TOCTINO CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ALITRETINOIN

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

D11AH04

INN (nume internaţional):

ALITRETINOIN

Dozare:

10MG

Forma farmaceutică:

CAPSULE

Compoziție:

ALITRETINOIN 10MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2023-07-14

Caracteristicilor produsului

_1343/521 TOCTINO _
_ _
_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
...................................