MACROTEC Unknown
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
HUMAN ALBUMIN MACRO AGGREGATED
Available from:
Amersham Health Srl
Pharmaceutical form:
Unknown
Authorization date:
2007-11-23
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)
PA0401/003/001
Case No: 1010602
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
AMERSHAM HEALTH SRL
VIA CRESCENTINO, 13040 SALUGGIA (VERCELLI), ITALY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MACROTEC
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 23/11/2007 until 22/11/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2007_
_CRN 1010602_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Macrotec
Powder for suspension for injection
Kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin macroaggregates (MAA) 2.0mg
Each vial contains 4.5 x 10
6
MAA particles. The size range is 10-90µm.
The product is prepared from batches of human albumin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for the preparation of Technetium (
99m
Tc) Macrosalb Injection PhEur. The product comprises five vials each
containing a sterile white to off-white solid deposit.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medical product is for diagnostic use only
After la
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