GLN-APREMILAST TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-08-2021
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Active ingredient:
APREMILAST
Available from:
GLENMARK PHARMACEUTICALS CANADA INC.
ATC code:
L04AA32
INN (International Name):
APREMILAST
Dosage:
30MG
Pharmaceutical form:
TABLET
Composition:
APREMILAST 30MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0156231002; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-11-14
Summary of Product characteristics
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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
_Pr_
_GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _
_Page 2 of 37_
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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