SUBUTEX

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

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 more about Buprenorphine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Subutex 2mg sublingual tablets	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
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)
AU	Pharmaceutical Benefits Scheme	6307Y, 6308B, 6309C
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00582999, 00583007, 00583065, 00583088, 00583094
FI	Lääkealan turvallisuus- ja kehittämiskeskus	132590, 534027
FR	Base de données publique des médicaments	63025935, 65150204, 68945058
GB	Medicines & Healthcare Products Regulatory Agency	139576, 162512, 162516, 162518, 19025, 19046, 19222, 373969, 377042
HR	Agencija za lijekove i medicinske proizvode	HR-H-445451077, HR-H-972538274
IL	מִשְׂרַד הַבְּרִיאוּת	4383, 4384
LT	Valstybinė vaistų kontrolės tarnyba	1019799, 1019800, 1019801, 1019802, 1021806, 1021807
MT	Medicines Authority	MA1259/00101, MA1259/00102
SG	Health Sciences Authority	11273P, 11274P, 11275P