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:

2017-01-13

Original market date: See footnote 1

2017-01-13

Product name:

NITISINONE TABLETS

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:

02458616

Product Monograph/Veterinary Labelling:

Date: 2022-06-08 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

CYCLE PHARMACEUTICALS LTD.
Broers Building, 21 Jj Thomson Ave.
Cambridge
Cambridgeshire
United Kingdom CB3 0FA

Class:

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

92:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AX04 NITISINONE

Active ingredient group (AIG) number:See footnote5

0158450001

List of active ingredient(s)
Active ingredient(s) Strength
NITISINONE 2 MG

Risk Management Plans See footnote 7

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

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