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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:

2002-06-20

Original market date: See footnote 1

1993-12-31

Product name:

SPORANOX

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:

02047454

Product Monograph/Veterinary Labelling:

Date: 2019-04-01 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada  M3C 1L9

Class: 

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:14.08   AZOLES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J02AC02  ITRACONAZOLE

Active ingredient group (AIG) number:See footnote 5

0123311002

List of active ingredient(s)
Active ingredient(s) Strength
ITRACONAZOLE 100 MG

Application information

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