Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
IPRATROPIUM BROMIDE/SALBUTAMOL
Imbat Limited
IPRATROPIUM BROMIDE/SALBUTAMOL
20/100 Mcg/Acutuation
Unknown
Withdrawn
2012-02-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/032/001 Case No: 2069197 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IMBAT LIMITED UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9 an authorisation, subject to the provisions of the said Regulations, in respect of the product COMBIVENT METERED AERSOL, 20/100 MCG/ACUTUATION 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 26/08/2009 until 21/06/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/09/2009_ _CRN 2069197_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combivent Metered Aerosol 20 micrograms/100 micrograms per metered dose Pressurised Inhalation, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose delivers 20 micrograms of ipratropium bromide (as monohydrate) and 100 micrograms of salbutamol (as sulphate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. _Product imported from Greece._ Pressurised metered dose inhaler with a metal canister covered with a transparent plastic cover and a grey mouthpiece and cap containing a creamy-white suspension. Boehringer logo is embossed Aqra d-dokument sħiħ