FLEBOGAMMA Solution for Infusion 50 g/l
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
HUMAN IMMUMOGLOBULINS
Available from:
Instituto Grifols S.A.
Dosage:
50 g/l
Pharmaceutical form:
Solution for Infusion
Authorization date:
2000-03-08
Summary of Product characteristics
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&#
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