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The Bulgarian Vaccine Suspended in Croatia Was Under Surveillance and Investigations for Months

Summary by IndexHR
BULGARIAN Bul Bio is under investigation due to production problems, while in Croatia the use of the vaccine has been suspended due to suspected serious side effects.

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Several Balkan countries have taken precautionary measures after suspicions of rare side effects associated with a BCG vaccine against tuberculosis, produced by the Bulgarian state-owned company Bul Bio. Croatia, North Macedonia and the Federation of Bosnia and Herzegovina have temporarily suspended the use or distribution of the vaccine while health authorities conduct further investigations. In response, authorities in Sofia said there was no …

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BULGARIAN Bul Bio is under investigation due to production problems, while in Croatia the use of the vaccine has been suspended due to suspected serious side effects.

·Zagreb, Croatia
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Following reports of suspected osteomyelitis in children, Croatia has suspended the distribution of BCG vaccines from the Bulgarian company Bul Bio, while investigations into financial and production irregularities at the company continue.

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The Institute of Public Health of the Federation of Bosnia and Herzegovina temporarily suspended the distribution of BCG vaccine from a Bulgarian manufacturer as of October 6 and ...

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Nakon Hrvatske, BCG cjepivo bugarskog proizvođača privremeno je obustavljeno i u Federaciji Bosne i Hercegovine. Povod water četiri slučaja sumnje na rijetku nus pojavu kod djece u Hrvatskoj. Nadležni u BiH ističu kako je riječ o mjeri predostrožnosti dok traje isstraga, a u Federaciji dosad nisu zabilježene ozbiljne neželjene reakcije. BCG cjepivo daje se novorođenčadi kako bi ih zaštitilo od najtežih oblika tuberkuloze.

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The Agency for Medicines and Medical Devices (HALMED) announced on Wednesday, regarding the alleged use of the wrong dose of BCG vaccine in Croatia, that it currently does not have data that would indicate this, and that it is working on additional checks and confirmations of such information as a priority.

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vecernji.ba broke the news on Wednesday, October 7, 2026.
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