APO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DIMETHYL FUMARATE

제공처:

APOTEX INC

ATC 코드:

L04AX07

INN (International Name):

DIMETHYL FUMARATE

복용량:

240MG

약제 형태:

CAPSULE (DELAYED RELEASE)

구성:

DIMETHYL FUMARATE 240MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2021-10-04

제품 특성 요약

_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.