TOCTINO CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ALITRETINOIN

Dostopno od:

GLAXOSMITHKLINE INC

Koda artikla:

D11AH04

INN (mednarodno ime):

ALITRETINOIN

Odmerek:

10MG

Farmacevtska oblika:

CAPSULE

Sestava:

ALITRETINOIN 10MG

Pot uporabe:

ORAL

Enote v paketu:

30

Tip zastaranja:

Prescription

Terapevtsko območje:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2023-07-14

Lastnosti izdelka

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