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November 2017

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24/11/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 27, Authorised
24/11/2017User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process) - Annex I (updated)
24/11/2017Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 36, Authorised
24/11/2017Minutes of the PRAC meeting 25-29 September 2017
24/11/2017Human medicines European public assessment report (EPAR): Prevenar,

pneumococcal saccharide conjugated vaccine, adsorbed

Revision: 23, Withdrawn
24/11/2017European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (updated)
24/11/2017News and press releases: ENCePP: 10 years for excellence in medicines safety
24/11/2017News and press releases: EU Ombudsman confirms EMA’s correct handling of declared interests
24/11/2017News and press releases: New guidelines on good manufacturing practices for advanced therapies
24/11/2017Support for advanced-therapy developers (updated)
24/11/2017Human medicines European public assessment report (EPAR): Fendrix,

hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

Revision: 10, Authorised
24/11/2017Human medicines European public assessment report (EPAR): Increlex,

mecasermin

Revision: 20, Authorised
24/11/2017Human medicines European public assessment report (EPAR): Savene,

dexrazoxane

Revision: 11, Authorised
24/11/2017Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 7, Authorised
24/11/2017Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau),

chenodeoxycholic acid

Revision: 3, Authorised
23/11/2017Human medicines European public assessment report (EPAR): Kanuma,

sebelipase alfa

Revision: 2, Authorised
23/11/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 12, Authorised
23/11/2017Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 7, Authorised
23/11/2017Haemophilus type b conjugate vaccines : List of nationally authorised medicinal products - PSUSA/00001584/201702
23/11/2017Haemophilus type b conjugate vaccines : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001584/201702
23/11/2017Human medicines European public assessment report (EPAR): Miglustat Gen.Orph,

miglustat

Revision: 0, Authorised
23/11/2017Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 6, Authorised
23/11/2017Timetable: Type II variation and worksharing application assessment - ATMP
23/11/2017Timetable: Type II variation and worksharing application alternative monthly assessment (updated)
23/11/2017Timetable: Type II variation and worksharing application monthly assessment (updated)
23/11/2017Minutes of the CHMP meeting 09-12 October 2017
23/11/2017Second industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 15-Nov-2017, To: 15-Nov-2017 (updated)
23/11/2017Human medicines European public assessment report (EPAR): Metalyse,

tenecteplase

Revision: 16, Authorised
23/11/2017eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 21-Jun-2018, To: 22-Jun-2018
23/11/2017eXtended EudraVigilance medicinal product dictionary face-to-face training course, Madrid, Aula Center, Madrid, Spain, From: 07-Jun-2018, To: 08-Jun-2018
23/11/2017eXtended EudraVigilance medicinal product dictionary face-to-face training course, Prague, Computer Help, Prague, Czech Republic, From: 09-Apr-2018, To: 10-Apr-2018
23/11/2017eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 15-Feb-2018, To: 16-Feb-2018
23/11/2017Human medicines European public assessment report (EPAR): Oprymea,

pramipexole

Revision: 17, Authorised
23/11/2017List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
23/11/2017Human medicines European public assessment report (EPAR): Rixathon,

rituximab

Revision: 1, Authorised
23/11/2017Application form - User guide for the electronic application form for a marketing authorisation (updated)
23/11/2017Human medicines European public assessment report (EPAR): Riximyo,

rituximab

Revision: 1, Authorised
23/11/2017Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 12, Authorised
22/11/2017Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 24, Authorised
22/11/2017Orphan designation:

Chimeric IgG monoclonal antibody cG250 (girentuximab)

for the: Treatment of renal cell carcinoma (updated)
22/11/2017Human medicines European public assessment report (EPAR): Retacrit,

epoetin zeta

Revision: 21, Authorised
22/11/2017PRAC recommendations on signals adopted at the PRAC meeting of 26-29 September 2016, adopted (updated)
22/11/2017Agenda: Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (updated)
22/11/2017Organising committee - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (updated)
22/11/2017Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 40, Authorised
22/11/2017Agenda: Programme and registration form - European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance (updated)
22/11/2017Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 20, Authorised
22/11/2017Human medicines European public assessment report (EPAR): Ozurdex,

dexamethasone

Revision: 8, Authorised
22/11/2017Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance (updated)
22/11/2017EudraVigilance training and support (updated)
22/11/2017EudraVigilance: electronic reporting (updated)
22/11/2017EudraVigilance change management (updated)
22/11/2017EudraVigilance (updated)
22/11/2017EudraVigilance system overview (updated)
22/11/2017EudraVigilance: how to register (updated)
22/11/2017Data submission on authorised medicines (Article 57) (updated)
22/11/2017Regulatory and procedural guideline: EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0
22/11/2017Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.0 - Release notes
22/11/2017Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.1 (updated)
22/11/2017Regulatory and procedural guideline: EudraVigilance auditable requirement project: EudraVigilance training plan - Version 5, adopted (updated)
22/11/2017The new EudraVigilance system – Public communications plan for European Medicines Agency and National Competent Authorities in the European Economic Area: overview of the planned public communication milestones (updated)
22/11/2017News and press releases: New EudraVigilance system is live
22/11/2017Regulatory and procedural guideline: EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 3.0 (updated)
22/11/2017Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders
22/11/2017Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (updated)
22/11/2017New functionalities in support of the medical literature monitoring service - User manual: EV ICHISCR Export Manager, MLM EVWEB and tracking spreadsheets (updated)
22/11/2017European Union BFC conversion (v.2.5) (updated)
22/11/2017Regulatory and procedural guideline: EudraVigilance stakeholder change management plan (updated)
22/11/2017Medical literature monitoring tracking sheet: search results (updated)
21/11/2017Human medicines European public assessment report (EPAR): Victrelis,

boceprevir

Revision: 22, Authorised
21/11/2017Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 0, Authorised
21/11/20176,7-dihydro-5H-pyrrolo[1,2-c] imidazol-5-yl) - (benzo derivative) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
21/11/2017Conduct of pharmacokinetic studies in target animal species (updated)
21/11/2017Scientific guideline: Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1, draft: consultation open
21/11/2017Questions and answers on adverse-event reporting (updated)
21/11/2017Questions and answers related to management and assessment of periodic safety update reports (PSURs) (updated)
21/11/2017Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 16, Authorised
21/11/2017Human medicines European public assessment report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 15, Authorised
21/11/2017Human medicines European public assessment report (EPAR): Selincro,

nalmefene

Revision: 8, Authorised
21/11/2017Report: Report - Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products
21/11/2017Allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity
21/11/2017Human medicines European public assessment report (EPAR): Numient,

levodopa / carbidopa

Revision: 2, Authorised
21/11/2017Clinical development of medicinal products for the treatment of autism spectrum disorder (ASD) (updated)
21/11/2017Scientific guideline: Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD), adopted
21/11/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2017
20/11/2017News and press releases: EMA to relocate to Amsterdam, the Netherlands
20/11/2017Registration form - Workshop on site and histology: independent indications in oncology
20/11/2017Workshop on site and histology: independent indications in oncology, European Medicines Agency, London, UK, From: 14-Dec-2017, To: 15-Dec-2017
20/11/2017Regulatory and procedural guideline: Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions
20/11/2017Minutes of the CVMP meeting of 3-5 October 2017
20/11/2017Minutes of the COMP meeting of 3-5 October 2017
20/11/2017Agenda: Agenda - HMPC agenda of the 20-21 November 2017 meeting
20/11/2017Human medicines European public assessment report (EPAR): Cinryze,

C1 inhibitor (human)

Revision: 15, Authorised
20/11/2017Human medicines European public assessment report (EPAR): Visudyne,

verteporfin

Revision: 30, Authorised
20/11/2017Herbal medicinal products: Glycine, Lecithinum ex soya, Glycine max (L.) Merr. (updated)
20/11/2017Bilastine: List of nationally authorised medicinal products - PSUSA/00003163/201703
20/11/2017Bilastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003163/201703
20/11/2017Amlodipine: List of nationally authorised medicinal products - PSUSA/00000174/201703
20/11/2017Amlodipine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000174/201703
20/11/2017Saccharomyces boulardii : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00009284/201702
20/11/2017Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/201702
20/11/2017Veterinary medicine European public assessment report (EPAR): Improvac,

gonadotropin-releasing-factor-analogue-protein conjugate

Revision: 17, Authorised
20/11/2017Eligible healthcare professionals' organisations (updated)
20/11/2017Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 10, Authorised
20/11/2017Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 21, Authorised
20/11/2017Scientific guideline: Guideline on the evaluation of anticancer medicinal products in man, adopted
20/11/2017Evaluation of anticancer medicinal products in man (updated)
20/11/2017List of signals discussed at the PRAC since September 2012 (updated)
20/11/2017PRAC recommendations on signals adopted at the 23-26 October 2017 PRAC meeting, adopted
20/11/2017Human medicines European public assessment report (EPAR): Ritonavir Mylan,

ritonavir

Revision: 0, Authorised
17/11/2017Scientific guideline: Overview of comments received on 'Draft Guideline on manufacture of the finished dosage form' (EMA/CHMP/QWP/245074) - Revision 1
17/11/2017Manufacture of the finished dosage form (updated)
17/11/2017Training session for patients and consumers interested in European Medicines Agency activities, European Medicines Agency, London, UK, From: 21-Nov-2017, To: 21-Nov-2017
17/11/2017European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 22-Nov-2017, To: 22-Nov-2017
17/11/2017Human medicines European public assessment report (EPAR): Cyltezo,

adalimumab

Revision: 0, Authorised
17/11/2017Referral: Article 31 referrals, Vancomycin-containing medicines,

vancomycin

(updated)
17/11/2017News and press releases: Towards a single development programme for new antibiotics in EU, Japan and US
17/11/2017Human medicines European public assessment report (EPAR): Yellox,

bromfenac

Revision: 8, Authorised
17/11/2017Antimicrobial resistance (updated)
17/11/2017Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 9, Authorised
17/11/2017Ethinylestradiol / gestodene (transdermal application): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010145/201702
17/11/2017Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201702
17/11/2017Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents, Kyoto, Japan, From: 24-Nov-2017, To: 25-Nov-2017
17/11/2017Meeting summary - Tripartite meeting held between the PMDA, EMA, and FDA in Kyoto, Japan to discuss convergence on approaches for the evaluation of antibacterial drugs
17/11/2017Human medicines European public assessment report (EPAR): Optruma,

raloxifene

Revision: 22, Authorised
17/11/2017Innovation and biomarkers in cancer drug development (IBCD) 2018, Brussels, Belgium, From: 29-Nov-2017, To: 30-Nov-2017
16/11/2017Human medicines European public assessment report (EPAR): Ryzodeg,

insulin degludec / insulin aspart

Revision: 9, Authorised
16/11/2017Agenda: Agenda - PDCO agenda of the 7-10 November 2017 meeting (updated)
16/11/2017Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 12, Authorised
16/11/2017Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines
16/11/2017Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability to CVMP based on the outcome of the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines
16/11/2017Human medicines European public assessment report (EPAR): Humalog,

insulin lispro

Revision: 27, Authorised
16/11/2017Human medicines European public assessment report (EPAR): Teysuno,

tegafur / gimeracil / oteracil

Revision: 14, Authorised
16/11/2017Human medicines European public assessment report (EPAR): Modigraf,

tacrolimus

Revision: 10, Authorised
16/11/2017Human medicines European public assessment report (EPAR): Tresiba,

insulin degludec

Revision: 8, Authorised
16/11/2017Human medicines European public assessment report (EPAR): Rasagiline ratiopharm,

rasagiline

Revision: 3, Authorised
16/11/2017Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 19, Authorised
16/11/2017Report: List of products granted eligibility to PRIME (updated)
16/11/2017Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 6-9 November 2017
15/11/2017Human medicines European public assessment report (EPAR): Silapo,

epoetin zeta

Revision: 13, Authorised
15/11/2017Omega-3-acid-ethyl esters: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010312/201701
15/11/2017Omega-3-acid-ethyl esters: List of nationally authorised medicinal products - PSUSA/00010312/201701
15/11/2017Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 12, Authorised
15/11/2017Referentials and organisations management services (updated)
15/11/2017Human medicines European public assessment report (EPAR): Betmiga,

mirabegron

Revision: 9, Authorised
15/11/2017Presentation - RMS and OMS: industry on-boarding to SPOR webinar with Industry Change Liaisons
15/11/2017Referentials Management Service (RMS) and Organisations Management Services (OMS) industry on-boarding plan (updated)
15/11/2017Organisation Management Services (OMS) operating model (updated)
15/11/2017SPOR data management services high level changes (updated)
15/11/2017Presentation - Challenges in performing field trials to support efficacy: companion animal vaccines (K. Hellmann)
15/11/2017New vacancy: Temporary Agent (AD8), Scientific Administrator, Veterinary Biologicals / Novel Therapies
15/11/2017New vacancy: Temporary Agent (AD8), Scientific Administrator, Veterinary Pharmaceutical Medicines Efficacy
15/11/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
15/11/2017Product-information requirements (updated)
15/11/2017European Medicines Agency action plan related to the European Commission’s recommendations on product information
15/11/2017News and press releases: EMA to work with stakeholders to improve the product information for EU medicines
15/11/2017News and press releases: European Antibiotic Awareness Day: Statement by Guido Rasi, Executive Director of the European Medicines Agency
15/11/2017Presentation - Non-animal approaches in support of medicinal product development - setting the scene (S. Beken)
15/11/2017Presentation - MPS – development status, first industrial adoption and current challenges (U. Marx)
15/11/2017Presentation - Populating organs-on-chip with cells derived from human stem cells (C. Mummery)
15/11/2017Presentation - In vitro in vivo extrapolation (IVIVE): why it is not as easy as you may think (A. Rostami)
15/11/2017Presentation - Organ-on-chip networking in Europe (J. van den Eijnden-van Raaij)
15/11/2017Presentation - Placing microphysiological systems in the pharmaceutical R&D strategy (L. Ewart)
15/11/2017Germanium (68Ge) chloride / gallium (68Ga) chloride: List of nationally authorised medicinal products - PSUSA/00010364/201703
15/11/2017Presentation - MEA assays using human iPSC-derived cardiomyocytes, challenges and opportunities (T. de Korte)
15/11/2017Presentation - Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions (S. Fitzpatrick)
15/11/2017Presentation - Detection of toxicity to reproduction for human pharmaceuticals (G. Waxenecker)
15/11/2017Presentation - Advanced cell models, organs on a chip and microphysiological systems in drug development (A. Roth)
14/11/2017Flubendazole: List of nationally authorised medicinal products - PSUSA/00001400/201702
14/11/2017Flubendazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001400/201702
14/11/2017Human medicines European public assessment report (EPAR): Vantobra,

tobramycin

Revision: 3, Authorised
14/11/2017Scientific publications (updated)
14/11/2017Human medicines European public assessment report (EPAR): Hycamtin,

topotecan

Revision: 28, Authorised
14/11/2017Agenda: Agenda - Industry stakeholder platform on research and development support
14/11/2017Plasma-master-file certifications (updated)
14/11/2017Q&A: Good clinical practice (GCP) (updated)
14/11/2017Referral: Article 34, Lincocin and its associated names,

lincomycin

14/11/2017Report: Report - Information session on antimicrobial resistance on 19 September 2017 (updated)
14/11/2017Veterinary medicine European public assessment report (EPAR): Easotic,

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

Revision: 6, Authorised
14/11/2017News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2017 by end of November
14/11/2017Agenda: Agenda – SME info day: supporting innovative medicines’ development and early access (updated)
13/11/2017Human medicines European public assessment report (EPAR): Sevelamer carbonate Zentiva,

sevelamer carbonate

Revision: 8, Authorised
13/11/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note, adopted (updated)
13/11/2017Regulatory and procedural guideline: Questions and answers on PSUSA: Guidance document for assessors (updated)
13/11/2017Orphan designation:

N-[2,6-bis(1-methylethyl)phenyl]-N’-[[1-[4-(dimethylamino) phenyl]cyclopentyl]methyl]urea, hydrochloride salt

for the: Treatment of adrenocortical carcinoma (updated)
13/11/2017Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017 (updated)
13/11/2017Regulatory and procedural guideline: Checklist for sponsors applying for the transfer of orphan medicinal product designation (updated)
13/11/2017The joint European Union Telematics governance model (updated)
13/11/2017Health technology assessment bodies (updated)
13/11/2017News and press releases: EMA and EUnetHTA finalise joint work plan for 2017-2020
13/11/2017EMA-EUnetHTA three-year work plan (2017-2020)
13/11/2017Human medicines European public assessment report (EPAR): Vedrop,

tocofersolan

Revision: 11, Authorised
13/11/2017Veterinary medicine European public assessment report (EPAR): Draxxin,

tulathromycin

Revision: 18, Authorised
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, Aula Center, Madrid, Spain, From: 04-Jun-2018, To: 06-Jun-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam , BCN Amsterdam Arena, Amsterdam, The Netherlands, From: 19-Mar-2018, To: 21-Mar-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris, Châteauform’ College, Paris, France, From: 13-Jun-2018, To: 15-Jun-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Prague, Computer Help, Prague, Czech Republic, From: 11-Apr-2018, To: 13-Apr-2018
13/11/2017Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 7, Authorised
13/11/2017We work together to fight antibiotic resistance keeping Europeans healthy
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna, Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, From: 05-Feb-2018, To: 07-Feb-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Athens, OTE Academy, Athens, Greece, From: 21-Feb-2018, To: 23-Feb-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, Infarmed, Lisbon, Portugal, From: 22-Jan-2018, To: 24-Jan-2018
13/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, one-by-one EDV-GmbH, Berlin, Germany, From: 15-Jan-2018, To: 17-Jan-2018
13/11/2017Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 5, Authorised
10/11/2017MRL pending EC decision: Porcine prolactin - Summary opinion of the CVMP on the establishment of maximum residue limits
10/11/2017MRL pending EC decision: Eprinomectin - Summary opinion of the CVMP on the establishment of maximum residue limits
10/11/2017Pending EC decision: Galliprant,

grapiprant

Opinion date: 09-Nov-2017
10/11/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017
10/11/2017Pending EC decision: Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Opinion date: 09-Nov-2017
10/11/2017Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 13, Authorised
10/11/2017Human medicines European public assessment report (EPAR): Emend,

aprepitant

Revision: 23, Authorised
10/11/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
10/11/2017News and press releases: New medicine for rare inflammatory condition of the oesophagus
10/11/2017News and press releases: New medicine to prevent cytomegalovirus disease in stem cell transplant patients
10/11/2017News and press releases: New medicine for multiple sclerosis
10/11/2017Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
10/11/2017Scientific advice and protocol assistance adopted during the CHMP meeting 6 – 9 November 2017, adopted
10/11/2017News and press releases: EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage
10/11/2017Pending EC decision: Onzeald,

etirinotecan pegol

Opinion date: 09-Nov-2017 (updated)
10/11/2017Pending EC decision: Adcetris,

brentuximab vedotin

Opinion date: 09-Nov-2017
10/11/2017Withdrawn application: Keytruda,

pembrolizumab

Post-authorisation
10/11/2017Pending EC decision: Orkambi,

lumacaftor / ivacaftor

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Fulvestrant Mylan,

fulvestrant

Opinion date: 09-Nov-2017
10/11/2017Withdrawn application: Kyomarc,

bevacizumab

Initial authorisation
10/11/2017Pending EC decision: Ocrevus,

ocrelizumab

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Darunavir Krka d.d.,

darunavir

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Prevymis,

letermovir

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Mvasi,

bevacizumab

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Nplate,

romiplostim

Opinion date: 09-Nov-2017
10/11/2017Withdrawn application: Plivensia,

sirukumab

Initial authorisation
10/11/2017Pending EC decision: Fasenra,

benralizumab

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Adynovi,

rurioctocog alfa pegol

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Jorveza,

budesonide

Opinion date: 09-Nov-2017
10/11/2017Pending EC decision: Fanaptum,

iloperidone

Opinion date: 09-Nov-2017 (updated)
10/11/2017Human medicines European public assessment report (EPAR): Akynzeo,

netupitant / palonosetron

Revision: 2, Authorised
10/11/2017Agenda: Agenda - Data anonymisation workshop
10/11/2017Human medicines European public assessment report (EPAR): CoAprovel,

irbesartan / hydrochlorothiazide

Revision: 33, Authorised
10/11/2017Pending EC decision: Intrarosa,

prasterone

Opinion date: 09-Nov-2017
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 12-Feb-2018, To: 14-Feb-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 18-Jun-2018, To: 20-Jun-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 28-May-2018, To: 30-May-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 23-Apr-2018, To: 25-Apr-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 29-Jan-2018, To: 31-Jan-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 30-May-2018, To: 01-Jun-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 10-Jan-2018, To: 11-Jan-2018
09/11/2017The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 16-Apr-2018, To: 18-Apr-2018
09/11/2017Letter of support for drug-induced vascular injury (DIVI) biomarker
09/11/2017Final European Union herbal monograph on Valeriana officinalis L., radix, adopted (updated)
09/11/2017Pending EC decision: Darunavir Krka,

darunavir

Opinion date: 09-Nov-2017
09/11/2017Agenda: Agenda - CVMP agenda of the 7-9 November 2017 meeting
09/11/2017Quality Review of Documents (QRD) working group plenary meeting dates - 2017 (updated)
09/11/2017Human medicines European public assessment report (EPAR): Binocrit,

epoetin alfa

Revision: 17, Authorised
09/11/2017Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 13, Authorised
09/11/2017Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 7, Authorised
08/11/2017Patient registries (updated)
08/11/2017Veterinary medicine European public assessment report (EPAR): Dexdomitor,

dexmedetomidine

Revision: 17, Authorised
08/11/2017Line listing example
08/11/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 61, Authorised
08/11/2017Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 28, Authorised
08/11/2017Newsletter: Human medicines highlights - November 2017
08/11/2017Medical literature monitoring tracking sheet: individual case safety reports (ICSRs)
07/11/2017PRAC meeting dates 2016, 2017 and 2018 (updated)
07/11/2017Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live

Revision: 26, Authorised
07/11/2017Newsletter: News bulletin for small and medium-sized enterprises - Issue 41
07/11/2017News and press releases: EMA gets ready for relocation decision
07/11/2017Pyramax H-W-2319 (updated)
07/11/2017European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance, European Medicines Agency, London, UK, From: 19-Dec-2017, To: 19-Dec-2017
07/11/2017Human medicines European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop),

irbesartan / hydrochlorothiazide

Revision: 22, Authorised
07/11/2017Minutes of the CHMP meeting 11-14 September 2017 (updated)
06/11/2017Human medicines European public assessment report (EPAR): Zoledronic acid Actavis,

zoledronic acid

Revision: 10, Authorised
06/11/2017Dexlansoprazole, lansoprazole: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001827/201612
06/11/2017Dexlansoprazole, lansoprazole: List of nationally authorised medicinal products - PSUSA/00001827/201612
06/11/2017Nabumetone: List of nationally authorised medicinal products - PSUSA/00002101/201703
06/11/2017Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 12, Authorised
06/11/2017Human medicines European public assessment report (EPAR): Abseamed,

epoetin alfa

Revision: 18, Authorised
06/11/2017Amoxicillin : List of nationally authorised medicinal products - PSUSA/00000187/201703
06/11/2017Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201703
06/11/2017Amoxicillin / clavulanate: List of nationally authorised medicinal products - PSUSA/00000188/201703
06/11/2017Human medicines European public assessment report (EPAR): Varuby,

rolapitant

Revision: 1, Authorised
06/11/2017Human medicines European public assessment report (EPAR): Insulin lispro Sanofi,

insulin lispro

Revision: 1, Authorised
06/11/2017Minutes of the CAT meeting 6-8 September 2017
06/11/2017Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 11, Authorised
06/11/2017Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 13, Authorised
06/11/2017Cinryze (C1 inhibitor, human) supply shortage (updated)
06/11/2017Agenda: Agenda - CHMP agenda of the 6-9 November 2017 meeting
06/11/2017Octenidine dihydrochloride / phenoxyethanol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002199/201701 (updated)
06/11/2017Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 32, Authorised
06/11/2017Human medicines European public assessment report (EPAR): Omnitrope,

somatropin

Revision: 13, Authorised
06/11/2017Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 40, Authorised