País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Arrow Generics Limited
1 Milligram
Tablets
2008-02-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1130/010/001 Case No: 2062932 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ARROW GENERICS LIMITED UNIT 2, EASTMAN WAY, STEVENAGE, HERTFORDSHIRE, SG1 4SZ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CABEREX 1MG 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 16/03/2010 until 07/02/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/03/2010_ _CRN 2062932_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caberex 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg cabergoline. Excipient: lactose monohydrate 74.5mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white to off-white, oval-shaped tablet, embossed with ‘C| 1’ on one side and ‘partial score >’ on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF PARKINSON’S DISEASE If treatment with a dopamine agonist is being considered, cabergoline is indicated as second line therapy in patients who are intole Leia o documento completo