Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
SULFASALAZINE
Rosemont Pharmaceuticals Ltd
250 MG/5ml
Oral Suspension
2009-10-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0312/019/001 Case No: 2073612 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0936/040/005. ROSEMONT PHARMACEUTICALS ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS LS11 9XE, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SALAZOPYRIN 250MG/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 30/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/11/2009_ _CRN 2073612_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salazopyrin 250mg/5ml Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Salazopyrin Oral Suspension contains 250mg Sulfasalazine in each 5ml. Excipients: Each 5 ml dose contains 1.55mg of sodium Each 5 ml dose contains 6.10mg of ethanol Each 5 ml dose contains 1.650g of sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension. An orange-yellow coloured suspension with an orange/lemon flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS a) Induction and maintenance of remission of ulcerative colitis; tre Διαβάστε το πλήρες έγγραφο