ROZEX

This brand name is authorized in Austria, Brazil, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, UK.

Active ingredients

The drug ROZEX contains one active pharmaceutical ingredient (API):

1	Methronidazole UNII 140QMO216E - METRONIDAZOLE
	Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.
	Read more about Methronidazole

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ROZEX Cream	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
D06BX01	Metronidazole	D Dermatologicals → D06 Antibiotics and chemotherapeutics for dermatological use → D06B Chemotherapeutics for topical use → D06BX Other chemotherapeutics
Discover more medicines within D06BX01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	510101401166314
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	20.833-1-02-04
EE	Ravimiamet	1012644, 1012655, 1046179, 1046180, 1046191, 1046203, 1046214, 1819234, 1829943
ES	Centro de información online de medicamentos de la AEMPS	60536
FI	Lääkealan turvallisuus- ja kehittämiskeskus	047317, 088909, 126503, 566040
FR	Base de données publique des médicaments	60647323, 67119549, 67763113
GB	Medicines & Healthcare Products Regulatory Agency	139633, 146681, 162359, 198608, 28405, 28406, 29236, 29238
HK	Department of Health Drug Office	34300
IE	Health Products Regulatory Authority	37406, 52357, 58859, 58890, 58991
IL	מִשְׂרַד הַבְּרִיאוּת	2910
JP	医薬品医療機器総合機構	2699713Q1026
LT	Valstybinė vaistų kontrolės tarnyba	1008622, 1008623, 1008624, 1008625, 1008626, 1068924, 1083923, 1086980, 1090231, 1091523
MT	Medicines Authority	MA117/00602
NL	Z-Index G-Standaard	13832778
NL	Z-Index G-Standaard, PRK	33480
NZ	Medicines and Medical Devices Safety Authority	5950, 5951
PL	Rejestru Produktów Leczniczych	100106296, 100106304, 100163035, 100258103, 100346340, 100350027, 100369771, 100394533, 100423996
SG	Health Sciences Authority	08453P, 11198P
ZA	Health Products Regulatory Authority	29/13.4.2/0771