Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
CELSENTRI 25 mg film-coated tablets.
CELSENTRI 75 mg film-coated tablets.
CELSENTRI 150 mg film-coated tablets.
CELSENTRI 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. CELSENTRI 25 mg film-coated tablets: Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”. CELSENTRI 75 mg film-coated tablets: Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”. CELSENTRI 150 mg film-coated tablets: Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”. CELSENTRI 300 mg film-coated tablets: Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”. |
CELSENTRI 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of maraviroc.
Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin.
CELSENTRI 75 mg film-coated tablets: Each film-coated tablet contains 75 mg of maraviroc.
Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin.
CELSENTRI 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of maraviroc.
Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin.
CELSENTRI 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of maraviroc.
Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Maraviroc |
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 |
|---|
|
Tablet core: Cellulose, microcrystalline Film-coat: Poly (vinyl alcohol) |
CELSENTRI 25 mg film-coated tablets: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
CELSENTRI 75 mg film-coated tablets: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
CELSENTRI 150 mg film-coated tablets: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
CELSENTRI 300 mg film-coated tablets: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Not all pack sizes may be marketed.
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
CELSENTRI 25 mg film-coated tablets:
EU/1/07/418/011
CELSENTRI 75 mg film-coated tablets:
EU/1/07/418/012
CELSENTRI 150 mg film-coated tablets:
EU/1/07/418/001 (180 tablets)
EU/1/07/418/002 (30 tablets)
EU/1/07/418/003 (60 tablets)
EU/1/07/418/004 (90 tablets)
EU/1/07/418/005 (2 × 90 tablets – multipack)
CELSENTRI 300 mg film-coated tablets:
EU/1/07/418/006 (180 tablets)
EU/1/07/418/007 (30 tablets)
EU/1/07/418/008 (60 tablets)
EU/1/07/418/009 (90 tablets)
EU/1/07/418/010 (2 × 90 tablets – multipack)
Date of first authorisation: 18th September 2007
Date of latest renewal: 20 July 2012
| 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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