THALOMID CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

THALIDOMIDE

Tilgjengelig fra:

CELGENE INC

ATC-kode:

L04AX02

INN (International Name):

THALIDOMIDE

Dosering :

200MG

Legemiddelform:

CAPSULE

Sammensetning:

THALIDOMIDE 200MG

Administreringsrute:

ORAL

Enheter i pakken:

28

Resept typen:

Prescription

Terapeutisk område:

Immunomodulatory Agents

Produkt oppsummering:

Active ingredient group (AIG) number: 0152770004; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-08-04

Preparatomtale

_ _
_ _
_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
_ _
_ _
_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
...