Distribution, Manufacturing and Inspection

Information about the recall of the batch 10714 B-2 of the medicinal product Bucain-Actavis 0.5% hyperbar (bupivacaine hydrochloride)

10.12.2013

The applicant for interventional import of the medicinal product Bucain-Actavis 0.5 % hyperbar (bupivacaine hydrochloride), Medika d.d., has, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) initiated a recall of the batch 10714 B-2 of this product from the Croatian market.
The recall procedure of this batch started after the 9 December 2013, when HALMED received a report to a suspected quality defect associated with a report to a suspected adverse reaction. The report to a suspected adverse reaction indicated a shortened duration of anaesthesia (20-30 min duration of blocks), independent from the dose and application technique, appearance of shudders, mild pain and uneasiness in arms after administration in four patients.
HALMED has asked the Ministry of Health to sample the aforementioned product batch.

Detailed information is available under the following link below.

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Information about the counterfeited medicine Pegasys 180 microgram solution for injection seized in Germany

29.10.2013

A counterfeited medicine Pegasys 180 microgram solution for injection (peginterferon alpha-2a), originating from parallel import has been discovered in Germany. The counterfeited medicine is labelled as “batch B1299B03 EXP 07 2015”. The batch number indicated on the counterfeited medicine is the same as the batch number on the original medicine of the marketing authorisation holder Roche Registration Limited. Roche’s original batch B1299 has been distributed in several countries of the European Union, Pakistan and Australia. We emphasize that the original batch has not been distributed in Croatia. Also, HALMED has neither received any report to quality defect for this medicinal product nor information indicating that the suspected counterfeited medicine Pegasys might be on the market, therefore no concern.
Detailed information is accessible under the following link:

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European Medicines Agency initiates a recall of certain batches of the medicinal product NovoMix 30 FlexPen and Penfill

25.10.2013

Due to a quality defect, certain batches of the medicinal product NovoMix 30 FlexPen and Penfill are being recalled from the market in the EU Member States where affected batches have been distributed. The affected batches are not on the Croatian market and therefore the recall does not concern the Croatian market. The affected batches have never been placed on the market in Croatia, because the product for the Croatian market is not released at the manufacturing site that released the affected batches that are being recalled in the EU. Also, the recalled batches have never been placed on the market via interventional or parallel entry/import. The supply of the Croatian market with this medicine is going smoothly and there are other batches on the market not affected with this quality defect and therefore no reason for concern.
Detailed information for doctors and patients who purchased the medicine out of the Croatian territory is uccessble under the following link.

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Information about the temporary distribution of Partusisten 5 mg tablets

01.10.2013

Boehringer Ingelheim Zagreb d.o.o. , the marketing authorisation holder for Partusisten 5 mg tablets (fenoterol) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to temporary interrupt the distribution of the medicinal product as a precaution measure until the outcome of the arbitration procedure in the course in the EU for short-acting beta agonists in obstetric indications, due to findings that indicate an insufficient efficacy of oral forms of these medicines.

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Information about the temporary suspension of distribution and use of three batches of Manit 10%

12.09.2013

The Agency for Medicinal Products and Medical devices has carried out a special quality control of the baches 2004032, 2004072 and 2050102 of Manit 10%.
We remind that on the 10th April 2013, HALMED informed about the initiation of the suspension of distribution and use of the batches 2004032, 2004072 and 2050102 of Manit 10%, upon a report from a healthcare professional to a suspected adverse reaction to trombolflebitis on the application site of manitol 10% in six patients.

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Information about the temporary suspension of distribution and use of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion

10.09.2013

The Agency for Medicinal Product and Medical Devices (HALMED) has completed the special quality control of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion.
We remind that the marketing authorisation holder, Sandoz d.o.o., upon HALMED’s request initiated a temporary suspension od distribution and use of the batch CU2047 of the aforementioned medicinal product due to reports to suspected product quality that was posted on HALMED’s web site on 17 June 2013.
With regard to the aforementioned, the temporary suspension of distribution of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion is abolished and the product may be distributed and used.

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