Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
PERGOLIDE MESILATE
Eli Lilly and Company Limited
1000 Microgram
Tablets
1993-10-18
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0047/073/003 Case No: 2085192 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ELI LILLY AND COMPANY LIMITED LILLY HOUSE, PRIESTLEY ROAD, BASINGSTOKE, HAMPSHIRE, RG24 9NL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CELANCE 1000 MICROGRAM TABLETS the particulars of which are set out in 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 07/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/07/2010_ _CRN 2085192_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celance 1000 microgram tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains pergolide mesilate equivalent to 1000 micrograms of pergolide. Excipient: Contains 286mg of lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pink, modified rectangle shaped, scored, marked “Lilly 4135”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pergolide mesilate is an ergot derivative dopamine receptor agonist at D 1 , D 2 and D 3 receptor sites. If treatment with a dopamine agonist is being considered, pergolide mesilate is indicated as second line the Perskaitykite visą dokumentą