Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
DEXTROMETHORPHAN HYDROBROMIDE
Bayer Limited
DEXTROMETHORPHAN HYDROBROMIDE
%v/v
Oral Suspension
Product not subject to medical prescription
Withdrawn
2010-09-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/043/001 Case No: 2043419 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0021/066/001. BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product DELSYM (CONTROLLED RELEASE) 30MG/5ML ORAL 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 21/11/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/11/2008_ _CRN 2043419_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Delsym (Controlled Release) 30mg/5 ml Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains dextromethorphan resin complex * equivalent to 30 mg of dextromethorphan hydrobromide. *Dextromethorphan resin complex as coated dextromethorphan polistirex and uncoated dextromethorphan polistirex. Excipients: Each 5ml contains sucrose (granulated sugar) 600mg, sunset yellow (E110) 0.115mg, methyl paradroxybenzoate (E218) 7.5 mg, propyl parahydroxybenzoate (E216) 1.5mg and high fructose corn syrup 1.5g. For a full list of excipients, see section 6.1. 3 PHARMA Citiți documentul complet