Register of Medicinal Products

AMMILY 2 MG / 0,03 MG

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1305829
Name of medicinal product:	AMMILY 2 MG / 0,03 MG
Active substances:	Dienogest+Ethinylestradiol Estonian, English, Latin
ATC code:	G03AA16
Dosage form:	film-coated tablet
Route of administration:	oral use
Strengh:	2mg+0,03mg
Amount in package:	63TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:	- Oral contraception. - Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive. The decision to prescribe [invented name] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).
Safety features:	Yes
Summary of product characteristics (SPC):	(last updated April 12, 2023)
Package information leaflet (PIL):	EST (last updated April 12, 2023)
Labelling:	(last updated November 3, 2021)
Last imported to Estonia:	Never imported to Estonia

Marketing authorization

Marketing authorization holder:	Orivas UAB
Marketing authorization number:	617409
Marketing authorization issued on:	February 6, 2009
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	Decentralised

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

Perscription conditions and restrictions

Description	Additional condition
Ämmaemandal on õigus välja kirjutada
Perearsti õel on õigus välja kirjutada	Välja arvatud esmane retsept

Entry/Changing date: April 12, 2023

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

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