ESTROFEM Film-coated tablet Ref.[49830] Active ingredients: Estradiol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Novo Nordisk A/S, Novo Alle, DK-2880, Bagsvaerd, Denmark

Product name and form

Estrofem 2 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Blue, film-coated, round biconvex tablets, engraved with NOVO 280.

Diameter 6 mm.

Qualitative and quantitative composition

Each film-coated tablet contains estradiol 2 mg (as estradiol hemihydrate).

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.

List of Excipients

The tablet core contains:

Lactose monohydrate
Maize starch
Hydroxypropylcellulose
Talc
Magnesium stearate

Film coating:

Hypromellose
Talc
Titanium dioxide (E171)
Macrogol 400
Indigo carmine (E132)

Pack sizes and marketing

1 × 28 tablets in a calendar dial pack.

The calendar 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 white non-transparent polystyrene.

Marketing authorization holder

Novo Nordisk A/S, Novo Alle, DK-2880, Bagsvaerd, Denmark

Marketing authorization dates and numbers

PA0218/050/001

Date of first authorisation: 01 May 1996
Date of last renewal: 01 May 2006

Drugs

Drug Countries
ESTROFEM Austria, Estonia, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, South Africa

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