Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Norton Waterford
50 Microgram
Nasal Spray Suspension
2006-03-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0436/028/002 Case No: 2065604 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, CORK ROAD, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product NASOBEC ALLERGY 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 26/02/2010 until 30/03/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/03/2010_ _CRN 2065604_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nasobec Allergy 50 Micrograms Aqueous Nasal Spray. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg spray contains 50 micrograms beclometasone dipropionate. For excipients, see 6.1 3 PHARMACEUTICAL FORM Nasal spray, suspension. A white opaque suspension, free from any visible matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nasobec Allergy prevents and relieves nasal congestion, sneezing and a runny, itchy nose due to hayfever and other seasonal allergic conditions. Once nasal congestion is cleared the pressure and pain around the eyes read_full_document