AURO-APREMILAST TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-01-2022
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Active ingredient:
APREMILAST; APREMILAST; APREMILAST
Available from:
AURO PHARMA INC
ATC code:
L04AA32
INN (International Name):
APREMILAST
Dosage:
10MG; 20MG; 30MG
Pharmaceutical form:
TABLET
Composition:
APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0356230001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-11-14
Summary of Product characteristics
Page 1 of 34
PRODUCT MONOGRAPH
PR
AURO-APREMILAST
Apremilast Tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
January 6, 2022
Submission Control No: 245218
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
.........................................................................................................3
WARNINGS AND PRECAUTIONS
.........................................................................................4
ADVERSE REACTIONS
..........................................................................................................6
DRUG INTERACTIONS
........................................................................................................
10
DOSAGE AND
ADMINISTRATION......................................................................................
12
OVERDOSAGE
.....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
13
STORAGE AND
STABILITY.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 16
PART II: SCIENTIFIC INFORMATION
................................................................................
18
PHARMACEUTICAL
INFORMATION..................................................................................
18
CLINICAL TRIALS
...............................................................................................
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