NOVOFEM Film-coated tablet Ref.[50471] Active ingredients: Estradiol Norethisterone

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

Product name and form

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.

Qualitative and quantitative composition

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
Maize starch
Hydroxypropylcellulose
Talc
Magnesium stearate

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.

Pack sizes and marketing

1 × 28 tablets or 3 × 28 tablets in calendar dial packs.

The calendar dial pack with 28 tablets consists of the following 3 parts:

  • The base made of coloured non-transparent polypropylene.
  • The ring-shaped lid made of transparent polystyrene.
  • The centre-dial made of coloured non-transparent polystyrene.

Not all pack sizes may be marketed.

Marketing authorization holder

Marketing Authorisation Holder: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA

Marketing authorization dates and numbers

PL 03132/0141

16/11/2006

Drugs

Drug Countries
NOVOFEM Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Poland, United Kingdom, South Africa

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