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💊 Medicine EU November 4, 2013

Fabrazyme

📷 Wikipedia: GLA (gene) · Source
Fabrazyme
📷 Wikipedia: GLA (gene) · Source
INN
agalsidase beta
Forms
Powder for concentrate for solution for infusion
Strengths
5 mg;35 mg
Area
Fabry Disease
Alternatives
No
🗄
Archived (older alert)
This alert was reported 4588 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
8 days in total
May 20, 2026 May 28, 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? Fabrazyme is a medicine used for Fabry disease. It comes as a powder that is mixed into a liquid and given as a drip.

What's happening? There was a shortage of Fabrazyme in the EU. This has now been resolved.

Does this affect me? If you take Fabrazyme, you may have been affected. Check with your doctor or pharmacist.

What should I do? Talk to your pharmacist or doctor before making any changes to your medicine.

🤖 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)
agalsidase beta
Brand(s) / product name(s)
Fabrazyme
Agency-published detail

INN: agalsidase beta · Forms: Powder for concentrate for solution for infusion · Strengths: 5 mg;35 mg · Area: Fabry Disease · Alternatives: No

First published
November 4, 2013
Last refreshed by us
6 days ago
Severity (as classified)
Medium
Official source
http://www.ema.europa.eu/en/medicines/human/shortages/fabrazyme

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?
Fabrazyme. INN: agalsidase beta · Forms: Powder for concentrate for solution for infusion · Strengths: 5 mg;35 mg · Area: Fabry Disease · Alternatives: No
▸ When was this alert issued?
This alert was issued on November 4, 2013 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.