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💊 Medicine EU 10 de julho de 2026

Azactam

INN
aztreonam
Forms
Powder for solution for injection;Powder for solution for infusion
Strengths
1 g;2 g
Area
Bacterial Infections
Alternatives
Yes
⚠️
Shortage ongoing
aztreonam está em falta em EU.
📈 Linha do tempo
19 dias ativos até agora
10 de julho de 2026 28 de julho de 2026

What is this? Azactam is a medicine with the active substance aztreonam. It is given by injection or infusion to treat bacterial infections.

What's happening? There is a shortage of Azactam in the EU. Supplies may be limited in some places.

Does this affect me? If you need Azactam for a bacterial infection, your treatment might be affected. Ask your pharmacist or doctor.

What should I do? Talk to your pharmacist or doctor about other treatment options that may be available.

🤖 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 2 semanas
Primeira publicação
10/07/2026
Medicamentos afetados
Azactam
Pontos afetados
1 g2 g
Status de escassez de suprimentos
Shortage ongoing
Área terapêutica (MeSH)
Bacterial Infections
Disponibilidade de alternativas
Yes
Formas farmacêuticas afetadas
Powder for solution for injectionPowder for solution for infusion
Nome internacional não proprietário (INN) ou nome comum
aztreonam

Conteúdo da página

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

Informações sobre escassez

There is an ongoing shortage of Azactam (aztreonam) in the EU/EAA (European Economic Area). 

Azactam (aztreonam) is an antibiotic used to treat a wide range of serious infections caused by bacteria which require an antibiotic injection. These include infections of the urinary tract, lungs, blood, brain, skin, and abdomen.

The company for Azactam, Delbert, is having manufacturing issues at a new production site. This means that new batches of Azactam 1g and 2g powder for injection or infusion cannot be released, which has resulted in supply shortages since the second quarter of 2026. The shortage is not due to any safety, efficacy or quality concern with currently available supplies of Azactam.

The shortage is expected to last until the end of June 2027.

The shortage affects all Member States where the product is currently marketed: France, Belgium, Luxembourg, Portugal, Austria, Finland, Norway, Sweden and Spain.

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 is closely monitoring the supply situation of Azactam and is engaging with the company to mitigate the impact of the shortage by:

  • supplying additional batches to the EU/EEA from stock not originally intended for this region; 
  • central EU/EEA stock management, including close monitoring of inventory levels to support allocation of supplies to countries based on demand and need; 
  • implementation of controlled distribution measures in countries where this is feasible.

Monitoring is carried out by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party). For further information see ‘related information’.
 

  • Manufacturing issues have led to shortages of Azactam in the EU/EAA which are expected to last until the end of June 2027. 
  • While the medicine is unavailable, healthcare professionals should follow the guidance issued by the relevant national medicines agency. This guidance may include recommendations to prioritise the use of available supplies for specific patient groups, particularly those with the greatest clinical need and for whom no suitable therapeutic alternatives are available. 
  • National guidance may also advise on suitable alternatives and provide advice on switching strategies, including any necessary monitoring or precautions to ensure continuity of care and minimise risks to patients.
  • A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States.
  • For additional information, consult your country’s shortage register or contact your national competent authority.
     

  • Manufacturing delays have led to shortages of Azactam in the EU/EAA which are expected to last until the end of June 2027. 
  • If Azactam is not available in your country, your doctor will prescribe an alternative antibiotic to treat your infection. 
  • 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 for Azactam, Delbert, is having manufacturing issues at a new production site. This means that new batches of Azactam 1g and 2g powder for injection or infusion cannot be released, which has resulted in supply shortages since the second quarter of 2026. The shortage is not due to any safety, efficacy or quality concern with currently available supplies of Azactam.

The shortage is expected to last until the end of June 2027.

Estados-Membros afetados

The shortage affects all Member States where the product is currently marketed: France, Belgium, Luxembourg, Portugal, Austria, Finland, Norway, Sweden and Spain.

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 is closely monitoring the supply situation of Azactam and is engaging with the company to mitigate the impact of the shortage by:

  • supplying additional batches to the EU/EEA from stock not originally intended for this region; 
  • central EU/EEA stock management, including close monitoring of inventory levels to support allocation of supplies to countries based on demand and need; 
  • implementation of controlled distribution measures in countries where this is feasible.

Monitoring is carried out by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party). For further information see ‘related information’.
 

Recomendações para profissionais de saúde

  • Manufacturing issues have led to shortages of Azactam in the EU/EAA which are expected to last until the end of June 2027. 
  • While the medicine is unavailable, healthcare professionals should follow the guidance issued by the relevant national medicines agency. This guidance may include recommendations to prioritise the use of available supplies for specific patient groups, particularly those with the greatest clinical need and for whom no suitable therapeutic alternatives are available. 
  • National guidance may also advise on suitable alternatives and provide advice on switching strategies, including any necessary monitoring or precautions to ensure continuity of care and minimise risks to patients.
  • A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States.
  • For additional information, consult your country’s shortage register or contact your national competent authority.
     

Recomendações para doentes e cuidadores

  • Manufacturing delays have led to shortages of Azactam in the EU/EAA which are expected to last until the end of June 2027. 
  • If Azactam is not available in your country, your doctor will prescribe an alternative antibiotic to treat your infection. 
  • 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
Azactam
Supply shortage status
Shortage ongoing
International non-proprietary name (INN) or common name
aztreonam
Therapeutic area (MESH)
Bacterial Infections
Pharmaceutical forms affected
  • Powder for solution for injection
  • Powder for solution for infusion
Strengths affected
  • 1 g
  • 2 g
Availability of alternatives
Yes

Datas importantes

First published

Informações relacionadas sobre saúde

O conteúdo acima é reproduzido da página oficial da agência (link abaixo). Não o editamos, interpretamos ou acrescentamos informações.
🔬 Detalhes médicos/técnicos (para profissionais)
Substância(s) ativa(s)
Marca(s) / nome(s) do(s) produto(s)
Detalhe publicado pela agência

INN: aztreonam · Forms: Powder for solution for injection;Powder for solution for infusion · Strengths: 1 g;2 g · Area: Bacterial Infections · Alternatives: Yes

Primeira publicação
10 de julho de 2026
Atualizado por nós
há 2 semanas
Gravidade (classificada)
Baixo
Fonte oficial
https://www.ema.europa.eu/en/medicines/human/shortages/azactam

Todas as informações desta página são provenientes do comunicado oficial da agência. Nós as traduzimos e resumimos; não adicionamos nem editamos factos.

❓ Perguntas frequentes

Sobre que alerta de medicine shortage se trata?
Azactam. INN: aztreonam · Forms: Powder for solution for injection;Powder for solution for infusion · Strengths: 1 g;2 g · Area: Bacterial Infections · Alternatives: Yes
Quando foi emitido este alerta?
Este alerta foi emitido em 10 de julho de 2026 por EMA (European Medicines Agency).
Quais países são afetados?
O alerta aplica-se a a totalidade da UE
Qual a gravidade deste alerta?
:severidade. A low risk means harm is unlikely under normal use. The alert is informational but still worth reading.
O que devo fazer?
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.
Onde posso encontrar o aviso oficial?
A íntegra do aviso oficial está publicada em www.ema.europa.eu.

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