Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Activelle 1 mg/0.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the Apis bull on the other. |
Each film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
|
| Norethisterone |
Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Hypromellose |
1 × 28 tablets or 3 × 28 tablets in calendar dial packs.
The calendar dial pack with 28 tablets consists of the following 3 parts:
Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
PA 218/52/1
Date of first authorisation: 28 August 1998
Date of latest renewal: 6th March 2013
| Drug | Countries | |
|---|---|---|
| ACTIVELLE | Austria, Canada, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Singapore, Turkey, South Africa |
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