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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:

2019-07-25

Original market date: See footnote 1

2019-07-25

Product name:

ONPATTRO

Description:

LIPID COMPLEX

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:

02489252

Product Monograph/Veterinary Labelling:

Date: 2021-03-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ALNYLAM NETHERLANDS B.V.
Antonio Vivaldistraat 150
Amsterdam
--
Netherlands  1083 HP

Class: 

Human

Dosage form(s):

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

92:92.00   OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07XX12  PATISIRAN

Active ingredient group (AIG) number:See footnote 5

0161490001

List of active ingredient(s)
Active ingredient(s) Strength
PATISIRAN (PATISIRAN SODIUM) 2 MG / ML

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