RETROVIR Concentrate for solution for infusion Ref.[8369] Active ingredients: Zidovudine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Retrovir 10 mg/ml IV Concentrate for Solution for Infusion.

Pharmaceutical Form

Concentrate for solution for infusion (Sterile concentrate).

Retrovir IV for Infusion is a clear, nearly colourless, sterile aqueous solution with a pH of approximately 5.5.

Qualitative and quantitative composition

Vials containing zidovudine 200 mg in 20ml solution (10 mg zidovudine/ml).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Zidovudine

Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV).

List of Excipients

Hydrochloric acid (pH for adjustment)
Sodium hydroxide (pH for adjustment)
Water for injection

Pack sizes and marketing

Type I glass vial (amber, neutral glass) with chlorobutyl rubber stopper containing 20ml sterile concentrate, available in pack sizes of 5.

Marketing authorization holder

ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 35728/0005

Date of first authorisation: 20 April 1993
Date of last renewal: 19 July 2011

Drugs

Drug Countries
RETROVIR Austria, Australia, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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