Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
RISPERIDONE
Sinclair IS Pharma Limited
RISPERIDONE
6 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-12-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0915/014/006 Case No: 2035485 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HELSINN BIREX THERAPEUTICS LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RADLINN 6MG FILM-COATED TABLETS 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 02/05/2008 until 01/05/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/05/2008_ _CRN 2035485_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Radlinn 6mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 6mg of risperidone and 345.90mg of lactose monohydrate. Each 6mg tablet also contains the colouring agent FD & C Yellow No.5 Al Lake (Tartrazine Lake) (E102). For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets Yellow, round shaped, biconvex film-coated tablet with “6” on one side and “RSP” on the other side with a score line separating the “R” from the “SP”. The score line is only to facilitate breaking for ease of swallowing and not to Lue koko asiakirja