Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France, Tel: +33 (0)1 47 03 66 33, Fax: +33 (0)1 47 03 66 30, e-mail: contact@bioprojet.com
Wakix 4.5 mg film-coated tablets.
Wakix 18 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Wakix 4.5 mg film-coated tablet: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side. Wakix 18 mg film-coated tablet: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side. |
Wakix 4.5 mg film-coated tablet: Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
Wakix 18 mg film-coated tablet: Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pitolisant |
Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Coating: Polyvinyl alcohol |
High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Bottle of 30 or 90 film-coated tablets.
Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Wakix 18 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 1 bottle of 90 tablets or multi-packs containing 90 (3 bottles of 30) tablets.
Not all pack sizes may be marketed.
Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France, Tel: +33 (0)1 47 03 66 33, Fax: +33 (0)1 47 03 66 30, e-mail: contact@bioprojet.com
EU/1/15/1068/001
EU/1/15/1068/002
EU/1/15/1068/003
EU/1/15/1068/004
Date of first authorisation: 31/03/2016
| Drug | Countries | |
|---|---|---|
| WAKIX | Austria, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, 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.
