CELSENTRI Oral solution Ref.[116178] Active ingredients: Maraviroc

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

CELSENTRI 20 mg/mL oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless, oral solution.

Qualitative and quantitative composition

Each mL of oral solution contains 20 mg maraviroc.

Excipient with known effect: Each mL of oral solution contains 1 mg sodium benzoate (E211).

For the full list of excipients, see section 6.1.

Active Ingredient

Maraviroc is a member of a therapeutic class called CCR5 antagonists. Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
List of Excipients

Citric acid (anhydrous)
Sodium citrate dihydrate
Sucralose
Sodium benzoate (E211)
Strawberry flavouring
Purified water

Pack sizes and marketing

High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution. The pack also includes a low density polyethylene or thermoplastic elastomeric press in bottle adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with mL graduations) and a polyethylene plunger.

The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.

Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/07/418/013

Date of first authorisation: 18th September 2007
Date of latest renewal: 20 July 2012

Drugs

Drug Countries
CELSENTRI Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa
 
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