Is Aflibercept registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Aflibercept, including EYLEA 40 mg/ml solution for injection (40 mg/ml, Solution for injection, SAR 3028.60); Eylea (114.3 mg/ml, Solution for injection, SAR 3028.60); Eylea 40 mg/ml Solution for injection in pre-filled syringe (40 mg/ml, Solution for injection in pre-filled syringe, SAR 3028.60); FOVLYA (40 mg/ml, Solution for injection, SAR 2271.45); Yesafili (40 mg/ml, Solution for injection, SAR 1968.60).

Is Aflibercept approved by the US FDA?

Drugs@FDA lists 8 application product lines for Aflibercept, including EYLEA (Prescription); EYLEA HD (Prescription); YESAFILI (Prescription); OPUVIZ (Prescription); AHZANTIVE (Prescription).

Is Aflibercept authorised in the European Union?

EMA lists 14 centrally authorised medicines containing Aflibercept: Pavblu, Eylea, Zaltrap, Yesafili, Opuviz, Afqlir, Baiama, Ahzantive.

Are there safety signals or safety updates for Aflibercept?

EMA PRAC: 6 entries; US FDA: 7 entries; MHRA: 1 entry (latest 2026-09-29).

Active substance

Aflibercept

SFDA 5
US FDA 8
EMA 15
Health Canada 12
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EYLEA 40 mg/ml solution for injection	40 mg/ml	Solution for injection · Intravitreal use	1 Vial	SAR 3028.60	Biological · Prescription	BAYER AG	Valid
Eylea	114.3 mg/ml	Solution for injection · Intravitreal use	1 Vial	SAR 3028.60	Biological · Prescription	BAYER AG	Valid
Eylea 40 mg/ml Solution for injection in pre-filled syringe	40 mg/ml	Solution for injection in pre-filled syringe · Intravitreal use	1 Pre-filled syringe	SAR 3028.60	Biological · Prescription	BAYER AG	Valid
FOVLYA	40 mg/ml	Solution for injection · Intravitreal use	1 Vial	SAR 2271.45	Biological · Prescription	MS Pharma Saudi (MSPS)	Valid
Yesafili	40 mg/ml	Solution for injection · Intravitreal use	1 Vial	SAR 1968.60	Biological · Prescription	Boston Oncology Arabia	Valid

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
EYLEA	40MG/ML	injectable · injection	REGENERON PHARMACEUTICALS	Prescription	18 Nov 2011
EYLEA HD	8MG(0.07ML;114.3MG/ML)	injectable · injection	REGENERON PHARMACEUTICALS	Prescription	18 Aug 2023
YESAFILI	2MG(0.05ML,40MG/ML)	injectable · injection	BIOCON BIOLOGICS INC	Prescription	20 May 2024
OPUVIZ	2MG(0.05ML,40MG/ML)	injectable · injection	SAMSUNG BIOEPIS CO LTD	Prescription	20 May 2024
AHZANTIVE	2MG(0.05ML OF 40MG/ML)	injectable · injection	FORMYCON AG	Prescription	28 Jun 2024
ENZEEVU	2MG(0.05ML of 40MG/ML)	injectable · injection	SANDOZ INC	Prescription	9 Aug 2024
PAVBLU	2 mg (0.05 mL of 40 mg/mL)	injectable · injection	AMGEN INC	Prescription	23 Aug 2024
EYDENZELT	2MG(0.05ML;40MG/ML)	injectable · injection	CELLTRION INC	Prescription	2 Oct 2025

EMA European Union — centrally authorised medicines

Pavblu Amgen Technology (Ireland) UC · Authorised · ATC S01LA05

Therapeutic indication (EMA)

Pavblu is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Eylea Bayer AG · Authorised · authorised 21 Nov 2012 · ATC S01LA05

Therapeutic indication (EMA)

Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)

Zaltrap Sanofi Winthrop Industrie · Authorised · authorised 1 Feb 2013 · ATC L01XX44

Therapeutic indication (EMA)

Treatment of metastatic colorectal cancer (MCRC).

Yesafili Biosimilar Collaborations Ireland Limited · Authorised · authorised 15 Sep 2023 · ATC S01LA05

Therapeutic indication (EMA)

Yesafili is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Opuviz Samsung Bioepis NL B.V. · Authorised · authorised 13 Nov 2024 · ATC S01LA05

Therapeutic indication (EMA)

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

Afqlir Sandoz GmbH · Authorised · authorised 13 Nov 2024 · ATC S01LA05

Therapeutic indication (EMA)

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

Baiama Formycon AG · Authorised · authorised 13 Jan 2025 · ATC S01LA05

Therapeutic indication (EMA)

Baiama is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Ahzantive Formycon AG · Authorised · authorised 13 Jan 2025 · ATC S01LA05

Therapeutic indication (EMA)

Ahzantive is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1), • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Eydenzelt Celltrion Healthcare Hungary Kft. · Authorised · authorised 12 Feb 2025 · ATC S01LA05

Therapeutic indication (EMA)

Eydenzelt is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Vgenfli Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. · Authorised · authorised 14 Aug 2025 · ATC S01LA05

Therapeutic indication (EMA)

Vgenfli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic macular oedema (DME),- visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Eiyzey Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. · Authorised · authorised 14 Aug 2025 · ATC S01LA05

Therapeutic indication (EMA)

Eiyzey is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- visual impairment due to diabetic macular oedema (DME) (see section 5.1),- visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1)s.

Mynzepli Advanz Pharma Limited · Authorised · authorised 18 Aug 2025 · ATC S01LA05

Therapeutic indication (EMA)

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

Afiveg STADA Arzneimittel AG · Authorised · authorised 18 Aug 2025 · ATC S01LA05

Therapeutic indication (EMA)

Afiveg is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Eyluxvi Biolitec pharma Limited Zweigniederlassung Jena · Authorised · authorised 15 Sep 2025 · ATC S01LA05

Therapeutic indication (EMA)

Eyluxvi is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),- visual impairment due to diabetic macular oedema (DME) (see section 5.1),- visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Skojoy Amgen Technology (Ireland) UC · Application withdrawn · ATC S01LA05

Therapeutic indication (EMA)

Treatment of age-related macular degeneration (AMD) and visual impairment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AFLIVU	02554178	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	APOTEX INC
AFLIVU	02554194	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	APOTEX INC
ENZEEVU	02562510	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	SANDOZ CANADA INCORPORATED
EYDENZELT	02563037	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	CELLTRION INC.
EYDENZELT	02563045	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	CELLTRION INC.
EYLEA	02415992	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	BAYER INC
EYLEA	02505355	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	BAYER INC
EYLEA HD	02545004	8 MG / 0.07 ML	SOLUTION · INTRAVITREAL	BAYER INC
EYLEA HD	02554798	8 MG / 0.07 ML	SOLUTION · INTRAVITREAL	BAYER INC
PAVBLU	02550636	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	AMGEN CANADA INC
YESAFILI	02535858	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	BIOCON BIOLOGICS CANADA INC
YESAFILI	02558238	2 MG / 0.05 ML	SOLUTION · INTRAVITREAL	BIOCON BIOLOGICS CANADA INC

Safety signals and safety-related labeling changes

US FDA 29 Sep 2026 EYDENZELT — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 28 Apr 2026 PAVBLU — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 2 Apr 2026 EYLEA HD — 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 12 Feb 2026 ENZEEVU — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 13 Jan 2026 YESAFILI — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 6 Jun 2025 OPUVIZ — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 10 Oct 2024 EYLEA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 May 2024 PRAC signal: Nephropathy toxic after intravitreal administration
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2024 PRAC signal: Nephropathy toxic after intravitreal administration
Action for MAH: update of the product information: No
MHRA 18 Apr 2016 Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw
Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
EMA PRAC 6 Nov 2015 PRAC signal: Higher systemic exposure compared to ranibizumab after intravitreal injection
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2015 PRAC signal: Higher systemic exposure compared to ranibizumab after intravitreal injection
Action for MAH: update of the product information: No
EMA PRAC 9 Oct 2014 PRAC signal: Higher systemic exposure compared to ranibizumab after intravitreal injection
Action for MAH: update of the product information: No
EMA PRAC 10 Oct 2013 PRAC signal: Blindness
Action for MAH: update of the product information: No

All safety entries for aflibercept →

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.