Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Norton Waterford
100 Mcg/Acutuation
Pressurised Inhalation Suspension
2000-09-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0436/033/001 Case No: 2055550 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD LIMITED T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AIROMIR INHALER 100 MICROGRAMS PER METERED DOSE PRESSURISED INHALATION SUSPENSION 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 01/10/2008 until 18/09/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/10/2008_ _CRN 2055550_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Airomir Inhaler 100 micrograms per metered dose pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 100 micrograms Salbutamol (as sulphate). For excipients see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension A homogenous, creamy – white to grey suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Airomir Inhaler is indicated for the treatment of acute attacks or exacerbations of bronchial asthma and for the treatment of reversible airways obstr Olvassa el a teljes dokumentumot