Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CELIPROLOL HYDROCHLORIDE
Ranbaxy Ireland Limited
CELIPROLOL HYDROCHLORIDE
200 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2010-09-10
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0408/058/001 Case No: 2085471 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CELIPROLOL HYDROCHLORIDE, 200 MILLIGRAM 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 06/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/08/2010_ _CRN 2085471_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celiprolol hydrochloride 200mg film coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg celiprolol hydrochloride. _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow coloured, capsule shaped, biconvex film coated tablets, debossed with ‘200’ on one side of the breakline and a deep breakline on the other side. The tablet can be broken into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celiprolol is indicated for the treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _The initial dose is 200 mg orally, taken once d Belgenin tamamını okuyun