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BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto: información para el usuario

Beyfortus 50mg solución inyectable en jeringa precargada

Beyfortus 100mg solución inyectable en jeringa precargada

nirsevimab

Este medicamento está sujeto a seguimiento adicional, lo que agilizará la detección de nueva información sobre su seguridad. Puede contribuir comunicando los efectos adversos que su hijo pudiera tener. La parte final de la sección 4 incluye información sobre cómo comunicar estos efectos adversos.

Lea todo el prospecto detenidamente antes de administrar a su hijo este medicamento, porque contiene información importante para usted y su hijo.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico, o farmacéutico o enfermero.
  • Si su hijo experimenta efectos adversos, consulte a su médico, o farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Beyfortus y para qué se utiliza
  2. Qué necesita saber antes de que se le administre Beyfortus a su hijo
  3. Cómo y cuándo se administra Beyfortus
  4. Posibles efectos adversos
  5. Conservación de Beyfortus
  6. Contenido del envase e información adicional

1. Qué es Beyfortus y para qué se utiliza

Qué es Beyfortus

Beyfortus es un medicamento que se administra como inyección para proteger a los bebés y niños menores de 2 años frente al virus respiratoriosincitial(VRS). El VRS es un virus respiratorio común que generalmente causa síntomas leves comparables a los del resfriado común. Sin embargo, especialmente en bebés, niños vulnerables y adultos mayores, el VRS puede causar enfermedades graves, como bronquiolitis (inflamación de las vías respiratorias pequeñas en el pulmón) y neumonía (infección de los pulmones) que puede conducir a la hospitalización o incluso a la muerte. El virus suele ser más común durante el invierno.

Beyfortus contiene el principio activo nirsevimab, que es un anticuerpo (una proteína diseñada para unirse a una diana específica) que se une a la proteína que el VRS necesita para infectar el cuerpo. Al unirse a esta proteína, Beyfortus bloquea su acción, impidiendo así que el virus entre e infecte las células humanas.

Para qué se utiliza Beyfortus

Beyfortus es un medicamento que se utiliza para proteger a su hijo frente a la enfermedad provocada por el VRS.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de que se le administre Beyfortus a su hijo

Su hijo no debe usar Beyfortus si es alérgico a nirsevimab o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).

Informe al médico, farmacéutico o enfermero de su hijo si esto le aplica a su hijo. Si no está seguro,consulte con el médico, farmacéutico o enfermero de su hijo antes de administrarle el medicamento.

Si su hijo muestra signos de una reacción alérgica grave,contacte con el médico inmediatamente.

Advertencias y precauciones

Consulte a su médico o busque ayuda médica inmediatamente si observa cualquier signo de reacción alérgica, como:

  • dificultad para respirar o tragar
  • hinchazón de la cara, labios, lengua o garganta
  • picor severo en la piel, con un sarpullido rojo o protuberancias elevadas

Consulte con su profesional sanitario antes de que se le administre Beyfortus a su hijo si tienen un número bajo de plaquetas en la sangre (que ayudan a la coagulación de la sangre), un problema de coagulación o hematomas con facilidad o si están tomando un anticoagulante (un medicamento para prevenir coágulos de sangre).

En determinadas enfermedades crónicas, en las que se pierden demasiadas proteínas a través de la orina o el intestino, por ejemplo el síndrome nefrótico y las enfermedades hepáticas crónicas, el nivel de protección de Beyfortus se puede ver reducido.

Beyfortus contiene 0,1 mg de polisorbato 80 en cada dosis de 50 mg (0,5 ml) y 0,2 mg en cada dosis de 100 mg (1 ml). Los polisorbatos pueden causar reacciones alérgicas. Informe a su médico si su hijo tiene cualquier alergia conocida.

Niños y adolescentes

No administre este medicamento a niños de entre 2 y 18 años de edad porque no ha sido estudiado en este grupo.

Otros medicamentos y Beyfortus

No se ha observado que Beyfortus interaccione con otros medicamentos. Sin embargo, informe a su médico, farmacéutico o enfermero si su hijo está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

Beyfortus se puede administrar al mismo tiempo que las vacunas que forman parte del programa nacional de vacunación.

3. Cómo y cuándo se administra Beyfortus

Beyfortus debe ser administrado por un profesional sanitario como una inyección en el músculo. Normalmente, se administra en la parte externa del muslo.

La dosis recomendada es:

  • 50 mg para niños que pesan menos de 5 kg y 100 mg para niños que pesan 5 kg o más en su primera temporada de VRS.
  • 200 mg para niños que siguen siendo vulnerables a la enfermedad grave por VRS en su segunda temporada de VRS (administrados como 2 inyecciones de 100 mg en sitios separados).

Beyfortus se debe administrar antes de la temporada del VRS. El virus suele ser más común durante el invierno (conocido como temporada del VRS). Si su hijo nace durante el invierno, Beyfortus se debe administrar después del nacimiento.

Si su hijo va a ser sometido a una operación cardíaca (cirugía cardíaca), se le puede administrar una dosis adicional de Beyfortus después de la operación para garantizar que tengan una protección adecuada durante el resto de la temporada del VRS.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico, farmacéutico o enfermero.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Los efectos adversos pueden incluir:

Poco frecuentes(pueden afectar hasta 1 de cada 100 niños)

  • sarpullido
  • reacción en el lugar de la inyección (es decir, enrojecimiento, hinchazón y dolor donde se administra la inyección)
  • fiebre

Frecuencia no conocida(no puede estimarse a partir de los datos disponibles)

  • reacciones alérgicas

Comunicación de efectos adversos

Si su hijo experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o enfermero, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Beyfortus

Su médico, farmacéutico o enfermero es responsable de conservar este medicamento y de eliminar correctamente cualquier producto no utilizado. La siguiente información está dirigida a los profesionales sanitarios.

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD. La fecha de caducidad es el último día del mes que se indica.

Conservar en nevera (entre 2ºC y 8ºC). Después de retirarlo de la nevera, Beyfortus se debe proteger de la luz y utilizar durante las 8 horas siguientes o desecharse.

Conservar la jeringa precargada en el embalaje exterior para protegerla de la luz.

No congelar, agitar ni exponer al calor directo.

La eliminación del medicamento no utilizado y de todos los materiales que hayan estado en contacto con él se realizará de acuerdo con la normativa local.

6. Contenido del envase e información adicional

Composición de Beyfortus

  • El principio activo es nirsevimab.
  • Una jeringa precargada de 0,5 ml de solución contiene 50 mg de nirsevimab.
  • Una jeringa precargada de 1 ml de solución contiene 100 mg de nirsevimab.
  • Los demás componentes son: L-histidina, clorhidrato de L-histidina, clorhidrato de L-arginina, sacarosa, polisorbato 80 (E433) y agua para preparaciones inyectables.

Aspecto de Beyfortus y contenido del envase

Beyfortus es una solución inyectable de incolora a amarilla.

Beyfortus está disponible en:

  • 1 o 5 jeringa(s) precargada(s) sin agujas.
  • 1 jeringa precargada envasada con dos agujas separadas de diferentes tamaños.

Puede que no se comercialicen todos los tamaños de envases.

Titular de la autorización de comercialización

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

Francia

Responsable de la fabricación

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Suecia

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 2 710.54.00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

Texto con el nombre de la empresa Swixx Biopharma Eood y su número de teléfono +359 2 4942 480 en idioma extranjero

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 2 710.54.00

Ceská republika

Sanofi s.r.o.

Tel: +420 233 086 111

Magyarország

sanofi-aventis zrt

Tel.: +36 1 505 0055

Danmark

Sanofi A/S

Tlf: +45 4516 7000

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel.: 0800 54 54 010

Tel. aus dem Ausland: +49 69 305 21 130

Nederland

Sanofi B.V.

Tel: +31 20 245 4000

Eesti

Swixx Biopharma OÜ

Tel: +372 640 10 30

Norge

Sanofi-aventis Norge AS

Tlf: + 47 67 10 71 00

Ελλ?δα

ΒΙΑΝΕΞ Α.Ε.

Τηλ: +30.210.8009111

Österreich

Sanofi-Aventis GmbH

Tel: +43 1 80 185-0

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

Sanofi Sp. z o. o.

Tel.: +48 22 280 00 00

France

Sanofi Pasteur Europe

Tél: 0800 222 555

Appel depuis l’étranger : +33 1 57 63 67 62

Portugal

Sanofi – Produtos Farmacêuticos, Lda.

Tel: + 351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o.

Tel: +385 1 2078 500

România

Sanofi Romania SRL

Tel: +40(21) 317 31 36

Ireland

sanofi-aventis Ireland T/A SANOFI

Tel: + 353 (0) 1 4035 600

Slovenija

Swixx Biopharma d.o.o

Tel: +386 1 235 51 00

Ísland

Vistor

Sími: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600

Italia

Sanofi S.r.l.

Tel: 800536389

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κ?προς

C.A. Papaellinas Ltd.

Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 8-634 50 00

Latvija

Swixx Biopharma SIA

Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +44 (0) 800 035 2525

Fecha de la última revisión de este prospecto:

La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos: http://www.ema.europa.eu.

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Esta información está destinada únicamente a profesionales sanitarios:

Con objeto de mejorar la trazabilidad de los medicamentos biológicos, el nombre y el número de lote del medicamento administrado deben estar claramente registrados.

Inspeccione visualmente Beyfortus para detectar partículas y decoloración antes de la administración. Beyfortus es una solución de transparente a opalescente, de incolora a amarilla. No inyecte Beyfortus si el líquido está turbio, decolorado o contiene partículas grandes o partículas extrañas.

No lo utilice si la jeringa precargada de Beyfortus se ha caído o dañado o si se ha roto el sello de seguridad del envase.

Administre todo el contenido de la jeringa precargada como inyección intramuscular, preferiblemente en la cara anterolateral del muslo. El músculo glúteo no se debe utilizar rutinariamente como sitio de inyección debido al riesgo de daño al nervio ciático.

Online doctors for BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe

Discuss questions about BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Sviatoslav Chekhun

Oncology 13 years exp.

Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

  •  for diagnosis or clarification of a cancer diagnosis
  •  to obtain a second opinion on an existing treatment plan 
  •  when you need a personalized treatment strategy 
  •  for interpretation of test results, CT, MRI, PET-CT, and biopsies 
  •  when choosing between treatment options (chemotherapy, targeted therapy, immunotherapy) 
  •  in case of doubts about treatment strategy or disease progression 

Consultation format

Dr. Chekhun provides online consultations, where you can receive:

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Important:
Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

Dr. Sviatoslav Chekhun combines clinical practice, research, and international experience, enabling him to provide patients with modern, evidence-based approaches in oncology.

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Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Taisiia Proida

Family medicine 7 years exp.

Taisiia Proida is a general practitioner with a specialization in mental health and a cognitive behavioral therapist (CBT), a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care. She specialises in consultations and ongoing support for a wide range of mental health concerns, including: 

  • Mood disorders: depression, bipolar disorder, postpartum depression.
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  • Post-traumatic stress disorder (PTSD) and complex PTSD.
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Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders. She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
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During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Get BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe Prescription Online

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Frequently Asked Questions

Is a prescription required for BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe?

BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

What is the active substance in BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe?

The active ingredient in BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe is nirsevimab. This information helps identify medicines with the same composition but different brand names.

Who manufactures BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe?

BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe is manufactured by Sanofi Winthrop Industrie. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe online?

Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

How to buy BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe?

Other medicines with the same active substance (nirsevimab) include BEYFORTUS 100 mg injectable solution in pre-filled syringe, EVUSHELD 150 MG +150 MG INJECTABLE SOLUTION, KAVIGALE 300 MG INJECTABLE SOLUTION AND PERFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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