TEMGESIC

This brand name is authorized in Austria, Finland, France, Germany, Hong Kong SAR China, Ireland, Mexico, Netherlands, New Zealand, Singapore, South Africa, Tunisia, Turkey, UK.

Active ingredients

The drug TEMGESIC 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 more about Buprenorphine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TEMGESIC Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
TEMGESIC Sublingual tablet	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		Classification
N02AE01	Buprenorphine	N Nervous system → N02 Analgesics → N02A Opioids → N02AE Oripavine derivatives
Discover more medicines within N02AE01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	09012306, 09012312, 09012335, 09012358
FI	Lääkealan turvallisuus- ja kehittämiskeskus	424959, 485473, 521634
FR	Base de données publique des médicaments	60549391, 62299972
GB	Medicines & Healthcare Products Regulatory Agency	19026, 19221, 36123
HK	Department of Health Drug Office	28718, 28719
IE	Health Products Regulatory Authority	48577
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	241M91, 467M89
NL	Z-Index G-Standaard	12505978
NL	Z-Index G-Standaard, PRK	16322, 72222
NZ	Medicines and Medical Devices Safety Authority	2325
SG	Health Sciences Authority	06115P, 06116P
TN	Direction de la Pharmacie et du Médicament	6523041BH
TR	İlaç ve Tıbbi Cihaz Kurumu	8699510050036, 8699510750639
ZA	Health Products Regulatory Authority	L/2.9/0158, L/2.9/157, S/2.7/327