Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
B & S Healthcare
20 Milligram
Film Coated Tablet
2006-10-13
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/047/001 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 ADALAT LA 20 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 26/03/2007 until 12/10/2011. 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 Adalat LA 20mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release Film-coated tablet contains 20 mg nifedipine. Excipients: Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release, film-coated tablet. _Product imported from Italy and the UK:_ Pink, circular biconvex tablets with “Adalat 20”, printed with black ink on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adalat LA 20: For the treatment of mild to moderate hypertension. For the management of chronic stable angina pectoris either as monotherapy or in combination with Lees het volledige document