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HERCEPTIN

600 MG/5ml Solution for Injection

Roche Registration LimitedEU/1/00/145/002

Main Information

Trade NameHERCEPTIN
Active SubstancesTRASTUZUMAB
Strength600 MG/5ml
Dosage FormSolution for Injection
Licence HolderRoche Registration Limited
Licence NumberEU/1/00/145/002

Group Information

ATC CodeL01XC03 Monoclonal antibodies

Status

Authorised/WithdrawnAuthorised
Licence Issued26/08/2013
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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