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Zubsolv



Accord Healthcare S.L.U.EU/1/17/1233/005

Main Information

Trade NameZubsolv
Active SubstancesBuprenorphine hydrochloride
Naloxone hydrochloride dihydrate
Dosage FormSublingual tablet
Licence HolderAccord Healthcare S.L.U.
Licence NumberEU/1/17/1233/005

Group Information

ATC CodeN07BC Drugs used in opioid dependence
N07BC51 buprenorphine, combinations

Status

License statusAuthorised
Licence Issued10/11/2017
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 2017.
Marketing StatusUnknown

Documents

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