Velbienne 1 mg/2 mg, film-coated tablet.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Tablets are light pink and rounded with a diameter of 6 mm approx. |
Each film-coated tablet contains: estradiol valerate 1.0 mg (equivalent to 0.764 mg estradiol) and dienogest 2.0 mg.
Excipients with known effect: each tablet contains 58.22 mg of lactose monohydrate.
For 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. |
|
| Estradiol |
Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy. |
| List of Excipients |
|---|
|
Core: Lactose monohydrate Coating: Polyvinyl alcohol (E1203) |
Blister of PVC/PVDC/aluminium.
Supplied in cartons containing 28, 3 × 28, or 6 × 28 coated tablets.
Not all pack sizes may be marketed.
Exeltis Healthcare S.L, Av. Miralcampo 7-Poligono Ind. Miralcampo 19200, Azuqueca de Henares, Guadalajara, Spain
RVG 118123
Date of first authorization: 21 juni 2018
Renewal of the authorization: 6 december 2021
| Drug | Countries | |
|---|---|---|
| VELBIENNE | Austria, Germany, Ecuador, Estonia, Spain, Lithuania, Poland, Turkey |
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