SUBOXONE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)

Commercializzato da:

INDIVIOR UK LIMITED

Codice ATC:

N07BC51

INN (Nome Internazionale):

BUPRENORPHINE, COMBINATIONS

Dosaggio:

8MG; 2MG

Forma farmaceutica:

TABLET

Composizione:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2MG

Via di somministrazione:

SUBLINGUAL

Confezione:

7/28

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE PARTIAL AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0252216002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2007-05-18

Scheda tecnica

_Product Monograph Master Template _
_Template Date: September 2020 _
_SUBOXONE (buprenorphine / naloxone) _
_Page 1 of 76_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
SUBOXONE®
Buprenorphine and Naloxone Sublingual Tablet
Sublingual Tablet; buprenorphine (as buprenorphine HCl) / naloxone (as
naloxone HCl),
2 mg / 0.5 mg, 8 mg / 2 mg, 12 mg / 3 mg and 16 mg / 4 mg, Sublingual
use
Manufacturer’s Standard
N
SUBOXONE®
Buprenorphine and Naloxone Film, soluble
Film, soluble; buprenorphine (as buprenorphine HCl) / naloxone (as
naloxone HCl),
2 mg / 0.5 mg, 4 mg / 1 mg, 8 mg / 2 mg and 12 mg / 3 mg, Buccal use,
Sublingual use
Partial Opioid Agonist
and
Opioid Antagonist
Manufactured by:
Indivior UK Limited
The Chapleo Building
Henry Boot Way
Hull, HU4 7DY
United Kingdom of Great Britain and Northern Ireland (the)
Imported and Distributed by:
Pharma Importing Inc.
39 Knighton Drive
Toronto, ON M4A 1V9
Date of Initial Authorization:
MAY 17, 2007
Date of Revision:
Mar 16, 2023
Submission Control Number: 269182
_Product Monograph Master Template _
_Template Date: September 2020 _
_SUBOXONE (buprenorphine / naloxone) _
_Page 2 of 76_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.4 Administration
03/2023
7 Warnings and Precautions, Gastrointestinal
03/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
.......