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Medicines
Spain
Denosumab

AEMPS 2025

Denosumab

Evfraxy 60 MG Solucion Inyectable en Jeringa Precargada

60 mg solución inyectable en jeringa precargadaSpainMarketedAuthorised 18 Sept 2025

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

EvfraxyEuropean UnionAuthorised

EvfraxyEuropean Union · Biosimilar Collaborations Ireland LimitedSame brand
EvfraxyCroatiaSame brand
EvfraxyItaly · Soluzione iniettabile in siringa pre-riempita · Biosimilar Collaborations Ireland LimitedSame brand
Evfraxy 60 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Biosimilar Collaborations Ireland LimitedSame brand
EVFRAXY solution for injection in pre-filled syringe 60mg/mLSingapore · 60mg/mL · injection, solution · Cedar Pharmaceuticals Pte. LTD.Same brand

More with the same substance on this register

Acvybra 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg · solución inyectable en jeringa precargadaSpain
Bildyos 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg/ml · solución inyectable en jeringa precargada

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇦🇷

ProliaArgentina · 60 MG/ML · solución inyectable · Monte Verde S.A.

Same form

🇮🇹AcvybraItaly · Soluzione iniettabile in siringa pre-riempita · Reddy Holding GMBHSame form

🇮🇹BildyosItaly · Soluzione iniettabile · Sciencepharma Spolka Z Ograniczona OdpowiedzialnosciaSame form

🇳🇱Acvybra 60 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Reddy Holding GmbHSame form

🇳🇱Bildyos 60 mg oplossing voor injectieNetherlands · Oplossing voor injectie · Sciencepharma Sp. z o.o.Same form

🇳🇿ProliaNew Zealand · Inj 60 mg per 1 ml prefilled syringeSame form

🇳🇿XgevaNew Zealand · Inj 120 mg per 1.7 ml vialSame form

🇷🇴ProliaRomania · 60mg/ml · sol. inj. in seringa preumpluta · Amgen Europe B.V.Same form

🇷🇴XGEVA 120mgRomania · 70mg/ml · sol inj. · Amgen Europe B.V.Same form

🇷🇸Prolia®Serbia · 60mg/mL · rastvor za injekciju u napunjenom injekcionom špricu · Amicus SRB D.O.O.Same form

🇸🇦Prolia 60MG/ML Solution for InjectionSaudi Arabia · Amgen Europe B.V.Same form

🇸🇦XGEVA 120 mg solution for injectionSaudi Arabia · Amgen Manufacturing LimitedSame form

🇸🇬Jubbonti Solution for Injection in Pre-Filled Syringe 60MG/MLSingapore · 60 mg/ml · injection, solution · Sandoz Singapore Pte. LTD.Same form

🇸🇬Osenvelt® solution for injection 120mg/1.7mLSingapore · 120 mg/1.7 ml · injection, solution · Celltrion Healthcare Singapore Private LimitedSame form

🇺🇸AukelsoUnited States · 120MG/1.7ML · injectable · Biocon Biologics INCSame form

🇺🇸BomyntraUnited States · 120MG/1.7ML · injection · Fresenius Kabi USA LLCSame form

🇺🇸BoncresaUnited States · 60MG/ML · injectable · Amneal Pharms LLCSame form

🇧🇷BomyntraBrazil · Fresenius Kabi Brasil LtdaSame substance

🇧🇷BosayaBrazil · Biocon Biologics do Brasil LtdaSame substance

🇧🇷ConexxenceBrazil · Fresenius Kabi Brasil LtdaSame substance

🇨🇦BildyosCanada · 60 MG / ML · Solution · Shanghai Henlius Biotech, INC.Same substance

🇨🇦DenozaCanada · 60 MG / ML · Solution · Apotex INCSame substance

🇨🇦IdenosCanada · 120 MG / 1.7 ML · Solution · Apotex INCSame substance

🇪🇺AcvybraEuropean Union · Reddy Holding GmbHSame substance

🇪🇺BildyosEuropean Union · Sciencepharma Sp. z o.oSame substance

🇭🇷BomyntraCroatiaSame substance

🇭🇷ConexxenceCroatiaSame substance

🇹🇼OssevaxTaiwan · 注射液劑 · 美時化學製藥股份有限公司Same substance

🇹🇼OssevyTaiwan · 注射液劑 · 美時化學製藥股份有限公司Same substance

Packs

Pack	Code	Status
EVFRAXY 60 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA, 1 jeringa precargada de 1 ml	768513

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Denosumab
Strength: 60 mg
Dosage form: solución inyectable en jeringa precargada
Route: vía subcutánea
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 18 Sept 2025
Registration: 1251946001
Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica
EU number: EU/1/25/1946

🇪🇸Spain

AEMPSBilprevda 120 MG Solucion InyectableDenosumab · 120 mg · solución inyectable🇪🇸Spain

AEMPSBomyntra 120 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 70 mg/ml · solución inyectable🇪🇸Spain

AEMPSBomyntra 120 MG Solucion Inyectable en VialDenosumab · 70 mg/ml · solución inyectable🇪🇸Spain

AEMPSConexxence 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg/ml · solución inyectable🇪🇸Spain

AEMPSEnwylma 120 MG Solucion InyectableDenosumab · 120 mg · solución inyectable🇪🇸Spain

AEMPSIzamby 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg · solución inyectable🇪🇸Spain

AEMPSJubbonti 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg · solución inyectable en jeringa precargada🇪🇸Spain

AEMPSJubereq 120 MG Solucion InyectableDenosumab · 133 mg · solución inyectable🇪🇸Spain

AEMPSJunod 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg/ml · solución inyectable en jeringa precargada🇪🇸Spain

AEMPSKefdensis 60 MG Solucion Inyectable en Jeringa PrecargadaDenosumab · 60 mg · solución inyectable en jeringa precargada🇪🇸Spain