Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Bristol-Myers Squibb Pharmaceuticals Ltd
10 Milligram
Tablets
1998-02-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/072/002 Case No: 2040468 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 CARACE TABLETS 10 MG. 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 23/02/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/03/2009_ _CRN 2040468_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carace Tablets 10 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of lisinopril (as dihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Yellow, half-scored, oval tablets, marked ‘CARACE’ and ‘10’. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension All grades of essential hypertension and renovascular hypertension. “Carace” may be used alone or with other antihypertensive agents. Heart Failure In heart failure, “Carace” is indicated as adjunctive Baca dokumen lengkapnya