GLN-APREMILAST TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
06-08-2021
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Werkstoffen:
APREMILAST; APREMILAST; APREMILAST
Beschikbaar vanaf:
GLENMARK PHARMACEUTICALS CANADA 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
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_GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _
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PRODUCT MONOGRAPH
PR
GLN-APREMILAST
apremilast tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West,
Suite 407, Concord, ON
L4K 4M2
Date of Preparation:
August 06, 2021
Submission Control No: 243974
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_GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _
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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
..................................................................................................
7
DRUG INTERACTIONS
................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE..............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 15
STORAGE AND STABILITY
........................................................................................
18
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................... 18
PART II: SCIENTIFIC INFORMATION
........................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL
TRIALS............................................................................
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