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💊 Medicine EU September 23, 2022

Actilyse and Actilyse Cathflo

📷 Wikipedia: Alteplase · Source
Actilyse and Actilyse Cathflo
📷 Wikipedia: Alteplase · Source
INN
alteplase
Forms
Powder and solvent for solution for injection/infusion
Strengths
10 mg (Actilyse);20 mg (Actilyse);50 mg (Actilyse);2 mg (Actilyse Cathflo)
Area
Myocardial Infarction
Alternatives
Yes
🗄
Archived (older alert)
This alert was reported 1449 days ago and has been moved from our active feed to the archive. The original safety information still applies — we have no confirmation from the issuing agency that the product is safe again. Refer to the official notice for the current status.
📈 Timeline
114 days in total
May 20, 2026 September 11, 2026
Daily snapshot data starts accumulating once the scheduler runs — for now this is interpolated from the agency's first/last dates.

What is this? Actilyse is a medicine called alteplase. It is used in hospitals to treat heart attacks and other serious clots.

What's happening? There is a short supply of Actilyse in the EU. Hospitals may have less of it for now.

Does this affect me? If you need this medicine for a heart attack or clot, your doctor will decide what to use instead.

What should I do? Do not stop or change your treatment. Ask your doctor or pharmacist for 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.

🔬 Medical / technical details (for professionals)
Active substance(s)
alteplase
Brand(s) / product name(s)
Actilyse and Actilyse Cathflo
Agency-published detail

INN: alteplase · Forms: Powder and solvent for solution for injection/infusion · Strengths: 10 mg (Actilyse);20 mg (Actilyse);50 mg (Actilyse);2 mg (Actilyse Cathflo) · Area: Myocardial Infarction · Alternatives: Yes

First published
September 23, 2022
Last refreshed by us
3 months ago
Severity (as classified)
Medium
Official source
http://www.ema.europa.eu/en/medicines/human/shortages/actilyse-actilyse-cathflo

All information on this page comes from the official agency notice. We translate and summarise it; we don't add or edit facts.

❓ Frequently asked questions

▸ What is this medicine shortage alert about?
Actilyse and Actilyse Cathflo. INN: alteplase · Forms: Powder and solvent for solution for injection/infusion · Strengths: 10 mg (Actilyse);20 mg (Actilyse);50 mg (Actilyse);2 mg (Actilyse Cathflo) · Area: Myocardial Infarction · Alternatives: Yes
▸ When was this alert issued?
This alert was issued on September 23, 2022 by EMA (European Medicines Agency).
▸ Which countries are affected?
The alert applies to the entire EU.
▸ How serious is this alert?
Medium risk. A medium risk means harm is possible under certain conditions. Read the notice and act on the recommended steps.
▸ What should I do?
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.
▸ Where can I find the official notice?
The full official notice is published on www.ema.europa.eu.

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⚠️ We aggregate official notices. We do not give medical advice. For medical or legal decisions, consult the source agency and a qualified professional.