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Update on New Drug and Medical Device Authorizations Français


News provided by

Health Canada

Apr 25, 2019, 10:54 ET

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Accelerating new treatment options for Canadians

OTTAWA, April 25, 2019 /CNW/ - Canadians want access to the latest treatments for themselves, and their friends and family, especially for diseases and conditions where limited options are available.

One area that has seen a great deal of change in treatment options is cancer. Based on Canadian Cancer Statistics, 45% of Canadian women and 49% of Canadian men will develop cancer during their lifetime. While treatments are available for many types of cancers, there are some cases where treatment options are limited, such as with rare types of leukemia.

In recent months, Health Canada has authorized several new drugs for patients with rare and debilitating cancers, including a new type of therapy called CAR-T cell immunotherapy, which helps provide a customized option for the treatment of an aggressive type of lymphoma. The Department prioritized many of these drug reviews to ensure faster access to treatment options for the people who need them.

Medical devices are equally critical for many Canadians to achieve and maintain their health. Health Canada has also licensed new medical devices that test blood, supplement oxygen, stimulate nerves and treat cardiac patients and patients with corneal ulcers.

These new drugs and devices have the potential to vastly improve the quality of lives of many Canadians, including children and seniors.

As of March 2019, information from drug submissions will be made available to Canadians through Health Canada's new Clinical Information Portal, following the Department's review of each drug submission. Health Canada will also make information about drugs and medical devices already on the market available upon request, and add this information to the portal. Beginning in 2021, the Department will start releasing information on new medical device submissions.

Canadians can follow @GovCanHealth on Twitter to find out when Health Canada has authorized new health products. For people who are not yet following us, our recent authorizations are listed below.

Drugs and medical devices authorized since January 2019

Drugs for Cancer and Rare Diseases

Date

Drug

Purpose

Jan 2019

Demylocan

For adult patients with certain types of the rare disease Myelodysplastic Syndromes (MDS)

Jan 2019

Cabometyx

For certain adult patients with advanced renal cell carcinoma (RCC)

Feb 2019

Idhifa

For adult patients with the rare disease relapsed or refractory Acute Myeloid Leukemia (AML) with an IDH2 mutation 

Feb 2019

Lorbrena

For patients with certain types of lung cancer

Feb 2019

Lutathera

For patients undergoing certain types of radiation for cancer treatment

Feb 2019

Vizimpro

For adult patients with certain types of lung cancer; this review was aligned with the review of government partners to expedite funding decision

Feb 2019

Yescarta

A CAR-T cell immunotherapy for patients with one type of lymphoma

Apr 2019

Truxima

 

For patients with non-Hodgkin's lymphoma, rheumatoid arthritis and certain types of leukemia

Apr 2019

Verzenio

For the treatment of certain types of breast cancer

Drugs for Eye or Skin Disorders

Date

Drug

Purpose

Jan 2019

Vyzulta

To reduce pressure inside the eyes of adult patients, including those with certain types of glaucoma

Feb 2019

Oxervate

For patients with moderate to severe corneal ulcers (neurotrophic keratitis)

Apr 2019

Skyrizi

For adult patients with moderate to severe plaque psoriasis

Drugs for Chronic Disease

Date

Drug

Purpose

Jan 2019

Onstryv

For certain patients with Parkinson's Disease

Drugs for General Use

Date

Drug

Purpose

Feb 2019

Vonvendi

To help stop bleeding for patients undergoing surgery or following trauma

General and Plastic Surgery Devices

Date

Device

Purpose

Jan 2019

Embotrap/Embotrap II Revascularization device

To restore blood flow in patients who have suffered a stroke, within eight hours of symptom onset

Jan 2019

Pipeline Flex embolization device with Shield Technology

For adult patients with certain types of intracranial aneurysms that cannot be treated with conventional surgery

Jan 2019

Gentrix Surgical Matrix Thick

To reinforce soft tissues for patients undergoing gastroenterological surgery

Feb 2019

FilaSilk Sterilised Surgical Needled Suture

For patients requiring cardiac, vascular, ophthalmic and skin tissue sutures

Feb 2019

FilaSilk Sterilised Surgical Suture

For patients requiring cardiac, vascular, ophthalmic and skin tissue suture

Feb 2019

PuraStat

To help stop bleeding during surgery

Feb 2019

Endoform Antimicrobial Dermal Template (EAG)

For patients who need a variety of wound dressings

Feb 2019

Flow Re-Direction Endoluminal Device (FRED) System

For patients with brain aneurysms

Feb 2019

Intellis Neurostimulation System

For patients requiring brain or nerve stimulation

Mar 2019

A-Oss Bone Substitute

For dental patients who require bone grafts

Cardiovascular Health Devices

Date

Device

Purpose

Feb 2019

Resolute Onyx Zotarolimus-Eluting Coronary Stent System

For patients who have a blocked artery in their heart

Feb 2019

GORE Molding and Occlusion Balloon Catheter (MOB)

To temporarily block vessels or to help expand stent grafts for cardiac patients

 

Feb 2019

Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System

For patients who have a blocked artery in their heart

Feb 2019

Plexa and Plexa (ProMRI) ICD Leads

For patients who require a pacemaker

Mar 2019

Reprocessed Electrophysiology Diagnostic Catheters

To evaluate cardiac structures and arrhythmias in heart patients 

Mar 2019

JointRep Injectable Implant

For patients with knee cartilage defects

In Vitro Diagnostic Devices

Date

Device

Purpose

Jan 2019

Elecsys HIV DUO

To screen blood donors for HIV and to aid in the diagnosis of HIV infection

Additional Health Canada Resources for Information about Drugs and Medical Devices:
2017 Highlights Report on New Drugs and Medical Devices
Report a Health and Safety Concern
Health Canada's Action Plan on Medical Devices
New Safety and Effectiveness Reviews
The Drug and Health Product Register
MedEffect Canada
Summary safety reviews
Drug product database

SOURCE Health Canada

For further information: Media Inquiries: Health Canada, (613) 957-2983, [email protected]; Public Inquiries: (613) 957-2991, 1-866 225-0709

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