Ulipristal Alvogen

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.

A new case of severe liver injury requiring transplantation and a justified suspicion that the medicine causes serious adverse reactions, altering the benefit–risk balance and creating a real, high probability of risk to patients’ health or life. Potential effects: severe liver damage, life‑threatening complications.

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Risk Level

Critical

Manufacturer

Alvogen Pharma Trading Europe EOOD, Bułgaria

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 Alvogen 5 mg from any batch; patients currently taking this medicine should promptly contact their doctor to review the therapy and possibly change treatment.

Actions Taken

All batches of the product were suspended from the market nationwide, the decision was granted immediate enforceability, and the marketing authorisation holder was obliged to undertake actions related...

Need Help?

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

Ulipristal Alvogen

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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