Rozex

Medicinal product

(Invented) name

Rozex

Active substance (s)

Metronidazolas

Strength

7,5 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)

D06BX01, Metronidazole

Marketing authorisation holder

Galderma International, Prancūzija

Date of authorisation

2001-12-19

Date of renewal

2008-07-03

Documents

1197 Rozex kremas PL 2021 09 10, VRA_19765.docx

1197 Pakuotės lapelis kremas 2021 09 10, VRA_19765.docx

Stage

Išregistruotas

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
Metronidazolas	7,5 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
3121	8625	1008625	tūbelė	15 g, N1		Receptinis	LT/1/01/1197/001	Netiekiama	-	-	No	-	-
3122	8626	1008626	tūbelė	30 g, N1		Receptinis	LT/1/01/1197/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-12	Išregistruotas
2008-07-03	Perregistruotas
2001-12-19	Registruotas