MAR-APREMILAST TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

APREMILAST; APREMILAST; APREMILAST

Disponible depuis:

MARCAN PHARMACEUTICALS INC

Code ATC:

L04AA32

DCI (Dénomination commune internationale):

APREMILAST

Dosage:

10MG; 20MG; 30MG

forme pharmaceutique:

TABLET

Composition:

APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0356230001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2022-11-14

Résumé des caractéristiques du produit

_Page 1 of 35 _
PRODUCT MONOGRAPH
PR
MAR-APREMILAST
apremilast tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
MARCAN PHARMACEUTICALS INC.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
SUBMISSION CONTROL NO.: 246219
DATE OF PREPARATION:
June 22, 2022
_Page 2 of 35 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
...........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................................
13
OVERDOSAGE
.....................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY...........................................................................
14
STORAGE AND STABILITY
...................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 17
PART II: SCIENTIFIC INFORMATION
...................................................................................
18
PHARMACEUTICAL INFORMATION
.....................................................................................
18
CLINICAL TRIALS
.............................................................