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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:

2019-05-15

Original market date: See footnote 1

2019-05-15

Product name:

CYSTADROPS

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:

02485605

Product Monograph/Veterinary Labelling:

Date: 2019-02-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

RECORDATI RARE DISEASES CANADA INC
3080 Yonge Street, Suite 6060
Toronto
Ontario
Canada  M4N 3N1

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Ophthalmic

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

52:92.00   EENT DRUGS, MISCELLANEOUS

Anatomical Therapeutic Chemical (ATC): See footnote 4

S01XA21  MERCAPTAMINE

Active ingredient group (AIG) number:See footnote 5

0159170004

List of active ingredient(s)
Active ingredient(s) Strength
CYSTEAMINE (CYSTEAMINE HYDROCHLORIDE) 0.37 % / W/W

Risk Management Plans See footnote 7

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

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