THALOMID CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

THALIDOMIDE

Available from:

CELGENE INC

ATC code:

L04AX02

INN (International Name):

THALIDOMIDE

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

THALIDOMIDE 100MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

Immunomodulatory Agents

Product summary:

Active ingredient group (AIG) number: 0152770002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-08-04

Summary of Product characteristics

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_Page 1 of 53_
PRODUCT MONOGRAPH
Pr
THALOMID
®
Thalidomide Capsules
House Standard
50 mg, 100 mg, 200 mg
Immunomodulatory Agent
SUBMISSION CONTROL NO: 283297
®
THALOMID is a registered trademark of Celgene Corporation used under
license by Bristol-Myers Squibb
Canada.
Bristol-Myers Squibb Canada
2344 Alfred-Nobel Blvd
Suite 300
Saint-Laurent, QC
H4S 0A4
DATE OF INITIAL AUTHORIZATION:
MAR 01, 2024
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_Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................3
SUMMARY PRODUCT INFORMATION
....................................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................................3
CONTRAINDICATIONS
...............................................................................................................5
WARNINGS AND PRECAUTIONS
..............................................................................................5
ADVERSE REACTIONS
..............................................................................................................15
DRUG INTERACTIONS
..............................................................................................................23
DOSAGE AND ADMINISTRATION
..........................................................................................25
OVERDOSAGE
............................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
........................................................................30
STORAGE AND STABILITY
......................................................................................................33
SPECIAL HANDLING INSTRUCTIONS
...................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................33
PART II: SCIENTIFIC INFORMATION
...