国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Profind Wholesale Ltd.
250 Microgram
Pressurised Inhalation Soln
2010-02-12
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/040/001 Case No: 2083758 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BECOTIDE EVOHALER 250 MICROGRAMS PRESSURISED INHALATION SOLUTION the particulars of which are set out in 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083758_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Becotide Evohaler 250 micrograms Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 250 micrograms beclometasone diproprionate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised Inhalation Solution _Product imported from Italy:_ Pressurised aluminium container closed with a metering valve containing a pressurised solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with 完全なドキュメントを読む