Epiduo

Medicinal product

(Invented) name

Epiduo

Active substance (s)

Adapalenas/Benzoilo peroksidas

Strength

3 mg/25 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10AD53, Adapalene, combinations

Marketing authorisation holder

Galderma International, Prancūzija

Date of authorisation

2022-11-08

Date of renewal

2024-05-21

Documents

5064 Epiduo 3mg_25mg_g PCS PL 2024 10 17.docx

5064 Pakuotės lapelis 2024 10 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

SE/H/0664/002/E/003

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Adapalenas	3 mg
Benzoilo peroksidas	25 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
109820	95927	1095927	tūbelė	2 g N1		Receptinis	LT/1/22/5064/001	Netiekiama	-	-	No	-	-
109821	95928	1095928	tūbelė	5 g N1		Receptinis	LT/1/22/5064/002	Netiekiama	-	-	No	-	-
109822	95929	1095929	daugiadozė talpyklė su sandariąja pompa	15 g N1		Receptinis	LT/1/22/5064/003	Netiekiama	-	-	No	-	-
109823	95930	1095930	daugiadozė talpyklė su sandariąja pompa	30 g N1		Receptinis	LT/1/22/5064/004	Netiekiama	-	-	No	-	-
109824	95931	1095931	daugiadozė talpyklė su sandariąja pompa	45 g N1		Receptinis	LT/1/22/5064/005	Netiekiama	-	-	No	-	-	Download
109825	95932	1095932	daugiadozė talpyklė su sandariąja pompa	60 g N1		Receptinis	LT/1/22/5064/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-21	Perregistruotas
2022-11-08	Registruotas