País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ESTROGENS CONJUGATED
John Wyeth & Brother Limited
1.25 Milligram
Tablets
1995-09-19
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0022/068/002 Case No: 2026843 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to JOHN WYETH & BROTHER LIMITED HUNTERCOMBE LANE SOUTH, TAPLOW, MAIDENHEAD, BERKSHIRE SL6 0PH, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CATHATE 1.25 MILLIGRAM TABLETS The particulars of which are set out in Part I and Part II of 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 24/11/2006 until 18/09/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/11/2006_ _CRN 2026843_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cathate* Tablets 1.25mg Coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cathate tablets contain 1.25 mg Conjugated Estrogens. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet A white coloured, oval coated tablet printed '1.25' in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cathate is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal and postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products appro Leia o documento completo