ENDOREM Concentrate for Susp for Inf 11.2 Base mg/ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
IRON OXIDE SUPERPAROMAGNETIC
Available from:
GUERBET
Dosage:
11.2 Base mg/ml
Pharmaceutical form:
Concentrate for Susp for Inf
Authorization date:
1995-03-14
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0686/001/001
Case No: 2058562
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GUERBET
BP 57400, 95943 ROISSY CDG CEDEX, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ENDOREM, 11.2 MG FE/ML, CONCENTRATE FOR SUSPENSION FOR 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 23/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/09/2009_
_CRN 2058562_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ENDOREM, 11.2 mg Fe/mL, concentrate for suspension for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
- Per 1 mL:
Superparamagnetic iron oxide nanoparticles
15.8 mg
corresponding to an iron content
11.2 mg
After dilution in 100 mL of 5% isotonic glucose solution, 1 mL contains 0.112 mg of iron
- Per ampoule (8 mL):
Superparamagnetic iron oxide nanoparticles
126.500 mg
corresponding to an iron content
89.600 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for suspension for infusion.
Dark brown to black dispersion of iron oxide nanoparticles
4 CLINICAL PARTICULARS
4.1 THERA
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