Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
Zafrilla 2mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White or almost white, round, flat, bevelled-edge tablets, engraved with “G 93” on one side and with “RG” on the other side. The diameter of the tablets is 7 mm. |
Each tablet contains 2 mg dienogest.
Excipient with known effect: each tablet contains 62.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dienogest |
Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest binds to the progesterone receptor of the human uterus with only 10% of the relative affinity of progesterone. |
| List of Excipients |
|---|
|
Lactose monohydrate |
28, 84, 168 Zafrilla 2 mg tablets are packaged in green, hard PVC//Al calendar blisters in folded carton box.
Not all pack sizes may be marketed.
Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
PA1330/023/001
Date of first authorisation: 12th April 2019
| Drug | Countries | |
|---|---|---|
| ZAFRILLA | Austria, Ireland, Malta, Poland, Romania |
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