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ATOSIBAN SUN

37.5/5 Mg/Ml Concentrate for Soln for Inf

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

Main Information

Trade NameATOSIBAN SUN
Active SubstancesATOSIBAN
Strength37.5/5 Mg/Ml
Dosage FormConcentrate for Soln for Inf
Licence HolderSun Phamaceutical Industries Europe B.V.
Licence NumberEU/1/13/852/002

Group Information

ATC CodeG02CX01 atosiban

Status

Authorised/WithdrawnAuthorised
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 StatusUnknown

Documents

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