ZAFRILLA Tablet Ref.[50403] Active ingredients: Dienogest

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary

Product name and form

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.

Qualitative and quantitative composition

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
Maize starch, pregelatinised
Cellulose, microcrystalline
Povidone K-25
Crospovidone (type A)
Talc
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary

Marketing authorization dates and numbers

PA1330/023/001

Date of first authorisation: 12th April 2019

Drugs

Drug Countries
ZAFRILLA Austria, Ireland, Malta, Poland, Romania

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