Skinoren

Medicinal product

(Invented) name

Skinoren

Active substance (s)

Azelaino rūgštis

Strength

200 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10AX03, Azelaic acid

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

1994-06-02

Date of renewal

2011-04-29

Documents

0279 Skinoren kremas PCS PL 2023 03 11.docx

0279 Pakuotės lapelis 2023 03 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g kremo yra	1 g
Azelaino rūgštis	200 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
17340	21233	1021233	tūbelė	30 g N1		Receptinis	LT/1/94/0279/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-04-29	Perregistruotas
1994-06-02	Registruotas