07.11.2014
On its November 2014 meeting the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) endorsed recommendations regarding the safe use of Corlentor/Procoralan (ivabradine), Kogenate Bayer/Helixate Nexgen and Tecfidera.
More information is accessible under the link below.
more
14.10.2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate in women and girls, concluded that there is no evidence that testosterone-containing medicines increase the cardiovascular risk in patients with hypogonadism and recommended further measures to minimise risk of blood vessel blockage with ponatinib at its October 2014 meeting.
More information is accessible under the link below.
more
14.10.2014
The PRAC has recommended strengthening the restrictions on the use due to risks of congenital malformations and development problems in children exposed to valproate during pregnancy. The PRAC has recommended that valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.
Valproate has been used to treat epilepsy and bipolar disorder. Some valproate medicines are also authorised in some EU Member States, Croatia included, to prevent migraine headaches.
More information is accessible under the link below.
more
14.10.2014
The European Medicines Agency has completed a review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the EMA has recommended that further measures should be put in place to minimise the risk of liver toxicity. Valdoxan and Thymanax are two identical medicines used to treat major depression in adults.
More information is accessible under the link below.
more
07.10.2014
The Co-ordination Group for Mutual Recognition and Decentralised Procedure for human medicines (CMDh) discussed at its meeting in September 2014 about the implementation of Commission’s Decisions after referral procedures pursuant to Article 30 of Directive 2001/83/EC of the European Parliament and Council for medicines, for which Commission’s Decision was adopted in August 2014.
Detailed information is accessible under the link below.
more
07.10.2014
The European Medicines Agency (EMA) monthly publishes recommendations of the Pharmacovigilance Risk Assessment Committee adopted based on the safety signal assessment.
EC marketing authorisation holders for medicines containing active substances that are subject to adopted recommendations are required to undertake respective measures in accordance with these recommendations. In cases where PRAC recommendations include a regulatory procedure, like introducing new information in the summary of product characteristics (SPC) and package leaflet (PIL), marketing authorisation holders are required to submit an application for variation.
Detailed information is accessible under the link below.
more
25.09.2014
The Agency for Medicinal Products and Medical Devices (HALMED) wants to provide hereby the information regarding the quality safety and efficacy of generic medicinal products in order to better clarify this issue:
Every medicinal product, regardless if it is an original or generic one, may be granted marketing authorisation and be accessible to patients, only if its safety and efficacy has been proved.
The generic medicinal product is a medicinal product containing the same amount of the same active substance as the original medicinal product acting in the same mechanism, same velocity and same efficacy as the original medicine. Generic medicines are equally well investigated and controlled as original medicines. Before being placed on the market, generic medicines must undergo bioequivalence studies, or clinical trials on patients where their equal efficacy to the reference original medicines must be proved.
The most important component of every medicine is its active substance. The active substance is a substance by which certain medicine achieves its therapeutic effect, it carries the therapeutic efficacy of the medicine. The generic medicine contains the same identical active substances in the same amount as the reference medicine, thus achieving an identical therapeutic effect. On the other side, in addition to the active substance, every medicine contains so called excipients without any therapeutic effect and therefore excipients may vary in certain generic medicines and their respective originals. So, only difference in the composition of generic and original medicines may be in their excipients used in their manufacturing, such as colours used to obtain different colouring of tablets to make them visually different, which is recommended for their easier differentiation. All these excipients of the generic medicine may obligatory fulfil the same criteria of quality and safety in the same manner as those in the original medicine.
Detailed information is accessible under the link below.
more
16.09.2014
Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.
Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.
more
15.09.2014
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) completed on its meeting held in September , the safety review of Valdoxan and Thymanax (agomelatine).
Detailed information is accessible under the link below.
more
11.09.2014
Amgen Europe B.V. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals on the new risk minimisation measures for osteonecrosis of the jaw (ONJ) and hypocalcaemia in patients treated with Prolia.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.
more
