KLIOGEST Film-coated tablet Ref.[50557] Active ingredients: Estradiol Norethisterone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Product name and form

Kliogest 2 mg/1 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White, film-coated, biconvex tablets, engraved with NOVO 281. Diameter 6 mm.

Qualitative and quantitative composition

Each film-coated tablet contains: estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.

Excipient with known effect: lactose monohydrate.

Each white film-coated tablet contains lactose monohydrate 36.3 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

Tablet core:

Lactose monohydrate
Maize starch
Hydroxypropylcellulose
Talc
Magnesium stearate

Film-coating:

White tablets:

Hypromellose
Triacetin
Talc

Pack sizes and marketing

1 × 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.

Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Marketing authorization dates and numbers

PA0218/022/001

Date of first authorisation: 18 November 1987
Date of last renewal: 18 November 2007

Drugs

Drug Countries
KLIOGEST Austria, Germany, Estonia, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Turkey, South Africa

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