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.
🤖 This plain-language summary is automatically generated from the official agency notice using AI. It is for general information only — not medical advice. For decisions about your health, always consult a pharmacist or doctor and read the official source linked below.
📋 From the official agency notice
Updated 2 months ago- First published
- 30/06/2026
- Medicines affected
- Mycobutin (rifabutin)
- Strengths affected
- 150 mg
- Expected resolution
- Expected to resolve by November 2026
- Supply shortage status
- Shortage ongoing
- Therapeutic area (MESH)
- TuberculosisAcquired Immunodeficiency Syndrome
- Availability of alternatives
- Yes, in some Member States
- Pharmaceutical forms affected
- Capsule
Page contents
- Shortage information
- Key facts
- Key dates
- Related medicine information
Shortage information
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.
Reason for shortage
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.
Member States affected
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.
Monitoring of shortage
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.
Recommendations for healthcare professionals
- 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.
Recommendations for patients and carers
- 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.
Key facts
- 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
Key dates
- Expected resolution
- Expected to resolve by November 2026
- First published
Related medicine information
🔬 Medical / technical details (for professionals)
Forms: Capsule · Strengths: 150 mg · Area: Tuberculosis;Acquired Immunodeficiency Syndrome · Alternatives: Yes, in some Member States
All information on this page comes from the official agency notice. We translate and summarise it; we don't add or edit facts.