Mid-year update: Health products approved in 2021

Learn about our work to support Canada's response to COVID-19, the new drugs, medical devices, over-the counter and natural health products that Health Canada approved for sale in Canada, as well as clinical information that was published.

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Message from the Assistant Deputy Ministers

We are pleased to provide an update on the drugs, medical devices, over-the-counter (non-prescription) drugs and natural health products approved by Health Canada between January and June 2021.

The regulatory response to COVID-19 has continued to play a key role in our work. This includes the approval of three additional COVID-19 vaccines, along with ongoing and rigorous post-market monitoring of COVID-19-related products.

While these remain extraordinary times, we are committed to working with our partners and stakeholders to provide the products and information Canadians need to stay safe and healthy as we move together toward a post-pandemic future.

Pierre Sabourin
Assistant Deputy Minister
Health Products and Food Branch

Manon Bombardier
Associate Assistant Deputy Minister
Health Products and Food Branch

Our COVID-19 regulatory response

As the national regulator of health products, we continue to play a key role in Canada's ongoing response to the COVID-19 pandemic. Since the start of the pandemic, we have leveraged an agile regulatory approach, which has included the introduction of emergency regulatory pathways and measures to support expedited access to needed health products.

Health products: Approvals

Between January and June, we approved:

Clinical trials

Clinical trials continue to be approved for the study of potential COVID-19 vaccines and treatments.

For example, on April 8, 2021, we authorized an adaptive Platform Treatment Trial for Outpatients with COVID-19 (by the National Institute of Allergy and Infectious Diseases) to evaluate the safety and effectiveness of different drugs in treating COVID-19 in outpatients. This study will test multiple drugs in people who have tested positive for COVID-19 but do not currently need hospitalization. This could help to prevent disease progression to more serious symptoms and complications, and the spread of COVID-19 in the community.

On May 5, 2021, we authorized the MOSAIC Study (Mix and match of the second COVID-19 vaccine dose for Safety and Immunogenicity). This Canadian study is examining the safety and immune response of mixing and matching approved COVID-19 vaccines using various time intervals in adults.

Moreover, Medicago's plant-based Recombinant Coronavirus-Like Particle COVID-19 Vaccine is now in phase III clinical trials. Medicago's COVID-19 vaccine is the first Canadian manufactured vaccine in a phase III trial. It is also unique in that it incorporates a plant-based protein.

Vaccines

Since approving the Pfizer and Moderna COVID-19 vaccines in December 2020, we authorized three other vaccines, i.e., Janssen, AstraZeneca, and the Serum Institute of India's version of the AstraZeneca vaccine, COVISHIELD.

On May 5, 2021, we approved the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for this age group and marks a significant milestone in Canada's fight against the COVID-19 pandemic.

Regulatory review and oversight for these products continues, with updated regulatory and product information added to the COVID-19 vaccines and treatments portal on an ongoing basis.

Self-testing and point-of-care devices

As we continue to adapt to the evolving challenges of the pandemic, the review of self-testing and point-of-care devices (which can be used by trained operators) is being prioritized to support greater access to COVID-19 testing. The first COVID-19 self-testing device was authorized for sale in April 2021. More information on Self-testing and point-of-care devices can be found on the website.

Hand sanitizers and disinfectants

We have also continued efforts in this area in response to COVID-19, by authorizing 182 hand sanitizers and 96 disinfectants between January and June. More information can be found on the website: Hard-surface disinfectants and hand sanitizers (COVID-19).

Monitoring and surveillance

We continue to monitor and assess the safety of all COVID-19-related products, including: those approved for the treatment of COVID-19 infection and those used off-label; authorized vaccines; technical grade ethanol-containing hand sanitizer products; over-the-counter drugs and natural health products used in the context of COVID-19; and medical devices authorized for the diagnosis, treatment, mitigation or prevention of COVID-19.

The data derived from these safety monitoring and surveillance activities has supported Health Canada's scientific and medical staff in collecting and analyzing product safety information (including reports of adverse events), conducting safety assessments, applying risk management measures, and communicating product risks to the public and healthcare professionals.

International collaboration

We continue to work with our international partners, participating in discussions regarding new COVID-19 treatments and vaccines, including the real-world safety and effectiveness of those products. Along with the Public Health Agency of Canada, we are collaborating worldwide on research, taking proactive steps to identify adverse events, and quickly implementing risk-management measures (such as labelling updates and risk communications). For more information on international engagement, visit the website.

Published data and information

We continue to publish regulatory and product information on the Health Canada website and the COVID-19 vaccines and treatments portal to support the high demand for credible scientific data.

Updated authorization requirements

On March 18, 2021, we introduced transition measures to provide a mechanism for COVID-19 products approved under the Interim Order to obtain a Notice of Compliance (NOC) in a timely manner. These transition measures ensure that Canadians have continued and timely access to safe, effective and quality COVID-19 drugs.

Extended regulatory emergency pathways

Finally, the emergency regulatory pathways for clinical trials and medical devices have been extended for another year, and amendments to the Food and Drug Regulations were made to maintain flexibilities for COVID-19-related drugs and vaccines on a longer-term basis.

Improving access to drugs for human use

While we have continued to respond to COVID-19, we also carry on authorizing other products that are vital to the health and well-being of Canadians. Specifically, between January and June, we authorized a number of clinical trials and new drugs, and updated regulations directed at improving available treatment options.

Expedited review

Through the expedited review of single patient clinical trials, Health Canada is contributing to improved access to investigational drugs for Canadians with serious, life-threatening conditions. These "open-label individual patient" studies are being carried out for those who are not eligible for or have exhausted alternative treatment options.

Special access products more readily available

Our Special Access Programme allows physicians and other health professionals to request access, for a specific patient, to a drug that has not yet been approved for use in Canada, when conventional approved therapies have failed, are unsuitable, or offer limited options. To support more straightforward retrieval of drugs frequently accessed through this programme, we approved several products that can now be prescribed directly by health professionals. For example, Ranexa (ranolazine) to treat heart-related chest pains, EVRYSDI (risdiplam) to treat spinal muscular atrophy, and Effient (prasugrel) to prevent the formation of blood clots, which used to be requested by health professionals more than 50 times per year through the Special Access Programme, can now be prescribed directly.

Working with global partners

In collaboration with the Access Consortium, we worked with partners in Australia, Canada, Singapore, Switzerland and the United Kingdom to approve new drugs.

In collaboration with the United States, through Project Orbis, we approved Retevmo (selpercatinib) to treat three different types of cancer (including tumours in pediatric patients). Also through Project Orbis, in collaboration with the United States, Australia, Singapore, Switzerland and Brazil, we approved Tagrisso (osimertinib) for patients with non-small cell lung cancer.

These are only some examples of how we work closely with our international regulatory partners to bring much needed health products to Canadians. We will continue to play a leadership role at the global level to maintain Canada's world-class regulatory system.

Drug authorizations

Between January and June, we authorized 43 new drugs (including three new biosimilar drugs) and 82 new generic drugs.

Antiinfectives for systemic use

Month authorized Drug Purpose
January Foclivia (pandemic influenza vaccine) Vaccine intended to prevent influenza (in an officially declared pandemic situation). It may be given to individuals 6 months of age and older.
January Supemtek (quadirvalent influenza vaccine) Vaccine used to prevent influenza. It may be given to adults 18 years of age and older.
February AstraZeneca COVID-19 Vaccine (ChAdOx1-S) Vaccine used to prevent COVID-19. It may be given to adults 18 years of age and older.
February COVISHIELD (ChAdOx1_nCoV19) Vaccine used to prevent COVID-19. It may be given to adults 18 years of age and older.
March Janssen COVID-19 Vaccine (Ad26.COV2-S) Vaccine used to prevent COVID-19. It may be given to adults 18 years of age and older.

Antineoplastic and immunomodulating agents

Month authorized Drug Purpose
January Humira Injection (adalimumab injection)

Used in:

  • adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (a form of arthritis), Crohn's disease, ulcerative colitis, psoriasis or uveitis;
  • patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis, the most common type of arthritis in children and teens;
  • children 13 to 17 years weighing at least 40 kg who have severe Crohn's disease or who have Crohn's disease which has not responded to other usual treatments;
  • patients 12 years of age or older with moderate to severe hidradenitis suppurativa who have not responded to antibiotics;
  • children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
January Kesimpta (ofatumumab) Treatment for adults with relapsing remitting multiple sclerosis.
January Zirabev (bevacizumab) Used in combination with chemotherapy to treat metastatic colorectal cancer, metastatic non-small cell lung cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer or glioblastoma.
January Onureg (azacitidine) A nucleoside metabolic inhibitor indicated for maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission, or complete remission with incomplete blood count recovery.
March Phesgo (pertuzumab, trastuzumab)

Used to treat people with breast cancer when:

  • a large number of HER2-positive cancer cells are involved;
  • the cancer has spread to areas near the breast or metastasized; or
  • the cancer has not spread to other parts of the body and treatment will be given after surgery.
March Riabni (rituximab) Used to stop cancer cell growth and potentially cause the death of cancer cells. Also used to reduce signs and symptoms of rheumatoid arthritis in combination with methotrexate. Also used to reduce inflammation associated with severe granulomatosis with polyangiitis (GPA, aka Wegener's granulomatosis) and microscopic polyangiitis (MPA), in combination with glucocorticoids or steroids.
March Braftovi (encorafenib) Used with Mektovi (binimetinib) to treat adults with melanoma, or metastatic colorectal cancer (a large intestine cancer).
March Mektovi (binimetinib) Used with BRAFTOVI (encorafenib) to treat adults with melanoma.
March Brukinsa (zanubrutinib) Used in adults to treat Waldenstr├Âm's Macroglobulinemia (WM), a slow-growing type of non-Hodgkin lymphoma.
April Enhertu (trastuzumab deruxtecan) Used in adults who have HER2-positive breast cancer that has metastasized, or has not been removable by surgery.
April Ponvory (ponesimod) Used to treat adults with relapsing remitting multiple sclerosis.
April Vyxeos (cytarabine, daunorubicin) Used to treat adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML), or AML with myelodysplasia-related changes (AML-MRC).
May Abecma (idecabtagene vicleucel) Used to treat adults with multiple myeloma when the cancer has not responded to at least 3 different treatments or has come back after these treatments.
May Ilumya (tildrakizumab) A prescription medicine used to treat adults with moderate to severe plaque psoriasis.
May Tepmetko (tepotinib) Used to treat non-small cell lung cancer in adults whose cancer has metastasized or has advanced and cannot be removed by surgery, and whose tumours have a specific abnormality in the mesenchymal epithelial transition (MET) gene.
June Tecartus (brexucabatagene autoleucel legada) A treatment for mantle cell lymphoma for use when at least two other available medicines have stopped working.
June Ledaga (chlormethine) A medicine used on the skin to treat adults with Stage IA or IB mycosis fungoides-type cutaneous T-cell lymphoma who have received previous skin treatment.
June Gavreto (pralsetinib)

Used to treat adults with a type of non-small cell lung cancer which:

  • is caused by abnormal Rearranged During Transfection (RET) gene(s); and
  • cannot be removed by surgery, or has metastasized.
June Retevmo (selpercatinib)

Used to treat cancers caused by abnormal rearranged during transfection (RET) genes in:

  • adults with non-small cell lung cancer that has metastasized;
  • adults and children 12 to 17 years old with medullary thyroid cancer when the cancer is advanced or has metastasized, and cannot be removed through surgery; or
  • adults with differentiated thyroid cancer when the cancer is advanced or has metastasized and can't be treated by alternative means.
June Trecondyv (treosulfan) Used with Fludara (fludarabine) to prepare patients over the age of one with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), for a blood stem cell transplant.

Alimentary tract and metabolism

Month authorized Drug Purpose
February Dojolvi (triheptanoin) Indicated as a source of calories and fatty acids for the treatment of adults and pediatric patients with long-chain fatty acid oxidation disorders.
February Vitamin D3 Oral Solution (vitamin D3) Used to treat vitamin D deficiency.
April Waymade-Trientine (trientine hydrochloride) Used in the treatment of Wilson's disease for people who cannot take the drug Cuprimine (penicillamine).
May Octasa (mesalazine) Used to treat ulcerative colitis where the lining of the bowel becomes inflamed.

Blood and blood forming organs

Month authorized Drug Purpose
February Reblozyl (luspatercept)
  • Used to treat adults who have anemia and require red blood cell transfusions due to the blood disorder ╬▓-thalassemia that affects the production of hemoglobin.
  • Also used in adults who suffer from anemia and require red blood cell transfusions due to a blood bone marrow disorder myelodysplastic syndromes with ring sideroblasts.
  • For treating patients who have not responded to or are not able to receive erythropoietin therapies.
March Vistaseal (human fibrinogen/human thrombin) Used as a sealant during surgical operations in adults.
April Triferic Avnu (iron) Used to maintain iron levels in adults with chronic kidney disease who are undergoing hemodialysis.

Genito urinary system and sex hormones

Month authorized Drug Purpose
March Nextstellis (dropirenone, estetrol monohydrate) Indicated to prevent pregnancy.
April Inprosub (progesterone) Treatment for adult women under 35 years of age who need extra progesterone while undergoing in vitro fertilization and who are unable to use or tolerate other products given through the vagina.

Musculo-skeletal system

Month authorized Drug Purpose
April Evrysdi (risdiplam) Used in patients 2 months old and up to treat spinal muscular atrophy, which affects the nervous system and leads to muscle weakness and atrophy.

Nervous system

Month authorized Drug Purpose
January Vyepti (eeptinezumab-jjmr) Used to prevent migraine in adults who have at least 4 migraine days per month.
May Sunosi (solriamfetol) Used to treat adults with narcolepsy or obstructive sleep apnea.
May Wakix (pitolisant hydrochloride) Used in adults with narcolepsy to reduce excessive sleepiness during the day, or to treat cataplexy.
June Ruzurgi (amifampridine) Used to treat symptoms of Lambert-Eaton myasthenic syndrome in patients 6 years of age and older.

Respiratory system

Month authorized Drug Purpose
June Trikafta (tezacaftor, elexacaftor, ivacaftor) Used for treatment of cystic fibrosis in patients 12 years of age and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.

Sensory organs

Month authorized Drug Purpose
January Tissueblue (brilliant blue G) Used as an aid in eye surgery, to stain a part of the eye called the internal limiting membrane.
February Cequa (cyclosporine) Used to treat a condition called keratoconjunctivitis sicca, also known as dry eye disease, by making the eyes produce more tears.

Improving access to over-the-counter (non-prescription) drugs and natural health products

Between January and June, we authorized 163 new over-the-counter drugs, including antiseptics, nonsteroidal anti-inflammatory drugs, analgesics/antipyretics, anti-allergy drugs, and sunscreens. We also authorized 4,149 natural health products, including alcohol based hand sanitizers, probiotics, herbal remedies, vitamins and minerals. More information can be found in the Licensed natural health products database and the Drug product database online query.

Regulatory modernization

Work moves forward on regulatory modernization, including through extensive consultation with stakeholders. As part of Phase I of the Self-Care Framework, we are proposing regulatory and policy changes to improve the labelling of natural health products. Work is also underway on a proposal to introduce flexibilities for biocides and to place them under a single regulatory framework.

Strengthened programming

The Commissioner of the Environment and Sustainable Development report on the audit of the Natural Health Products Program was tabled in Parliament on April 22, 2021. Health Canada accepted each of the Commissioner's recommendations and is already taking steps to accelerate its efforts to strengthen the Program, including increasing oversight of quality, advertising and labelling, and piloting proactive inspections.

Improving access to drugs for veterinary use

We are moving ahead on work to protect human and animal health and the safety of Canada's food supply. Between January and June, we authorized seven veterinary drugs and accepted 199 veterinary health product notifications.

New drugs

Month authorized Drug Purpose
January Nexgard Combo (praziquantel, afoxolaner, eprinomectin)
  • Used to treat and control fleas, ticks, roundworms and tapeworms;
  • Prevent heartworm disease; and
  • Treat ear mites in cats.
February Solofer (iron dextran complex) Used to treat and prevent iron deficiency anemia in newborn piglets.
February Librela (bedinvetmab) Alleviates pain associated with osteoarthritis in dogs.

New generic drugs

Month authorized Drug Purpose
February Tilmovet AC (tilmicosin phosphate) May help to reduce the severity of swine respiratory disease.
February Bacitracin MD Soluble (bacitracin methylene disalicylate) May help to prevent necrotic enteritis in broiler chicken.
March Respotil (tilmicosin phosphate) May help to reduce the severity of swine respiratory disease.
June Increxxa (tulathromycin) Used to treat bovine/swine respiratory disease, infectious conjunctivitis in cattle, and foot rot in sheep and cattle.

Improving access to medical devices

We continue to implement measures per our Action plan on medical devices to improve the safety of medical devices marketed in Canada. We recently published a Medical devices action plan: Progress report that highlights activities and achievements related to the Action Plan's objectives, including:

We licensed 30 new Class IV medical devices and 139 new Class III medical devices between January and June 2021. We also authorized 167 COVID-19 devices under the Interim Order for medical devices during that period.

Cardiovascular

Month authorized Device Purpose
January Achieve Advance Mapping Catheter Used in electrophysiological mapping of the cardiac structures of the heart.
January HeartStart Intrepid Monitor/Defibrillator Used in emergency resuscitation to defibrillate the heart.
January SoundBite Crossing System - Peripheral (14P) Used for placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions via atherectomy.
February Mynx Control Vascular Closure Device Used to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures.
February OmniWire Pressure Guide Wire Used to measure pressure in blood vessels during diagnostic angiography and/or any interventional procedures, and to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels.
February Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System Used to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions in the femoral and proximal popliteal arteries.
February Stealth 360 Peripheral Orbital Atherectomy System Used as therapy in patients with occlusive atherosclerotic disease in peripheral arteries who are acceptable candidates for percutaneous transluminal atherectomy.
March Alto Abdominal Stent Graft System Used for treatment of patients with infrarenal abdominal aortic aneurysms which have the vascular morphology suitable for endovascular repair with the device.
March Orsiro Sirolimus Eluting Coronary Stent System Used for improving coronary luminal diameter in patients.
March ZOLL AED 3 Aviation Used when a suspected cardiac arrest victim has an apparent lack of circulation, automatically activating defibrillation of the heart through application of electrical shocks to the chest surface.
April COMET II Pressure Guidewire Used to direct a catheter through a blood vessel and to measure physiological parameters in the coronary blood vessels.
May EmboCube Embolization Gelatin Used in embolization of blood vessels to occlude blood flow, in order to control bleeding or hemorrhaging.
May EMBOTRAP III Revascularization Device Intended to restore blood flow in the neurovasculature within 8 hours of symptom onset by removing thrombus in patients experiencing ischemic stroke.
May Tornado Embolization Coils And Microcoils Intended for arterial and venous embolization in the peripheral vasculature.

Gastroenterology and urology

Month authorized Device Purpose
March Sapphire II PRO Balloon Dilatation Catheter Used for balloon dilatation of artery or bypass graft stenosis for the purpose of improving myocardial perfusion or the treatment of acute myocardial infarction.
April TriClip G4 System Used for reconstruction of the insufficient tricuspid valve through tissue approximation.

General and plastic surgery

Month authorized Device Purpose
February neXus Ultrasonic Surgical Aspirator System Intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

Microbiology

Month authorized Device Purpose
January PK CMV-PA System Used as a passive particle agglutination assay intended for the qualitative detection of IgG and IgM antibodies to cytomegalovirus (CMV) in human EDTA plasma and serum from blood donors.
March Atellica IM HBc Total 2 Used for in vitro diagnostic in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus in human serum or plasma.

Neurology

Month authorized Device Purpose
January WaveWriter Alpha Spinal Cord Stimulator System Indicated as an aid in the management of chronic intractable pain.
March eCLIPs System Intended to treat intracranial saccular aneurysms that was unruptured, stable, or previously ruptured in over 30 days.
March WaveWriter Alpha Spinal Cord Stimulator System - Alpha 16 Indicated as an aid in the management of chronic intractable pain.
March WaveWriter Alpha Spinal Cord Stimulator System - Alpha Prime Indicated as an aid in the management of chronic intractable pain.
March WaveWriter Alpha Spinal Cord Stimulator System - Alpha Prime 16 Indicated as an aid in the management of chronic intractable pain.
May Nester Embolization Coils and Microcoils Intended for arterial and venous embolization in the peripheral vasculature.

Publicly released clinical information

We are now in our third year of releasing clinical information that was used to decide whether a drug or medical device can be sold in Canada. The clinical information published through Health Canada's Clinical Information Portal has been viewed and downloaded tens of thousands of times, and the scope of information being published continues to grow.

Clinical information on drugs and medical devices published between January and June is listed below.

Drug publications

Publication Date Drug Purpose
January Bamlanivimab (LY3819253) Antibody therapy used to treat cases of mild to moderate COVID-19 infection at high risk of disease progression in patients 12 years of age and older.
January Inrebic (fedratinib) Used to treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis (blood cancer/leukemia).
February Lescol (fluvastatin) Statin used to lower blood pressure.
February Pravachol (pravastatin) Statin used to lower blood pressure.
February Luxturna (voretigene neparvovec-rzyl) Gene-therapy used to treat certain adult and pediatric patients with inherited retinal dystrophy.
February Suboxone (buprenorphine) Substitution treatment used for opioid drug dependence in adults, indicated for use within a framework of medical, social and psychological support.
February Sovaldi (sofosbuvir) Used in combination with antiviral treatments to treat adults with chronic hepatitis C.
February Givlarii (givosiran) Used to treat adult patients with acute hepatic porphyria (a hereditary liver disease).
March Tissueblue (brilliant blue G ophthalmic solution) Ophthalmic surgery aid used to stain the internal limiting membrane of the eye.
March Daurismo (glasdegib) Used to treat acute myeloid leukemia that has not been treated before in adults 75 years of age and older, or in those who cannot receive intensive chemotherapy.
March Moderna COVID-19 Vaccine (nucleoside modified) Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
March Opdivo (nivolumab) Used alone or in combination with Yervoy (ipilimumab) to treat a variety of cancers.
March Pfizer-BioNTech COVID-19 Vaccine (tozinameran) Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
March Zeposia (ozanimod) Used to treat adults with relapsing remitting forms of multiple sclerosis.
March Lipitor (atorvastatin) Statin used to lower blood pressure.
April Corzyna (ranolazine) Add-on therapy used for symptomatic treatment of stable angina resultant from heart disease in adults.
April Adacel-Polio (Tdap polio) Active booster immunization used for prevention of tetanus, diphtheria, pertussis and poliomyelitis in individuals 4 years of age and older.
April Supemtek (quadrivalent influenza vaccine) Recombinant influenza A and B vaccine for adults.
April Dayvigo (lemborexant) Used to treat adult patients with insomnia.
April Tavalisse (fostamatinib) Used to treat chronic immune thrombocytopenia (low blood platelets) in adult patients unresponsive to other treatments.
April Belkyra (deoxycholic acid injection) Cosmetic treatment for submental (under-chin, neck) fat in adults.
April Abilify Maintena (aripiprazole) Used to treat adults with schizophrenia.
May Xenleta (lefamulin) Used to treat adults with community-acquired pneumonia.
May Lancora (Ivabradine) Used to treat adult patients at risk of complications from chronic heart failure.
May Apo-Tenofovir (tenofovir disoproxil fumarate) Used in combination with other antiretroviral agents to treat HIV-1 infection in patient 12 years of age and older and chronic Hepatitis B infection in adults.
May Zocor (simvastatin) Statin to lower blood pressure.
May Vascepa (icosapent ethyl) Used to reduce cardiovascular events, such as heart attacks or strokes in high-risk adult patients with high blood cholesterol.
May Lescol (fluvastatin) Statin used to lower blood pressure.
May Bavencio (avelumab) Used to treat metastatic Merkel cell carcinoma in patients 12 years of age and older.
May Repatha (evolocumab) Used to treat hyperlipidemia in adult patients with cardiovascular disease who are at risk of heart attack or stroke.
June Amoxicillin Sodium and Potassium Clavulanate for injection (amoxicillin, clavulanic acid) Used for treatment of bacterial infections.
June Pravachol (pravastatin sodium) Statin to lower blood pressure.
June Opdivo (nivolumab) Used for treatment of inoperable/metastatic melanoma (skin cancer) in previously untreated adults.
June Symbicort 100, 200 Forte Turbo Inhaler (budesonide, formoterol fumarate dehydrate) Used for the control and prevention of symptoms associated with asthma or COPD.
June Brukinsa (zanubrutinib) Used for treatment of Waldenstrom's macroglobulinemia (a type of Non-Hodgkin lymphoma).
June Zolgensma (onasemnogene abeparvovec) A gene-therapy indicated for treatment of spinal muscular atrophy in pediatric patients less than 2 years of age.

Device publications

Month Device Purpose
February Baylis V4C-560 Ventilator Respiratory ventilator for use on adults with severe symptomatic respiratory illness.
March ID NOW COVID-19 PCR-based qualitative test device indicated for use in support of clinical diagnosis re: COVID-19 infection.
March The Spartan COVID-19 V2 System PCR-based qualitative test device indicated for use in support of clinical diagnosis re: COVID-19 infection.
March TECNIS Multifocal 2.75D ADD 1-piece Intraocular Lens / TECNIS Multifocal 3.25D ADD 1-piece Intraocular Lens Implantable medical device used for correction/restoration of vision after cataract removal in adults.
April AT LISA tri Implantable medical device used for the treatment of presbyopia in adults.
April Sofia SARS Antigen FIA Test device indicated for use in support of COVID-19 diagnosis.
June BKIT Virus Finder COVID-19 PCR-based qualitative test device indicated for use in support of COVID-19 diagnosis.
June CUE COVID-19 Test PCR-based qualitative test device indicated for use in support of COVID-19 diagnosis.

Adverse reactions and incidents

Since mandatory hospital reporting was implemented in Canada in December 2019, Health Canada's Canada vigilance program (CVP) has received a high number of serious Adverse reaction (AR) and Medical device incident (MDI) reports from more than 800 hospitals. These reports provide valuable information used in the identification and assessment of new safety signals.

The following table presents the number of domestic Adverse events following immunization (AEFI) reports, Adverse reaction (AR) reports, and Medical device incident (MDI) reports regarding COVID-related products received by the Canada vigilance program between January and June.

COVID-related products

COVID-19 related products Total number of AEFIs, ARs and MDIs received by the Canada Vigilance Program
January to June 2021
Number of serious reports
COVID-19 Vaccines (see below Table footnote 1 re: total) 1912Table footnote 1 1624
Pfizer-Biontech COVID-19 Vaccine (Tozinameran) 1243 1094
Moderna COVID-19 Vaccine (MRNA-1273 SARS-COV-2) 216 145
AstraZeneca COVID-19 Vaccine (ChAdOx1-S) / COVISHIELD 347 294
COVID Vaccine reports where brand name not specified 106 91
COVID-19 Treatments 3 3
Veklury (remdesivir) 3 3
Medical Device Incidents Reported on COVID-related Medical Devices (see belowTable footnote 2 re: total) 939Table footnote 2 90Table footnote 2

Table footnotes

Table footnote 1

This figure includes the total number of domestic (i.e., Canadian source) COVID-19 vaccine Adverse Events Following Immunization (AEFI's) reported to Health Canada by consumers, hospitals, and COVID vaccine manufacturers. (Does not include reports in the Canadian Adverse Events Following Immunization Surveillance System.)

Return to table footnote 1 referrer

Table footnote 2

Includes medical device incidents involving a COVID authorized device or an incident involving a medical device with a preference name code (PNC) that is shared with selected COVID devices. (A PNC is a medical device group designation.)

Return to table footnote 2 referrer

Conclusion

We are proud of the progress we have made as we continue to serve the needs of Canadians, and are committed to moving forward, together with our partners, stakeholders, and Canadians, toward a post-pandemic future.

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