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OPDIVO

10 Mg/Ml Concentrate for Soln for Inf

Bristol-Myers Squibb Pharma EEIGEU/1/15/1014/001-002

Main Information

Trade NameOPDIVO
Active SubstancesNIVOLUMAB
NIVOLUMAB
Strength10 Mg/Ml
Dosage FormConcentrate for Soln for Inf
Licence HolderBristol-Myers Squibb Pharma EEIG
Licence NumberEU/1/15/1014/001-002

Group Information

ATC CodeL01XC Monoclonal antibodies

Status

Authorised/WithdrawnAuthorised
Licence Issued19/06/2015
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

Educational Materials - HCP

HCP Brochure

Educational Materials - Patient

Patient Alert Card (Read Only)
Patient Alert Card (Printer Friendly)
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