APO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
11-01-2023
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DIMETHYL FUMARATE
Fáanlegur frá:
APOTEX INC
ATC númer:
L04AX07
INN (Alþjóðlegt nafn):
DIMETHYL FUMARATE
Skammtar:
240MG
Lyfjaform:
CAPSULE (DELAYED RELEASE)
Samsetning:
DIMETHYL FUMARATE 240MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0154210002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-10-04
Vara einkenni
_APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, Oral
Antineoplastic and Immunomodulating Agents
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 04, 2021
Date of Revision:
January 11, 2023
Submission Control Number: 266551
_APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
01/2023
2 CONTRAINDICATIONS
01/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
01/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
7 WARNINGS AND PRECAUTIONS, Immune
01/2023
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
Pediatrics
.......................................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................................4
4
DOSAGE AND ADMINISTRATION
.................................................................................................4
4.
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