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Zalviso



FGK Representative Service GmbHEU/1/15/1042/001-006

Main Information

Trade NameZalviso
Active SubstancesSUFENTANIL CITRATE
Dosage FormSublingual tablet
Licence HolderFGK Representative Service GmbH
Licence NumberEU/1/15/1042/001-006

Group Information

ATC CodeN01AH Opioid anesthetics
N01AH03 sufentanil

Status

License statusWithdrawn
Withdrawn Date05/08/2022
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). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988), as amended.
Marketing StatusNot marketed

Documents

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

Educational Materials - HCP

Administration Guide
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