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10 UN %v/v Pdr+Solv for Soln for Inj

Actavis Group PTC ehfEU/1/96/018/001

Main Information

Active SubstancesRETEPLASE
Strength10 UN %v/v
Dosage FormPdr+Solv for Soln for Inj
Licence HolderActavis Group PTC ehf
Licence NumberEU/1/96/018/001

Group Information

ATC CodeB01AD07 reteplase


Licence Issued29/08/1996
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 Status


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