Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PROPOFOL
AstraZeneca UK Limited
10 Mg/Ml
Emulsion for Inj/Inf
1999-05-25
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 Read the complete document