البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Breathe Pharmaceuticals Limited
2.5/2.5 Mg/Ml
Nebuliser Solution
2009-07-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1518/004/001 Case No: 2072881 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BREATHE PHARMACEUTICALS LIMITED UNIT 20A BECKETT WAY, PARK WEST BUSINESS PARK, DUBLIN 12, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SALBUVENT 2.5 MG/2.5 ML NEBULISER SOLUTION 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 05/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/11/2009_ _CRN 2072881_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salbuvent 2.5 mg/2.5 ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 2.5mg salbutamol (as sulphate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser Solution A clear, colourless to pale yellow solution in a clear, plastic single dose ampoule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salbuvent Nebuliser Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Salbuvent اقرأ الوثيقة كاملة