TOCTINO CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-06-2019
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Active ingredient:
ALITRETINOIN
Available from:
GLAXOSMITHKLINE INC
ATC code:
D11AH04
INN (International Name):
ALITRETINOIN
Dosage:
30MG
Pharmaceutical form:
CAPSULE
Composition:
ALITRETINOIN 30MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Product summary:
Active ingredient group (AIG) number: 0137581003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2023-07-14
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
TOCTINO
alitretinoin
Soft capsule 10 mg and 30 mg
Immunomodulator/Anti-inflammatory
agent
GlaxoSmithKline
Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Submission
Control No. : 225922
Date of Revision:
June 25, 2019
_©_
_ 2019 GSK group of companies or its licensor_
_Trademarks are owned by or licensed to the GSK group of companies. _
_1343/521 TOCTINO _
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_Page 2 of 43_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
.........................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
.......................................................................................
13
DRUG INTERACTIONS
........................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................
19
OVERDOSAGE
....................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 21
STORAGE AND STABILITY
.................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
................................................................. 24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 24
PART II: SCIENTIFIC
INFORMATION.......................................................................
25
PHARMACEUTICAL INFORMATION
................................................................... 25
CLINICAL TRIALS
...................................
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