Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BECLOMETASONE
Mercury Pharmaceuticals Ltd
50mcg/dose Mcg/Dose
Nasal Spray Suspension
2006-11-10
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0899/017/002 Case No: 1025955 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GOLDSHIELD PHARMACEUTICALS LTD NLA TOWER, 12-16 ADDISCOMBE ROAD,CROYDON, SURREY CRO 0XT, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BECLO-RHINO ALLERGY 50 MICROGRAM AQUEOUS NASAL SPRAY 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 10/11/2006 until 09/11/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/11/2006_ _CRN 1025955_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beclo-Rhino Allergy 50 microgram Aqueous Nasal Spray Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Beclometasone Dipropionate 50 micrograms per spray. For full list of Excipients see section 6.1. 3 PHARMACEUTICAL FORM Nasal Spray, Suspension. A glass vial fitted with a metering pump and nasal tip containing an opaque white nasal spray suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 Spray = 50µg beclometasone dipropionate For administration by the int Read the complete document