MAR-APREMILAST TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
22-06-2022
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Werkstoffen:
APREMILAST; APREMILAST; APREMILAST
Beschikbaar vanaf:
MARCAN PHARMACEUTICALS INC
ATC-code:
L04AA32
INN (Algemene Internationale Benaming):
APREMILAST
Dosering:
10MG; 20MG; 30MG
farmaceutische vorm:
TABLET
Samenstelling:
APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Product samenvatting:
Active ingredient group (AIG) number: 0356230001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2022-11-14
Productkenmerken
_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
.............................................................
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