BALANCE 2.3% GLUCOSE, 1.75MMOL/L CALCIUM

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE ANHYDROUS SODIUM LACTATE

Available from:

Fresenius Medical Care Deutschland GmbH

Dosage:

2.3%/1.75mmol/l %v/v

Pharmaceutical form:

Soln for Peritoneal Dialysis

Authorization date:

2003-09-19

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)
PA0953/005/003
Case No: 2066197
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Fresenius Medical Care Deutschland GmbH
D-61346 Bad Homburg, Germany
an authorisation, subject to the provisions of the said Regulations, in respect of the product
balance 2.3% glucose, 1.75mmol/l calcium, solution for peritoneal dialysis
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 17/11/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 28/01/2010
CRN 2066197
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
balance 2.3% glucose, 1.75 mmol/l calcium, solution for perito