Pharmacovigilance

Dear Healthcare Professional Letter against off-label use of basiliximab (Simulect) in heart transplantations

09.09.2014

Novartis Croatia d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals to warn them against off-label use of basiliximab (Simulect) in heart transplantation.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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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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EudraVigilance Workshop – Electronic Individual Case Safety Reporting (ICSR) in the EEA

26.08.2014

From 17 to 19 September 2014 an EudraVigilance Workshop will be held in Zagreb on electronic Individual Case Safety Reporting (ICSR) in the EU entitled “Electronic Reporting of ICSRs in the EEA”, organised by Drug Information Association (DIA) and the European Medicines Agency (EMA). The workshop will be held at the HALMED’s premises, at the address: Robert Frangeš Mihanović Street 9 (Sky Office Business Building).
Detailed information is accessible under the link below.

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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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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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