HETLIOZ Hard capsule Ref.[114772] Active ingredients: Tasimelteon

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Vanda Pharmaceuticals Netherlands B.V., Basisweg 10, 1043 AP Amsterdam, The Netherlands

Product name and form

HETLIOZ 20 mg hard capsules.

Pharmaceutical Form
Hard capsule. Dark blue opaque, hard capsule (dimensions 19.4 mm x 6.9 mm) marked with ‘VANDA 20 mg’ in white ink.

Qualitative and quantitative composition

Each hard capsule contains 20 mg tasimelteon.

Excipients with known effect:

Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Tasimelteon	Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN). Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT₁ and MT₂ receptors. These receptors are thought to be involved in the control of circadian rhythms.

List of Excipients
Hard capsule core: Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Hard capsule shell: Gelatin Titanium dioxide Brilliant Blue FCF Erythrosine Orange Yellow S (E110) White printing ink: Shellac Propylene glycol Sodium hydroxide Povidone Titanium dioxide

Pack sizes and marketing

High density polyethylene (HDPE) bottle containing 30 hard capsules with polypropylene child-resistant closures containing polypropylene resin induction seals. Each bottle also contains a 1.5 g silica gel desiccant canister and polyester dunnage.

Pack size: 30 hard capsules.

Marketing authorization holder

Vanda Pharmaceuticals Netherlands B.V., Basisweg 10, 1043 AP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/15/1008/001

Date of first authorisation: 3 July 2015
Date of latest renewal: 3 July 2020

Drugs

Drug	Countries
HETLIOZ	Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, United States

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