Distribution, Manufacturing and Inspection

HALMED participated in the Pangea VIII operation against counterfeit medicines

20.06.2015

The Agency for Medicinal Product and Medical Devices (HALMED) participated in the international operation “Pangea VIII” conducted and co-ordinated by Interpol and implemented by police, customs, national agencies and other competent authorities for medicines around the world with the aim to fight sale of counterfeit medicines. According to the final report published in June 2015, in the action conducted from 9 to 16 June 2015 in 115 countries, operations of 2414 internet pages linked to sale of illicit and counterfeited medicines was discovered and stopped, 156 individuals involved in these illicit activities were arrested and approximately 20.7 million potentially dangerous medicines worth 543 million kuna was ceased.

Further information is accessible under the link below.

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Notice on temporary discontinuation in the supply chain and use of the batch 718356 of Augmentin 1000 mg+200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

11.06.2015

GlaxoSmithKline d.o.o., the marketing authorisation holder for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) of a temporary discontinuation in the supply chain and use of the batch 718356 of this medicinal product due to a suspected quality defect.

The suspicion in a quality defect is following to an inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at the GSK manufacturing site in Worthing, UK. This discontinuation of the supply chain and use will be in effect by the end of the GMP audit.

According to HALMED’s data, this batch is no longer available in wholesalers in the Republic of Croatia.

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Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.

26.05.2015

Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia.

The procedure of discontinuation of distribution and use of these batches has been initiated over concern on a suspected quality defect based on an increased number of suspected adverse reactions to these medicines reported to HALMED in the last several weeks.

More information is accessible under the link below.

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Notice on recall of the batch 14160 of Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin)

10.04.2015

PharmaMar S.A., marketing authorisation holder for Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin), has notified the Agency for medicinal Products and Medical Devices (HALMED) on the recall of the batch 14160 of this medicine due to a discovered quality defect. The quality defect consists of a risk of foreign particles in vials. As a precaution measure, further distribution and use of this batch is stopped in all hospital settings in the Republic of Croatia, where this medicine is used.The recall of this batch is being conducted at the hospital level.

Further information is accessible under the link below.

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Notice on recall of one batch of Oronazol 20 mg/g shampoo

23.03.2015

Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for Oronazol 20 mg/g shampoo has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the recall of the batch EKB1Z00, EUR code: 6160803 from wholesalers and pharmacies. The recall is being conducted due to a batch labelled in Slovenian and mistakenly placed on the Croatian market during distribution.

This recall of the medicine labelled for the Slovenian market will not affect the regular supply chain with this medicine in Croatia.

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Notice on returning of the batch of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion to the Croatian market

13.03.2015

Following to the Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, published on 14 November 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs on the returning of the batch 15HG229F1 of this medicinal product.

The procedure of discontinuation of the supply chain and use of this medicine was initiated as a precautionary measure, due to a suspected quality defect following to an allergic adverse reaction reported to HALMED.
Based on the conducted investigation and special quality control, HALMED concludes that the samples of the medicine comply to the specification with regard tested parameters. Following to these results, the temporary discontinuation of the supply chain and use of the batch 15HG2291 of this medicine is being alleviated and the existing stocks may be returned to distribution and use.

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Notice on recall of Ramipril H Farmal 5 mg/25mg tablets (ramipril, hydrochlorothiazide)

02.03.2015

Farmal d.d., the marketing authorisation holder for Ramipril H Farmal 5 mg/25 mg tablets (ramipril, hydrochlorothiazide) has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch 140802 of this medicine due to a discovered quality defect. The quality defect relates to the labelling on the aluminium foil on blisters in Ramipril H Farmal 5 mg/25 mg tablets, where there is an incorrect product name Ramipril Farmal 5 mg tablets (ramipril) instead of Ramipril H farmal 5mg/25 mg tablets (ramipril, hydrochlorothiazide).

It is a pharmacy level recall.

Further information is accessible under the link below.

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Notice on temporary discontinuation in the supply chain and use of the batch BL10AD of Medioclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

02.03.2015

Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation in the supply chain and use of the batch BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid).

The procedure of discontinuation in the supply chain and use of this batch is being conducted following to a reported quality defect by a healthcare professional. The quality defect relates to appearance of an unusual colour of the diluted product (dark yellow solution colour).

Further information is accessible under the link below.

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Notice on re-marketing of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)

23.02.2015

Further to the 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), published on 18 July 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about re-marketing of the said batch.

The procedure of temporary interruption of distribution and use of the said batch was launched as a precautionary measure due to a suspected quality defect report on the discovered turbid solution received by healthcare professionals.

Since based on the investigation the quality defect has not been confirmed, the temporary interruption of distribution and use of the batch HC 68E of this medicine has been revoked, and the existing stock can be dispensed and used again.

More information is accessible under the link below.

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Notice on quality defect of the batch 3055005A of Cadil 25 mg tablets and the batch 4242001B of Excita 10 mg film-coated tablets

06.02.2015

Farmal d.d., the marketing authorisation holder for Cadil 25 mg tablets and Excita 10 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the discovered quality defect of the batch 3055005A of Cadil 25 mg and batch 4242001B of Excita 10 mg.

The concerned batches are placed on the Croatian market with an obligation to provide a written note on this quality defect to pharmacies.

More information is accessible under the link below.

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