SANDOZ DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DIMETHYL FUMARATE

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

L04AX07

INN (nume internaţional):

DIMETHYL FUMARATE

Dozare:

240MG

Forma farmaceutică:

CAPSULE (DELAYED RELEASE)

Compoziție:

DIMETHYL FUMARATE 240MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0154210002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-10-04

Caracteristicilor produsului

_Sandoz Dimethyl Fumarate _
_Page 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ DIMETHYL FUMARATE
dimethyl fumarate delayed-release capsules
delayed-release capsules, 120 mg and 240 mg, oral
Antineoplastic and Immunomodulating Agents
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1E6
Date of Initial Authorization:
October 4, 2021
Date of Revision:
May 19, 2022
Submission Control Number: 259700
_Sandoz Dimethyl Fumarate _
_Page 2 of 46 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
05/2022
2 CONTRAINDICATIONS
05/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
05/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
05/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..................................................................................................
2
TABLE OF
CONTENTS...................................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................................
4
1
INDICATIONS
......................................................................................................................
4
1.1
P
EDIATRICS
..........................................................................................................................
4
1.2
G
ERIATRICS
..........................................................................................................................
4
2
CONTRAINDICATIONS..........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1
D
OSING
C
ONSIDERATI ONS
..............................................................................................