My HPRA: Register

HETLIOZ

20 Milligram Capsules Hard

Vanda Pharmaceuticals LimitedEU/1/15/1008/001

Main Information

Trade NameHETLIOZ
Active SubstancesTASIMELTEON
Strength20 Milligram
Dosage FormCapsules Hard
Licence HolderVanda Pharmaceuticals Limited
Licence NumberEU/1/15/1008/001

Group Information

ATC CodeN05CH03 tasimelteon

Status

Authorised/WithdrawnAuthorised
Licence Issued22/07/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of Licence

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print