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:

2017-09-06

Original market date: See footnote 1

2017-09-06

Product name:

DEFITELIO

Description:

MEDICINAL INGREDIENT ALSO CALLED 'DEFIBROTIDE SODIUM'

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DIN:

02465981

Product Monograph/Veterinary Labelling:

Date: 2019-12-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

JAZZ PHARMACEUTICALS IRELAND LIMITED
5th Floor, Waterloo Exchange, Waterloo Rd.
Dublin
Dublin
Ireland D04 E5W7

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D ,  Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

20:12.20 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B01AX01 DEFIBROTIDE

Active ingredient group (AIG) number:See footnote5

0159250001

List of active ingredient(s)
Active ingredient(s) Strength
DEFIBROTIDE 80 MG / ML

Risk Management Plans See footnote 7

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

Pharmacovigilance/Monitoring Activity
Registry
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