Distribution, Manufacturing and Inspection

Recall of certain batches of Norcuron 10 mg powder for solution for injection or infusion (vecuronium bromide)

30.07.2014

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Norcuron 10 mg powder for solution for injection or infusion, has informed the Agency for Medicinal Products and Medicla Devices (HALMED) on the recall of the batches 665196 and 668521 of this medicine from wholesalers.
The recall is due to an error discovered in the Package leaflet.
Detailed information is accessible under the link below.

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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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Information about recall of the batch 0380313 of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel)

03.07.2014

Pliva Croatia d.o.o., the marketing authorisation for Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel), has informed the Agency for Medicinal Products and Medical Devices (HALMED) abot the decision to recall the batch 0380313 of this medicinal product due to a quality defect. The quality defect was discovered during stability studies at 25°C/60%RH, after 12 months, where the obtained result was out of specification for the parameter Related substances.
There are sufficient quantities of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion batches not affected by this quality defect and recall and that are available on the Croatian market.
Detailed information is accessible 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 the recall of Soliris 300 mg concentrate for solution for infusion

05.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received via rapid alert system from the Italian Medicines Agency the information that Alexion Europe SAS-France, the marketing authorisation holder for Soliris 300 mg concentrate for solution for infusion (eculizumab), has started a preventive recall procedure of certain batches of this medicinal product.
A recall procedure is being currently carried out from the healthcare settings in the Republic of Croatia where batches No 00017D, 00021C, 00023C,00024C and 12SOL2D, manufactured by using the Pall component, have been distributed.
Detailed information is available under the link below.

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Notice about 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)

03.06.2014

GlaxoSmithKline d.o.o., marketing authorisation holder for Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), has upon request of the Agency for Medicinal Products and Medical Devices (HALMED) carried out a procedure of temporary distribution and use interruption of the batch AHBVC 262CD of this medicine.
The procedure of temporary distribution and use interruption of this batch of the medicine has been initiated as a caution measure, due to a suspected quality defect reported from a healthcare professional. The suspected quality defect consists in the change in appearance of the medicine (less milky than usual) and presence of precipitate particles that do not dissolve by remaining at the room temperature.
Detailed information is accessible under the link below.

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