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ELOCTA

500 International Unit Pdr+Solv for Soln for Inj

Swedish Orphan Biovitrum International ABEU/1/15/1046/002

Main Information

Trade NameELOCTA
Active SubstancesEFMOROCTOCOG ALFA
Strength500 International Unit
Dosage FormPdr+Solv for Soln for Inj
Licence HolderSwedish Orphan Biovitrum International AB
Licence NumberEU/1/15/1046/002

Group Information

ATC CodeB02BD02 Blood coagulation factors

Status

Authorised/WithdrawnAuthorised
Licence Issued19/11/2015
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
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