País: Canadá
Língua: inglês
Origem: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
TEVA CANADA LIMITED
N04BD02
RASAGILINE
1MG
TABLET
RASAGILINE (RASAGILINE MESYLATE) 1MG
ORAL
30
Prescription
MONOAMINE OXIDASE B INHIBITORS
Active ingredient group (AIG) number: 0151662002; AHFS:
APPROVED
2013-12-13
TEVA-RASAGILINE Page 1 of 48 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TEVA-RASAGILINE Rasagiline Mesylate Tablets Tablets, 0.5 mg and 1 mg , Oral ANTIPARKINSON AGENT Teva Canada Limited 30 Novopharm Court Toronto, Ontario, M1B 2K9 Canada www.tevacanada.com Date of Initial Authorization: August 18, 2014 Date of Revision: September 22, 2022 Submission Control Number: 263230 RECENT MAJOR LABEL CHANGES TEVA-RASAGILINE Page 2 of 48 2 Contraindications 09/2022 7 Warnings and Precautions 09/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .............................................................................................. 1 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION................................................................... 4 1 INDICATIONS................................................................................................................ 4 1.1 Pediatrics ........................................................................................................... 4 1.2 Geriatrics ............................................................................................................ 4 2 CONTRAINDICATIONS................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 6 4.1 Dosing Considerations ........................................................................................ 6 4.2 Recommended Dose and Dosage Adjustment ..................................................... 6 4.4 Administration ................................................................................................... 7 4 Leia o documento completo