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:

2021-04-09

Original market date: See footnote 1

2021-04-09

Product name:

REDESCA

Description:

MULTIDOSE VIALS

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:

02509121

Product Monograph/Veterinary Labelling:

Date: 2021-03-16 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SHENZHEN TECHDOW PHARMACEUTICAL CO., LTD.
No. 1 Rongtian South, Kengzi Sub-District, Pingshan New District
Shenzhen City
--
China 518122

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous ,  Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription

Biosimilar Biologic Drug:

Yes

American Hospital Formulary Service (AHFS): See footnote 3

20:12.04.16 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B01AB05 ENOXAPARIN

Active ingredient group (AIG) number:See footnote5

0131860001

List of active ingredient(s)
Active ingredient(s) Strength
ENOXAPARIN SODIUM 300 MG / 3 ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Version 4.0.2
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