Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
CARBOCISTEINE
UCB S.A.
100 MG/5ml
Syrup
1993-02-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0230/006/003 Case No: 2043903 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to UCB S.A. ALLEE DE LA RECHERCHE 60, B-1070 BRUSSELS, BELGIUM an authorisation, subject to the provisions of the said Regulations, in respect of the product PULMOCLASE 100MG/5ML PAEDIATRIC SYRUP 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 08/02/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/05/2010_ _CRN 2043903_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pulmoclase 100mg/5ml Paediatric Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carbocisteine: 100mg/5ml. Excipients: each 5ml contains 2.7g liquid Maltitol (E965), 10mg parahydroxybenzoates (E218, E214, E216). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup Clear, pale yellow to colourless syrup with a sweet taste and pineapple flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a mucolytic adjunct in the management of lower respiratory tract disorders characterised by excessive or viscous mucus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Children aged 5 to 12 years: The usual dose is two 5ml Διαβάστε το πλήρες έγγραφο