Distribution, Manufacturing and Inspection

Notice on the occurrence of suspected falsified batches of MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion

08.12.2014

Via the Rapid Alert System from the German competent authority, the Agency for Medicinal Products and Medical Devices (HALMED) has received a notice on the suspected counterfeit batches of MabThera 100 mg concentrate for solution for infusion (batch: H0156B09, shelf-life: 05/2016) and MabThera 500 mg concentrate for solution for infusion (batch: H0721B04, shelf-life: 04/2016).

These batches reported as a suspected counterfeit have never been placed on the Croatian market.

More information is accessible under the link below.

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Notice on cases of illegal distribution of medicinal products in the EU

18.11.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received a notice from Spanish competent authorities concerning discovered illegal medicines distribution in Spain that may affect also other EU Member States and third countries. For illegally distributed medicinal products quality, safety and efficacy cannot be granted and therefore these medicines are considered counterfeits.

More information is accessible under the link below.

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Notification on possible occurrence of falsified medicines Retacrit, Silapo and Eporatio on the EU market

22.09.2014

The German competent authority for medicines has notified HALMED that certain amount of erythropoietin-containing medicinal products has disappeared from stocks of an authorised wholesaler. Taking account that disappeared medicines have been outside the legal cold chain, or controlled storage conditions, they will be considered as counterfeit, should they be placed again on the market.

Detailed information is accessible under the link below.

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Information about counterfeited Kaletra (lopinavir, ritonavir) in Germany

17.06.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received an information about a suspected counterfeit of Kaletra (lopinavir, ritonavir) in Germany. This medicine is used in treatment of human immunodeficiency (HIV-1) infection.
The suspected counterfeited medicine has been reported by a parallel trade company from Germany, who discovered during the check up of purchased quantities a non-conformity in labelling of the outer package and the package leaflet with the information figuring on the original product packaging.
The following batches are affected by the suspected counterfeit: 276268D, 345118D, 336398D. The manufacturer’s investigation is in the course and further distribution of these batches from the stock has been suspended.
Detailed information is accessible under the link below

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Information about counterfeit Herceptin (trastuzumab) on the Czech market

26.05.2014

Following the previous information about the counterfeit Herceptin (trastuzumab) on the EU market, the Agency for Medicinal Products and Medical Devices (HALMED) has been informed about a suspected counterfeit Herceptin on the Czech market.
In the Czech Republic, a medicinal product was found to have different labelling of the expiry date and batch number on the inner and outer packaging and to be labelled in different languages. The inner package was labelled with the batch number H0758, whereas indicated batch number on the outer packaging was H4342B01. The inner packaging and the package leaflet were prepared in Romanian and Bulgarian, whereas the outer packaging was prepared in Romanian language.
Detailed information is accessible under the link below.

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Information on recall of falsified Norditropin SimpleXx 10 mg/1,5 ml solution for injection (somatropin) on the German market

23.05.2014

The Agency for Medicinal Products and medical Devices (HALMED) has received the information about a falsified Morditropim SimpleXx 10 mg/1,5 ml solution for injection (somatropin), used for growth failure and disorders on the German market. A falsified batch of the medicine has been discovered, batch No LL38548, shelf life 10/2015, that has never been released by the manufacturer, Novo Nordisk A/S, Denmark. This falsified medicine is suspected to be purchased in an illicit distribution chain in Germany.
Further information is accessible under the link 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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