WAKIX Film-coated tablet Ref.[7629] Active ingredients: Pitolisant

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

Product name and form

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.

Qualitative and quantitative composition

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
Crospovidone type A
Talc
Magnesium stearate
Colloidal anhydrous silica

Coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

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

Drugs

Drug Countries
WAKIX Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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