News and Educations

Dear Healthcare professional letter on the risk of serious and life-threatening infusion reactions during the use of ofatumumab (Arzerra)

28.07.2014

GlaxoSmithKline d.o.o. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals to remind them of the risk of serious and lifethreatening infusion reactions during use of ofatumumab.
Detailed information and the Dear healthcare Professional Letter are accessible under th elink below.

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CHMP and CMDh News – July 2014

28.07.2014

The European Medicines Agency's (EMA's) Committee for Human Medicinal Products (CHMP) has recommended five new medicines for a marketing authorisation, endorsed seven recommendations for extension of therapeutic indications and concluded the review of medicines for emergency contraception.
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) has endorsed the recommenation to suspend the marketing authorisation of methadone oral solutions containing high molecular weight povidone.
Detailed information is accessible under the link below.

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CHMP concluded that emergency contraceptives containing levonorgestrel or ulipristal can continue to be adequate choice in women regardless of the body weight

28.07.2014

The CHMP has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal. The review of these medicines was carried out due to their suspected lower efficacy in women with higher body weight, observed in certain clinical trials. The CHMP concluded that there is a trend for reduced effectiveness with increasing body weight in parts of the available clinical trials, however this trend was not observed in other clinical trials. Therefore, the CHMP having reviewed all the available proofs of efficacy for emergency contraception, concluded that the available data are not robust enough to draw definite conclusions on the reduced effectiveness of emergency contraception with increasing body weight. Based on the above, these medicines remain an appropriate choice for emergency contraception, independent from the body weight of the woman who uses it.
Detailed information is accessible under the link below.

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Quality defect report to the one batch of KlavoPhar 875 mg/125 mg film-coated tablets (amocillin, clavulanic acid)

28.07.2014

PharmaS d.o.o., the marketing authorisation for KlavoPhar 875 mg/125 mg film-coated tablets (amoxicillin, clavulanic acid), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the quality defect of this medicine.
The quality defect report refers to the outer and inner labelling of the product where the “Expiry date” and “Batch No” of certain batches are labelled in English instead of the Croatian language on the blister and package. The following batches have been affected by this quality defect: KTABV0001, KTABV0002, KTABV0003, KTABV0004, KTABV0005, KTABV0006, KTABV0007, KTABV0008, KTABV0009.
Detailed information is accessible under the link below.

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Interruption in the supply chain with Silapen 1 000 000 IU/7 ml oral suspension (phenoxymethypenicillin)

25.07.2014

Belupo d.d., the marketing authorisation holder for Silapen 1 000 000 IU/7 ml oral suspension (phenoxymethylpenicillin) has informed the Agency for Medicinal Products and Medical Devices about the intereruption in the supply chain of this medicine. The decision about the interruption of the supply chain has been brought due to commercial reasons and it is not associated with quality, efficacy or safe use of the medicine.
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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