News and Educations

Dear Healthcare Professional Letter on the risk of osteonecrosis of the jaw associated with use of denosumab (XGEVA): new contraindication and introduction of a patient reminder card to minimise the risk

30.10.2015

Amgen d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), would like to inform healthcare professionals of a new contraindication in patients with unhealed lesions from a dental or oral surgery and the introduction of a patient reminder card, to minimise the risk of osteonecrosis of the jaw during treatment with XGEVA (denosumab).

Further information and the Dear Healthcare Professional Letter are accessible here.

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Notice on reinstatement of batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batch 15IB515P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion

20.10.2015

Following to the Notice on temporary discontinuation of distribution and use of the batches 15HK211F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and the batches 15IB515P2 and Ciprofloxacin Kabi 200 mg/100 ml solution for infusion, released on 26th May 2015, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform on the reinstatement of these batches on the market.

Further information is accessible under the link below.

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Notice on availability of tetanus vaccine in the Republic of Croatia

20.10.2015

Following to the misleading information on shortage of tetanus vaccine on the Croatian market, the Agency for Medicinal Products and Medical Devices would like to inform the public on the availability of this vaccine.

The vaccine Tetavax, suspension for injection in pre-filled syringe, tetanus vaccine, adsorbed is authorised in the Republic of Croatia.

According to the information that HALMED received from the local marketing authorisation holder’s representative for Tetavax, this vaccine is placed on the Croatian market and sufficient amount of the product is available for an undisturbed supply of the Croatian market. From the end of September 2015, 9500 doses of this vaccine has been placed on the Croatian market and in the beginning of November, a delivery of 32000 new doses is expected, therefore, there is no shortage of tetanus vaccine in Croatia.

In the case that there is a discontinuation in the supply chain or shortage of Tetavax, the marketing authorisation holder is obliged to notify HALMED, who will promptly make this information publically available and undertake adequate measures for ensuring adequate supply of the market with this vaccine.

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