Ulipristal Acetate Gedeon Richter

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

The PRAC Committee recorded a new case of severe liver injury after the use of ulipristal 5 mg, which required a liver transplant; the existing risk minimisation measures were deemed insufficient. Potential effects: severe liver damage, liver failure, life-threatening condition.

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Risk Level

Critical

Manufacturer

Gedeon Richter Plc. Węgry

Batch Number

wszystkie serie

Notice Date

13.03.2020

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use Ulipristal Acetate Gedeon Richter, check any packs you have and, if you possess them, consult a doctor to choose an alternative treatment.

Actions Taken

The Chief Pharmaceutical Inspector suspended the marketing of all batches of the product throughout the country and granted the decision immediate enforceability; the marketing authorisation holder mu...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Ulipristal Acetate Gedeon Richter

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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