Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi Mature IP, 54 rue La Boétie, 75008, Paris, France
RILUTEK 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. The tablets are capsule-shaped, white and engraved with “RPR 202” on one side. |
Each film-coated tablet contains 50 mg of riluzole.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Riluzole |
Riluzole is proposed to act by inhibiting glutamate processes. The mode of action is unclear. It is suggested that glutamate (the primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the ALS disease. |
| List of Excipients |
|---|
|
Core: Dibasic calcium phosphate, anhydrous Coating: Hypromellose |
Tablets are packaged in opaque pvc/aluminium blister cards.
Each package contains 56 tablets.
Sanofi Mature IP, 54 rue La Boétie, 75008, Paris, France
EU/1/96/010/001
Date of first authorisation: 10 June 1996
Date of last renewal: 10 June 2006
| Drug | Countries | |
|---|---|---|
| RILUTEK | Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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