KLIOVANCE Film-coated tablet Ref.[27883] Active ingredients: Estradiol Norethisterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA

Product name and form

Kliovance 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.

Qualitative and quantitative composition

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
Maize starch
Copovidone
Talc
Magnesium stearate

Film-coating:

Hypromellose
Triacetin
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

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

Marketing authorization dates and numbers

PL 03132/0125

Date of first authorisation: 06 March 1998
Date of latest renewal: 06 March 2013

Drugs

Drug Countries
KLIOVANCE New Zealand, United Kingdom

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