Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando 1609
MIRELLE 0,015 mg/0,06 mg film-coated tablet.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. The hormone-containing tablet is pale yellow, round with convex faces. The hormone-free tablet is white, round with convex faces. |
The 28-day pack (Every-Day pack) contains:
24 hormone-containing pale yellow coated tablets: Each coated tablet contains ethinylestradiol 0,015 mg and gestodene 0,06 mg
Contains sugar (lactose – 38 mg).
4 hormone-free white coated tablets.
Contains sugar (lactose – 38 mg)
For a full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 17 alpha-Ethinylestradiol |
Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. |
|
| Gestodene |
|
| List of Excipients |
|---|
|
Ferric oxide red |
MIRELLE is packed in colourless transparent PVC/aluminium blisters containing 24 pale yellow hormonecontaining tablets plus 4 white hormone-free tablets per blister strip.
The blister strip is packed into an outer cardboard carton.
Pack sizes: 28 tablets.
Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando 1609
33/18.8/0364
24 August 2000
| Drug | Countries | |
|---|---|---|
| MIRELLE | Austria, Brazil, Estonia, Lithuania, South Africa |
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