Euvax B

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

The need to verify circumstances related to a reported adverse post-vaccination reaction associated with potential administration of the medicinal product. Analysis of the collected documentation did not confirm a threat to public health. Potential effects: possible more severe post-vaccination reactions and a risk to patients’ health.

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Risk Level

Critical

Manufacturer

LG Chem Life Sciences Poland sp. z o. o. z siedzibą w Warszawie

Batch Number

UFA 22507

Notice Date

12.12.2024

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

The product may be used in accordance with the doctor’s recommendations and the Summary of Product Characteristics; if any worrying symptoms occur after vaccination, patients should contact a doctor a...

Actions Taken

The Chief Pharmaceutical Inspector revoked decision No. 17/WS/2024 suspending distribution of batch UFA 22507 of the Euvax B vaccine and discontinued the first-instance proceedings in their entirety.

Need Help?

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

Euvax B

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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