DIPRIVAN Emulsion for injection or infusion Ref.[8033] Active ingredients: Propofol

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Diprivan 10 mg/ml (1%) emulsion for injection or infusion.

Pharmaceutical Form
Emulsion for injection or infusion. White aqueous isotonic oil-in-water emulsion.

Qualitative and quantitative composition

Propofol 10 mg/ml.

Excipient(s) with known effect: Soya-bean Oil, Refined Ph Eur

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Propofol	Propofol (2, 6-diisopropylphenol) is a short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds.

List of Excipients
Glycerol Ph Eur Purified egg phosphatide Sodium hydroxide Ph Eur Soya-bean oil, refined Ph Eur Water for injections Ph Eur Nitrogen Ph Eur Disodium edetate Ph Eur

Pack sizes and marketing

a) Clear neutral glass ampoules of 20 ml in boxes of 5

b) Clear neutral glass vials of 50 ml and 100 ml

c) Type 1 glass pre-filled syringe of 50 ml

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0074

Date of first authorisation: 15^th April 1986

Date of latest renewal: 24^th September 2004

Drugs

Drug	Countries
DIPRIVAN	Brazil, Canada, Cyprus, Ecuador, Spain, France, Hong Kong, Ireland, Japan, Mexico, Nigeria, Netherlands, New Zealand, Poland, United Kingdom, United States, South Africa

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