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Sun Phamaceutical Industries Europe B.V.EU/1/13/852/002

Main Information

Active SubstancesATOSIBAN
Dosage FormConcentrate for solution for infusion
Licence HolderSun Phamaceutical Industries Europe B.V.
Licence NumberEU/1/13/852/002

Group Information

ATC CodeG02CX01 atosiban


License statusAuthorised
Licence Issued31/07/2013
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 products on “restricted” medical prescription, reserved for use in certain specialised areas (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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