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Diacomit



BiocodexEU/1/06/367/013

Main Information

Trade NameDiacomit
Active SubstancesStiripentol
Dosage FormCapsule, hard
Licence HolderBiocodex
Licence NumberEU/1/06/367/013

Group Information

ATC CodeN03AX17 stiripentol

Status

Authorised/WithdrawnAuthorised
Licence Issued09/03/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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