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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)
PA0970/005/002
Case No: 2063056
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DIPRIVAN 1% W/V EMULSION FOR INJECTION OR INFUSION
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 29/07/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/07/2009_
_CRN 2063056_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diprivan 1% w/v Emulsion for Injection or Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Propofol 10mg/ml.
Each 50ml vial contains 500mg Propofol.
Each 100ml vial contains 1,000mg Propofol.
Contains sodium 0.0018mmol/ml.
Contains refined Soya-bean oil 100mg/ ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection or infusion.
A white or almost white emulsion for injection or infusion, supplied in Type I glass vials.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diprivan is a short-acting intravenous anaesthetic agent suitable for induction and
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