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TRUST News Review Pages: What is this and how to use it?
This TRUST News Page is a continuously updated, concise pharmaceutical & medical devices industry news overview, meant as an efficient, "Scrip-like" news research and review tool. It is generated by RSS feed at the moment you access this page, and is therefore always up-to-date.

 

You can select your specific news area of interest by clicking it in the Content Index Map above. You are free to bookmark or link to this page, if you deem this useful. Furthermore, each news item summary below possesses a quick link, enabling you to share the news item quickly on Twitter, LinkedIn, or Facebook.

 

Please note that TRUST can not alter or influence the messages displayed, nor is it responsible for its content. If needed, refer to the original European Medicines Agency website.

TRUST Consultancy News Topic: European Medicines Agency (EMA) - Patient safety, news and press releases

News and press releases: EMA reviewing veterinary medicine Velactis
Item published on line: June 24th, 2016 | 15:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002560.jsp&mid=WC0b01ac058004d5c1
Review triggered by serious adverse events in cattle
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News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
Item published on line: June 24th, 2016 | 13:00:06 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002553.jsp&mid=WC0b01ac058004d5c1
Six new medicines, including one cell-based therapy, recommended for approval
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News and press releases: New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
Item published on line: June 24th, 2016 | 13:00:05 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002555.jsp&mid=WC0b01ac058004d5c1
Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation
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News and press releases: Start of review of medicines manufactured at Pharmaceutics International Inc., USA
Item published on line: June 24th, 2016 | 13:00:04 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002559.jsp&mid=WC0b01ac058004d5c1
EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA.
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News and press releases: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
Item published on line: June 24th, 2016 | 13:00:03 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002556.jsp&mid=WC0b01ac058004d5c1
EMA recommends suspension of one medicine
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News and press releases: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
Item published on line: June 24th, 2016 | 13:00:02 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002558.jsp&mid=WC0b01ac058004d5c1
EMA recommendation follows early termination of a clinical trial in these patients
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News and press releases: EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable
Item published on line: June 24th, 2016 | 13:00:01 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002557.jsp&mid=WC0b01ac058004d5c1
Prescriptions should indicate which dose form is intended
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News and press releases: EMA and FDA reinforce collaboration on patient engagement
Item published on line: June 22nd, 2016 | 01:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002554.jsp&mid=WC0b01ac058004d5c1
New working group established to exchange best practices
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News and press releases: EMA Management Board: highlights of June 2016 meeting
Item published on line: June 17th, 2016 | 16:20:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002552.jsp&mid=WC0b01ac058004d5c1
New civil society representatives join the Board; EMA multiannual work plan to 2020 and overarching stakeholder relations management framework adopted
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News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 2016
Item published on line: June 17th, 2016 | 15:45:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002551.jsp&mid=WC0b01ac058004d5c1
The Committee elected Dr David Murphy from Ireland as Chair for a three-year mandate.
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News and press releases: David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (CVMP)
Item published on line: June 15th, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002549.jsp&mid=WC0b01ac058004d5c1
The new Chair’s mandate covers three years starting in June 2016
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News and press releases: EMA celebrates ten years of its patients and consumers working party
Item published on line: June 10th, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002548.jsp&mid=WC0b01ac058004d5c1
Join the live broadcast on Tuesday, 14 June from 14:00 to 17:00
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News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016
Item published on line: June 10th, 2016 | 13:00:01 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002546.jsp&mid=WC0b01ac058004d5c1
The Committee focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines.
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News and press releases: Single, central platform now mandatory for all periodic safety update reports
Item published on line: June 10th, 2016 | 11:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002547.jsp&mid=WC0b01ac058004d5c1
PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU
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News and press releases: Regulation of advanced therapy medicines
Item published on line: June 3rd, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002543.jsp&mid=WC0b01ac058004d5c1
Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the EU
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News and press releases: Regulatory information - Management of changes to risk management plans and certain quality aspects simplified
Item published on line: June 2nd, 2016 | 12:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002542.jsp&mid=WC0b01ac058004d5c1
New post-authorisation guidance is published today
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News and press releases: First statistics on PRIME are released
Item published on line: June 1st, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002541.jsp&mid=WC0b01ac058004d5c1
Four medicines in development are accepted under the scheme
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News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
Item published on line: May 27th, 2016 | 13:00:01 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002535.jsp&mid=WC0b01ac058004d5c1
Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval
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News and press releases: Two new combination therapies against chronic hepatitis C
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002537.jsp&mid=WC0b01ac058004d5c1
Direct-acting antivirals Epclusa and Zepatier recommended for approval
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News and press releases: Improving safety of first-in-human clinical trials
Item published on line: May 27th, 2016 | 11:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002538.jsp&mid=WC0b01ac058004d5c1
EMA starts EU-wide reflection on necessary changes to best practices
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News and press releases: European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance
Item published on line: May 26th, 2016 | 17:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:16:57 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002536.jsp&mid=WC0b01ac058004d5c1
Updated advice is released for public consultation
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Withdrawn Products & Applications

Withdrawn application: Kyndrisa, drisapersen, Initial authorisation
Item published on line: June 24th, 2016 | 16:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003846/wapp/Initial_authorisation/human_wapp_000213.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Arikayce, amikacin, Initial authorisation
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003936/wapp/Initial_authorisation/human_wapp_000211.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Alendronic Acid / Colecalciferol Mylan, alendronic acid / colecalciferol, Initial authorisation
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004172/wapp/Initial_authorisation/human_wapp_000210.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Docetaxel SUN, docetaxel, Initial authorisation
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004086/wapp/Initial_authorisation/human_wapp_000212.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Xegafri, rociletinib, Initial authorisation
Item published on line: June 22nd, 2016 | 16:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004053/wapp/Initial_authorisation/human_wapp_000208.jsp&mid=WC0b01ac058001d128

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Withdrawn application: Opsiria, sirolimus, Initial authorisation
Item published on line: May 27th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:15:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003978/wapp/Initial_authorisation/human_wapp_000209.jsp&mid=WC0b01ac058001d128

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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Meetings & Events

EMA public workshop on extrapolation of efficacy and safety in medicine development, European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016
Item published on line: June 24th, 2016 | 17:16:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2015/10/event_detail_001230.jsp&mid=WC0b01ac058004d5c3
In 2013, the European Medicines Agency (EMA) published a concept paper on extrapolation of efficacy and safety in medicine development. It aims to discuss the need and possibility of developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework will set out a structured approach for each extrapolation exercise, in order to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. This workshop will present the reflection paper and seek feedback from developers.
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Workshop on single-arm trials (SAT) in oncology, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 30-Jun-2016
Item published on line: June 23rd, 2016 | 16:20:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001285.jsp&mid=WC0b01ac058004d5c3
Single-arm trials (SATs) have led to regulatory approval of oncology products in case of dramatic activity in well-defined populations with high unmet medical need. Further, when randomized-controlled trials are not possible, SATs augmented with statistical approaches may become the standard basis of evidence of efficacy for new applications. However, what constitutes dramatic activity and high unmet medical need is often debated and there is no regulatory guidance on cancer drug development in these situations and how to manage the remaining uncertainties optimally. This workshop, co-organised with the European Society for Medical Oncology (ESMO), will debate the experience gained with these types of approvals, the strengths and weaknesses of different approaches, explore the views of different stakeholders and underlying principles, and will discuss the need and appropriateness for further regulatory guidance.
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European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 09-Mar-2016, To: 09-Mar-2016
Item published on line: June 23rd, 2016 | 15:15:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/03/event_detail_001263.jsp&mid=WC0b01ac058004d5c3
This is a joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations. Participants will be updated on the 2015 EMA annual report, the PCWP and HCPWP 2016-2019 mandates and elections of co-chairs, updated EMA dedicated webpages for patients and healthcare professionals, European Union and global initiatives, pharmacovigilance activities and feedback from the scientific committees.
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European Union (EU) workshop on ICH Q3D from a quality perspective, European Medicines Agency, London, UK, From: 05-Apr-2016, To: 06-Apr-2016
Item published on line: June 21st, 2016 | 18:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/03/event_detail_001265.jsp&mid=WC0b01ac058004d5c3
The new ICH Q3D guideline on elemental impurities will be the subject of a workshop at the European Medicines Agency (EMA) between EU regulators, the European Pharmacopoeia and the pharmaceutical industry. The workshop will focus mainly on the quality aspects of the guideline and its implementation in the European regulatory system. The training modules developed and endorsed by the Q3D Implementation Working Group will be used as a basis for the material presented at the workshop.
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Management Board meeting: 16 June 2016, European Medicines Agency, London, UK, From: 16-Jun-2016, To: 16-Jun-2016
Item published on line: June 21st, 2016 | 17:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2014/06/event_detail_000969.jsp&mid=WC0b01ac058004d5c3
The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.
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Follow up information session on the TransCelerate initiative , European Medicines Agency, London, UK, From: 17-Jun-2016, To: 17-Jun-2016
Item published on line: June 16th, 2016 | 17:20:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001305.jsp&mid=WC0b01ac058004d5c3
The meeting provides an opportunity for TransCelerate to update the EMA on progress with ongoing initiatives and new areas of work, which focuses on the development of practical solutions to overcome inefficiencies in clinical trials.
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Periodic safety update report information day , European Medicines Agency, London, UK, From: 28-Oct-2016, To: 28-Oct-2016
Item published on line: June 14th, 2016 | 14:50:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001304.jsp&mid=WC0b01ac058004d5c3
This information day provides a forum to discuss ongoing activities and status of periodic safety update report (PSUR) single assessment procedures, with a particular emphasis on the PSUR roadmap and how it supports reaching a common understanding of the single assessment. The roadmap is key to optimising the process and content of PSURs and the EU single assessment (PSUSA). The information day will also look into the procedural improvements that are already implemented and discuss further improvements based on views from the pharmaceutical industry. The event will also provide an opportunity for industry, EMA and national competent authorities to share experiences on the mandatory use of the PSUR repository lessons learned from the transition. It will also outline the role of PSURs in inspections from inspectors’ and industry’s point of view.
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Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016
Item published on line: June 10th, 2016 | 15:20:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001291.jsp&mid=WC0b01ac058004d5c3
In view of the growing complexity with which new medicines are being developed, evaluated and monitored it has become indispensable that academia and regulators develop a partnership that will foster a proactive process to support innovation and channel it into the continuous evolution of regulatory science. The European Union (EU) Medicines Agencies Network Strategy to 2020 highlights the importance of developing a sound collaboration between the EU Regulatory Network and the academic world to ensure that innovative medicinal products can be optimally developed for the benefit of all European citizens. This workshop represents the culmination of the consultation process that will allow for the definition of a framework of collaboration based on robust foundations. The specific objectives of the workshop are to collectively review the status quo, present different perspectives and expectations, and discuss the main pillars of the framework.
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European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting, European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016
Item published on line: June 10th, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001289.jsp&mid=WC0b01ac058004d5c3
This PCWP meeting welcomes the new members and representatives for the 2016 – 2019 mandate. Updates will be given on the EMA initiatives to support and accelerate early access: adaptive pathways and the PRIME initiative. Also to be discussed is the proactive publication of clinical study reports; the EUPATI guidance documents will be presented and feedback will be given from the scientific committees.
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10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP), European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016
Item published on line: June 10th, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/03/event_detail_001264.jsp&mid=WC0b01ac058004d5c3
2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) PCWP. A working group of patients' organisations was first created in 2003. Following endorsement of its framework of interaction by EMA’s Management Board, the working group was formalised into an official working party, the PCWP. Building on the importance of multi-stakeholder dialogue, the PCWP regularly holds its annual meetings jointly with the Healthcare Professionals’ Working Party. The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. The EMA is proud of the work of the PCWP and this anniversary meeting will be an opportunity to reflect on past successes and to plan for the future.
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European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016
Item published on line: June 10th, 2016 | 11:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001290.jsp&mid=WC0b01ac058004d5c3
The EMA Human Scientific Committees' Working Party with Healthcare Professionals' Organisations (HCPWP) meeting marks the start of the 2016 -2019 mandate. The discussion will focus on the revision of the EMA framework of interaction with the healthcare professionals.
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Committee for Orphan Medicinal Products (COMP): 14-16 June 2016, European Medicines Agency, London, UK, From: 14-Jun-2016, To: 16-Jun-2016
Item published on line: June 10th, 2016 | 11:20:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2014/06/event_detail_000957.jsp&mid=WC0b01ac058004d5c3
The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.
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Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis, European Medicines Agency, London, UK, From: 07-Jun-2016, To: 07-Jun-2016
Item published on line: June 9th, 2016 | 15:50:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001282.jsp&mid=WC0b01ac058004d5c3
In the frame of public consultation on the revision of the guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis, the European Medicines Agency is hosting a meeting to supplement the ongoing debate.
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Information day on risk management planning and post-authorisation studies, European Medicines Agency, London, UK, From: 07-Nov-2016, To: 07-Nov-2016
Item published on line: June 9th, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/06/event_detail_001287.jsp&mid=WC0b01ac058004d5c3
The European Medicines Agency (EMA) has proposed significant changes to the European Union (EU) pharmacovigilance guideline on risk management plans (GVP Module V). This information day will aim to explain marketing authorisation holders and applicants the changes, using practical examples. The information day will also look into the topic of post-authorisation safety studies (PASS), providing an insight into current activities and lesson learned from EMA committees. The guideline on PASS has set up the procedure for requiring PASS whenever there are concerns about the risks of an authorised medicine. In addition, the event will include a session on EMA progress in engaging patients and the public in medicines safety.
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Information Day on Medication Errors, European Medicines Agency, London, UK, From: 20-Oct-2016, To: 20-Oct-2016
Item published on line: June 7th, 2016 | 11:10:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/02/event_detail_001262.jsp&mid=WC0b01ac058004d5c3
Medication errors are a major public health burden and error prevention is a shared responsibility between patients, healthcare professionals, regulators and pharmaceutical industry at all levels of healthcare delivery. This information day is an opportunity for pharmaceutical industry and regulatory agencies to exchange experience on the new European Union (EU) good practice guide on medication errors published by the EU regulatory network in 2015. The objective is to raise awareness of EU pharmacovigilance obligations for medication errors and to discuss operational aspects and good practice recommendations with regard to medication error reporting, evaluation and prevention, with insight into the current regulatory thinking on how to tackle medication errors within health care delivery systems for the benefit of patient safety.
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Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance, European Medicines Agency, London, UK, From: 13-Jun-2016, To: 13-Jun-2016
Item published on line: May 31st, 2016 | 11:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/05/event_detail_001286.jsp&mid=WC0b01ac058004d5c3
The focus group meeting aims to facilitate the exchange of views from regulators, industry, research and veterinarians as part of the public consultation process on the revised draft reflection paper on anthelmintic resistance (CVMP/EWP/573536/2013-Rev.1). The Efficacy Working Party of the Committee for Medicinal Products for Veterinary Use (CVMP) revised the first version of the draft reflection paper to take into account comments received during public consultation. The CVMP adopted the revised reflection paper in April 2016 and released it for a second public consultation until 31 July 2016.
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European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines, European Medicines Agency, London, UK, From: 15-Apr-2016, To: 15-Apr-2016
Item published on line: May 27th, 2016 | 16:35:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:10 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2016/04/event_detail_001276.jsp&mid=WC0b01ac058004d5c3
The European Medicines Agency (EMA) is hosting the second EMA-Industry Stakeholders Platform meeting on paediatric medicines. This meeting will serve as stage to discuss among other topics the experience, so far, with paediatric standard paediatric-investigation plans (PIPs), the pilot on early interaction on paediatric development and changes to the summary report and electronic submission.
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TRUST Consultancy News Topic: European Medicines Agency (EMA) - Ongoing public consultations

Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus, draft: consultation open
Item published on line: June 15th, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500208671
Submission period: 15 June 2016 - 15 September 2016
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Call for scientific data for the systematic review of the monograph on Tanacetum parthenium (L.) Schulz Bip., herba, draft: consultation open
Item published on line: June 15th, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500208685
Submission period: 15 June 2016 - 15 September 2016
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Call for scientific data for the systematic review of the monograph on Calendula officinalis L., flos, draft: consultation open
Item published on line: June 15th, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500208684
Submission period: 15 June 2016 - 15 September 2016
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Call for scientific data for the systematic review of the monograph on Verbascum thapsus L., V. densiflorum Bertol., V. phlomoides L., flos, draft: consultation open
Item published on line: June 15th, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500208673
Submission period: 15 June 2016 - 15 September 2016
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Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus, draft: consultation open
Item published on line: June 15th, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500208672
Submission period: 15 June 2016 - 15 September 2016
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Scientific guideline: Draft guideline on core SmPC and package leaflet for gadoteric acid, draft: consultation open
Item published on line: June 1st, 2016 | 15:00:02 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207735
This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for gadoteric acid.
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Scientific guideline: Draft guideline on core SmPC and package leaflet for fluorodopa (18F), draft: consultation open
Item published on line: June 1st, 2016 | 15:00:01 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207734
This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for fluorodopa (18F).
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Scientific guideline: Draft guideline on core SmPC and package leaflet for (68Ge/68Ga) generator, draft: consultation open
Item published on line: June 1st, 2016 | 15:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207733
This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for (68Ge/68Ga) generator.
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Scientific guideline: ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers, draft: consultation open
Item published on line: May 31st, 2016 | 10:25:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207524
The S3A Guideline has been successfully implemented in 1994 and, in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be widely used in Toxicokinetic (TK) assessment. This Q&A document focuses on points to consider before incorporating the microsampling method in TK studies, acknowledges its benefits (and some limitations) for assessment of TKs in main study animals and its overall important contribution to the 3Rs benefits (Replacement, Reduction and efinement) by reducing or eliminating the need for TK satellite animals.
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Scientific guideline: Draft guideline on the plant testing strategy for veterinary medicinal products, draft: consultation open
Item published on line: May 27th, 2016 | 17:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207463
Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for veterinary medicinal products Phase II (CVMP/VICH/790/2003) (CVMP/VICH, 2005).
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Scientific guideline: Draft reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media), draft: consultation open
Item published on line: May 27th, 2016 | 17:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207464
It is acknowledged that the topics of reports published in peer-reviewed worldwide literature and information on adverse events from the internet are introduced in Volume 9B of the Rules Governing Medicinal Products in the European Union (EU). However detailed guidance on handling such reports is not given and interpretation of requirements has been variable between national competent authorities (NCAs) to date.
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Scientific guideline: Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health, draft: consultation open
Item published on line: May 26th, 2016 | 17:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:17:23 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500207233
Colistin is an antibacterial agent of the polymyxin class. Following the discovery of a gene (called mcr-1) that causes bacteria to become resistant to colistin, the European Commission requested the European Medicines Agency to update its 2013 advice on the use of colistin in animals. This updated advice provides an analysis of colistin toxicity, susceptibility testing, activity and resistance mechanisms, risk profile (based on consumption patterns and epidemiology), and risk management options.
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TRUST Consultancy News Topic: European Medicines Agency (EMA)
Pending EC decisions and European Public Assessment Reports (EPARs): Human medicinal products

Pending EC decision: Arzerra, ofatumumab, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 15:33:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Negative/human_smop_001006.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Ilaris, canakinumab, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001109/smops/Positive/human_smop_000994.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Nevanac, nepafenac, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000818/smops/Positive/human_smop_000995.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Atazanavir Mylan, atazanavir, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004048/smops/Positive/human_smop_000997.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Aerivio Spiromax, fluticasone propionate / salmeterol, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002752/smops/Positive/human_smop_000998.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Cinqaero, reslizumab, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003912/smops/Positive/human_smop_001001.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Keytruda, pembrolizumab, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003820/smops/Positive/human_smop_001002.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000721/smops/Positive/human_smop_001003.jsp&mid=WC0b01ac058001d127

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Pending EC decision: RoActemra, tocilizumab, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000955/smops/Positive/human_smop_001004.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Zontivity, vorapaxar, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002814/smops/Positive/human_smop_001005.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Nordimet, methotrexate, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003983/smops/Positive/human_smop_000993.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Zalmoxis, Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002801/smops/Positive/human_smop_001000.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Airexar Spiromax, fluticasone propionate / salmeterol, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004267/smops/Positive/human_smop_000999.jsp&mid=WC0b01ac058001d127

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Pending EC decision: Ryzodeg, insulin degludec / insulin aspart, Opinion date: 23-Jun-2016
Item published on line: June 24th, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002499/smops/Positive/human_smop_000996.jsp&mid=WC0b01ac058001d127

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Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Revision: 19, Authorised
Item published on line: June 23rd, 2016 | 13:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000220/human_med_001094.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Prandin, repaglinide, Revision: 15, Authorised
Item published on line: June 23rd, 2016 | 11:28:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000362/human_med_000983.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Revision: 5, Authorised
Item published on line: June 23rd, 2016 | 11:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002393/human_med_001646.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Synagis, palivizumab, Revision: 33, Authorised
Item published on line: June 23rd, 2016 | 10:57:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000257/human_med_001070.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Halaven, eribulin, Revision: 13, Authorised
Item published on line: June 23rd, 2016 | 10:38:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002084/human_med_001427.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Trobalt, retigabine, Revision: 11, Authorised
Item published on line: June 23rd, 2016 | 10:25:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001245/human_med_001431.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Revision: 5, Authorised
Item published on line: June 23rd, 2016 | 10:25:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002669/human_med_001651.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Plenadren, hydrocortisone, Revision: 5, Authorised
Item published on line: June 23rd, 2016 | 10:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002185/human_med_001495.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Docetaxel Winthrop, docetaxel, Revision: 22, Authorised
Item published on line: June 22nd, 2016 | 18:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000808/human_med_000743.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Xadago, safinamide, Revision: 4, Authorised
Item published on line: June 22nd, 2016 | 18:00:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002396/human_med_001847.jsp&mid=WC0b01ac058001d124

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Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Revision: 13, Authorised
Item published on line: June 22nd, 2016 | 17:30:00 CEST +0200
Item accessed: June 26th, 2016 | 00:46:32 CEST +0200
Item source URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002018/human_med_001428.jsp&mid=WC0b01ac058001d124

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