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AMGEVITA

40 Milligram Solution for Injection

Amgen Europe B.V.EU/1/16/1164/002-009

Main Information

Trade NameAMGEVITA
Active SubstancesADALIMUMAB
Strength40 Milligram
Dosage FormSolution for Injection
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/16/1164/002-009

Group Information

ATC CodeL04AB04 Tumor necrosis factor alpha (TNF-a) inhibitors

Status

Authorised/WithdrawnAuthorised
Licence Issued
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 LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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