FOLINIC ACID
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
CALCIUM FOLINATE
Available from:
Ebewe Pharma Ges.m.b.H Nfg. KG
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Inj/Inf
Authorization date:
2001-07-27
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0789/011/001
Case No: 2057845
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
EBEWE PHARMA GES.M.B.H NFG. KG
MONDSEESTRASSE 11, A-4866 UNTERACH, AUSTRIA
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FOLINIC ACID (AS CALCIUM FOLINATE) 10MG/ML SOLUTION FOR INJECTION OR INFUSION, AMPOULES
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 03/10/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/10/2010_
_CRN 2057845_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion, ampoules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
12.71 mg of calcium folinate 5H
2
O equivalent to 10 mg of folinic acid per ml
Each 3 ml ampoule contains 30 mg of folinic acid provided as calcium folinate.
Each 5 ml ampoule contains 50 mg of folinic acid provided as calcium folinate.
Each 10 ml ampoule contains 100 mg of folinic acid provided as calcium folinate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
Folinic acid (as calcium folinate)
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