Episalvan

Medicinal product

(Invented) name

Episalvan

Active substance (s)

Beržų (Betula pendula/pubescens) žievės rafinuotas sausasis ekstraktas

Strength

100 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

D03AX13, Betulae cortex

Marketing authorisation holder

Amryt GmbH, Vokietija

Date of authorisation

2016-01-14

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Gel	1 g
Beržų (Betula pendula/pubescens) žievės rafinuotas sausasis ekstraktas	100 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
64778	79267	1079267	tūbelė	23,4 g N1		Receptinis	EU/1/15/1069/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Išregistruotas
2016-01-14	Registruotas