Active substance
Nebivolol
- SFDA 7
- US FDA 19
- Health Canada 9
- US price lines 8
- NHS prices 4
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Bivocard | 5 mg | Tablet · Oral use | 30 Blister | SAR 25.95 | Generic · Prescription | SPIMACO | Valid |
| Bivocard | 2.5 mg | Tablet · Oral use | 30 Blister | SAR 15.30 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| Bivoneb | 5 mg | Tablet · Oral use | 30 Blister | SAR 25.95 | Generic · Prescription | Saudi Amarox | Valid |
| Bivoneb | 5 mg | Tablet · Oral use | 60 Blister | SAR 51.90 | Generic · Prescription | Saudi Amarox | Valid |
| Mavilor | 5 mg | Tablet · Oral use | 30 Blister | SAR 25.95 | Generic · Prescription | Apex Pharma | Valid |
| NEBILET 5MG TABLETS | 5 mg | Tablet · Oral use | 28 Blister | SAR 31.95 | NCE · Prescription | A MENARINI INDUSTRIE FARMACEUTICHE S.R.L | Valid |
| Novibon | 5 mg | Tablet · Oral use | 30 Blister | SAR 25.95 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
Indications — CHI Daman Drug Formulary
ATRIAL FIBRILLATION; CONGESTIVE HEART FAILURE; HYPERTENSION
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BYSTOLIC | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | ALLERGAN | Prescription | 17 Dec 2007 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | ANI PHARMS | Prescription | 16 Apr 2015 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | INDCHEMIE HEALTH | Prescription | 29 Jul 2015 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | GLENMARK PHARMS LTD | Prescription | 25 May 2017 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | HETERO LABS LTD III | Prescription | 3 Nov 2020 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | CADILA PHARMS LTD | Prescription | 17 Dec 2021 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 17 Dec 2021 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | REYOUNG | Prescription | 17 Dec 2021 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | UNICHEM | Prescription | 15 Mar 2022 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | PRINSTON INC | Prescription | 7 Apr 2022 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | MANKIND PHARMA | Prescription | 14 Nov 2022 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | REGCON HOLDINGS | Prescription | 30 Mar 2023 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | MSN | Prescription | 1 Oct 2024 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | MACLEODS PHARMS | Prescription | 28 Jan 2025 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | ALKEM LABS LTD | Discontinued | 24 Jun 2015 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | WATSON LABS INC | Discontinued | 27 Nov 2015 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | TORRENT | Discontinued | 2 Mar 2018 |
| NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE | tablet · oral | CHARTWELL RX | Discontinued | 31 Mar 2022 |
| NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | tablet · oral | APOTEX | Discontinued | 27 Feb 2024 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BYSTOLIC | 02398990 | 2.5 MG | TABLET · ORAL | ABBVIE CORPORATION |
| BYSTOLIC | 02399008 | 5 MG | TABLET · ORAL | ABBVIE CORPORATION |
| BYSTOLIC | 02399016 | 10 MG | TABLET · ORAL | ABBVIE CORPORATION |
| BYSTOLIC | 02399024 | 20 MG | TABLET · ORAL | ABBVIE CORPORATION |
| JAMP NEBIVOLOL | 02543508 | 5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PRZ-NEBIVOLOL | 02548704 | 2.5 MG | TABLET · ORAL | PHARMARIS CANADA INC |
| PRZ-NEBIVOLOL | 02548712 | 5 MG | TABLET · ORAL | PHARMARIS CANADA INC |
| PRZ-NEBIVOLOL | 02548720 | 10 MG | TABLET · ORAL | PHARMARIS CANADA INC |
| PRZ-NEBIVOLOL | 02548739 | 20 MG | TABLET · ORAL | PHARMARIS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BYSTOLIC 10 MG TABLET | $6.40917 | per EA | 23 Sep 2026 |
| US NADAC | BYSTOLIC 2.5 MG TABLET | $6.4462 | per EA | 23 Sep 2026 |
| US NADAC | BYSTOLIC 20 MG TABLET | $6.42189 | per EA | 23 Sep 2026 |
| US NADAC | BYSTOLIC 5 MG TABLET | $6.45128 | per EA | 23 Sep 2026 |
| US NADAC | NEBIVOLOL 10 MG TABLET | $0.14144 | per EA | 23 Sep 2026 |
| US NADAC | NEBIVOLOL 2.5 MG TABLET | $0.11695 | per EA | 23 Sep 2026 |
| US NADAC | NEBIVOLOL 20 MG TABLET | $0.17489 | per EA | 23 Sep 2026 |
| US NADAC | NEBIVOLOL 5 MG TABLET | $0.11337 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Nebivolol 1.25mg tablets | £220.00 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Nebivolol 10mg tablets | £6.51 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Nebivolol 2.5mg tablets | £2.17 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Nebivolol 5mg tablets | £1.04 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 16 Jun 2023 BYSTOLIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 16 Jun 2023 BYVALSON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.