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Tuberculosis Vaccine for Newborns Suspended in Croatia

Summary by IndexHR
The AGENCY for Medicines and Medical Devices (HALMED) announced today on its official website that the distribution and use of all batches of BCG vaccines against severe forms of tuberculosis are being suspended in Croatia.

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The AGENCY for Medicines and Medical Devices (HALMED) announced today on its official website that the distribution and use of all batches of BCG vaccines against severe forms of tuberculosis are being suspended in Croatia.

·Zagreb, Croatia
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At the request of the Agency for Medicines and Medical Devices of the Republic of Croatia (HALMED), the BCG vaccine from the Bulgarian manufacturer Bul Bio NCIPD Ltd. is being withdrawn from distribution and use due to suspected quality defects, and this measure will be in effect until the investigation is completed, HALMED announced on Monday.

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At the request of the Agency for Medicines and Medical Devices (HALMED), the distributor Medical Intertrade d.o.o. is suspending the distribution and use of all batches of BCG Vaccine from the Bulgarian manufacturer Bul Bio NCIPD Ltd. This is a vaccine against severe forms of tuberculosis that is given to newborns immediately...

·Split, Croatia
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It is a live attenuated vaccine against severe forms of tuberculosis that is administered immediately after birth.

Four reports of side effects received, investigation launched

Osteomyelitis after BCG vaccination is a rare type of bone infection caused by a weakened strain of Mycobacterium bovis bacteria present in the vaccine and is an expected side effect of this vaccine.

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Večernji list broke the news on Monday, October 5, 2026.
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