RETROVIR Capsules, hard Ref.[8367] 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 250 mg capsules, hard.

Pharmaceutical Form

Capsules, hard.

Hard gelatin capsules with opaque blue cap and opaque white body coded GSJV2.

Qualitative and quantitative composition

Each capsule contains 250 mg zidovudine.

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

Capsule core:

Maize starch
Microcrystalline cellulose
Sodium starch glycollate
Magnesium stearate

Capsule coating:

Titanium dioxide E171
Gelatin

Printing ink (black inks opacode 10A1 or 10A2):

Shellac
Black iron oxide E172
Propylene glycol
Ammonium hydroxide, 28% (in black ink opacode 10A1 only)
Strong ammonium solution (in black ink opacode 10A2 only)
Potassium hydroxide (in black ink opacode 10A2 only)

Pack sizes and marketing

PVC/aluminium foil blister pack containing 40 capsules.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 35728/0002

Date of first authorisation: 03 March 1987
Date of last renewal: 14 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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