Medicinal Products

Dear healthcare professional letter on risks from thrombotic microangiopathy and nephrotic syndrome associated with the use of intereferon beta

08.09.2014

Medis Adria d.o.o., Bayer d.o.o., Novartis Croatia d.o.o. and Merck d.o.o. have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) send a letter to healthcare professionals on the risks from thrombotic microangiopathy and nephrotic syndrome associated with the use of interferon beta in treatment of multiple sclerosis.
Detailed information and the Deah Healthcare Professional Letter are accessible under the link below.

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Supply of the Croatian market with antitoxin for counteracting the effects of the black widow spider venom

11.08.2014

In the Republic of Croatia there are no medicinal products containing immunoglobulin-antitoxin for counteracting the effects of black widow spider venom which have been granted a marketing authorisation. For emergency treatments of patients in the Republic of Croatia, the Agency for Medicinal Products and Medical Devices (HALMED) grants approval for entry/import of medicinal product without marketing authorization.

In line with the legal requirements, obliging the wholesalers to ensure a suitable and continuous supply of medicinal products within the limits of their responsibilities, HALMED has received a wholesaler request for the import of the antitoxin for counteracting the effects of the black widow spider venom of the manufacturer Merck Sharp & Dohme Corp., USA. HALMED has promptly granted approval for import, and the delivery is currently in progress.

HALMED will continue to monitor the supply of the Croatian market with antitoxin for counteracting the effects of the black widow spider venom and will promptly inform the public on all new information.

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Dear Healthcare Professional Letter on the potential risk for patients and healthcare personnel when handling broken/cracked Velcade vials

31.07.2014

Johnson&Johnson S.E. d.o.o. has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the potential risk for patientrs and healthcare personnel on the potential risk for patients and healthcare personnel handling with broken/cracked Velcade 1 mg and 3,5 mg vials during use of the product.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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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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