Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
PINDOLOL
Novartis Pharmaceuticals UK Ltd
5 mg Milligram
Tablets
1975-01-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/001/002 Case No: 2059261 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS PHARMACEUTICALS UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VISKEN 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 18/02/2009 until 30/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/02/2009_ _CRN 2059261_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VISKEN 5mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.0mg of pindolol. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. White, circular, flat, bevelled edge, anglescored and scored as well as coded “LB” on one side, “SANDOZ” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the control of essential hypertension and in the prophylactic treatment of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Hypertension Initially, one 15mg tablet daily with breakfast, or 5mg two or three times daily. Most patien Belgenin tamamını okuyun