SUBUTEX

This brand name is authorized in Austria, Australia, Germany, Finland, France, Croatia, Ireland, Israel, Lithuania, Malta, Singapore, United Kingdom

Active ingredients

The drug SUBUTEX contains one active pharmaceutical ingredient (API):

1 Buprenorphine
UNII 56W8MW3EN1 - BUPRENORPHINE HYDROCHLORIDE

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.

Read about Buprenorphine

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
Subutex 2mg sublingual tablets Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
N07BC01 Buprenorphine N Nervous system → N07 Other nervous system drugs → N07B Drugs used in addictive disorders → N07BC Drugs used in opioid dependence
Discover more medicines within N07BC01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 6307Y, 6308B, 6309C
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00582999, 00583007, 00583065, 00583088, 00583094
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 132590, 534027
Country: FR Base de données publique des médicaments Identifier(s): 63025935, 65150204, 68945058
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 139576, 162512, 162516, 162518, 19025, 19046, 19222, 373969, 377042
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4383, 4384
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1019799, 1019800, 1019801, 1019802, 1021806, 1021807
Country: MT Medicines Authority Identifier(s): MA1259/00101, MA1259/00102
Country: SG Health Sciences Authority Identifier(s): 11273P, 11274P, 11275P

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