Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
QUINAPRIL
Teva Pharma B.V.
40 Milligram
Film Coated Tablet
2005-05-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0749/008/004 Case No: 2055853 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TEVA PHARMA B.V. COMPUTERWEG 10, 3542 DR UTRECHT, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product QUINAPRIL 40 MG FILM-COATED 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 06/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/09/2009_ _CRN 2055853_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinapril 40 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg quinapril (as quinapril hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow, oval film-coated tablet debossed “40” on one side and with a score line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Treatment of essential hypertension o Treatment of congestive heart failure 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral Aqra d-dokument sħiħ