My HPRA: Register

ZALVISO

15 Microgram Tablet Sublingual

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

Main Information

Trade NameZALVISO
Active SubstancesSUFENTANIL CITRATE
Strength15 Microgram
Dosage FormTablet Sublingual
Licence HolderGrunenthal GmbH
Licence NumberEU/1/15/1042/001-006

Group Information

ATC CodeN01AH03 SUFENTANIL

Status

Authorised/WithdrawnAuthorised
Licence Issued18/09/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing StatusMarketed
Promotion StatusPromotion 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.

Documents

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

Educational Materials - HCP

Administration Guide
« Back
Follow medicine

Print