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Dupixent

200 milligram(s) Solution for injection

Sanofi-Aventis GroupeEU/1/17/1229/009-0016

Main Information

Trade NameDupixent
Active SubstancesDupilumab
Strength200 milligram(s)
Dosage FormSolution for injection
Licence HolderSanofi-Aventis Groupe
Licence NumberEU/1/17/1229/009-0016

Group Information

ATC CodeD11AH05 dupilumab

Status

Authorised/WithdrawnAuthorised
Licence Issued27/09/2017
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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