Qlaira, film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Dark yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DD” in a regular hexagon. Medium red film-coated tablet, round with biconvex faces, one side is marked with the letters “DJ” in a regular hexagon. Light yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DH” in a regular hexagon. Dark red film-coated tablet, round with biconvex faces, one side is marked with the letters “DN” in a regular hexagon. White film-coated tablet, round with biconvex faces, one side is marked with the letters “DT” in a regular hexagon. |
Each wallet (28 film-coated tablets) contains in the following order:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets do not contain active substances
Excipient with known effect: lactose (not more than 50 mg per tablet)
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. |
|
| 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 |
|---|
Active film-coated tabletsTablet core: Lactose monohydrate Tablet coating: Hypromellose type 2910 (E464) Placebo (inactive) film-coated tabletTablet core: Lactose monohydrate Tablet coating: Hypromellose type 2910 (E464) |
Transparent PVC/Aluminium blister in a cardboard wallet
Pack sizes:
1 × 28 film-coated tablets
3 × 28 film-coated tablets
6 × 28 film-coated tablets
Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets and 5 medium red tablets and 17 light yellow tablets and 2 dark red tablets and 2 white tablets
Not all pack sizes may be marketed.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL00010/0576
First Authorisation: 08.12.2008
Renewal of Authorisation: 03.11.2013
| Drug | Countries | |
|---|---|---|
| QLAIRA | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa |
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