This brand name is authorized in Austria, Australia, Germany, Finland, France, Croatia, Ireland, Israel, Lithuania, Malta, Singapore, United Kingdom
The drug SUBUTEX contains one active pharmaceutical ingredient (API):
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1
Buprenorphine
UNII 56W8MW3EN1 - BUPRENORPHINE HYDROCHLORIDE
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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. |
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 |
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 |
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: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-445451077, HR-H-972538274 |
| 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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