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💊 Medicine EU 30 iunie 2026

Mycobutin (rifabutin)

📷 Wikipedia: Rifabutin · Vă rugăm să așteptați
Mycobutin (rifabutin)
📷 Wikipedia: Rifabutin · Vă rugăm să așteptați
Forms
Capsule
Strengths
150 mg
Area
Tuberculosis;Acquired Immunodeficiency Syndrome
Alternatives
Yes, in some Member States
⚠️
Shortage ongoing
este în prezent în cantitate insuficientă în EU.
📈 Linie temporală
27 zile activ până acum
1 iulie 2026 27 iulie 2026

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.

🤖 Această prezentare simplificată este generată automat din comunicatul oficial al agenției folosind inteligență artificială. Este doar pentru informare generală — nu reprezintă sfaturi medicale. Pentru decizii privind sănătatea dumneavoastră, consultați întotdeauna un farmacist sau un medic și citiți sursa oficială de mai jos.

📋 Din comunicatul oficial al agenției

Actualizat 3 săptămâni în urmă
Prima publicare
30/06/2026
Medicamentele afectate
Mycobutin (rifabutin)
Puncte forte afectate
150 mg
Rezoluție așteptată
Expected to resolve by November 2026
Stare deficit
Shortage ongoing
Arii terapeutice (MeSH)
TuberculosisAcquired Immunodeficiency Syndrome
Disponibilitate alternativelor
Yes, in some Member States
Forme farmaceutice afectate
Capsule

Conținutul paginii

  • Shortage information
  • Key facts
  • Key dates
  • Related medicine information

Informații despre penurie

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. 

Motivul penuriei

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.

State membre afectate

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.

Monitorizarea deficitului

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.

Recomandări pentru profesioniștii din domeniul sănătății

  • 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.

Recomandări pentru pacienți și îngrijitori

  • 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. 

Informații cheie

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

Date cheie

Expected resolution
Expected to resolve by November 2026
First published

Informații medicale conexe

Conținutul de mai sus este reprodus din pagina oficială a agenției (legătură mai jos). Nu îl edităm, interpretăm sau adăugăm la el.
🔬 Detalii medicale / tehnice pentru profesioniști
Mărci / nume de produse
Detalii publicate de agenție

Forms: Capsule · Strengths: 150 mg · Area: Tuberculosis;Acquired Immunodeficiency Syndrome · Alternatives: Yes, in some Member States

Prima publicare
30 iunie 2026
Actualizat de noi
3 săptămâni în urmă
Severitate (clasificată)
Scăzut
Sursă oficială
https://www.ema.europa.eu/en/medicines/human/shortages/mycobutin-rifabutin

Toate informațiile de pe această pagină provin din comunicatul oficial al agenției. Noi le traducem și le sintetizăm; nu adăugăm și nu modificăm fapte.

❓ Întrebări frecvente

Despre ce este alerta medicine shortage?
Mycobutin (rifabutin). Forms: Capsule · Strengths: 150 mg · Area: Tuberculosis;Acquired Immunodeficiency Syndrome · Alternatives: Yes, in some Member States
Când a fost emisă această alertă?
Această alertă a fost emisă la 30 iunie 2026 de către EMA (European Medicines Agency).
Ce țări sunt afectate?
Alerta se aplică pentru întregul EU.
Cât de gravă este această alertă?
:severitate. A low risk means harm is unlikely under normal use. The alert is informational but still worth reading.
Ce să fac?
If you take this medicine, contact your pharmacist or prescribing doctor. They can advise on alternative products or substitutes. Do not stop taking prescription medicine without medical advice.
Unde pot găsi anunțul oficial?
Avertismentul oficial complet este publicat pe www.ema.europa.eu.

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