Mycobutin (rifabutin)
- Forms
- Capsule
- Strengths
- 150 mg
- Area
- Tuberculosis;Acquired Immunodeficiency Syndrome
- Alternatives
- Yes, in some Member States
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 resumo em linguagem simples é gerado automaticamente a partir do comunicado oficial da agência, com recurso a IA. Destina-se apenas a fins informativos — não constitui aconselhamento médico. Para tomar decisões sobre a sua saúde, consulte sempre um farmacêutico ou médico e leia a fonte oficial vinculada abaixo.
📋 Da notificação oficial da agência
Atualizado há 3 semanas- Primeira publicação
- 30/06/2026
- Medicamentos afetados
- Mycobutin (rifabutin)
- Pontos afetados
- 150 mg
- Resolução esperada
- Expected to resolve by November 2026
- Status de escassez de suprimentos
- Shortage ongoing
- Área terapêutica (MeSH)
- TuberculosisAcquired Immunodeficiency Syndrome
- Disponibilidade de alternativas
- Yes, in some Member States
- Formas farmacêuticas afetadas
- Capsule
Conteúdo da página
- Shortage information
- Key facts
- Key dates
- Related medicine information
Informações sobre escassez
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 da escassez
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-Membros afetados
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.
Monitorização de escassez
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.
Recomendações para profissionais de saúde
- 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.
Recomendações para doentes e 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.
Principais informações
- 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
Datas importantes
- Expected resolution
- Expected to resolve by November 2026
- First published
Informações relacionadas sobre saúde
🔬 Detalhes médicos/técnicos (para profissionais)
Forms: Capsule · Strengths: 150 mg · Area: Tuberculosis;Acquired Immunodeficiency Syndrome · Alternatives: Yes, in some Member States
Todas as informações desta página são provenientes do comunicado oficial da agência. Nós as traduzimos e resumimos; não adicionamos nem editamos factos.