Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Bristol-Myers Squibb Pharmaceuticals Ltd
12.5 Milligram
Tablets
1986-09-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/039/004 Case No: 2050595 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CAPOTEN 12.5 MG 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 26/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/03/2009_ _CRN 2050595_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capoten 12.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains captopril 12.5 mg Excipients: Lactose monohydrate 33.0 mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Slightly mottled, white, flat-faced, bevel-edged, capsule-shaped tablets, engraved with ‘Squibb’ and ‘450’ on one side with a bisecting bar on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Capoten is indicated for the treatment of hypertension. HEART FAILURE: Capoten is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination wit Perskaitykite visą dokumentą