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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0050/062/007
Case No: 2075450
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROCHE PRODUCTS LTD
6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ROCEPHIN, 2 G GRAMS
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 02/11/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/01/2010_
_CRN 2075450_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rocephin 2 g powder for solution for injection or infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 g vial contains 2 g ceftriaxone as 2.39 g ceftriaxone sodium.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White to yellowish-orange crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more
susceptible micro-organisms (see section 5.1) and when parenteral therapy is required:
o
Respiratory tract infections including pneumonia, acute and chronic bronchitis
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