13.07.2015
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of HPV vaccines to further clarify aspects of their safety profile. In addition, the PRAC has voted to prolong, for another three years, the mandates of Dr June Raine and Dr Álmath Spooner as Chair and Vice-chair respectively.
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13.07.2015
The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer (cancer of the neck of the womb) and various other cancers and conditions caused by HPV.
The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).
In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing there is no change in recommendations for the use of the vaccine.
Further information is accessible under the link below.
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10.07.2015
In agreement with the European Medicines Agency (EMA) and the Agency for Medicinal Products and Medical Devices (HALMED), AstraZeneca AB (marketing authorisation holder’s local representative: AstraZeneca d.o.o.), Boehringer Ingelheim International GmbH (marketing authorisation holder’s local representative: Boehringer Ingelheim Zagreb d.o.o.) and Janssen Cilag International N.V. (marketing authorisation holder’s local representative: Johnson & Johnson S.E. d.o.o.) would like to inform healthcare professionals on the risk of diabetic ketoacidosis during the treatment with SGLT2 inhibitors [Invokana (canagliflozin), Vokanamet* (canagliflozin/metformin), Jardiance* (empagliflozin), Synjardy* (empagliflozin/metformin)].
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01.07.2015
EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.
Having assessed all the available data, EMA’s Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis. However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.
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26.06.2015
At its June 2015 meeting, the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) recommended ten new medicines for approval, gave a negative opinion for a new medicine and adopted four recommendations on extensions of therapeutic indication. Also, the CHMP recommended several measures to ensure that patients and carers use adrenaline auto-injectors successfully.
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12.06.2015
The European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review of the following medicines from the SGLT2 inhibitor group: kanagliflozin, dapagliflozin and empagliflozin.
Further information ias accessible under the link below.
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12.06.2015
The European Medicines Agency (EMA) has started a review of canaglifozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis, a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.
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10.06.2015
Swedish Orphan Biovitrum (Sobi) has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) sent a letter to healthcare professionals on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra).
Further information and the Dear Healthcare Professional Letter is accessible under the link below.
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08.06.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has initiated in collaboration with the Croatian Association of General Practitioners (HDOD), Croatian Pharmaceutical Society (HFD) and Croatian Society of Cardiology (HKD) a survey on views of healthcare professionals how competent authorities, like HALMED in Croatia, communicate towards healthcare professionals new safety issues related to use of medicines.
The survey is part of a broader pharmacovigilance EU project entitled SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe) aimed at improving the health safety of patients in the EU, by promoting co-operation among member states and providing support to competent authorities for medicines to meet the requirements of the EU pharmacovigilance legislation.
As a result of HALMED’s efforts, the Republic of Croatia has been chosen with other Member States to participate in running this survey within the SCOPE project with the aim to provide a possibility to health care professionals to express their opinions and views on safety communication in medicines use. Other participating countries are Spain, United Kingdom, Ireland, Italy, Sweden, The Netherlands, Norway and Denmark.
The aim of this survey is to search through experiences of healthcare professionals in communicating the competent authority’s safety information, research their views on the efficacy of such a communication and find out what are health care professionals’ preferred communication channels.
According to settings of the SCOPE project, HALMED invites all general practitioners, pharmacists and cardiologists to participate in the survey as a target group.
The survey is running in June 2015 and the deadline for completing the survey is June 2015.
Further information on the survey is accessible under the link below.
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28.05.2015
At its meeting in May 2015, the Co-ordination Group for Mutual Recognition and Decentralised Procedure, agreed by consensus the following:
- the PRAC recommendation that the marketing authorisations for ibuprofen and dexibuprofen-containing medicines should be updated to minimise the small increased risk of cardiovascular problems, such as heart attacks and strokes
- the PRAC recommendation following PSUSA assessment for nationally authorised medicines containing the combination atenolol/chlortalidone.
At the same meeting, concerning the implementation of Art. 31 referral on polymyxin-containing medicines, the CMDh emphasised that addition of intrathecal & intraventricular routes of administration is expected to be suitable for the currently approved products for parentheral administration, provided that the pharmaceutical characteristics of the product are appropriate for these routes of administration.
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