Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
McDowell Pharmaceuticals
50 Microgram
Nasal Spray Suspension
2009-04-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/016/001 Case No: 2059693 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDOWELL PHARMACEUTICALS 4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB an authorisation, subject to the provisions of the said Regulations, in respect of the product BECONASE 50 MICROGRAMS AQUEOUS NASAL SPRAY 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 24/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/04/2009_ _CRN 2059693_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beconase 50 micrograms Aqueous Nasal Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100mg spray contains beclomethasone dipropionate monohydrate equivalent to 50 micrograms of beclomethasone dipropionate. Excipients: Contains benzalkonium chloride For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension (short term: Nasal spray) _Product imported from the UK:_ An aqueous, white, opaque, suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of perennial and seasonal allergic and vasomotor rhinitis. Beconase can significantly delay the recurrence Read the complete document