Medicinal Products

Recall of Ecalin cream, Ecalin pessaries and Ecalin cutaneous spray, solution, due to expiration of marketing authorisations

24.07.2014

Medical intertrade d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall from the market of all batches of Ecalin cream, Ecalin pessaries and Ecalin cutaneous spray, solution. These medicines are being recalled due to regulatory reasons, which means due to the expiration of the marketing authorisation granted by HALMED and under provisions laid down in the paragraph 2 of the Art. 113 of the Medicinal Products Act (Official Gazette, No 76/13) according to which a batch may remain in the distribution no longer than 18 months after the expiration of the marketing authorisation or shelf life.
Pharmacies are being advised to return the remaining stock to providing wholesalers.

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Recall of the one batch of Neurobion 100 mg + 100 mg + 1 mg solution for injection

22.07.2014

Merck d.o.o., the marketing authorisation holder for Neurobion 100 mg + 100 mg + 1 mg solution for injection has in collaboration with the Agency for Medicinal Products and Medical Devices initiated a recall of the batch 180707 of this medicine.
The recall is due to an error on the inner and outer labelling of the medicine, where there is “subcutaneous use” instead of “intramuscular use”. The package leaflet is correctly labelled with “intramuscular use”.

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Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)

18.07.2014

Pfizer Croatia d.o.o., the marketing authorisation holder for Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan) has upon Agency’s request initiated a temporary procedure of interruption and use of the batch HC 68E of this medicine. The procedure is due to a suspected quality defect report on the discovered turbid solution that HALMED received on 16 July 2014 by a healthcare professional.The interruption of use of this medicine will be in effect until the results of the extraordinary quality control have been achieved and conclusions on the discovered quality defect made, which will be promptly made publicly available.
The temporary interruption of dispensation and use relates only to the batch HC 68 of this medicine, whereas other available batches may be further dispensed and used.
Detailed information is available under the link below.

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Notice on recall of one batch of Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etoposide) due to an error in the product name in the package leaflet and labelling

26.06.2014

Pfizer Croatia d.o.o., the marketing authorisation holder for Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etopodide), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of the batch HW52C of this medicine. The recall is due to an error in the product name in the package leaflet and labelling.

Detailed information is accessible under the link below.

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Information about the recovery of the supply chain with a batch of Engerix B for children 10 micrograms/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)

18.06.2014

Following to the Notice about the temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0,5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), published on the 3rd June 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the recovery of the supply chain with the batch AHBVC 262 CD of this medicine.
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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Notice about shortage of Androgel 50 mg, gel in sachet (testosterone)

17.06.2014

The marketing authorisation holder for the medicinal product Androgel 50 mg, gel in sachet (testosterone), Hospitalija trgovina d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the shortage of this medicine on the Croatian market. The shortage is due to a manufacturing delay.
The normalisation of the supply chain is expected in the middle of July.
Taking account that there is no other medicinal product with the same pharmaceutical form, same active substance in the Republic of Croatia and in order to ensure an adequate and continued market supply with this medicine, the marketing authorisation holder will ensure a sufficient quantity of this medicine from another market with a partial approval from HALMED for legal exemption from the labelling and package leaflet in the Croatian language.

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Notice about shortage of Dexamethason Krka 0.5 mg tablets (dexamethasone)

17.06.2014

The marketing authorisation holder for Dexamethason Krka 0.5 mg tablets (dexamethasone), Krka – farma d.o.o, has informed the Agency for Medicinal Products and Medical devices (HALMED) about a shortage of this medicine on the Croatian market. The shortage is due to a manufacturing delay.
The normalisation of the supply chain is expected by the middle of July.
There is another authorised medicinal product with the same pharmaceutical form, same active substance on the Croatian market. For urgent cases, HALMED will, upon wholesaler’s request, approve enter/import of medicines without marketing authorisation in Croatia, but having the same active substance like the medicine affected with this shortage.

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