Distribution, Manufacturing and Inspection

Information about temporary distribution and use disruption of the batch 37/I of the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection

16.05.2014

Institute of Immunology, the marketing authorisation holder for the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection, has at request of the Agency for Medicinal Products and Medical Devices (HALMED) temporary interrupted the distribution and use of the batch 37/1 of this vaccine on the Croatian market. There are sufficient quantities of the other on the Croatian market which is not affected by this suspected quality defect and that may be further distributed and used so that the vaccination program is not at risk.
Detailed information is accessible under the link below.

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Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection

09.05.2014

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Esmeron 10 mg/ml solution for injection has started, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure for temporary interruption of the batch 557867 of this medicine from the Croatian market.
The procedure of temporary interruption of distribution and use of this batch of the medicine has been initiated due to a suspected quality defect, after HALMED received on 8 and 9 May 2014 from healthcare professionals six reports to allergic reactions, ranged from mild redness and rash to anaphylactic reaction.
More information is accessible under the link below.

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

30.04.2014

Pliva Croatia d.o.o. 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 available under the link below.

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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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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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Quality defect report to Soliris 300 mg concentrate for solution for infusion

12.03.2014

Alexion Pharma International has informed the Agency for Medicinal Products and Medical Devices (HALMED) of the quality defect of two batches of Soliris 300 mg concentrate for solution for infusion (eculizumab) of the marketing authorisation holder Alexion Europe SAS-France. The report refers to the batch No 00009 and No 00016, where in the Republic of Croatia only the batch No 00016 is distributed.

Detailed information is accessible under the link below.

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Information on the recall of Thymoglobuline 25 mg powder for solution for infusion

05.03.2014

The company sanofi-aventis Croatia d.o.o., the marketing authorisation holder for Thymoglobuline 25 mg powder for solution for infusion has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision to recall the batches of the above mentioned medicinal product, because the product’s manufacturer found that it fell out of specification during ongoing stability study.

The recall has been initiated for the following batches on the Croatian market: C1272H05, C1272H19, C1282H11, C1282H42, C1306H03 and C1306H23. The recall is preventive and is performed to the wholesalers’ level. The marketing authorisation holder will inform them about the recall. The recall of the above mentioned batches does not affect the regular supply chain with Thymoglobuline 25 mg powder for solution for injection as other batches not affected by this problem are available on the market.

Further information is accessible under the link below.

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Information on the recall of two batches of Tyrez 2.5 mg film-coated tablets (bisoprolol)

28.02.2014

The company Alkaloid d.o.o., marketing authorisation holder for Tyrez 2.5 mg film-coated tablets (bisoprolol), has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision of the manufacturer, Alkaloid Int. d.o.o. on the recall of two batches of this medicinal product. Due to a quality defect discovered during further stability testing, the batches No 587770213 and 646340713 are being recalled from the market. The toxicological evaluation has confirmed no toxicological risk for patients. The medicinal product has been recalled due to preventive reasons at the level of wholesales, who are informed by the marketing authorisation holder about the recall.

There are other batches of Tyre2, 2.5 mg film-coated tablets currently available in Croatia and not affected by this quality defect and recall.

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