Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
Azalia 75 microgram film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White or almost white, round, biconvex film-coated tablets of about 5,5 mm in diameter, with a sign “D” on one side and “75” on the other side. |
Each film-coated tablet contains 75 microgram desogestrel.
Excipient with known effect: 52.34 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Desogestrel |
Desogestrel is a progestogen. Like other progestogen-only pills, desogestrel is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of desogestrel is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coat: Poly[vinyl alcohol] |
Azalia film-coated tablets are packaged in a blister made of transparent, hard PVC/PVDC-Aluminium foil. Each blister is placed in a laminated aluminium sachet. The blisters in the sachets are packed into a folded carton box with a patient leaflet and etui storing bag.
Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets.
Not all pack sizes may be marketed.
Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
PA1330/010/001
Date of first authorisation: 8th October 2010
Date of last renewal: 26th October 2014
| Drug | Countries | |
|---|---|---|
| AZALIA | Spain, Finland, Ireland, Lithuania, Poland, Romania |
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