Pharmacovigilance

Dear Healthcare Professional Letter on the introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa-2b)

20.02.2014

Merck Sharp & Dohme (MSD), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) has sent a letter to healthcare professionals on the introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa -2b).

Detailed information and the Dear Healthcare Professional Letter are accessible below.

PRAC News – February 2014

11.02.2014

During its meeting in February 2014, the Pharmacovigilance and Risk Assessment Committee (PRAC) did not start any safety review of medicines, neither new recommendations were adopted and the Committee focused on the wide spectrum of its responsibilities encompassing all aspects of risk management regarding the use of medicines.

Detailed information is available under the following link.

Questions and answers on combined oral contraceptives – information for patients

28.01.2014

A comprehensive review of the benefits and risks of oral contraceptives was recently carried out paying special attention to the risk of formation of blood clots associated with the use of these medicines.
Hereby, HALMED wants to provide more information on the risk of blood clots associated with use of combined oral contraceptives; including information on conditions increasing the risk of blood clots, information on signs and symptoms of blood clot and information when to tell the doctor or pharmacist about using these medicines.
Taking account that the recent benefit risk ratio referred to formation of blood clots, this document contains a number of information related to this risk.
The data concern only progestogen-containing medicines and not ethynylestradiol or estradiol.

The questions and answers list of combined hormone contraceptives is accessible here.

Dear Healthcare Professional Letter on the risk of thromboembolism associated with use of combined hormone contraceptives (Adexa, Belara, Cilest, Estal, Evra, Lindynette, Logest, Novynette, NuvaRing, Qlaira, Yasmin, Yaz)

28.01.2014

Bayer d.o.o., Farmal d.d., MSD d.o.o., Sandoz d.o.o. and Johnson&Johnson SE d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA), have sent a letter to healthcare professionals on the results of safety assessment of combined hormone contraceptives (CHC) carried out in Europe and the newest evidence on the risk of thromboembolism associated with certain CHC.

Detailed information, the Dear Healthcare Professional Letter and information on CHC for patients in a Q&A form are accessible here.

European Medicines Agency started a review of emergency contraceptives

24.01.2014

The European Medicines Agency (EMA) has started a review of emergency contraceptives to assess whether increased body weight and body mass index reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or conceptive failure.

Detailed information is accessible under the link below.

Dear Healthcare Professional Letter on the new information on dosing of ondansetron (Zofran) for intravenous use due to the association with QT prolongation

14.01.2014

GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter to healthcare professionals on the new information related to dosing of intravenous ondansetron used to prevent chemotherapy-induced nausea and vomiting (CINV). This includes new recommendations for repeated dosing and application in elderly patients.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

PRAC recommends suspending use of Protelos and Osseor (strontium ranelate)

13.01.2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos and Osseor should no longer be used to treat osteoporosis.

Detailed information is available under the link below.

Dear Healthcare Professional Letter on the need for carrying out hepatitis B screening in all patients before treatment with Arzerra (ofatumumab)

13.01.2014

GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter with new recommendations related to the screening of patients for hepatitis B antigen before the ofatumumab treatment.

Detailed information and the Dear Healthcare professional letter is accessible under the link below.

Dear Healthcare Professional Letter on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF)

08.01.2014

GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products (HALMED), has sent a letter to healthcare professionals on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF).

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

Dear Healthcare Professional Letter on the importance of the wild type RAS status determination (exons 2, 3 and 4 of KRAS and NRAS) prior to Erbitux (cetuximab) treatment

07.01.2014

Merck Serono has, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED), sent out a letter to healthcare professionals about the variation in the authorised indication of Erbitux in metastatic colorectal cancer (mCRC).

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

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