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Zalviso

15 microgram(s) Sublingual tablet

Grunenthal GmbHEU/1/15/1042/001-006

Main Information

Trade NameZalviso
Active SubstancesSUFENTANIL CITRATE
Strength15 microgram(s)
Dosage FormSublingual tablet
Licence HolderGrunenthal GmbH
Licence NumberEU/1/15/1042/001-006

Group Information

ATC CodeN01AH Opioid anesthetics
N01AH03 sufentanil

Status

Authorised/WithdrawnAuthorised
Licence Issued18/09/2015
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

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