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Sativex Oromucosal Spray



Jazz Pharmaceuticals Ireland LimitedPA23494/001/001

Main Information

Trade NameSativex Oromucosal Spray
Active SubstancesDelta-9-tetrahydrocannabinol botanical drug substance (thc bds)
Cannabidiol botanical drug substance (cbd bds)
Dosage FormOromucosal spray, solution
Licence HolderJazz Pharmaceuticals Ireland Limited
Licence NumberPA23494/001/001

Group Information

ATC CodeN02B OTHER ANALGESICS AND ANTIPYRETICS
N02BG10 cannabinoids

Status

License statusAuthorised
Licence Issued18/07/2014
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 Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017.
Marketing StatusMarketed

Documents

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