Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Sanofi-Aventis Ireland Limited
2 %w/v %w/v
Nasal Spray Solution
2004-12-03
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0540/123/002 Case No: 2029151 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RYNACROM 2% W/V NASAL SPRAY, SOLUTION 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 26/10/2006 until 14/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/11/2006_ _CRN 2029151_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rynacrom 2 % w/v Nasal Spray, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 2.6 mg sodium cromoglicate. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution. A clear, colourless or pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rynacrom is indicated for the preventative treatment of allergic rhinitis (seasonal and perennial) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For nasal use. Adults and children: One spray to each nostril four to six times daily at three to four hourly intervals (i.e. on average daily dosage between 10.4 mg a Lees het volledige document