Country: Canada
Language: English
Source: Health Canada
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
ANGITA PHARMA INC.
J05AH02
OSELTAMIVIR
45MG
CAPSULE
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 45MG
ORAL
100
Prescription
NEURAMINIDASE INHIBITORS
Active ingredient group (AIG) number: 0139501004; AHFS:
APPROVED
2021-01-07
AG-Oseltamivir (oseltamivir phosphate) Page1 of43 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr AG-Oseltamivir Oseltamivir PhosphateCapsules Capsule, 30 mg,45mgand75 mg oseltamivir (asoseltamivir phosphate),oral USP Antiviral Agent Angita Pharma Inc. 1310 rueNobel Boucherville,Quebec J4B 5H3,Canada SubmissionControl Number: 277564 Dateofinitial Authorization: JAN 07,2021 DateofRevision: AUG29,2023 AG-Oseltamivir (oseltamivir phosphate) Page2 of43 RECENT MAJORLABELCHANGES 4Dosage and Administration 08/2023 7Warnings and Precautions,7.1.1 PregnantWomen 08/2023 TABLE OF CONTENTS Sections or subsections that arenot applicable at thetimeof authorization arenot listed. RECENT MAJORLABELCHANGES.................................................................................... 2 TABLE OF CONTENTS...................................................................................................... 2 PART I:HEALTH PROFESSIONALINFORMATION.............................................................. 4 1 INDICATIONS ...................................................................................................... 4 1.1 Pediatrics ...........................................................................................................5 1.2 Geriatrics............................................................................................................5 2 CONTRAINDICATIONS ......................................................................................... 5 4 DOSAGE AND ADMINISTRATION......................................................................... 5 4.1 DosingConsiderations .......................................................................................5 4.2 RecommendedDose and DosageAdjustment..................................................6 4.4 Administration .................................................................................................11 4.5 Missed Dose..................................................................................................... 1 Read the complete document