08.02.2013
On 8th February 2013, the European Medicines Agency published a press release about the beginning of the safety review of the use of the medicinal product Diane 35 and its generics that we transmit in the continuation of this information.
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01.02.2013
The Agency for Medicinal Products and Medical Devices (HALMED) participates as a sponsor and participant of the 5th Public Educational Campaign on Promotion of Rational Use of Antimicrobial Medicines – JEKA. The main goal of this campaign is to reduce by means of a public campaign, the unnecessary and inappropriate use of antibiotics.
Further information about antibiotics and the JEKA action you may find in the continuation of this information.
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01.02.2013
The company GlaxoSmithKline d.o.o., the marketing authorisation holder for the medicinal product Tyverb 250 mg film-coated tablets (lapatinib), has, in collaboration with the Agency for Medicinal Product and Medical Devices (HALMED) sent out a letter to health care professionals about the comparative data based on the medicinal product Tyverb 250 mg film-coated tablets as compared to the regimen based on the medicinal product Herceptin 250 mg powder for solution for injection (trastuzumab) in certain patient groups.
You may view the text of the letter in the continuation of this information.
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31.01.2013
On 30 January 20013, the European Medicines Agency published a press release about Diane 35 and its generics for acne treatment, that you can find in the continuation of this information.
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30.01.2013
Due to a recent initiative to reduce the use of third- and fourth-generation combined oral contraceptives, the European Medicines Agency has been requested by France to review the benefits risks ratio of third- and fourth-generation (so called "newer" combined oral contraceptives) combined oral contraceptives. The review of benefits risks ratio is being carried out in order to determine whether there is a need to restrict the use of these medicinal products to women who cannot take other combined oral contraceptives. The EMA’s Pharmacovigilance Assessment Committee (PRAC) will be reviewing whether the currently available product information on combined oral contraceptives provides the best information possible for patients and doctors to take appropriate healthcare decisions. New information about the review by the PRAC will be available by the end of next week.
You may find further details in the continuation of this information.
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28.01.2013
The company Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for the medicinal product Incivo 375 mg, film-coated tablets (telaprevir) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of Severe Cutaneous Adverse Reactions (SCAR), associated with the use of the medicinal product Incivo. The letter reminds health care professionals on the current recommendations for the monitoring and treatment of skin adverse reactions listed in the Summary of Product Characteristics for Incivo 375 mg, film-coated tablets.
You may view the letter in the continuation of this information.
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24.01.2013
The company Servier Pharma d.o.o., the marketing authorisation holder for Valdoxan 25 mg film-coated tablets (apomelatin) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about several reports of serious liver injury associated with the use of the aforementioned medicinal product. The letter reminds health care professionals on the importance of monitoring of liver function tests in patients throughout their entire treatment.
You may view the letter to health care professionals in the continuation of this information.
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15.01.2013
The company Agmar d.o.o., the marketing authorisation holder for the medicinal product Tisseel Lyo has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals informing them about the risk of fatal air or gas embolism due to inappropriate use (exceeded recommended pressure, inadequate distance from the tissue surface) of the spray applicator attached to a pressure regulator during administration of the sprayable fibrin sealant Tisseel Lyo.
You may view the Dear Health Care Professional Letter in the continuation of this information.
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09.01.2013
The company Boehringer Ingelheim Zagreb d.o.o., the marketing authorisation holder for the medicinal product Pradaxa, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care providers notifying them about the new contraindication in patients with a prosthetic heart valve that need anticoagulant treatment. The contraindication is introduced due to an increased risk of thromboembolia and bleeding as compared to warfarin.
You may view the text of the letter in the continuation of this information.
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