SUBOXONE

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

The drug SUBOXONE contains a combination of these active pharmaceutical ingredients (APIs):

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
2	Naloxone UNII F850569PQR - NALOXONE HYDROCHLORIDE
	Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists, such as pentazocine, for example, but also nalorphine.
	Read more about Naloxone

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SUBOXONE Sublingual tablet	MPI, EU: SmPC	European Medicines Agency (EU)

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
N07BC51	Buprenorphine, combinations	N Nervous system → N07 Other nervous system drugs → N07B Drugs used in addictive disorders → N07BC Drugs used in opioid dependence
Discover more medicines within N07BC51
V03AB15	Naloxone	V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes
Discover more medicines within V03AB15

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	9749D, 9750E
CA	Health Products and Food Branch	02295695, 02295709, 02468085, 02468093
EE	Ravimiamet	1266825, 1266836, 1266847, 1266858, 1703382, 1703393, 1823161, 1823172, 1823183, 1823194, 1823206, 1823217, 1823228, 1823239, 1823240, 1823251, 1823262, 1823273
ES	Centro de información online de medicamentos de la AEMPS	06359001, 06359003, 106359004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	039291, 407425, 407899, 431919, 462302, 520546
FR	Base de données publique des médicaments	63827255, 64381336
GB	Medicines & Healthcare Products Regulatory Agency	110476, 110484, 196202, 329024, 375357, 375359, 377038, 377040, 381682, 391637, 391641
HK	Department of Health Drug Office	56197, 56198
IL	מִשְׂרַד הַבְּרִיאוּת	7180, 7181, 9077, 9078
IT	Agenzia del Farmaco	037604016, 037604028, 037604030, 037604042, 037604055, 037604067, 037604079, 037604081, 037604093, 037604105, 037604117, 037604129, 037604131, 037604143, 037604156, 037604168, 037604170, 037604182
LT	Valstybinė vaistų kontrolės tarnyba	1030892, 1030893, 1037489, 1037490, 1079263, 1079264, 1090800, 1090801, 1090802, 1090803, 1090804, 1090805, 1090806, 1090807, 1090808, 1090809, 1090810, 1090811
NL	Z-Index G-Standaard, PRK	150193, 82155, 82163
NZ	Medicines and Medical Devices Safety Authority	21057, 21058, 21059, 21060, 9704, 9705
PL	Rejestru Produktów Leczniczych	100139456, 100174978, 100388768, 100442232, 100442249, 100442255, 100442261
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67344001, W67344002, W67345001, W67345002
SG	Health Sciences Authority	13404P, 13405P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699510050012, 8699510050029, 8699510050043, 8699510050050
US	FDA, National Drug Code	12496-1202, 12496-1204, 12496-1208, 12496-1212
ZA	Health Products Regulatory Authority	41/34/1010, 41/34/1011