Archive for the ‘European Medicines Agency’ Category

Scientific guideline: Recommendation to marketing authorisation holders for veterinary vaccines, highlighting the need to update marketing authorisations to remove the target animal batch safety test (TABST) following removal of the requirement from the European Pharmacopoeia monographs, adopted

Monday, June 17th, 2013

The requirement for the target animal batch safety test (TABST) for veterinary vaccines has been formally withdrawn from the European Pharmacopoeia, effective as of April 2013.
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European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development, European Medicines Agency, London, UK, From: 26-Nov-2013, To: 26-Nov-2013

Friday, June 14th, 2013

The European Medicines Agency (EMA) is holding a one-day workshop on parallel scientific advice with health-technology-assessment (HTA) bodies on evidence-generation in human-medicine development. The workshop is a joint undertaking of the EMA, HTA bodies and developers. Registration open until 30/08/2013. Places limited.
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News and press releases: Registration opens for workshop on EMA-HTA parallel scientific advice in drug development

Friday, June 14th, 2013

The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on parallel scientific advice in drug development with health-technology-assessment (HTA) bodies on 26 November 2013.
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News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 11-13 June 2013

Friday, June 14th, 2013

The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Econor (valnemulin) from Novartis Animal Health GmbH concerning the addition of a new target species, rabbits for reduction of mortality during an outbreak of epizootic rabbit enteropathy.
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MRL pending EC decision: Chloroform – Summary opinion of the CVMP on the establishment of maximum residue limits

Friday, June 14th, 2013

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MRL pending EC decision: Butafosfan – Summary opinion of the CVMP on the establishment of maximum residue limits

Friday, June 14th, 2013

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News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013

Friday, June 14th, 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting.
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News and press releases: PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch

Friday, June 14th, 2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.
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News and press releases: PRAC recommends restricting the use of codeine when used for pain relief in children

Friday, June 14th, 2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
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News and press releases: PRAC recommends restricting the use of flupirtine-containing medicines

Friday, June 14th, 2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of flupirtine-containing medicines and recommended restrictions in their use.
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News and press releases: PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors

Friday, June 14th, 2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules, tablets or injections) are similar to those of selective COX-2 inhibitors, another group of painkillers.
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Human medicines European Public Assessment Report (EPAR): Esbriet, pirfenidone, Revision: 5, Authorised

Tuesday, June 11th, 2013

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Human medicines European Public Assessment Report (EPAR): Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed), Revision: 5, Authorised

Monday, June 10th, 2013

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Human medicines European Public Assessment Report (EPAR): Cubicin, daptomycin, Revision: 13, Authorised

Monday, June 10th, 2013

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Scientific guideline: Guideline on quality of biological active substances produced by transgene expression in animals, adopted

Monday, June 10th, 2013

The principal aim of this guideline is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal systems.
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News and press releases: Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation

Monday, June 10th, 2013

The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation.
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Scientific guideline: Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, draft: consultation open

Monday, June 10th, 2013

This guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed (“biosimilar”).
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Human medicines European Public Assessment Report (EPAR): Zyprexa Velotab, olanzapine, Revision: 23, Authorised

Monday, June 10th, 2013

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Human medicines European Public Assessment Report (EPAR): Zypadhera, olanzapine, Revision: 8, Authorised

Friday, June 7th, 2013

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Human medicines European Public Assessment Report (EPAR): Zyprexa, olanzapine, Revision: 30, Authorised

Friday, June 7th, 2013

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News and press releases: European Medicines Agency publishes interim fee advice for bluetongue-vaccine manufacturers

Friday, June 7th, 2013

The European Medicines Agency has published a public statement on authorisation of bluetongue vaccines, which proposes changes to the implementing rules of the fee regulation related to inactivated vaccines against bluetongue disease.
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Scientific guideline: Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measure, adopted

Friday, June 7th, 2013

The aim of this position paper is to raise awareness for this issue, provide insight with regards to how the benefit-risk assessment of such products might be impacted and to discuss in general terms how the risk of medication errors could be adequately addressed.
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Human medicines European Public Assessment Report (EPAR): Rivastigmine Actavis, rivastigmine, Revision: 4, Authorised

Friday, June 7th, 2013

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News and press releases: Public consultation open on guideline on the acceptability of names for human medicines

Friday, June 7th, 2013

The European Medicines Agency has released the sixth revision of the guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consultation.
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Regulatory and procedural guideline: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure, draft: consultation open

Friday, June 7th, 2013

The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure. Specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues, product-specific concerns and the procedure for submission of proposed (invented) names requests are further clarified.
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Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VI – Management and reporting of adverse reactions to medicinal products, draft: consultation open

Friday, June 7th, 2013

This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).
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Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators, draft: consultation open

Friday, June 7th, 2013

Risk minimisation measures are public health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management.
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News and press releases: Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions

Friday, June 7th, 2013

The European Medicines Agency has released a revision of the guideline on good pharmacovigilance practices (GVP) module VI on the management and reporting of adverse reactions to medicinal products for a two-month public consultation.
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Human medicines European Public Assessment Report (EPAR): Pantoloc Control, pantoprazole, Revision: 6, Authorised

Friday, June 7th, 2013

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News and press releases: European Medicines Agency and EUnetHTA review progress of their cooperation

Friday, June 7th, 2013

The European Medicines Agency (EMA) and EUnetHTA, the European Network for Health Technology Assessment, met to review the progress of their cooperation in London on 14 May 2013.
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Human medicines European Public Assessment Report (EPAR): Pantecta Control, pantoprazole, Revision: 4, Authorised

Thursday, June 6th, 2013

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Human medicines European Public Assessment Report (EPAR): Velmetia, sitagliptin / metformin, Revision: 12, Authorised

Thursday, June 6th, 2013

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Revised provisional priority list for studies into off-patent paediatric medicinal products

Wednesday, June 5th, 2013

This provisional priority list of off-patent medicines is intended to be the basis for potential future funding within the Horizon 2020 Programme of the European Commission. As preparations for Horizon 2020 still are under way, no further information can be provided concerning the availability, timing and organisational aspects of any possible future calls involving off-patent paediatric medicinal products.
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Human medicines European Public Assessment Report (EPAR): Vfend, voriconazole, Revision: 27, Authorised

Wednesday, June 5th, 2013

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News and press releases: Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders

Wednesday, June 5th, 2013

Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union (EU):
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Human medicines European Public Assessment Report (EPAR): Firmagon, degarelix, Revision: 6, Authorised

Wednesday, June 5th, 2013

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Human medicines European Public Assessment Report (EPAR): Efficib, sitagliptin / metformin, Revision: 11, Authorised

Wednesday, June 5th, 2013

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Human medicines European Public Assessment Report (EPAR): Janumet, sitagliptin / metformin, Revision: 11, Authorised

Tuesday, June 4th, 2013

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Human medicines European Public Assessment Report (EPAR): Ventavis, iloprost, Revision: 20, Authorised

Tuesday, June 4th, 2013

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CVMP interested parties’ meeting, European Medicines Agency, London, UK, From: 15-May-2013, To: 15-May-2013

Tuesday, June 4th, 2013

This meeting is part of regular stakeholder liaison. Subjects discussed include the threat to innovation in the area of antimicrobials, an update on current issues in the area of residues to veterinary medicines in foodstuff of anima origin, measures taken to promove the 3 Rs (replacement, reduction and refinement) and the availability of products for bees.
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Committee for Medicinal Products for Veterinary Use (CVMP) interested parties’ meeting, European Medicines Agency, London, UK, From: 15-May-2013, To: 15-May-2013

Tuesday, June 4th, 2013

This meeting is part of regular stakeholder liaison. Subjects discussed included the threat to innovation in the area of antimicrobials; update on current issues in the area of residues to veterinary medicines in foodstuff of anima origin; measures taken to promove the 3 Rs (replacement, reduction and refinement) and the availability of products for bees.
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Scientific guideline: Guideline on the use of bovine serum in the manufacture of human biological medicinal products, adopted

Tuesday, June 4th, 2013

This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02).
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News and press releases: Revised version of application form for initial evaluation of human medicines available

Monday, June 3rd, 2013

The European Commission has published a revised version of the application form for all marketing-authorisation applications for medicines for human use.
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Human medicines European Public Assessment Report (EPAR): Zevalin, ibritumomab tiuxetan, Revision: 18, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): Champix, varenicline, Revision: 19, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): Zylagren, clopidogrel, Revision: 3, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): Plenadren, hydrocortisone, Revision: 2, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): Relistor, methylnaltrexone bromide, Revision: 7, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): Iscover, clopidogrel, Revision: 27, Authorised

Monday, June 3rd, 2013

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Human medicines European Public Assessment Report (EPAR): HyQvia, human normal immunoglobulin, Revision: 0, Authorised

Monday, June 3rd, 2013

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