Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
PHARMASCIENCE INC
L04AE01
FINGOLIMOD
0.5MG
CAPSULE
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
ORAL
28
Prescription
Immunomodulatory Agents
Active ingredient group (AIG) number: 0152886001; AHFS:
APPROVED
2019-03-11
_pms-FINGOLIMOD (fingolimod) _ _Page 1 of 63_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-FINGOLIMOD Fingolimod Capsules Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral Sphingosine 1-phosphate Receptor Modulator PHARMASCIENCE INC. 6111 Ave. Royalmount Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control Number: 257639 Date of Initial Authorization March 11, 2019 Date of revision: April 6, 2022 _pms-FINGOLIMOD (fingolimod) _ _Page 2 of 63_ RECENT MAJOR LABEL CHANGES 2 Contraindications 04/2022 4 Dosage and Administration 04/2022 7 Warnings and Precautions 04/2022 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 Pediatrics................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................... 4 4 DOSAGE AND ADMINISTRATION........................................................................................... 5 4.1 Dosing Considerations................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ............................................................. 7 4.4 Administration .................................... Baca dokumen lengkap