Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Marketing Authorisation Holder: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
Novofem film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. Red film-coated, biconvex tablets engraved with NOVO 282. Diameter: 6 mm. White film-coated, biconvex tablets engraved with NOVO 283. Diameter: 6 mm. |
One red film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate).
One white film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.
Excipient with known effect: lactose monohydrate.
Each red film-coated tablet contains lactose monohydrate 37.3 mg.
Each white film-coated tablet contains lactose monohydrate 36.8 mg.
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 |
|---|
|
Both the white and the red tablets contain: Lactose monohydrate Film-coating: White film-coated tablet: Hypromellose, triacetin and talc. Red film-coated tablet: Hypromellose, red iron oxide (E172), titanium dioxide (E171), propylene glycol and talc. |
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.
Marketing Authorisation Holder: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
PL 03132/0141
16/11/2006
| Drug | Countries | |
|---|---|---|
| NOVOFEM | Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Poland, United Kingdom, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
