SUBOXONE

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

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 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 about Naloxone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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