AG-OSELTAMIVIR CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-08-2023
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Active ingredient:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Available from:
ANGITA PHARMA INC.
ATC code:
J05AH02
INN (International Name):
OSELTAMIVIR
Dosage:
30MG
Pharmaceutical form:
CAPSULE
Composition:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NEURAMINIDASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0139501003; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-08-23
Summary of Product characteristics
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
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