ESTROFEM Tablets 1 mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE
Available from:
Novo Nordisk A/S
Dosage:
1 mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1998-02-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0218/050/002
Case No: 2067320
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVO NORDISK A/S
NOVO ALLE, DK-2880, BAGSVAERD, DENMARK
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ESTROFEM 1MG FILM-COATED TABLETS
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 20/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/07/2010_
_CRN 2067320_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estrofem 1mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains estradiol 1 mg as estradiol hemihydrate.
Excipients: lactose monohydrate 37.3mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red, film-coated, biconvex tablets, engraved with NOVO 282, diameter 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms.
In women with intact uterus, progestogen therapy should be added.
The experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Estrofem is an oestrogen-only produc
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