27.01.2015
The Croatian Institute for Transfusion Medicine, the marketing authorisation holder for Soludeks 40, 100 mg/ml solution for infusion has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of batches 1280064, 1281064, 1282064, 1283064 of this medicine.
More information is accessible under the link below.
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23.01.2015
Based on recommendations of the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices (HALMED) temporarily suspended the placing on the market of nine medicinal products in Croatia due to non-compliance with the good clinical practice. The clinical trials based on which the concerned medicinal products are authorised were carried out by GVK Biosciences at the investigational site in Hyderabad in India. Based on the fact that an inspection at the site discovered non-compliances with the good clinical practice rules, this temporary decision will be in effect until marketing authorisation holders have submitted new data, or carried out new trials on other sites.
In addition to the temporary suspension of placing on the market of these medicines, those medicines already on the market are being recalled to the pharmacy level.
This temporary suspension of placing on the market and recalls are being carried out as a precaution measures and are not initiated by safety reasons.
The list of medicines affected by the temporary suspension in Croatia is accessible here.
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