MAR-APREMILAST TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

APREMILAST; APREMILAST; APREMILAST

Доступно од:

MARCAN PHARMACEUTICALS INC

АТЦ код:

L04AA32

INN (Међународно име):

APREMILAST

Дозирање:

10MG; 20MG; 30MG

Фармацеутски облик:

TABLET

Састав:

APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-11-14

Карактеристике производа

_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
.............................................................