AMMILY 2 MG / 0,03 MG
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1305830
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:
126TK
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 12 April 2023)
Package information leaflet (PIL):
EST
(last updated 12 April 2023)
Labelling:
(last updated 03 November 2021)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Orivas UAB
Marketing authorization number:
617409
Marketing authorization issued on:
06 February 2009
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
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: 12 April 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription