AMIKIN Solution for Injection 250 %v/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
AMIKACIN SULFATE
Available from:
Bristol-Myers Squibb (Holdings) Limited
Dosage:
250 %v/v
Pharmaceutical form:
Solution for Injection
Authorization date:
1976-07-17
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)
PA0048/004/006
Case No: 2050682
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Bristol-Myers Squibb (Holdings)
T/A Bristol-Myers Pharmaceuticals, Swords, Co. Dublin, Ireland
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Amikin Injection 500mg/2ml.
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 28/01/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 28/01/2009
CRN 2050682
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Amikin Injection 500 mg/2 ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml vial contai
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