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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:

2021-05-28

Original market date: See footnote 1

2021-05-28

Product name:

XYDALBA

Description:

SINGLE USE VIAL

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:

02480522

Product Monograph/Veterinary Labelling:

Date: 2021-04-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ENDO VENTURES LTD.
1st Floor, Minerva House, Simmonscourt Road
Ballsbridge
Dublin
Ireland  D04 H9P8

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:12.28.16   GLYCOPEPTIDES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J01XA04  DALBAVANCIN

Active ingredient group (AIG) number:See footnote 5

0160631001

List of active ingredient(s)
Active ingredient(s) Strength
DALBAVANCIN (DALBAVANCIN HYDROCHLORIDE) 500 MG / VIAL

Risk Management Plans See footnote 7

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

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