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Spravato



Janssen-Cilag International NVEU/1/19/1410/001-004

Main Information

Trade NameSpravato
Active SubstancesESKETAMINE HYDROCHLORIDE
Esketamine
Dosage FormNasal spray, solution
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/19/1410/001-004

Group Information

ATC CodeN06AX27 esketamine

Status

License statusAuthorised
Licence Issued18/12/2019
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 StatusUnknown

Documents

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

Educational Materials - HCP

HCP Checklist
HCP Guide

Educational Materials - Patient

Patient Guide
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