DARAPRIM Tablet Ref.[9301] Active ingredients: Pyrimethamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: The Wellcome Foundation Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Trading as: GlaxoSmithKline UK

Product name and form

Daraprim 25 mg Tablets.

Pharmaceutical Form

Tablet.

Each tablet is white and round with the marking GS A3A.

Qualitative and quantitative composition

Each tablet contains 25 mg of pyrimethamine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pyrimethamine

Pyrimethamine is an antiparasitic agent. The antiparasitic action of pyrimethamine is due to its specific activity on folic acid metabolism in the Plasmodium and Toxoplasma parasites.

List of Excipients

Lactose monohydrate
Maize starch
Hydrolysed starch
Docusate sodium
Magnesium stearate

Pack sizes and marketing

PVC/PVdC/aluminium foil blister pack or PVC/PVdC/child-resistant aluminium foil blister pack.

Pack size: 30 tablets.

Marketing authorization holder

The Wellcome Foundation Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Trading as: GlaxoSmithKline UK

Marketing authorization dates and numbers

PL 00003/5026R

Date of first authorisation: 25 September 1986

Date of latest renewal: 19 February 2011

Drugs

Drug Countries
DARAPRIM Brazil, Estonia, Spain, Malta, Mexico, Netherlands, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.