Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
INDOCYANINE GREEN
PULSION Medical Systems AG
INDOCYANINE GREEN
50 Milligram
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-10-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1177/001/002 Case No: 2066940 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PULSION MEDICAL SYSTEMS AG JOSEPH-WILD-STR.20, 81829 MUNICH, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product ICG-PULSION 50 MG POWDER FOR SOLUTION FOR INJECTION 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 22/07/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/07/2009_ _CRN 2066940_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ICG-PULSION 50 mg, Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg indocyanine green (to be reconstituted with 10 ml of water for injections). 1 ml of the reconstituted solution for injection contains 5 mg indocyanine green. For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for Solution for Injection. Dark-green powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Diagnostic indications CARDIAC, CIRCULATORY AND MICRO-CIRCULATORY DIAGNOSTICS: o measurement of cardiac output and Lestu allt skjalið