Varilrix, Live varicella vaccine, Powder and solvent for solution for injection, not less than 10^3.3 PFU of varicella virus, Oka strain/0.5 ml; 1 dose (0.5 ml)

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 reported signal concerned the occurrence of a serious adverse reaction related to the medicinal product and was assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA). Potential effects: serious adverse reactions, post-vaccination complications.

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Varilrix, Live varicella vaccine, Powder and solvent for solution for injection, not less than 10^3.3 PFU of varicella virus, Oka strain/0.5 ml; 1 dose (0.5 ml)

Risk Level

Critical

Batch Number

A70CD868B

Notice Date

04.12.2025

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

Stop using the product immediately and return it to the store for a refund.

Actions Taken

Suspension of distribution of the Varilrix vaccine batch throughout the country. Conducting supervisory proceedings and verification of storage and distribution conditions. Sending batch A70CD868B for...

Need Help?

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

Varilrix, Live varicella vaccine, Powder and solvent for solution for injection, not less than 10^3.3 PFU of varicella virus, Oka strain/0.5 ml; 1 dose (0.5 ml)

What to do if you have this product?

What You Should Know

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Actions Taken

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