Product information

From Health Canada

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:

2016-06-29

Original market date: See footnote 1

2016-06-29

Product name:

BIO-ROSUVASTATIN

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DIN:

02444968

Product Monograph/Veterinary Labelling:

Date: 2021-08-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BIOMED PHARMA
1B 9450 Boul. Langelier
Montreal
Quebec
Canada H1P 3H8

Class:

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

24:06.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

C10AA07 ROSUVASTATIN

Active ingredient group (AIG) number:See footnote5

0148963004

List of active ingredient(s)
Active ingredient(s) Strength
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5 MG
Version 4.0.2
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