Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
METOPROLOL TARTRATE
B & S Healthcare
METOPROLOL TARTRATE
50 Milligram
Tablets
Withdrawn
2011-01-11
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/020/001 Case No: 2034068 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BETALOC 50 MILLIGRAM 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 26/03/2007 until 10/08/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2034068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betaloc Tablets 50 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Metoprolol tartrate 50mg. Excipient: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK:_ White to off-white, circular, biconvex tablet, scored and engraved ‘A/BB’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Betaloc in acute myocardial infarction reduces infarct size a Olvassa el a teljes dokumentumot