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May 2017

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24/05/2017European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
24/05/2017Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly),

tadalafil

Revision: 11, Authorised
24/05/2017Human medicines European public assessment report (EPAR): Cialis,

tadalafil

Revision: 26, Authorised
24/05/2017Orphan designation:

Chimeric monoclonal antibody against GD2

for the: Treatment of neuroblastoma (updated)
24/05/2017Report: List of products granted eligibility to PRIME (updated)
24/05/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 15-18 May 2017
24/05/2017COMP meeting report on the review of applications for orphan designation: May 2017
24/05/2017Veterinary medicine European public assessment report (EPAR): Coliprotec F4/F18,

Porcine post-weaning diarrhoea vaccine (live)

Revision: 1, Authorised
24/05/2017Visit of the East African Community (EAC), European Medicines Agency, London, UK, From: 18-May-2017, To: 19-May-2017
24/05/2017Veterinary medicine European public assessment report (EPAR): Letifend,

canine leishmaniasis vaccine (recombinant protein)

Revision: 2, Authorised
24/05/2017Veterinary medicine European public assessment report (EPAR): Poulvac E. coli,

Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens

Revision: 7, Authorised
24/05/2017Tripartite meeting between EMA, PMDA and FDA on regulatory approaches for the evaluation of antibacterial agents , European Medicines Agency, London, United Kingdom, From: 01-Sep-2016, To: 02-Sep-2016
24/05/2017Second tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents, Vienna, Austria, From: 26-Apr-2017, To: 27-Apr-2017
23/05/2017Penciclovir: List of nationally authorised medicinal products - PSUSA/00002333/201608
23/05/2017Non-spontaneous adverse event reports (literature, internet and social media) for veterinary medicinal products
23/05/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 58, Authorised
23/05/2017Highlight report of the Industry stakeholder platform on research and development support (from the meeting on 25 April 2017)
23/05/2017Highlight report of the Industry stakeholder platform on research and development support
23/05/2017News and press releases: East African Community looks to EMA as model for future regional agency
23/05/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
23/05/2017Presentation - Approaches for quality control testing of LSD vaccines (Annebel De Vleeschauwer and Kris De Clercq)
23/05/2017Presentation - Industry challenges on supplying emergency vaccines in Africa – OBP perspectives (Bethuel Nthangeni)
23/05/2017Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka,

emtricitabine / tenofovir disoproxil

Revision: 1, Authorised
23/05/2017News and press releases: European Medicines Agency closed 25-26 May 2017
23/05/2017Human medicines European public assessment report (EPAR): Suliqua,

insulin glargine / lixisenatide

Revision: 1, Authorised
23/05/2017Executive Director (updated)
23/05/2017Scientific guideline: Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, draft: consultation open
23/05/2017Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (updated)
22/05/2017Drospirenone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00010217/201609
22/05/2017Plasma-master-file certifications (updated)
22/05/2017Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 10, Authorised
22/05/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 8, Authorised
22/05/2017Second 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 17-May-2017, To: 17-May-2017 (updated)
22/05/2017EU Innovation Network: E-mail addresses for users
22/05/2017EU Innovation Network: core profile within the network
22/05/2017Announcement of the EMA Management Board - Confirmation of full functionality of the EudraVigilance database
22/05/2017News and press releases: Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
22/05/2017EudraVigilance training and support (updated)
22/05/2017EudraVigilance (updated)
22/05/2017Annual report on deferral granted in the paediatric investigation plan - (PED6) certified (updated)
22/05/2017Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified (updated)
22/05/2017Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified (updated)
22/05/2017Pending EC decision: Sevelamer carbonate Zentiva,

sevelamer carbonate

Opinion date: 18-May-2017
22/05/2017Pending EC decision: Renvela,

sevelamer carbonate

Opinion date: 18-May-2017
22/05/2017EudraVigilance user declaration (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
22/05/2017Change of qualified person for pharmacovigilance and responsible person for EudraVigilance (updated)
22/05/2017EudraVigilance registration documents (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
22/05/2017Delegating the EudraVigilance registration process (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
22/05/2017Minutes of the HMPC 30-31 January 2017 meeting
22/05/2017Joint European Medicines Agency / Drug Information Association information day on measuring the impact of pharmacovigilance activities, European Medicines Agency, London, UK, From: 14-Nov-2017, To: 14-Nov-2017
22/05/2017Nominations to the European Union Telematics governance bodies (updated)
22/05/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
22/05/2017Agenda: Agenda - 2017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) (updated)
22/05/2017Human medicines European public assessment report (EPAR): Iblias,

octocog alfa

Revision: 2, Authorised
22/05/2017Human medicines European public assessment report (EPAR): Cinqaero,

reslizumab

Revision: 1, Authorised
22/05/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 5, Authorised
22/05/2017Human medicines European public assessment report (EPAR): Praluent,

alirocumab

Revision: 7, Authorised
22/05/2017Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 8, Authorised
22/05/2017Veterinary medicine European public assessment report (EPAR): Zactran,

gamithromycin

Revision: 9, Authorised
22/05/2017News and press releases: EMA website briefly unavailable on 23 May
19/05/2017The 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: 20-Nov-2017, To: 22-Nov-2017
19/05/2017The 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: 15-Nov-2017, To: 17-Nov-2017
19/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, OTE Academy, Athens, Greece, From: 04-Dec-2017, To: 06-Dec-2017
19/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vipper Systemas, Madrid, Spain, From: 27-Nov-2017, To: 29-Nov-2017
19/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, INFARMED, Lisbon, Portugal, From: 08-Nov-2017, To: 10-Nov-2017
19/05/2017Timeline - European Medicines Agency-FDA parallel scientific advice
19/05/2017Minutes of the CAT meeting 15-17 March 2017
19/05/2017Chemistry of active substances (chemistry of new active substances) (updated)
19/05/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 2017
19/05/2017News and press releases: New advanced therapy to repair cartilage defects in the knee
19/05/2017News and press releases: New medicine for rare eye disease
19/05/2017Pending EC decision: Reagila,

cariprazine

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Blitzima,

rituximab

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Ritemvia,

rituximab

Opinion date: 18-May-2017
19/05/2017News and press releases: EMA recommends changes to prescribing information for vancomycin antibiotics
19/05/2017Pending EC decision: Komboglyze,

saxagliptin / metformin hydrochloride

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Izba,

travoprost

Opinion date: 18-May-2017
19/05/2017Referral: Article 13 referrals, Cardioxane,

dexrazoxane

19/05/2017Pending EC decision: Isentress,

raltegravir

Opinion date: 18-May-2017
19/05/2017Referral: Article 31 referrals, Vancomycin-containing medicines,

vancomycin

(updated)
19/05/2017Pending EC decision: Kyntheum,

brodalumab

Opinion date: 18-May-2017
19/05/2017Withdrawn application: Qinprezo,

vosaroxin

Initial authorisation
19/05/2017Pending EC decision: Onglyza,

saxagliptin

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva,

efavirenz / emtricitabine / tenofovir disoproxil

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Tuxella,

rituximab

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Veltassa,

patiromer sorbitex calcium

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Insulin lispro Sanofi,

insulin lispro

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech,

human IgG1 monoclonal antibody specific for human interleukin-1 alpha

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Oxervate,

cenegermin

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Trimbow,

beclometasone / formoterol / glycopyrronium bromide

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Uptravi,

selexipag

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Zykadia,

ceritinib

Opinion date: 18-May-2017
19/05/2017Referral: Article 29(4) referrals, Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets,

paracetamol-ibuprofen

19/05/2017Pending EC decision: Adlumiz,

anamorelin

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Masipro,

masitinib

Opinion date: 18-May-2017
19/05/2017Pending EC decision: Spherox,

spheroids of human autologous matrix-associated chondrocytes

Opinion date: 18-May-2017
18/05/2017Report: PRIME - The first 12 months
18/05/2017Cookies
18/05/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: April 2017
18/05/2017Minutes of the CVMP meeting of 10-12 April 2017
18/05/2017The 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: 13-Sep-2017, To: 15-Sep-2017
18/05/2017The 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: 11-Oct-2017, To: 13-Oct-2017
18/05/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
18/05/2017The 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-Oct-2017, To: 20-Oct-2017
18/05/2017The 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-Oct-2017, To: 18-Oct-2017
18/05/2017Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 20, Authorised
18/05/2017The 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: 09-Oct-2017, To: 11-Oct-2017
18/05/2017The 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-Sep-2017, To: 20-Sep-2017
18/05/2017The 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: 11-Sep-2017, To: 13-Sep-2017
18/05/2017The 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: 06-Sep-2017, To: 08-Sep-2017
18/05/2017The 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: 04-Sep-2017, To: 06-Sep-2017
18/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , Prague, Czech Republic, From: 23-Oct-2017, To: 25-Oct-2017
18/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , Vienna, Austria, From: 02-Oct-2017, To: 04-Oct-2017
18/05/2017The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course , Amsterdam, The Netherlands, From: 27-Sep-2017, To: 29-Sep-2017
18/05/2017Notices of calls for tender - 2016 (updated)
18/05/2017Presentation - European Union - lumpy skin disease and other exotic diseases antigen/vaccine banks: Current status, policy and future considerations (Andrea Gavinelli and Dimitrios Dilaveris)
18/05/2017Presentation - In vivo evaluation of lumpy skin disease vaccine efficacy in controlled environment (Kris De Clercq)
18/05/2017Presentation - Industry challenges for developing emergency vaccines (David John)
18/05/2017Presentation - Lumpy skin disease experience in Greece (Sotiria-Eleni Antoniou and Ioannis Malemis)
18/05/2017Presentation - Industry challenges for producing emergency vaccines in Europe (Alasdair King)
17/05/2017Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 18, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 17, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Zepatier,

elbasvir / grazoprevir

Revision: 3, Authorised
17/05/2017Marketing authorisation holders invited to register EudraVigilance Data Analysis System (EVDAS) users - timeslots to register
17/05/2017User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process) - Annex I
17/05/2017EudraVigilance: how to register (updated)
17/05/2017Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 35, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 30, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 25, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Pioglitazone Accord,

pioglitazone

Revision: 4, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Pergoveris,

follitropin alfa / lutropin alfa

Revision: 11, Authorised
17/05/2017Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 45, Authorised
17/05/2017Work plan for the Pharmacovigilance Inspectors Working Group for 2017
17/05/2017Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines, European Medicines Agency, London, UK, From: 14-Mar-2017, To: 14-Mar-2017 (updated)
17/05/2017Orphan designation:

Chimeric locked nucleic acid-deoxynucleoside phosphorothioate-linked oligonucleotide directed against microRNA-451

for the: Treatment of polycythaemia vera (updated)
17/05/2017Orphan designation:

Eculizumab

for the: Prevention of delayed graft function after solid organ transplantation (updated)
17/05/2017Orphan designation:

3-[5-(2-Fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid

for the: Treatment of cystic fibrosis (updated)
17/05/2017Orphan designation:

N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate

for the: Treatment of renal-cell carcinoma (updated)
17/05/2017Orphan designation:

Apremilast

for the: Treatment of Behçet’s disease (updated)
17/05/2017Report: Report - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines
17/05/2017Agenda: Agenda - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines (updated)
17/05/2017Orphan designation:

Beloranib

for the: Treatment of Prader-Willi syndrome (updated)
17/05/2017Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for the treatment of ATTR amyloidosis

for the: Treatment of ATTR amyloidosis (updated)
17/05/2017Orphan designation:

Synthetic double-stranded oligomer specific to the SERPINA1 gene and containing a cholesterol-conjugated, acyclic nucleobase analogue

for the: Treatment of congenital alpha-1 antitrypsin deficiency (updated)
17/05/2017Orphan designation:

Beloranib

for the: Treatment of craniopharyngioma (updated)
17/05/2017Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against claudin-5 complexed with polyethyleneimine (prior to administration of doxorubicin)

for the: Treatment of glioma (updated)
17/05/2017Orphan designation:

Doxorubicin (administered after synthetic double-stranded siRNA oligonucleotide directed against claudin-5 complexed with polyethyleneimine)

for the: Treatment of glioma (updated)
16/05/2017Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 50, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Picato,

ingenol mebutate

Revision: 6, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Effentora,

fentanyl

Revision: 18, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Increlex,

mecasermin

Revision: 18, Authorised
16/05/2017Withdrawn application: Blectifor,

caffeine citrate

Initial authorisation (updated)
16/05/2017Minutes - Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union
16/05/2017Human medicines European public assessment report (EPAR): Controloc Control,

pantoprazole

Revision: 9, Authorised
16/05/2017Focus group on promotion of pharmacovigilance for food producing animals, European Medicines Agency, London, UK, From: 23-Nov-2016, To: 23-Nov-2016
16/05/2017Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 5, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 5, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Alecensa,

alectinib

Revision: 1, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 8, Authorised
16/05/2017Veterinary medicine European public assessment report (EPAR): Cepedex,

dexmedetomidine

Revision: 1, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 6, Authorised
16/05/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
16/05/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
16/05/2017Post-authorisation safety studies: questions and answers (updated)
16/05/2017Post-authorisation measures: questions and answers (updated)
16/05/2017Transparency: questions and answers (updated)
16/05/2017Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 16, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Plavix,

clopidogrel

Revision: 34, Authorised
16/05/2017Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
16/05/2017Human medicines European public assessment report (EPAR): Pramipexole Accord,

pramipexole

Revision: 5, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Somac Control,

pantoprazole

Revision: 10, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Cholestagel,

colesevelam

Revision: 18, Authorised
16/05/2017Human medicines European public assessment report (EPAR): Defitelio,

defibrotide

Revision: 6, Authorised
16/05/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.7) (updated)
16/05/2017Newsletter: News bulletin for small and medium-sized enterprises - Issue 39
16/05/2017Human medicines European public assessment report (EPAR): Pantozol Control,

pantoprazole

Revision: 11, Authorised
16/05/2017Referral: Article 30 referrals, Saroten and associated names,

amitriptyline

(updated)
15/05/2017Agenda: Agenda - CHMP agenda of the 15-18 May 2017 meeting
15/05/2017Human medicines European public assessment report (EPAR): Xenical,

orlistat

Revision: 22, Authorised
15/05/2017Human medicines European public assessment report (EPAR): Kiovig,

human normal immunoglobulin

Revision: 18, Authorised
15/05/2017Regulatory and procedural guideline: INS-GCP-4 procedure for reporting of good-clinical-practice inspections requested by the CHMP, adopted (updated)
15/05/2017Regulatory and procedural guideline: Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report (updated)
15/05/2017Regulatory and procedural guideline: Appendix 2 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP integrated inspection report (updated)
15/05/2017Orphan designation:

N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine

for the: Treatment of fragile X syndrome
15/05/2017Orphan designation:

20% Intravenous fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection

for the: Treatment of poisoning by local anaesthetics
15/05/2017Orphan designation:

Human normal immunoglobulin

for the: Treatment in solid organ transplantation
15/05/2017Orphan designation:

Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains

for the: Treatment of multiple myeloma
15/05/2017Orphan designation:

Rituximab

for the: Treatment in solid organ transplantation
15/05/2017Orphan designation:

Emeramide

for the: Prevention of mercury toxicity
15/05/2017Orphan designation:

(S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester

for the: Treatment of pulmonary arterial hypertension
15/05/2017Orphan designation:

Modified messenger ribonucleic acid encoding human ornithine transcarbamylase enzyme encapsulated into lipid nanoparticles

for the: Treatment of ornithine transcarbamylase deficiency
15/05/2017Orphan designation:

Estetrol

for the: Treatment of neonatal encephalopathy
15/05/2017Orphan designation:

Thymidine and deoxycytidine

for the: Treatment of mitochondrial DNA depletion syndrome, myopathic form
15/05/2017Orphan designation:

Autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells

for the: Treatment of Asherman's syndrome
15/05/2017Patient Registry Initiative- Strategy and Mandate of the Cross-Committee Task Force
15/05/2017Pending EC decision: Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Opinion date: 12-May-2017
15/05/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 May 2017
15/05/2017Work plan for the Organisational Matters Drafting Group (ORGAM DG) 2017 (updated)
15/05/2017Marketing authorisation status - product template
15/05/2017Q&A: Application of the so-called 'sunset clause' to centrally authorised veterinary medicinal products (updated)
15/05/2017Biperiden : List of nationally authorised medicinal products - PSUSA/00000415/201608
15/05/2017Esketamine : List of nationally authorised medicinal products - PSUSA/00001266/201608
15/05/2017Human medicines European public assessment report (EPAR): Dinutuximab beta Apeiron,

dinutuximab beta

Revision: 0, Authorised
15/05/2017Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201609
15/05/2017Orphan designation:

Pentosan polysulfate sodium

for the: Treatment of interstitial cystitis (updated)
15/05/2017Human medicines European public assessment report (EPAR): Marixino (previously Maruxa),

memantine

Revision: 4, Authorised
15/05/2017Human medicines European public assessment report (EPAR): Vepacel,

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)

Revision: 8, Authorised
15/05/2017Human medicines European public assessment report (EPAR): Lojuxta,

lomitapide

Revision: 8, Authorised
12/05/2017Vectibix : EPAR - Summary for the public (updated)
12/05/2017Human medicines European public assessment report (EPAR): Vectibix,

panitumumab

Revision: 27, Authorised
12/05/2017Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva,

tenofovir disoproxil

Revision: 2, Authorised
12/05/2017Presentation - Facilitating engagement with the FDA to allow shaping paediatric development programmes (Irmgard Eichler)
12/05/2017Presentation - Implementation of the 2016 Notice on the application of the orphan regulation (Kristina Larsson)
12/05/2017Presentation - Regulatory HTA parallel scientific advice throughout the life-cycle of the product (Jane Moseley)
12/05/2017Presentation - Experience and opportunities for the co-development (process) of companion diagnostics and medicinal products (in the EU) (Falk Ehmann, Efthymios Manolis and Armin Ritzhaupt)
12/05/2017Agenda: Agenda – Industry stakeholder platform on research and development support
12/05/2017Presentation - Optimising the guidance on significant benefit demonstration in the context of protocol assistance (Matthias Hofer)
12/05/2017Presentation - Use of real world data in development programmes (Dr Alison Cave and Dr Francesca Cerreta)
12/05/2017Presentation - Early dialogue for paediatric development plans (Gunter Egger)
12/05/2017Human medicines European public assessment report (EPAR): Pregabalin Accord,

pregabalin

Revision: 2, Authorised
12/05/2017Agenda: Agenda - CAT agenda of the 10-12 May 2017 meeting
12/05/2017Estradiol (without cream/balm/emulsion for application in the female genital area): List of nationally authorised medicinal products - PSUSA/00010440/201608
12/05/2017Ketoprofen (topical use only): List of nationally authorised medicinal products - PSUSA/00009205/201609
12/05/2017Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201610
12/05/2017Pilocarpine (ophthalmic formulation): List of nationally authorised medicinal products - PSUSA/00002410/201608
12/05/2017Work instructions for marketing status and sunset clause monitoring for centrally authorised veterinary medicinal products, adopted
12/05/2017Human medicines European public assessment report (EPAR): Evotaz,

atazanavir / cobicistat

Revision: 3, Authorised
12/05/2017Veterinary medicine European public assessment report (EPAR): Zulvac BTV Ovis,

bluetongue vaccine (inactivated)

Revision: 0, Authorised
12/05/2017Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
12/05/2017Generic medicines (updated)
12/05/2017Generic and hybrid applications
12/05/2017Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
12/05/2017Human medicines European public assessment report (EPAR): Nucala,

mepolizumab

Revision: 4, Authorised
12/05/2017Orphan designation:

Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19

for the: Treatment in haematopoietic stem cell transplantation (updated)
12/05/2017Orphan designation:

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

for the: Treatment of post-polycythaemia vera myelofibrosis (updated)
12/05/2017Orphan designation:

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

for the: Treatment of post-essential thrombocythaemia myelofibrosis (updated)
12/05/2017Minutes - Twelfth joint EMA/EUnetHTA dialogue meeting
12/05/2017Orphan designation:

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

for the: Treatment of primary myelofibrosis (updated)
11/05/2017Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 9, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 36, Authorised
11/05/2017Herbal medicinal products: Glycine, Soiae oleum raffinatum, Glycine max (L.) Merr. (updated)
11/05/2017Veterinary medicine European public assessment report (EPAR): Credelio,

lotilaner

Revision: 0, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Jakavi,

ruxolitinib

Revision: 14, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Imatinib medac,

imatinib

Revision: 4, Authorised
11/05/2017First anniversary of PRIME: experience so far, European Medicines Agency, London, UK, From: 19-May-2017, To: 19-May-2017 (updated)
11/05/2017Human medicines European public assessment report (EPAR): Praxbind,

idarucizumab

Revision: 2, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Fycompa,

perampanel

Revision: 11, Authorised
11/05/2017Agenda: Agenda - COMP agenda of the 10-12 May 2017 meeting
11/05/2017Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 1, Authorised
11/05/2017Report: Medicinal products for human use: monthly figures - March 2017
11/05/2017Report: Medicinal products for human use: monthly figures - April 2017
11/05/2017CHMP ORGAM minutes for the meeting on 10 April 2017
11/05/2017Human medicines European public assessment report (EPAR): Anoro,

umeclidinium bromide / vilanterol

Revision: 6, Authorised
11/05/2017Referral: Article 30 referrals, Haldol Decanoate and associated names,

haloperidol decanoate

(updated)
11/05/2017Human medicines European public assessment report (EPAR): Imprida,

amlodipine / valsartan

Revision: 20, Withdrawn
11/05/2017Human medicines European public assessment report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 25, Authorised
11/05/2017Referral: Article 31 referrals, Retinoid-containing medicinal products,

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene

(updated)
11/05/2017Human medicines European public assessment report (EPAR): Qutenza,

capsaicin

Revision: 10, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Sialanar,

glycopyrronium

Revision: 1, Authorised
11/05/2017Orphan designation:

Chenodeoxycholic acid

for the: Treatment of inborn errors in primary bile acid synthesis (updated)
11/05/2017Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 8, Authorised
11/05/2017Minutes - PDCO minutes of the 21-24 March 2017 meeting
11/05/2017Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 3, Authorised
10/05/2017Human medicines European public assessment report (EPAR): GONAL-f,

follitropin alfa

Revision: 20, Authorised
10/05/2017Work instructions for Processing requests for inclusion in the list of substances not falling within the scope of Regulation EC 470/2009 (out of scope), adopted
10/05/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs)
10/05/2017Tolterodine : List of nationally authorised medicinal products - PSUSA/00002993/201609
10/05/2017Human medicines European public assessment report (EPAR): Afstyla,

lonoctocog alfa

Revision: 1, Authorised
10/05/2017News and press releases: Communication@EMA – how are we doing?
10/05/2017Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/201608
10/05/2017Referral: Article 31 referrals, Quinolone- and fluoroquinolone-containing medicinal products,

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin

(updated)
10/05/2017Human medicines European public assessment report (EPAR): Actrapid,

human insulin (rDNA)

Revision: 14, Authorised
10/05/2017CAT work plan 2017
10/05/2017Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan,

tenofovir disoproxil

Revision: 1, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Xiliarx,

vildagliptin

Revision: 13, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 8, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 11, Authorised
10/05/2017Practical information for patients visiting the European Medicines Agency (updated)
10/05/2017Practical information for experts visiting the European Medicines Agency (updated)
10/05/2017Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 5, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 10, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 5, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Multaq,

dronedarone

Revision: 11, Authorised
10/05/2017Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 3, Authorised
10/05/2017News and press releases: Progress on science, medicines and health
10/05/2017Annex 10 - 2016 annual report of the European Medicines Agency - Positive and negative opinions; Withdrawn applications
10/05/2017Annexes - 2016 annual report of the European Medicines Agency
10/05/20172016 annual report of the European Medicines Agency
08/05/2017Agenda: Agenda - CVMP agenda of the 10-11 May 2017 meeting
08/05/2017Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 3, Authorised
08/05/2017News and press releases: Involving patients in discussions on benefits and risks of medicines
08/05/2017Report: Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings
08/05/2017Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 8, Authorised
08/05/2017Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 8, Authorised
08/05/2017Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 7, Authorised
08/05/2017Referral: Article 20 procedures, SGLT2 inhibitors (previously canagliflozin),

canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin

(updated)
08/05/2017Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 14, Authorised
08/05/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2017
08/05/2017Report: Applications for new human medicines under evaluation by the CHMP: May 2017
08/05/2017Decision of the Executive Director on the rules governing the traineeship programme at the European Medicines Agency (updated)
05/05/2017Referral: Article 30 referrals, Haldol and associated names,

haloperidol

(updated)
05/05/2017Human medicines European public assessment report (EPAR): DuoResp Spiromax,

budesonide / formoterol

Revision: 4, Authorised
05/05/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2017
05/05/2017Referral: Article 31 referrals, Factor VIII (updated)
05/05/2017News and press releases: European Medicines Agency closed 9 May 2017
05/05/2017Human medicines European public assessment report (EPAR): Lartruvo,

olaratumab

Revision: 1, Authorised
05/05/2017Orphan designation:

(S)-ethyl 2-amino-3-(4-(2-amino-6((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

for the: Treatment of carcinoid syndrome (updated)
05/05/2017Human medicines European public assessment report (EPAR): Movymia,

teriparatide

Revision: 1, Authorised
05/05/2017Orphan designation:

Inebilizumab

for the: Treatment of neuromyelitis optica spectrum disorders
05/05/2017Orphan designation:

Poly-cyclodextrin-bis-cysteine-PEG3400-camptothecin-conjugate

for the: Treatment of ovarian cancer
05/05/2017Orphan designation:

Cannabidiol

for the: Treatment of Lennox-Gastaut syndrome
05/05/2017Orphan designation:

Autologous adipose tissue-derived mesenchymal stem cells

for the: Treatment of thromboangiitis obliterans (Buerger's disease)
05/05/2017Orphan designation:

Antisense oligonucleotide targeting the USH2A gene

for the: Treatment of retinitis pigmentosa
05/05/2017Orphan designation:

Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells

for the: Treatment in haematopoietic stem cell transplantation
05/05/2017Orphan designation:

Adeno-associated viral vector serotype rh.10 expressing beta-galactosidase

for the: Treatment of GM1 gangliosidosis
05/05/2017Orphan designation:

Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase

for the: Treatment of ornithine transcarbamylase deficiency
05/05/2017Orphan designation:

Adeno-associated viral vector serotype 8 containing the human alpha-galactosidase A gene

for the: Treatment of Fabry disease
05/05/2017Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA (also known as patisiran)

for the: Treatment of transthyretin-mediated amyloidosis (updated)
05/05/2017Orphan designation:

Acetylleucine

for the: Treatment of Niemann-Pick disease
05/05/2017Orphan designation:

(3'R,4'S,5'R)-N-[(3R,6S)-6-carbamoyltetrahydro-2H-pyran-3-yl]-6''-chloro-4'-(2-chloro-3-fluoropyridin-4-yl)-4,4-dimethyl-2''-oxo-1'',2''-dihydrodispiro[cyclohexane-1,2'-pyrrolidine-3',3''-indole]-5'-carboxamide mono(4-methylbenzenesulfonate) monohydrate

for the: Treatment of soft tissue sarcoma
05/05/2017Veterinary medicine European public assessment report (EPAR): Cytopoint,

lokivetmab

Revision: 0, Authorised
05/05/2017Orphan designation:

Phosphoinositide 3-kinase gamma peptide

for the: Treatment of cystic fibrosis
05/05/2017Orphan designation:

Megestrol acetate

for the: Treatment of granulosa cell tumours
05/05/2017Orphan designation:

Ketoconazole

for the: Treatment of granulosa cell tumours
05/05/2017Orphan designation:

Sialic acid (also known as aceneuramic acid)

for the: Treatment of GNE myopathy (updated)
05/05/2017Orphan designation:

Recombinant human acid sphingomyelinase (also known as olipudase alfa)

for the: Treatment of Niemann-Pick disease (updated)
05/05/2017Human medicines European public assessment report (EPAR): Chenodeoxycholic acid sigma-tau,

chenodeoxycholic acid

Revision: 0, Authorised
05/05/2017Appendix V - Adverse-drug-reaction reporting details (updated)
05/05/2017Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 9, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 10, Authorised
05/05/2017MRL report: Tiamulin: Summary Report (1) – Committee for Veterinary Medicinal Products (updated)
05/05/2017Minutes of the PRAC meeting 6-9 March 2017
05/05/2017Human medicines European public assessment report (EPAR): Zinplava,

bezlotoxumab

Revision: 1, Authorised
05/05/2017Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/201608
05/05/2017Meloxicam: List of nationally authorised medicinal products - PSUSA/00010474/201607
05/05/2017Meloxicam: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010474/201607
05/05/2017Trimetazidine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003043/201608
05/05/2017Human medicines European public assessment report (EPAR): BiResp Spiromax,

budesonide / formoterol

Revision: 4, Authorised
05/05/2017Biosimilars in the EU - Information guide for healthcare professionals
05/05/2017Human medicines European public assessment report (EPAR): Terrosa,

teriparatide

Revision: 1, Authorised
05/05/2017Biosimilar medicines
05/05/2017Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes) (updated)
05/05/2017Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (updated)
05/05/2017Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 17, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 11, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Kengrexal,

cangrelor

Revision: 3, Authorised
05/05/2017Minutes of the PRAC meeting 6-9 February 2017
05/05/2017Human medicines European public assessment report (EPAR): Nulojix,

belatacept

Revision: 7, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 24, Authorised
05/05/2017Human medicines European public assessment report (EPAR): M-M-RVAXPRO,

measles, mumps and rubella vaccine (live)

Revision: 17, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 23, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 15, Authorised
05/05/2017Human medicines European public assessment report (EPAR): Izba,

travoprost

Revision: 1, Authorised
05/05/2017Withdrawn application: Xgeva,

denosumab

Post-authorisation (updated)
04/05/2017Minutes of the CAT meeting 15-17 February 2017
04/05/2017Human medicines European public assessment report (EPAR): Kovaltry,

octocog alfa

Revision: 3, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 11, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover),

clopidogrel / acetylsalicylic acid

Revision: 19, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Vaniqa,

eflornithine

Revision: 21, Authorised
04/05/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 18-21 April 2017
04/05/2017Minutes - PDCO minutes of the 21-24 February 2017 meeting
04/05/2017Scientific guideline: Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza, draft: consultation open
04/05/2017Minutes of the COMP meeting 14-16 February 2017
04/05/2017Human medicines European public assessment report (EPAR): Ebilfumin,

oseltamivir

Revision: 5, Authorised
04/05/2017Veterinary medicine European public assessment report (EPAR): Bravecto,

Fluralaner

Revision: 4, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop),

clopidogrel

Revision: 20, Authorised
04/05/2017Human medicines European public assessment report (EPAR): SomaKit TOC,

edotreotide

Revision: 1, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 15, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 12, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Opatanol,

olopatadine

Revision: 15, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 10, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Yellox,

bromfenac

Revision: 7, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 15, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Stelara,

ustekinumab

Revision: 20, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Roteas,

edoxaban

Revision: 0, Authorised
04/05/2017Human medicines European public assessment report (EPAR): Hexacima,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 13, Authorised
04/05/2017Scientific guideline: Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population, draft: consultation open
04/05/2017Role of pharmacokinetics in the development of medicinal products in the paediatric population (updated)
04/05/2017Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 20, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Mixtard,

insulin human (rDNA)

Revision: 15, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Ibrance,

palbociclib

Revision: 2, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan,

lopinavir/ritonavir

Revision: 3, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Integrilin,

eptifibatide

Revision: 21, Authorised
03/05/2017Minutes of the 95th meeting of the Management Board: 16 March 2017
03/05/2017Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 13, Authorised
03/05/2017Human medicines European public assessment report (EPAR): NeuroBloc,

botulinum toxin type B

Revision: 27, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 6, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH,

pregabalin

Revision: 3, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Kalydeco,

ivacaftor

Revision: 13, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Inovelon,

rufinamide

Revision: 14, Authorised
03/05/2017Human medicines European public assessment report (EPAR): Aripiprazole Zentiva,

aripiprazole

Revision: 4, Authorised
02/05/2017Agenda: Agenda - PRAC draft agenda of meeting 2-5 May 2017
02/05/2017Human medicines European public assessment report (EPAR): Xofigo,

radium Ra223 dichloride

Revision: 6, Authorised
02/05/2017Human medicines European public assessment report (EPAR): Tresiba,

insulin degludec

Revision: 6, Authorised
02/05/2017Human medicines European public assessment report (EPAR): Hexyon,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 14, Authorised
02/05/2017Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use
02/05/2017United Kingdom’s withdrawal from the European Union (updated)
02/05/2017PRAC recommendations on signals adopted at the PRAC meeting of 3-6 April 2017 , adopted
02/05/2017List of signals discussed at the PRAC since September 2012 (updated)
02/05/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 April 2017 PRAC
02/05/2017Human medicines European public assessment report (EPAR): Victrelis,

boceprevir

Revision: 20, Authorised
02/05/2017Veterinary medicine European public assessment report (EPAR): Trocoxil,

mavacoxib

Revision: 7, Authorised
02/05/2017European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting, European Medicines Agency, London, UK, From: 10-Mar-2017, To: 10-Mar-2017 (updated)
02/05/2017Human medicines European public assessment report (EPAR): Neparvis,

sacubitril / valsartan

Revision: 3, Authorised
02/05/2017Requirements for the production and control of immunological veterinary medicinal products (updated)
02/05/2017Human medicines European public assessment report (EPAR): Zurampic,

lesinurad

Revision: 2, Authorised