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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:

2020-05-21

Original market date: See footnote 1

2016-01-28

Product name:

SIGNIFOR LAR

Description:

KIT INCLUDES 2ML DILUENT IN A PREFILLED SYRINGE

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:

02437252

Product Monograph/Veterinary Labelling:

Date: 2020-05-19 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):

Kit,  Powder For Suspension, Sustained-Release

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

68:29.04   Somatostatin Agonists

Anatomical Therapeutic Chemical (ATC): See footnote 4

H01CB05  Pasireotide

Active ingredient group (AIG) number:See footnote 5

0154790004

List of active ingredient(s)
Active ingredient(s) Strength
PASIREOTIDE (PASIREOTIDE PAMOATE) 20 MG / VIAL

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Controlled Distribution Program
Healthcare Professional Education
Patient Consent
Patient Education

Application information

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