News and Educations

HALMED participates in the SUTRA (Tomorrow) project – self-medication in pregnancy and lactation

30.12.2013

A public health-educational project SUTRA (Tomorrow) – self-medication in pregnancy and lactation, organised by the Croatian Pharmaceutical Society, under the high auspices of the Croatian Ministry of Health and the Agency for Medicinal Products and Medical Devices (HALMED) is taking place in the Republic of Croatia. One of the key missions of the project is to raise awareness among the both general public and health care professionals on the importance of educating pregnant and breast-feeding women about the risks and self-medication possibilities and positively influence to prevent side-effects through self-medication.

Detailed information may be found under the link below.

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CHMP and CMD news – December 2013

23.12.2013

The CMDh has endorsed the PRAC recommendation about the restriction of use of apimox-containing medicinal products.
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted the PRAC recommendations for medicinal products Kogenate Bayer and Helixate Nexgen, recommended approval of the medicinal product for the treatment of multiresistant tuberculosis, recommended approval of five new medicines, adopted a positive scientific opinion for Tritanrix HB and adopted a recommendation for extension of therapeutic indications for Jentadueto.

More information is available under the following link.

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Launch of a new text “Placing medicinal product on the market, shortages, interruption in the supply chain within the section “Distribution”

20.12.2013

A new subsection “Distribution” has been launched within the section “Distribution; manufacturing and inspection on the Agency for Medicinal Products and Medical Devices (HALMED) webpages. This section contains the text “Placing medicinal product on the market, shortages, interruption in the supply chain.

Detailed information is available under the link below.

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Opening hours of the Registry Office on the 24 and 31 December 2013

19.12.2013

We inform all our customers that the opening hours of the Registry Office of the Agency for Medicinal Products and Medical Devices on Tuesday, 24 and Tuesday, 31 December 2013 will be from 8.00 a.m. to 12 a.m.

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Newly approved medicinal products

19.12.2013

The list of newly approved medicinal products for the period between 1st November 2013 and 30th November 2013 is available in the continuation of this notice.

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Dear Healthcare Professional Letter on the severe skin reactions associated with the use of capecitabine (Xeloda)

13.12.2013

Roche d.o.o. has, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the severe skin reactions associated with the use of capecitabine (Xeloda).

Detailed information and the Dear Healthcare Professional Letter are available under the following link below.

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Dear Healthcare Professional Letter on the severe hepatotoxicity associated with the use of temozolomide (Blastomat, Temodal and Temazol)

12.12.2013

Alvogen, Merck Sharp & Dohme (MSD) and Pliva have in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter with new information to healthcare professionals concerning the safe use of temozolomide.

Detailed information and the Dear Healthcare Professional Letter are available under the following link below.

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Dear Healthcare Professional letter on the safe use of the medicinal product Peyona (caffeine citrate)

11.12.2013

The company Chiesi Farmacutici S.p.A., marketing authorisation holder for the medicinalproduct Peyona 20 mg/ml solution for infusion and oral solution, has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter with relevant information to healthcare professionals concerning the safe use of this medicinal product.

Detailed information and the Dear Healthcare Professional Letter are available under the followink link below.

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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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New section launch “Generic Medicinal Products and Interchangeability” within Medicinal Products section

09.12.2013

A new subsection entitled “Generic medicinal products and interchangeability” has been launched within Medicinal Products Section on the webpages of the Agency for Medicinal Products and Medical Devices (HALMED).
In the new subsection HALMED provides questions and answers related to characteristics of generic medicinal products, their safety, efficacy and quality requirements and their post-market monitoring. Answers to questions related to medicinal products interchangeability are also provided, as well as particularities of biosimilars.

The subsection is available under the following link below.

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