FLUDARABINE PHOSPHATE ACTAVIS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
FLUDARABINE PHOSPHATE
Available from:
Actavis Group PTC ehf
Dosage:
50 Milligram
Pharmaceutical form:
Lyophilisate for solution for injection
Authorization date:
2008-08-22
Summary of Product characteristics
License
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. No.540 of 2007)
PA1380/003/001
Case No: 2064890
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
Fludarabine Phosphate Actavis 50 mg Powder For Solution For Injection or Infusion
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 24/07/2009 until 21/08/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 24/07/2009
CRN 2064890
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Fludarabine Phosphate Actavis 50
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