Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
CLOSTRIDIUM BOTULINUM TYP A-ANTITOXIN
Ipsen Limited
500 Units/ml
Pdr for Soln for Injection
2008-12-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0583/001/002 Case No: 2047433 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IPSEN LIMITED 190 BATH ROAD, SLOUGH, BERKSHIRE SL1 3XE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DYSPORT, POWDER FOR SOLUTION FOR INJECTION 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 19/12/2008 until 07/12/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/12/2008_ _CRN 2047433_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dysport, powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Clostridium botulinum _type A toxin-haemagglutinin complex 500 U * * U = Unit of Activity = 1 mouse LD50 (MLD50) which is the quantity of material that kills 50% of mice when injected intraperitoneally. During the development of botulinum type A toxin haemagglutinin complex, the activity was commonly expressed in terms of a nominal weight, based upon a standard specific activity of 4 x 10 7 units/mg. Any reference to this product expressed in nanograms, whether in the literature or elsewhere, may therefor Izlasiet visu dokumentu