Silseq

Medicinal product

(Invented) name

Silseq

Active substance (s)

Adapalenas/Benzoilo peroksidas su vandeniu

Strength

1 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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2025-03-10

Date of renewal

Documents

5730 Pakuotės lapelis 2025 05 26.docx

5730 Silseq 1_25 RPP 2025 05 26.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/5902/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Adapalenas	1 mg
Benzoilo peroksidas su vandeniu	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
116897	103001	1103001	tūbelė	30 g N1		Receptinis	LT/1/25/5730/001	Netiekiama	-	-	No	-	-
116898	103002	1103002	tūbelė	45 g N1		Receptinis	LT/1/25/5730/002	Netiekiama	-	-	No	-	-
116899	103003	1103003	tūbelė	60 g N1		Receptinis	LT/1/25/5730/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-10	Registruotas