Mycobutin (rifabutin)
- Rifabutina Forma
- cápsula
- Concentración
- 150 mg
- Uso
- tuberculosis; síndrome de inmunodeficiencia adquirida
What is this? Mycobutin is a medicine in capsules. It helps treat tuberculosis and some infections in people with weak immune systems.
What's happening? There is a shortage of Mycobutin capsules in the EU. Other similar medicines may be available.
Does this affect me? If you take Mycobutin, your supply may be affected. Check with your pharmacist.
What should I do? Ask your pharmacist or doctor about other options. Do not stop taking your medicine without advice.
🤖 Este resumen en lenguaje sencillo se genera automáticamente a partir del aviso oficial de la agencia mediante IA. Es solo para fines informativos — no es un consejo médico. Para tomar decisiones sobre su salud, consulte siempre a un farmacéutico o médico y lea la fuente oficial vinculada a continuación.
📋 De la notificación oficial de la agencia
Actualizado hace 3 semanas- Primera publicación
- 30/06/2026
- Medicamentos afectados
- Mycobutin (rifabutin)
- Aptitudes afectadas
- 150 mg
- Resolución esperada
- Expected to resolve by November 2026
- Estado de escasez de suministro
- Shortage ongoing
- Área terapéutica (MESH)
- TuberculosisAcquired Immunodeficiency Syndrome
- Disponibilidad de alternativas
- Yes, in some Member States
- Formas farmacéuticas afectadas
- Capsule
Contenido de la página
- Shortage information
- Key facts
- Key dates
- Related medicine information
Información de escasez
There is a shortage of Mycobutin in EU/EEA countries.
Mycobutin is a medicine for the prevention and treatment of Mycobacterium avium complex infections, often in AIDS patients, and the treatment of tuberculosis (TB).
The company that supplies Mycobutin is experiencing manufacturing issues, as a supplier has stopped production of the starting material rifamycin S, used to produce the active substance rifabutin. This has led to a shortage of Mycobutin. The shortage is not related to a quality defect of the product or a safety issue.
The shortage is expected to last until at least November 2026.
The shortage affects all Member States where the product is marketed: Austria, Belgium, Czechia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden.
This information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority using the below links.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
The company has contracted another supplier of rifamycin S and is taking the necessary steps to have the supplier registered and authorised. Regulatory support is being provided by the National Competent Authorities.
The SPOC Working Party supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- There is an ongoing shortage of Mycobutin in EU/EEA countries, which is expected to last until at least November 2026.
- For additional information consult your country’s shortage register or contact your national competent authority.
- There is an ongoing shortage of Mycobutin in EU/EEA countries, which is expected to last until at least November 2026.
- If Mycobutin is not available, your doctor will discuss with you alternatives such as switching to a different medicine, where available.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority using the below links.
Motivo de escasez
The company that supplies Mycobutin is experiencing manufacturing issues, as a supplier has stopped production of the starting material rifamycin S, used to produce the active substance rifabutin. This has led to a shortage of Mycobutin. The shortage is not related to a quality defect of the product or a safety issue.
The shortage is expected to last until at least November 2026.
Estados miembros afectados
The shortage affects all Member States where the product is marketed: Austria, Belgium, Czechia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden.
This information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority using the below links.
Seguimiento de escasez
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
The company has contracted another supplier of rifamycin S and is taking the necessary steps to have the supplier registered and authorised. Regulatory support is being provided by the National Competent Authorities.
The SPOC Working Party supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
Recomendaciones para profesionales de la salud
- There is an ongoing shortage of Mycobutin in EU/EEA countries, which is expected to last until at least November 2026.
- For additional information consult your country’s shortage register or contact your national competent authority.
Recomendaciones para pacientes y cuidadores
- There is an ongoing shortage of Mycobutin in EU/EEA countries, which is expected to last until at least November 2026.
- If Mycobutin is not available, your doctor will discuss with you alternatives such as switching to a different medicine, where available.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority using the below links.
Datos clave
- Medicines affected
- Mycobutin (rifabutin)
- Supply shortage status
- Shortage ongoing
- Therapeutic area (MESH)
- Tuberculosis
- Acquired Immunodeficiency Syndrome
- Pharmaceutical forms affected
- Capsule
- Strengths affected
- 150 mg
- Availability of alternatives
- Yes, in some Member States
Fechas clave
- Expected resolution
- Expected to resolve by November 2026
- First published
Información relacionada sobre salud
🔬 Detalles médicos/técnicos Para profesionales
Forms: Capsule · Strengths: 150 mg · Area: Tuberculosis;Acquired Immunodeficiency Syndrome · Alternatives: Yes, in some Member States
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