VISANNE Tablet Ref.[8727] Active ingredients: Dienogest

Source: European Medicines Agency (EU) 

Product name and form

Visanne 2 mg tablets.

Pharmaceutical Form

Tablets.

White to off-white, round, flat-faced, bevelled-edge tablets with a debossed “B” on one side and a diameter of 7 mm.

Qualitative and quantitative composition

Each tablet contains 2 mg dienogest.

Excipient with known effect: each tablet contains 62.8 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

Crospovidone
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Potato starch
Povidone K25
Talc

Pack sizes and marketing

The tablets are contained in blister packs consisting of green transparent films made of polyvinylidene chloride (PVDC) coated polyvinyl chloride (PVC) and metallic foils made of aluminum (mat side hot sealable).

Pack sizes: 28, 84 and 168 tablets.

Not all pack sizes may be marketed.

Drugs

Drug Countries
VISANNE Austria, Canada, Ecuador, Finland, France, Hong Kong, Croatia, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, South Africa

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