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Esketamine Sintetica 5 mg/ml solution for injection/infusion



Sintetica GmbHPA22835/002/001

Main Information

Trade NameEsketamine Sintetica 5 mg/ml solution for injection/infusion
Active SubstancesESKETAMINE HYDROCHLORIDE
Dosage FormSolution for injection/infusion
Licence HolderSintetica GmbH
Licence NumberPA22835/002/001

Group Information

ATC CodeN01AX14 esketamine

Status

License statusAuthorised
Licence Issued02/10/2020
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 special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 3(2) to the Misuse of Drugs Regulations 2017.
Marketing StatusNot marketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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