Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE
Pfizer Healthcare Ireland
PERINDOPRIL TERT-BUTYLAMINE
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2012-04-26
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0822/041/002 Case No: 2043318 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PFIZER HEALTHCARE IRELAND 9 RIVERWALK, NATIONAL DIGITAL PARK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product PERINDOPRIL TERT-BUTYLAMINE PFIZER 8 MG 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 28/01/2011 until 27/01/2016. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/01/2011_ _CRN 2043318_ _page number: 1_ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine Pfizer 8 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg perindopril tert-butylamine salt equivalent to 6.676 mg perindopril. Excipient: 118.660 mg lactose / tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, coloured round biconvex, uncoated tablets with debossing “D” on one side and “5” & “9” on either side of the break line on another side. The tablet can be divided into two equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of h Baca dokumen lengkap