Register of Medicinal Products

METRONIDAZOL ORIFARM

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1008706
Name of medicinal product:	METRONIDAZOL ORIFARM
Active substances:	Metronidazole Estonian, English, Latin
ATC code:	P01AB01
Dosage form:	film-coated tablet
Route of administration:	oral use
Strengh:	500mg
Amount in package:	10TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Safety features:	Yes
Summary of product characteristics (SPC):	(last updated January 11, 2022)
Package information leaflet (PIL):	EST (last updated January 11, 2022)
Labelling:	(last updated January 11, 2022)
Last imported to Estonia:	March 1, 2023

Marketing authorization

Marketing authorization holder:	Orifarm Healthcare A/S
Marketing authorization number:	233698
Marketing authorization issued on:	October 27, 2000
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	National

Percent	Valid from	Valid until	Valid	Diagnosis	Doctor's speciality	Primary	Age	Other
100	01.04.2023		Yes			No	until 4 years
50	01.04.2023		Yes			No

Reference price:
Under reference price:
Reference price of daily dose:

Entry/Changing date: June 6, 2022

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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