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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:

Approved

Current status date:

2018-10-03

Product name:

RADICAVA

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:

02475472

Product Monograph/Veterinary Labelling:

Date: 2018-10-02 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

MITSUBISHI TANABE PHARMA CORPORATION
3-2-10 Doshomachi
Chuo-Ku
Osaka-Fu
Japan  541-0045

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

28:92.00   MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07XX14  EDARAVONE

Active ingredient group (AIG) number:See footnote 5

0160190001

List of active ingredient(s)
Active ingredient(s) Strength
EDARAVONE 30 MG / 100 ML

Risk Management Plans See footnote 7

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

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