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

UAB Niromed, Lietuva

Date of authorisation

2025-03-21

Date of renewal

Documents

2433_Rozex_gel_PIL.docx

2433_Rozex_gel_PZ.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
116989	103090	1103090	tūbelė	30 g N1		Receptinis	LT/L/25/2433/001	Tiekiama	2025-06-13	-	No	-	-	Download

Stadijos

Data	Stadija
2025-03-21	Registruotas