Regulatory PathRegulatory requirements compared

Active substance

Ranibizumab

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Amelivu10 mg/mlSolution for injection · Intravitreal use1 VialSAR 1530.65Biological · PrescriptionSamsung Bioepis Co LtdValid
LUCENTIS 10MG-ML INTRAVITREAL Injection10 mg/mlSolution for injection · Intravenous use1 VialSAR 2353.90Biological · PrescriptionNOVARTIS PHARMA AGValid
Ravegza 2.3 mg per 0.23 ml10 mg/mlSolution for injection · Intravitreal use1 VialSAR 2206.80Biological · PrescriptionMS Pharma Saudi (MSPS)Valid
ximluci10 mg/mlSolution for injection · Intravitreal use1 VialSAR 1618.30Biological · PrescriptionSTADA ARZNEIMITTEL GmbHValid
Indications — CHI Daman Drug Formulary

AGE RELATED MACULAR DEGENERATION; DIABETIC RETINOPATHY

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
LUCENTIS10MG/ML; 6MG/MLinjectable · injectionGENENTECHPrescription30 Jun 2006
BYOOVIZ0.5MG(10MG/ML)injectable · injectionSAMSUNG BIOEPIS CO LTDPrescription17 Sep 2021
SUSVIMO100MG/MLsolution · injectionGENENTECH INCPrescription22 Oct 2021
CIMERLI0.3MG(6MG/ML); 0.5MG(10MG/ML)injectable · injectionSANDOZ INCPrescription2 Aug 2022
NUFYMCO6MG/ML; 10MG/MLinjectionFORMYCON AGPrescription18 Dec 2025
RANLUSPEC10MG/ML; 6MG/MLinjectionLUPIN LIMITEDPrescription2 Jun 2026

EMA European Union — centrally authorised medicines

Lucentis Novartis Europharm Limited · Authorised · authorised 22 Jan 2007 · ATC S01LA04

Therapeutic indication (EMA)

Lucentis is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to choroidal neovascularisation (CNV) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)

Byooviz Samsung Bioepis NL B.V. · Authorised · authorised 18 Aug 2021 · ATC S01LA04

Therapeutic indication (EMA)

Byooviz is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)

Ranivisio Midas Pharma GmbH · Authorised · authorised 25 Aug 2022 · ATC S01LA04

Therapeutic indication (EMA)

Ranivisio is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (AMD) • The treatment of visual impairment due to diabetic macular oedema (DME) • The treatment of proliferative diabetic retinopathy (PDR) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) • The treatment of visual impairment due to choroidal neovascularisation (CNV)

Ximluci STADA Arzneimittel AG · Authorised · authorised 9 Nov 2022 · ATC S01LA04

Therapeutic indication (EMA)

Ximluci is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)

Rimmyrah Qilu Pharma Spain S.L. · Authorised · authorised 5 Jan 2024 · ATC S01LA04

Therapeutic indication (EMA)

Rimmyrah is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)

Epruvy (previously Ranibizumab Midas) Midas Pharma GmbH · Authorised · authorised 19 Sep 2024 · ATC S01LA04

Therapeutic indication (EMA)

Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV).

Ranluspec Lupin Europe GmbH · Authorised · authorised 10 Feb 2026 · ATC S01LA04

Therapeutic indication (EMA)

Ranluspec is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)

Rexatilux Intas Third Party Sales 2005 S.L. · Authorised · authorised 19 Jun 2026 · ATC S01LA04

Therapeutic indication (EMA)

Rexatilux is indicated in adults for: - The treatment of neovascular (wet) age-related macular degeneration (AMD) - The treatment of visual impairment due to diabetic macular oedema (DME) - The treatment of proliferative diabetic retinopathy (PDR) - The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) - The treatment of visual impairment due to choroidal neovascularisation (CNV).

Vislyfa Lupin Europe GmbH · Authorised · authorised 15 Jul 2026 · ATC S01LA04

Therapeutic indication (EMA)

Vislyfa is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)

Susvimo Roche Registration GmbH · Authorised · authorised 18 Sep 2026 · ATC S01LA04

Therapeutic indication (EMA)

Susvimo is indicated in adult patients for the treatment of neovascular (wet) age-related macular degeneration (nAMD) who have achieved stable disease after previously responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor medicinal product.

Susvimo Roche Registration GmbH · Application withdrawn · ATC S01LA04

Therapeutic indication (EMA)

Treatment of neovascular age-related macular degeneration in adults.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LUCENTIS0229681010 MG / MLSOLUTION · INTRAVITREALNOVARTIS PHARMACEUTICALS CANADA INC
LUCENTIS0242562910 MG / MLSOLUTION · INTRAVITREALNOVARTIS PHARMACEUTICALS CANADA INC
MELVIZO0252585210 MG / MLSOLUTION · INTRAVITREALSAMSUNG BIOEPIS CO., LTD
RANOPTO0254225010 MG / MLSOLUTION · INTRAVITREALTEVA CANADA LIMITED

Safety signals and safety-related labeling changes

All safety entries for ranibizumab →

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.