DACARBAZINE FOR INJECTION BP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
DACARBAZINE
Available from:
HOSPIRA UK Ltd
Dosage:
200 Milligram
Pharmaceutical form:
Pdr for Soln for Injection
Authorization date:
1998-05-15
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)
PA0437/040/002
Case No: 2072705
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
HOSPIRA UK LTD
QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DACARBAZINE 200MG 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 15/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/01/2010_
_CRN 2072705_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacarbazine 200mg Powder for Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200mg of dacarbazine.
When reconstituted as directed in sections 4.2 and 6.6, each ml of medicinal solution contains 10mg of
dacarbazine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White or very pale yellow powder or plug.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
Metastatic malignant melanoma
2.
Solid tumours
3.
Hodgkin's disease
In addition, dacarbazine has been shown, when used in combination with other a
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