News and Educations

Information on temporary recall of Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefiximum)

30.04.2014

Jadran Galenski laboratoj d.d. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is accessible under the link below.

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Dear Healthcare Professional Letter on eventual need for earlier re-vaccination with conjugated vaccines in individuals vaccinated with Mencevax ACWY Vaccine, who are highly at risk of exposure to serogroups A, W-135 and Y

25.04.2014

GlaxoSmithKline d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the available persistence data of Mencevax ACWY Vaccine.
Detailed information and the dear Healthcare professional Letter is assessible under th elink below.

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Dear Healthcare Professional Letter on falsified medicines labelled as Herceptin 150 mg, powder for concentrate for solution for infusion (trastuzumab)

24.04.2014

Following to the Note to healthcare professionals about falsified Herceptin in the EU and Information on counterfeited Herceptin, Alimta and Remicade on the EU market, Roche d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals, The letter contains the updated information on falsified medicines labelled as Herceptin 150 mg powder for concentrate for solution for infusion (trastuzumab) in the EU as well as instructions for visual inspection of vials before preparation and administration of medicines.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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Information on counterfeited Herceptin, Alimta and Remicade on the EU market

18.04.2014

Following to the Note to healthcare professionals about falsified Herceptin in the EU, issued on 16 April 2014, HALMED informs hereby that, apart from Herceptin, the suspected counterfeited medicines in the EU are also linked to vials of Alimta (pemetrexed) and Remicade (infliximab) that have been reported as stolen in Italy.
In addition to Herceptin batch numbers H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09 and H4303B01, the following batch numbers are now also confirmed to be concerned: H4143B01, H4293B01, H4180B01, N1010B02, H4105B01, H4136B02, H4150B01, H4152B04, H4168B02, H4169B01, H4171B01, H4179B02, H4184B01, H4185B02, H4194B01, H4195B01, H4261B01, H4263B02, H4279B01, N1001B01, N1002B02 and N1002B03.For Alimta, the following batch numbers are known to be concerned: C134092E, C021161E and C160908C and for Remicade batch numbers 3RMA66304, 3RMA67102, 3RMA68106 and 3RMA67602.
Neither of these batches has been found on the Croatian market.

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Note to healthcare professionals about falsified Herceptin in the EU

16.04.2014

The European Medicines Agency (EMA) has been informed about the vials of the cancer medicine Herceptin (trastuzumab). It is thought that these vials have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some Member States.
The numbers of suspected batches are H411B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H427B01, H4301B09 and H4303B01. None of these batches is present on the Croatian market.
Further information is accessible under the link below.

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