Rozex

Medicinal product

(Invented) name

Rozex

Active substance (s)

Metronidazolas

Strength

7,5 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)

D06BX01, Metronidazole

Marketing authorisation holder

Galderma International, Prancūzija

Date of authorisation

2001-12-19

Date of renewal

2008-07-03

Documents

1197 Pakuotės lapelis gelis 2021 09 10, VRA_19765.docx

1197 Rozex gelis PL 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 gelio 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
3118	8622	1008622	tūbelė	15 g, N1		Receptinis	LT/1/01/1197/003	Netiekiama	-	-	No	-	-
3119	8623	1008623	tūbelė	30 g, N1		Receptinis	LT/1/01/1197/004	Netiekiama	-	-	No	-	-	Download
3120	8624	1008624	tūbelė	50 g, N1		Receptinis	LT/1/01/1197/005	Netiekiama	-	-	No	-	-

Stadijos

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