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, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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