THALOMID CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-08-2019
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Active ingredient:
THALIDOMIDE
Available from:
CELGENE INC
ATC code:
L04AX02
INN (International Name):
THALIDOMIDE
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
THALIDOMIDE 150MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
Immunomodulatory Agents
Product summary:
Active ingredient group (AIG) number: 0152770003; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-08-04
Summary of Product characteristics
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_Page 1 of 43_
PRODUCT MONOGRAPH
Pr
THALOMID
®
Thalidomide Capsules House Standard
50 mg, 100 mg, 200 mg
Immunomodulatory Agent
Celgene Inc.
6755 Mississauga Road
Suite 600
Mississauga, ON
L5N 7Y2
DATE OF REVISION:
August 19, 2019
SUBMISSION CONTROL NO: 229244
©
2010-2019 Celgene Corporation.
®
THALOMID is a registered trademark of Celgene Corporation.
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_Page 2 of 43_
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
..............................................................................................................13
DRUG INTERACTIONS
..............................................................................................................17
DOSAGE AND ADMINISTRATION
..........................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
........................................................................24
STORAGE AND STABILITY
......................................................................................................27
SPECIAL HANDLING INSTRUCTIONS
...................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................28
PART II: SCIENTIFIC INFORMATION
....................................................................................29
PHARMACEUTICAL INFORMATION
.......................................................................
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