Locametz

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
  • Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

A single unknown impurity exceeding the quality specification limit was found in batch PG21PL2505, which may affect the medicinal product's quality and does not allow exclusion of a risk to human health. Potential effects: possible unexpected adverse reactions or lack of full certainty regarding treatment safety.

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Locametz
Risk Level
Medium
Manufacturer
Novartis Europharm Limited z siedzibą w Dublinie, Irlandia
Batch Number
PG21PL2505
Notice Date
16.01.2026
View official statement

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