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Remsima

120 milligram(s)/millilitre Solution for injection in pre-filled pen

Celltrion Healthcare Hungary Kft.EU/1/13/853/012-014

Main Information

Trade NameRemsima
Active SubstancesInfliximab
Strength120 milligram(s)/millilitre
Dosage FormSolution for injection in pre-filled pen
Licence HolderCelltrion Healthcare Hungary Kft.
Licence NumberEU/1/13/853/012-014

Group Information

ATC CodeL04AB02 infliximab

Status

Authorised/WithdrawnAuthorised
Licence Issued22/11/2019
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

Educational Materials - Patient

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