מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CICLOSPORIN
Actavis Group PTC ehf
CICLOSPORIN
50 Milligram
Capsule
Withdrawn
2009-03-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1380/029/002 Case No: 2057297 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACTAVIS GROUP PTC EHF REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CICLOSPORIN PHARMACHEMIE, 50 MILLIGRAM 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 05/11/2008 until . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/11/2008_ _CRN 2057297_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciclosporin Pharmachemie 50 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg Ciclosporin. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. Ciclosporin Pharmachemie 50 mg Capsules are grey soft gelatin capsules with imprinting “DX 50 mg”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ORGAN TRANSPLANTATION_ Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas transplants. Treatment of transplant rejection in patients previously receiving other immunosuppressive agents. _BONE MARROW TRANSPLANTATION_ Prevention of g קרא את המסמך השלם