Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Novo Nordisk A/S
1 mg Milligram
Tablets
1998-02-06
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 Lugege kogu dokumenti