This brand name is authorized in Austria, Germany, Finland, France, Hong Kong, Ireland, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa
The drug TEMGESIC 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 | |
|---|---|---|---|
| TEMGESIC Solution for injection | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC | |
| TEMGESIC Sublingual tablet | 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 |
|---|---|---|
| N02AE01 | Buprenorphine | N Nervous system → N02 Analgesics → N02A Opioids → N02AE Oripavine derivatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: DE | Bundesinstitut für Arzneimittel und Medizinprodukte | Identifier(s): 09012306, 09012312, 09012335, 09012358 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 424959, 485473, 521634 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60549391, 62299972 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 19026, 19221, 36123 |
| Country: HK | Department of Health Drug Office | Identifier(s): 28718, 28719 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 48577 |
| Country: MX | Comisión Federal para la Protección contra Riesgos Sanitarios | Identifier(s): 241M91, 467M89 |
| Country: NL | Z-Index G-Standaard | Identifier(s): 12505978 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 16322, 72222 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 2325 |
| Country: SG | Health Sciences Authority | Identifier(s): 06115P, 06116P |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 6523041BH |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699510050036, 8699510750639 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): L/2.9/0158, L/2.9/157, S/2.7/327 |
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