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ROZEX
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1012655
Name of medicinal product:
ROZEX
Active substances:
Metronidazole
Estonian
,
English
,
Latin
ATC code:
D06BX01
Dosage form:
cream
Route of administration:
cutaneous use
Strengh:
7,5mg 1g
Amount in package:
5g 1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Topical treatment of rosacea.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated June 30, 2021)
Package information leaflet (PIL):
EST
(last updated November 15, 2022)
Labelling:
(last updated June 30, 2021)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Galderma International
Marketing authorization number:
356201
Marketing authorization issued on:
August 17, 2001
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: November 15, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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