient is refined sunflower oil. what episalvan looks like and contents of the pack episalvan is a colourless to slightly yellowish, opalescent gel. episalvan gel is packed in white collapsible aluminium tubes. the tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. the single-use tube is packed in a cardboard box. pack size:1 tube of 23.4 g gel.', 'Entity_Recognition': [{'Text': 'episalvan', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 5, 'EndOffset': 14, 'Score': 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'RelationshipScore': 0.9997496008872986, 'RelationshipType': 'DOSAGE', 'Id': 6, 'BeginOffset': 97, 'EndOffset': 103, 'Text': '100 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 8, 'BeginOffset': 143, 'EndOffset': 153, 'Score': 0.8093007802963257, 'Text': 'birch bark', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 159, 'EndOffset': 173, 'Score': 0.8036539554595947, 'Text': 'betula pendula', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 175, 'EndOffset': 191, 'Score': 0.4662458598613739, 'Text': 'betula pubescens', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9719902276992798, 'RelationshipScore': 0.7535595297813416, 'RelationshipType': 'DOSAGE', 'Id': 13, 'BeginOffset': 282, 'EndOffset': 290, 'Text': '72-88 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'both species', 'Type': 'PROBLEM', 'BeginOffset': 214, 'EndOffset': 226}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 246, 'EndOffset': 247}, {'Id': 12, 'BeginOffset': 252, 'EndOffset': 262, 'Score': 0.8736742734909058, 'Text': 'birch bark', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.6891246438026428, 'RelationshipScore': 0.9995556473731995, 'RelationshipType': 'DOSAGE', 'Id': 11, 'BeginOffset': 242, 'EndOffset': 251, 'Text': '0.5-1.0 g', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 14, 'BeginOffset': 291, 'EndOffset': 298, 'Score': 0.8488485813140869, 'Text': 'betulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9719902276992798, 'RelationshipScore': 1.0, 'RelationshipType': 'DOSAGE', 'Id': 13, 'BeginOffset': 282, 'EndOffset': 290, 'Text': '72-88 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 15, 'BeginOffset': 320, 'EndOffset': 329, 'Score': 0.6680188775062561, 'Text': 'n-heptane', 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