TOCTINO CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALITRETINOIN

Fáanlegur frá:

GLAXOSMITHKLINE INC

ATC númer:

D11AH04

INN (Alþjóðlegt nafn):

ALITRETINOIN

Skammtar:

10MG

Lyfjaform:

CAPSULE

Samsetning:

ALITRETINOIN 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30

Gerð lyfseðils:

Prescription

Lækningarsvæði:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0137581002; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2023-07-14

Vara einkenni

_1343/521 TOCTINO _
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_Page 1 of 43_
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 _
_ _
_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
..........................................................................
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
...................................