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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2020-10-02

Original market date: See footnote 1

2020-10-02

Product name:

OSELTAMIVIR PHOSPHATE CAPSULES

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02504014

Product Monograph/Veterinary Labelling:

Date: 2020-08-20 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

STRIDES PHARMA CANADA INC
1565, Boul. Lionel-Boulet
Varennes
Quebec
Canada  J3X 1P7

Class: 

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:18.28   NEURAMINIDASE INHIBITORS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J05AH02  OSELTAMIVIR

Active ingredient group (AIG) number:See footnote 5

0139501004

List of active ingredient(s)
Active ingredient(s) Strength
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 45 MG

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