Source: HPRA (Health Products Regulatory Authority)
Instituto Grifols S.A.
Solution for Infusion
License IRISH MEDICINES BOARD ACT 1995, as amended Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended PA0849/004/001 Case No: 2070717 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Instituto Grifols S.A. CAN Guasch 2, Parets del Valles 08150, Barcelona, Spain an authorisation, subject to the provisions of the said Regulations, in respect of the product Flebogamma 5% Solution for Infusion. Human Normal Immunoglobulin for Intravenous Administration. 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 08/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. Irish Medicines Board ______________________________________________________________________________________________________________________ Date Printed 24/08/2010 CRN 2070717 page number: 1 Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Flebogamma 5%. Solution for Infusion. Human Normal Immunoglobulin Read the complete document