BiH Medicines Agency on Suspension of BCG Vaccine: The Child Should Be Examined by a Pediatrician in Case of Symptoms of Osteitis
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Bul Bio released the new information after the Croatian Agency for Medicines and Medical Devices (HALMED) requested on October 5th the suspension of the distribution and use of the manufacturer's BCG vaccine due to four reports of osteitis or osteomyelitis following vaccination.
In Croatia, the distribution and administration of all series of BCG vaccine from the Bulgarian manufacturer “Bul Bio NCIPD”, which is given to newborns to protect against severe forms of tuberculosis, has been temporarily suspended. The decision was made after four reports of suspected rare but serious bone inflammation in children. As reported by “Dnevnik.hr”, the Croatian Agency for Medicines and Medical Devices — “HALMED” requested [...] The…
ALMBIH reports that all batches of BCG vaccines imported into BiH during 2026 have passed quality control and that no adverse reactions have been reported.
The Medicines Agency of Bosnia and Herzegovina announced the decision of the competent Croatian agency to suspend the distribution and use of the BCG vaccine, manufactured by Bul Bio NCIPD Ltd., Bul. Yanko Sakazov from Bulgaria.
The Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALMBH) announced that the quality of the BCG vaccines imported to BiH in 2026 is satisfactory, and that no reports of adverse reactions to this vaccine have been received so far.
The agency has sent a recommendation to parents and pediatricians stating that no special measures are required for a child without symptoms, and if symptoms that may indicate osteitis/osteomyelitis occur, the child should be examined by a pediatrician who will assess the need for further treatment.
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