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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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TENOFOVIR ALAFENAMIDE

All products: Limited Use (codes 517, 518, 519, 520, 521)

Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable

  • Abacavir (Ziagen): general benefit
  • Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
  • Entecavir (Baraclude): limited Use 505, 506, 507, 508
  • Tenofovir disoproxil (Viread): limited Use 517, 518, 519, 520, 521, 522
  • Adefovir dipivoxil (Hepsera): not a benefit
  • Zidovudine (Retrovir): not a benefit

44 more in the class list below

Vemlidy · DIN 02464241 · 25mg · tablet

Limited Use — Reason for Use code 517, 518, 519, 520, 521 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 517, 518, 519, 520, 521 required
Write on scriptLU code 517, 518, 519, 520, 521 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521
Reason for Use code 517 Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis OR - Documented evidence of cirrhosis Coverage limit: LU Authorization Period: 1 year Reason for Use code 518 For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine. Coverage limit: LU Authorization Period: 1 year Reason for Use code 519 Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL. Coverage limit: LU Authorization Period: 1 year Reason for Use code 520 Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation. Coverage limit: LU Authorization Period: 1 year Reason for Use code 521 Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment. Coverage limit: LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Vemlidy · DIN 02464241 Manufacturer: Gilead Sciences Canada, Inc.; listing date 2026-01-30 Health Canada: Marketed since 2017-06-20 · brand VEMLIDY · ATC J05AF13 TENOFOVIR ALAFENAMIDE · form Tablet · route Oral · ingredients TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG · company Gilead sciences canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Vemlidy: Formulary list price $19.5537/unit (unit not stated in source; not the patient's cost)

Ministry pays: $19.5537 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95241 · Verify on the e-Formulary ↗ (DIN 02464241)

Source record
DIN 02464241: Vemlidy Raw flags: sec12=Y, sec3=Y Item: 081800422; group id 112; item number 0194; lccId 00425; manufacturer id GIL Source form: Tab; strength: 25mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $19.5537; ministry $19.5537 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02464241 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95241
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02464241
Shortage record checked 2026-09-13T08:10:21.292534+00:00

BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE

All products: general benefit

Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable

  • Abacavir (Ziagen): general benefit
  • Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
  • Entecavir (Baraclude): limited Use 505, 506, 507, 508
  • Tenofovir disoproxil (Viread): limited Use 517, 518, 519, 520, 521, 522
  • Adefovir dipivoxil (Hepsera): not a benefit
  • Zidovudine (Retrovir): not a benefit

44 more in the class list below

Biktarvy · DIN 02478579 · 50mg & 200mg & 25mg · tablet

General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

MAX Gilead Support Program for Biktarvy

Manufacturer assistance may reduce costs not paid by public coverage. Ask your pharmacist about MAX Gilead support for Biktarvy.

1-855-711-4629 · Canadian MAX enrolment and card activation

Manufacturer assistance is not subtracted from public estimates. Final out-of-pocket cost is not established.

Assistance conditions and dated sources

Financial eligibility criteria, assistance amount, cap and duration are not confirmed by the current public Canadian materials. Assistance is not guaranteed.

The current public enrolment materials do not state how MAX assistance affects the Trillium deductible. Ask MAX and the pharmacist to confirm. No assistance is subtracted from this estimate.

Ask the pharmacist or MAX about enrolment and obtaining a MAX card. The Canadian portal requires the card's Client ID; after activation, bring the card and prescription to the pharmacy.

Biktarvy must be prescribed. The enrolment portal asks for physician information; the program confirms financial eligibility.

Monday to Friday, 8 am to 8 pm EST, as stated by MAX.

Possible financial assistance for Biktarvy; the amount and duration must be confirmed. This is separate from Ontario's Special Drugs Program.

“The MAX Gilead Support Program® provides financial assistance to eligible patients who have been prescribed an applicable Gilead treatment, including Biktarvy.” Undated Canadian manufacturer page; accessed 2026-09-18

“call 1-855-711-4MAX (4629) between 8 am and 8 pm EST Monday to Friday” Undated Canadian enrolment portal; accessed 2026-09-18

“reimbursement navigation and financial assistance” page 1; undated current linked consent, accessed 2026-09-18

“be provided with a MAX Gilead Patient Support Program® Client ID” page 1; last revised April 2026, accessed 2026-09-18

No interchangeable product listed in the Ontario extract
Biktarvy · DIN 02478579 Manufacturer: Gilead Sciences Canada, Inc.; listing date 2019-07-31 Health Canada: Marketed since 2018-08-08 · brand BIKTARVY · ATC J05AR20 EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR · form Tablet · route Oral · ingredients BICTEGRAVIR (BICTEGRAVIR SODIUM) 50 MG, EMTRICITABINE 200 MG, TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG · company Gilead sciences canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Biktarvy: Formulary list price $40.1640/unit (unit not stated in source; not the patient's cost)

Ministry pays: $40.1640 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96935 · Verify on the e-Formulary ↗ (DIN 02478579)

Source record
DIN 02478579: Biktarvy Raw flags: sec3=Y Item: 081800393; group id 65; item number 0129; lccId None; manufacturer id GIL Source form: Tab; strength: 50mg & 200mg & 25mg Recorded listing: General benefit Source prices (unrounded): $40.1640; ministry $40.1640 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02478579 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96935
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02478579
Shortage record checked 2026-09-13T08:10:21.292534+00:00

DARUNAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE

All products: general benefit

Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable

  • Abacavir (Ziagen): general benefit
  • Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
  • Entecavir (Baraclude): limited Use 505, 506, 507, 508
  • Tenofovir disoproxil (Viread): limited Use 517, 518, 519, 520, 521, 522
  • Adefovir dipivoxil (Hepsera): not a benefit
  • Zidovudine (Retrovir): not a benefit

44 more in the class list below

Symtuza · DIN 02473720 · 800mg & 150mg & 200mg & 10mg · tablet

General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
No interchangeable product listed in the Ontario extract
Symtuza · DIN 02473720 Manufacturer: Janssen Inc.; listing date 2026-08-31 Health Canada: Marketed since 2018-04-25 · brand SYMTUZA · ATC J05AR22 EMTRICITABINE, TENOFOVIR ALAFENAMIDE, DARUNAVIR AND COBICISTAT · form Tablet · route Oral · ingredients EMTRICITABINE 200 MG, COBICISTAT 150 MG, TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 10 MG, DARUNAVIR (DARUNAVIR ETHANOLATE) 800 MG · company Janssen inc · schedule Prescription
Check this DIN again · Health Canada product record

Symtuza: Formulary list price $51.1040/unit (unit not stated in source; not the patient's cost)

Ministry pays: $51.1040 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96312 · Verify on the e-Formulary ↗ (DIN 02473720)

Source record
DIN 02473720: Symtuza Raw flags: sec3=Y Item: 081800423; group id 71; item number 0139; lccId None; manufacturer id JAN Source form: Tab; strength: 800mg & 150mg & 200mg & 10mg Recorded listing: General benefit Source prices (unrounded): $51.1040; ministry $51.1040 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02473720 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96312
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02473720
Shortage record checked 2026-09-13T08:10:21.292534+00:00

ELVITEGRAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE

All products: general benefit

Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable

  • Abacavir (Ziagen): general benefit
  • Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
  • Entecavir (Baraclude): limited Use 505, 506, 507, 508
  • Tenofovir disoproxil (Viread): limited Use 517, 518, 519, 520, 521, 522
  • Adefovir dipivoxil (Hepsera): not a benefit
  • Zidovudine (Retrovir): not a benefit

44 more in the class list below

Genvoya · DIN 02449498 · 150mg & 150mg & 200mg & 10mg · tablet

General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
No interchangeable product listed in the Ontario extract
Genvoya · DIN 02449498 Manufacturer: Gilead Sciences Canada, Inc.; listing date 2017-04-27 Health Canada: Marketed since 2016-02-03 · brand GENVOYA · ATC J05AR18 EMTRICITABINE, TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT, J05AR18 EMTRICITABINE, TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT · form Tablet · route Oral · ingredients COBICISTAT 150 MG, ELVITEGRAVIR 150 MG, EMTRICITABINE 200 MG, TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 10 MG · company Gilead sciences canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Genvoya: Formulary list price $46.2273/unit (unit not stated in source; not the patient's cost)

Ministry pays: $46.2273 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93532 · Verify on the e-Formulary ↗ (DIN 02449498)

Source record
DIN 02449498: Genvoya Raw flags: sec3=Y Item: 081800387; group id 81; item number 0149; lccId None; manufacturer id GIL Source form: Tab; strength: 150mg & 150mg & 200mg & 10mg Recorded listing: General benefit Source prices (unrounded): $46.2273; ministry $46.2273 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02449498 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93532
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02449498
Shortage record checked 2026-09-13T08:10:21.292534+00:00

EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE

All products: general benefit

Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable

  • Abacavir (Ziagen): general benefit
  • Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
  • Entecavir (Baraclude): limited Use 505, 506, 507, 508
  • Tenofovir disoproxil (Viread): limited Use 517, 518, 519, 520, 521, 522
  • Adefovir dipivoxil (Hepsera): not a benefit
  • Zidovudine (Retrovir): not a benefit

44 more in the class list below

Odefsey · DIN 02461463 · 200mg & 25mg & 25mg · tablet

General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
No interchangeable product listed in the Ontario extract
Odefsey · DIN 02461463 Manufacturer: Gilead Sciences Canada, Inc.; listing date 2018-08-30 Health Canada: Marketed since 2017-03-20 · brand ODEFSEY · ATC J05AR19 EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND RILPIVIRINE, J05AR19 EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND RILPIVIRINE · form Tablet · route Oral · ingredients TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG, EMTRICITABINE 200 MG, RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25 MG · company Gilead sciences canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Odefsey: Formulary list price $43.3837/unit (unit not stated in source; not the patient's cost)

Ministry pays: $43.3837 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94909 · Verify on the e-Formulary ↗ (DIN 02461463)

Source record
DIN 02461463: Odefsey Raw flags: sec3=Y Item: 081800390; group id 82; item number 0150; lccId None; manufacturer id GIL Source form: Tab; strength: 200mg & 25mg & 25mg Recorded listing: General benefit Source prices (unrounded): $43.3837; ministry $43.3837 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461463 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94909
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02461463
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (08:18 Antivirals) and how they are covered

Matched class: 08:18 Antivirals

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ABACAVIR & LAMIVUDINE & ZIDOVUDINE, ABACAVIR SULFATE, ABACAVIR SULFATE & LAMIVUDINE, CABOTEGRAVIR, CABOTEGRAVIR & RILPIVIRINE, COBICISTAT & ELVITEGRAVIR & EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, DARUNAVIR & COBICISTAT, DELAVIRDINE MESYLATE, DOLUTEGRAVIR, DOLUTEGRAVIR & ABACAVIR & LAMIVUDINE, DOLUTEGRAVIR & RILPIVIRINE, DOLUTEGRAVIR SODIUM/LAMIVUDINE, DORAVIRINE, DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ/TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL, EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, ETRAVIRINE, FOSAMPRENAVIR CALCIUM, GANCICLOVIR SODIUM, LAMIVUDINE & ZIDOVUDINE, LOPINAVIR & RITONAVIR, MARAVIROC, NELFINAVIR MESYLATE, RALTEGRAVIR POTASSIUM, RILPIVIRINE HYDROCHLORIDE, RITONAVIR Some products covered without a code (check the product listing): ACYCLOVIR, ATAZANAVIR SULFATE, DARUNAVIR, EFAVIRENZ, LAMIVUDINE, NEVIRAPINE, VALACYCLOVIR 08:18 Antivirals

ABACAVIR SULFATE

· 4 products · General benefit · strengths: 20mg/mL, 300mg · O/L, Tab

LAMIVUDINE

· 10 products · General benefit (7), Listed, not a benefit (1), Limited Use, codes 502, 503, 504 (2) · strengths: 10mg/mL, 100mg, 150mg, 300mg · O/L, Tab

ENTECAVIR

· 8 products · Limited Use, codes 505, 506, 507, 508 · strengths: 0.5mg · Tab

TENOFOVIR DISOPROXIL

· 11 products · Limited Use, codes 517, 518, 519, 520, 521, 522 · strengths: 300mg · Tab

ADEFOVIR DIPIVOXIL

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 10mg · Tab

ZIDOVUDINE

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg · Cap

ABACAVIR & LAMIVUDINE & ZIDOVUDINE

· 2 products · General benefit · strengths: 300mg & 150mg & 300mg · Tab

ABACAVIR SULFATE & LAMIVUDINE

· 7 products · General benefit · strengths: 600mg & 300mg · Tab

ACYCLOVIR

· 15 products · Listed, not a benefit (2), General benefit (13) · strengths: 200mg, 400mg, 800mg · Tab

ATAZANAVIR SULFATE

· 12 products · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 150mg, 200mg, 300mg · Cap

CABOTEGRAVIR

· 3 products · General benefit · strengths: 200mg/mL, 30mg · Inj Sol-ER Susp 3mL Vial Kit Pk, Tab

CABOTEGRAVIR & RILPIVIRINE

· 2 products · General benefit · strengths: 200mg/mL & 300mg/mL · Inj Sol-2mL Kit, Inj Sol-3mL Kit Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 08:18 and 38 more
Full class listing Related classes: 08:08 Anthelmintics, 08:12 Antibiotics, 08:14 Antifungals, 08:16 Antitubercular Agents, 08:20 Plasmodicides (Antimalarials), 08:24 Sulfonamides, 08:30 Antiprotozoals, 08:32 Trichomonacides, 08:36 Urinary Anti-Infectives, 08:40 Miscellaneous Anti-Infectives Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: adults infected with hiv-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor, human immunodeficiency virus type 1, human immunodeficiency virus-1
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL, ETRAVIRINE, RILPIVIRINE HYDROCHLORIDE ATAZANAVIR SULFATE · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4) 1 INDICATIONS TEVA-ATAZANAVIR (atazanavir capsules) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 6 years of age and older weighing at least 20 kg. PM: https://pdf.hres.ca/dpd_pm/00078880.PDF; date April 18, 2017; DIN 02443791; fetched 2026-09-10 Product monograph DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE · General benefit 1 Indications DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir. 1.1 Pediatrics Pediatrics ( 12 to < 18 years of age): The safety and efficacy of DELSTRIGO® in pediatric patients 12 years of age and older and weighing at least 35 kg receiving DELSTRIGO® once daily have been established (see 8.2.1 Clinical Trial Adverse Reactions – Pediatrics and 14 Clinical trial). PM: https://pdf.hres.ca/dpd_pm/00081855.PDF; date not captured; DIN 02482592; fetched 2026-09-10 Product monograph EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL · General benefit INDICATIONS AND CLINICAL USE COMPLERA® (emtricitabine [FTC]/rilpivirine [RPV]/tenofovir disoproxil fumarate [TDF]) is indicated for use as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or FTC, and with a viral load less than or equal to 100,000 copies/mL. PM: https://pdf.hres.ca/dpd_pm/00053856.PDF; date October 17, 2019; DIN 02374129; fetched 2026-09-10 Product monograph ETRAVIRINE · General benefit 1 INDICATIONS INTELENCE® (etravirine), in combination with other antiretroviral agents, is indicated for: • the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment- experienced adult and pediatric (from 6 to <18 years of age and weighing ≥30 kg) patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents, including NNRTIs (see 4 DOSAGE AND ADMINISTRATION). PM: https://pdf.hres.ca/dpd_pm/00075096.PDF; date March 27, 2008; DIN 02306778; fetched 2026-09-10 Product monograph RILPIVIRINE HYDROCHLORIDE · General benefit 1 INDICATIONS EDURANT® (rilpivirine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment- naïve adult and pediatric patients 12 years of age and older (and weighing ≥35 kg) with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. 1.1 Pediatrics Pediatrics (12 to <18 years of age and weighing at least 35 kg): The safety, efficacy and pharmacokinetics of Edurant has been established in antiretroviral treatment-naïve, HIV-1 infected pediatric subjects 12 to less than 18 years of age and weighing at least 35 kg (see 4.2 Recommended Dose and Dosage Adjustment, 10.3 Pharmacokinetics, Pediatrics and 14.1 Clinical Trials by Indication, Treatment-Naïve Pediatric Patients (12 years to less than 18 years of age)). PM: https://pdf.hres.ca/dpd_pm/00077884.PDF; date July 20, 2011; DIN 02370603; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE VEMLIDY is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease (see WARNINGS AND PRECAUTIONS). Geriatrics (≥ 65 years of age) Clinical trials of VEMLIDY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (see ACTION AND CLINICAL PHARMACOLOGY). Pediatrics (< 18 years of age) Safety and effectiveness of VEMLIDY in pediatric patients less than 18 years of age have not been established. https://pdf.hres.ca/dpd_pm/00058101.PDF PM date: August 20, 2020 Source product: VEMLIDY; DIN 02464241; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
1 INDICATIONS BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg with no known substitution associated with resistance to bictegravir or tenofovir. 1.1 Pediatrics Pediatrics (weighing ≥ 25 kg): The safety and efficacy in pediatric patients weighing ≥ 25 kg are based on data from an open-label clinical study (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Safety and efficacy of BIKTARVY in children weighing < 25 kg have not been established. 1.2 Geriatrics Geriatrics (≥ 65 years of age): No differences in safety or efficacy have been observed between elderly patients and adult patients < 65 years of age (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). https://pdf.hres.ca/dpd_pm/00080778.PDF PM date: July 10, 2018 Source product: BIKTARVY; DIN 02478579; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
1 INDICATIONS SYMTUZA® (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for: • the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg) and with no known mutations associated with resistance to the individual components of SYMTUZA®. For a description of the clinical data and dosing in support of this indication, refer to 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS. 1.1 Pediatrics Pediatrics (≥12 and <18 years of age with body weight ≥40 kg) Pediatrics (≥12 years of age with body weight ≥40 kg): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of SYMTUZA in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use. (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS). 1.2 Geriatrics Geriatrics (≥65 years of age) Limited information is available on the use of SYMTUZA® in patients aged 65 and over (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS, and 10 CLINICAL PHARMACOLOGY)… https://pdf.hres.ca/dpd_pm/00069792.PDF PM date: March 07, 2018 Source product: SYMTUZA; DIN 02473720; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
1 INDICATIONS GENVOYA (150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/10 mg tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg and with no known mutations associated with resistance to the individual components of GENVOYA. 1.1 Pediatrics Pediatrics (weighing ≥ 25 kg): The safety and efficacy in children weighing ≥ 25 kg are based on data from an open-label clinical study (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Pediatrics (weighing < 25 kg): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for use in pediatrics weighing < 25 kg. 1.2 Geriatrics Geriatrics (≥ 65 years of age): No differences in safety or efficacy have been observed between elderly patients and adult patients < 65 years of age (see 10 CLINICAL PHARMACOLOGY). https://pdf.hres.ca/dpd_pm/00062412.PDF PM date: November 27, 2015 Source product: GENVOYA; DIN 02449498; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
1. INDICATIONS ODEFSEY (emtricitabine [FTC]/rilpivirine [RPV]/tenofovir alafenamide [TAF]) is indicated as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or FTC, and with a viral load ≤ 100,000 copies/mL. The safety and efficacy of ODEFSEY has not been established in patients with a prior history of virologic failure. The following points should be considered prior to the initiation of therapy in patients with no antiretroviral treatment history:  Regardless of HIV-1 RNA at the start of therapy, more RPV-treated patients with CD4+ cell count less than 200 cells/mm3 at the start of therapy experienced virologic failure compared to patients with CD4+ cell count greater than or equal to 200 cells/mm3.  The observed virologic failure rate in RPV-treated patients conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to the control (efavirenz) (see WARNINGS AND PRECAUTIONS, Resistance/Cross- resistance, MICROBIOLOGY, Resistance… https://pdf.hres.ca/dpd_pm/00053935.PDF PM date: November 13, 2019 Source product: ODEFSEY; DIN 02461463; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.