Finacea

Medicinal product

(Invented) name

Finacea

Active substance (s)

Azelaino rūgštis

Strength

150 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)

D10AX03, Azelaic acid

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

2009-05-19

Date of renewal

2014-01-24

Documents

1579 Pakuotės lapelis 2022 11 15.docx

1579 Finacea 150mg_g gelis PL 2022 11 15, VRA_20332.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/0167/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Azelaino rūgštis	150 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
27852	30394	1030394	tūbelė	5 g N1		Receptinis	LT/1/09/1579/001	Netiekiama	-	-	No	-	-
27853	30395	1030395	tūbelė	10 g N1		Receptinis	LT/1/09/1579/002	Netiekiama	-	-	No	-	-
27854	30396	1030396	tūbelė	15 g N1		Receptinis	LT/1/09/1579/003	Netiekiama	-	-	No	-	-
27855	30397	1030397	tūbelė	30 g N1		Receptinis	LT/1/09/1579/004	Netiekiama	-	-	No	-	-	Download
27856	30398	1030398	tūbelė	50 g N1		Receptinis	LT/1/09/1579/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-24	Perregistruotas
2009-05-19	Registruotas