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30/04/2018 Other: Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...
30/04/2018 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2018
30/04/2018 Human medicines European public assessment report (EPAR): Hizentra, human normal immunoglobulin (SCIg), Immunologic Deficiency Syndromes, 14/04/2011, 16, Authorised
30/04/2018 Other: Biologics Working Party (BWP) ad-hoc influenza working group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2018/2019
30/04/2018 News and press releases: Update of EU recommendations for 2018/2019 seasonal flu vaccine composition
30/04/2018 Human medicines European public assessment report (EPAR): Insulin Human Winthrop, insulin human, Diabetes Mellitus, 17/01/2007, 15, Withdrawn
30/04/2018 Herbal - Call for data: Call for scientific data for the review of the HMPC assessment on Centella asiatica L. Urban, herba - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the review of the HMPC assessment on Angelica sinensis (Oliv.) Diels, radix - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the review of the HMPC assessment on Andrographis paniculata Nees, folium - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Capsella bursa-pastoris (L.) Medikus, herba - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the review of the HMPC assessment on Withania somnifera (L.) Dunal, radix - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria L.), herba - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria L.), flos - First version
30/04/2018 Herbal - Call for data: Call for scientific data for the review of the HMPC assessment on Adhatoda vasica Nees, folium - Revision 1
30/04/2018 News and press releases: Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee
30/04/2018 Herbal medicinal product: Withaniae somniferae radix, Withaniae somniferae radix, F: Assessment finalised
30/04/2018 Herbal medicinal product: Adhatodae vasicae folium, Adhatodae vasicae folium, F: Assessment finalised
30/04/2018 Herbal medicinal product: Centellae asiaticae herba, Centellae asiaticae herba, F: Assessment finalised
30/04/2018 Herbal medicinal product: Andrographidis paniculatae folium , Andrographidis paniculatae folium, F: Assessment finalised
30/04/2018 Herbal medicinal product: Filipendulae ulmariae flos, Filipendulae ulmariae flos, F: Assessment finalised
30/04/2018 Herbal medicinal product: Filipendulae ulmariae herba, Filipendulae ulmariae herba, F: Assessment finalised
30/04/2018 Herbal medicinal product: Bursae pastoris herba, Bursae pastoris herba, F: Assessment finalised
30/04/2018 Herbal medicinal product: Angelicae sinensis radix, Angelicae sinensis radix, F: Assessment finalised
30/04/2018 Work programme: Work plan for the CVMP Immunologicals Working Party 2018
30/04/2018 Regulatory and procedural guideline: Draft EudraVigilance access policy for medicines for veterinary use - Revision 1
30/04/2018 Scientific guideline: Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
30/04/2018 Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 11, Authorised
30/04/2018 Veterinary medicines European public assessment report (EPAR): Purevax RC, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), 23/02/2005, 10, Authorised
30/04/2018 Overview of comments: Overview of comments on 'Guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater' (EMA/CVMP/ERA/103555/2015)
27/04/2018 Eleventh stakeholder forum on the pharmacovigilance legislation , European Medicines Agency, London, UK, from 21/09/2017 to 21/09/2017
27/04/2018 Human medicines European public assessment report (EPAR): Iblias, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 4, Authorised
27/04/2018 Periodic safety update single assessment: Oxytocin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002263/201706
27/04/2018 Periodic safety update single assessment: Oxytocin: List of nationally authorised medicinal products - PSUSA/00002263/201706
27/04/2018 Withdrawn application: Qtern, saxagliptin / dapagliflozin, Date of withdrawal: 03/04/2018, Post-authorisation
27/04/2018 Summary of opinion: Prolia, denosumab, 26/04/2018, Positive
27/04/2018 Summary of opinion: Perjeta, pertuzumab, 26/04/2018, Positive
27/04/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018
27/04/2018 Annex to CHMP highlights: Start of community reviews - CHMP meeting of 23-26 April 2018
27/04/2018 Periodic safety update single assessment: Levocetirizine: List of nationally authorised medicinal products - PSUSA/00001850/201707
27/04/2018 Periodic safety update single assessment: Levocetirizine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001850/201707
27/04/2018 Minutes: Minutes of the 99th meeting of the Management Board: 15 March 2018
27/04/2018 News and press releases: European Medicines Agency closed 1 May 2018
27/04/2018 Periodic safety update single assessment: Diclofenac / misoprostol: List of national authorised medicinal products - PSUSA/00001040/201707
27/04/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: March 2018
27/04/2018 Human medicines European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), telmisartan, Hypertension, 16/12/1998, 29, Authorised
26/04/2018 News and press releases: Updated rules for clinical development of vaccines
26/04/2018 Scientific guideline: Draft guideline on clinical evaluation of vaccines - Revision 1
26/04/2018 Supporting SMEs
26/04/2018 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone dipropionate anhydrous, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 23/04/2018, Authorised
26/04/2018 Periodic safety update single assessment: Cefadroxil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000584/201707
26/04/2018 Periodic safety update single assessment: Cefadroxil: List of nationally authorised medicinal products - PSUSA/00000584/201707
26/04/2018 Veterinary medicines European public assessment report (EPAR): Panacur AquaSol, fenbendazole, 09/12/2011, 6, Authorised
26/04/2018 Veterinary medicines European public assessment report (EPAR): Convenia, cefovecin, 19/06/2006, 10, Authorised
26/04/2018 Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Ovarian Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 12/11/1996, 29, Authorised
26/04/2018 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 April 2018
26/04/2018 Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union , European Medicines Agency, London, UK, from 24/11/2017 to 24/11/2017
26/04/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2018
26/04/2018 ICH E9 statistical principles for clinical trials
26/04/2018 Overview of comments: Overview of comments received on ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals (EMA/CHMP/ICH/544278/1998)
26/04/2018 Overview of comments: Overview of comments received on draft ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017)
26/04/2018 Other: Suptavumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
26/04/2018 Human medicines European public assessment report (EPAR): Pritor, telmisartan, Hypertension, 11/12/1998, 28, Authorised
25/04/2018 Extended EudraVigilance medicinal product dictionary (XEVMPD) training
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of an authorised medicinal product
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a pharmacovigilance system master file location
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Update of an authorised medicinal product
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of an organisation
25/04/2018 Orphan designation: Recombinant human acid ceramidase for the: Treatment of cystic fibrosis, 10/08/2015, Positive
25/04/2018 News and press releases: Ten years promoting high-quality scientific research in paediatric medicines
25/04/2018 Other: Coordinating group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
25/04/2018 Template or form: Registration form - 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
25/04/2018 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 12, Authorised
25/04/2018 Veterinary medicines European public assessment report (EPAR): ProZinc, insulin human, 12/07/2013, 7, Authorised
25/04/2018 Human medicines European public assessment report (EPAR): Alpivab, Peramivir, Influenza, Human, 13/04/2018, Additional monitoring, Authorised
25/04/2018 Veterinary medicines European public assessment report (EPAR): Meloxidolor, meloxicam, 22/04/2013, Generic, 6, Authorised
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Maintenance operations - Update of a marketing authorisation holder (MAH) organisation entity in the XEVMPD
25/04/2018 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Maintenance operations - Invalidation of an authorised medicinal product (AMP) entity in the XEVMPD
24/04/2018 Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 March 2018 , European Medicines Agency, London, UK, from 13/03/2018 to 15/03/2018
24/04/2018 Minutes: Minutes of the CVMP meeting of 13-15 March 2018
24/04/2018 Herbal medicinal product: Meliloti herba, Meliloti herba, F: Assessment finalised
24/04/2018 Agenda: Agenda - PDCO agenda of the 24-27 April 2018 meeting
24/04/2018 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests, Helicobacter Infections, 14/08/1997, 15, Authorised
24/04/2018 Periodic safety update single assessment: Delapril / manidipine, delapril / indapamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010496/201706
24/04/2018 Periodic safety update single assessment: Delapril / manidipine, delapril / indapamide: List of nationally authorised medicinal products - PSUSA/00010496/201706
24/04/2018 Veterinary medicines European public assessment report (EPAR): Oncept IL-2, vCP1338 virus, 03/05/2013, 2, Authorised
24/04/2018 Veterinary medicines European public assessment report (EPAR): Porcilis PCV ID, porcine circovirus type 2 ORF2 subunit antigen, 28/08/2015, 1, Authorised
24/04/2018 Withdrawn application: Aranesp, darbepoetin alfa, Date of withdrawal: 21/02/2018, Post-authorisation
24/04/2018 News and press releases: The European Medicines Agency and the Netherlands agree on Seat Agreement
24/04/2018 Template or form: Application for authorisation to engage in an occupation after leaving the European Medicines Agency - National expert on secondment
24/04/2018 Template or form: Application for authorisation to engage in an occupation after leaving the European Medicines Agency - Article 16 of the Staff Regulations
23/04/2018 News and press releases: European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European Medicines Agency
23/04/2018 Agenda: Agenda - CHMP agenda of the 23-26 April 2018 meeting