Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
PERGOLIDE MESILATE
Eli Lilly and Company Limited
PERGOLIDE MESILATE
50 Microgram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2012-05-31
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0047/073/001 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 50 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 50 microgram tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains pergolide mesilate equivalent to 50 micrograms of pergolide. Excipient: Contains 287mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Ivory, modified rectangle shaped tablet, scored and marked “Lilly 4131”. 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 l Прочетете целия документ