Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
SODIUM CROMOGLICATE
Sanofi-Aventis Ireland Limited T/A SANOFI
SODIUM CROMOGLICATE
5 Milligram
Unknown
Product subject to prescription which may be renewed (B)
Withdrawn
2010-04-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/103/002 Case No: 2068748 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product INTAL CFC-FREE INHALER 5MG 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 12/08/2009 until 12/03/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2009_ _CRN 2068748_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Intal CFC-Free Inhaler 5mg pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium cromoglicate 5 mg per metered dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension Pressurised container fitted with a metering valve containing a white pressurised inhalation suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intal CFC-Free is indicated for the preventative treatment of bronchial asthma, in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intal CFC-Free is for inhalation use Lue koko asiakirja