PMS-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DIMETHYL FUMARATE

Inapatikana kutoka:

PHARMASCIENCE INC

ATC kanuni:

L04AX07

INN (Jina la Kimataifa):

DIMETHYL FUMARATE

Kipimo:

120MG

Dawa fomu:

CAPSULE (DELAYED RELEASE)

Tungo:

DIMETHYL FUMARATE 120MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0154210001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2021-10-04

Tabia za bidhaa

_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, for Oral Use
House Standard
Antineoplastic and Immunomodulating Agents
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Initial Authorization:
OCT 4, 2021
Date of Revision:
NOV 8, 2023
www.pharmascience.com
Submission Control Number: 277364
_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
06/2022
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings: Hematologic,
Clinical
Chemistry and Other Quantitative Data
05/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
05/2023
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
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2
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
.....................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................