Beovu Novartis Europharm Limited · Authorised · authorised 13 Feb 2020 · ATC S01
Therapeutic indication (EMA)
Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Active substance
Brolucizumab
- SFDA 2
- US FDA 1
- EMA 1
- Health Canada 1
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Beovu | 120 mg/ml | Solution for injection · Intravitreal use | 1 Pre-filled syringe | SAR 2754.15 | Biological · Prescription | Novartis Europharm Limited | Valid |
| Beovu | 120 mg/ml | Solution for injection · Intravitreal use | 1 Vial | SAR 2754.15 | Biological · Prescription | Novartis Europharm Limited | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
AGE RELATED MACULAR DEGENERATION; DIABETIC RETINOPATHY
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BEOVU | 6MG/0.05ML | injectable · intravitreal | NOVARTIS PHARMS CORP | Prescription | 7 Oct 2019 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BEOVU | 02496976 | 6 MG / 0.05 ML | SOLUTION · INTRAVITREAL | NOVARTIS PHARMACEUTICALS CANADA INC |
Safety signals and safety-related labeling changes
- US FDA 29 Jul 2024 BEOVU — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 30 Nov 2023 PRAC signal: Scleritis
Action for MAH: update of the product information: No - MHRA 18 Jan 2022 Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals
Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
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.