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May 2017

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31/05/2017Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 5, Authorised
31/05/2017Human medicines European public assessment report (EPAR): MicardisPlus,

telmisartan / hydrochlorothiazide

Revision: 26, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Simulect,

basiliximab

Revision: 21, Authorised
31/05/2017SME Office annual report 2016
31/05/2017EMA action plan for small and medium-sized enterprises (SMEs)
31/05/2017News and press releases: New action plan to support SMEs as drivers of pharmaceutical innovation
31/05/2017Engaging with SMEs (updated)
31/05/2017Human medicines European public assessment report (EPAR): Varuby,

rolapitant

Revision: 0, Authorised
31/05/2017Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure
31/05/2017United Kingdom’s withdrawal from the European Union (updated)
31/05/2017News and press releases: Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
31/05/2017Human medicines European public assessment report (EPAR): Xiliarx,

vildagliptin

Revision: 14, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Kinzalkomb,

telmisartan / hydrochlorothiazide

Revision: 31, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Duloxetine Zentiva,

duloxetine

Revision: 2, Authorised
31/05/2017List of medicines under additional monitoring (updated)
31/05/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
31/05/2017Human medicines European public assessment report (EPAR): Lonsurf,

trifluridine / tipiracil

Revision: 1, Authorised
31/05/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
31/05/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
31/05/2017List of medicinal products under additional monitoring (updated)
31/05/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
31/05/2017List of medicinal products under additional monitoring (updated)
31/05/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2017
31/05/2017Human medicines European public assessment report (EPAR): Inlyta,

axitinib

Revision: 7, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Oncaspar,

pegaspargase

Revision: 3, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Desloratadine Actavis,

desloratadine

Revision: 8, Authorised
31/05/2017Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 25, Authorised
30/05/2017Finasteride : List of nationally authorised medicinal products - PSUSA/00001392/201608
30/05/2017Finasteride : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001392/201608
30/05/2017Human medicines European public assessment report (EPAR): Desloratadine ratiopharm,

desloratadine

Revision: 6, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 6, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 35, Authorised
30/05/2017Veterinary medicine European public assessment report (EPAR): Zeleris,

florfenicol / meloxicam

Revision: 0, Authorised
30/05/2017Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live

Revision: 25, Authorised
30/05/2017Eritoran - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
30/05/2017Terms of reference 2016 - 2017: ESVAC species Expert Advisory Group
30/05/2017Terms of reference 2015 - 2017: ESVAC sales Expert Advisory Group
30/05/2017Human medicines European public assessment report (EPAR): Brilique,

ticagrelor

Revision: 10, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Volibris,

ambrisentan

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

aflibercept

Revision: 10, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Pemetrexed Hospira UK Limited,

pemetrexed

Revision: 0, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Sylvant,

siltuximab

Revision: 6, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 19, Authorised
30/05/2017First European Medicines Agency-EuropaBio annual bilateral meeting, European Medicines Agency, London, UK, From: 09-Jun-2017, To: 09-Jun-2017
30/05/2017Agenda: Agenda - First European Medicines Agency-EuropaBio annual bilateral meeting
30/05/2017Human medicines European public assessment report (EPAR): Zoledronic acid Teva Pharma,

zoledronic acid

Revision: 10, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Zomarist,

vildagliptin / metformin

Revision: 16, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 16, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 3, Authorised
30/05/2017Consolidated final report on the activities of patients’ and consumers’ working party and healthcare professionals’ working party topic groups (2015)
30/05/2017Human medicines European public assessment report (EPAR): Idelvion,

albutrepenonacog alfa

Revision: 2, Authorised
30/05/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.7) (updated)
30/05/2017Human medicines European public assessment report (EPAR): Firmagon,

degarelix

Revision: 12, Authorised
30/05/2017Human medicines European public assessment report (EPAR): Envarsus,

tacrolimus

Revision: 5, Authorised
30/05/2017Referral: Article 31 referrals, Gadolinium-containing contrast agents,

gadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid

(updated)
29/05/2017Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 5, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Zoledronic acid Teva,

zoledronic acid

Revision: 8, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Jalra,

vildagliptin

Revision: 14, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 16, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Aerinaze,

desloratadine / pseudoephedrine

Revision: 13, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Galvus,

vildagliptin

Revision: 14, Authorised
29/05/2017Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 9, Authorised
29/05/2017Human medicines European public assessment report (EPAR): M-M-RVaxPro,

measles, mumps and rubella vaccine (live)

Revision: 18, Authorised
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Doravirine

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Doravirine

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): MabThera,

Rituximab

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Stelara,

Ustekinumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu,

Oseltamivir (phosphate)

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Kisplyx,

Lenvatinib

Therapeutic area: Oncology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Feraccru,

Ferric maltol

Therapeutic area: Haematology-Hemostaseology (updated)
29/05/2017Veterinary medicine European public assessment report (EPAR): Procox,

emodepside / toltrazuril

Revision: 12, Authorised
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Repatha,

Evolocumab

Therapeutic area: Cardiovascular diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,

Ibrutinib

Therapeutic area: Oncology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Trifarotene

Therapeutic area: Dermatology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Siponimod (hemifumarate)

Therapeutic area: Neurology (updated)
29/05/2017List of signals discussed at the PRAC since September 2012 (updated)
29/05/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 May 2017 PRAC
29/05/2017PRAC recommendations on signals adopted at the PRAC meeting of 2-5 May 2017 , adopted
29/05/2017Human medicines European public assessment report (EPAR): Victrelis,

boceprevir

Revision: 21, Authorised
29/05/2017Agenda: Agenda - HMPC agenda of the 29-30 May 2017 meeting
29/05/2017Human medicines European public assessment report (EPAR): Vitekta,

elvitegravir

Revision: 4, Withdrawn
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human N-acetylglucosaminidase (rhNAGLU)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
29/05/2017Human medicines European public assessment report (EPAR): Iscover,

clopidogrel

Revision: 36, Authorised
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Orbactiv,

Oritavancin (diphosphate)

Therapeutic area: Dermatology/Infectious diseases (updated)
29/05/2017Human medicines European public assessment report (EPAR): Iressa,

gefitinib

Revision: 11, Authorised
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Incivo,

Telaprevir

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Noxafil,

Posaconazole

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Stivarga,

Regorafenib

Therapeutic area: Oncology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Letermovir

Therapeutic area: Infectious diseases (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Circadin,

Melatonin

Therapeutic area: Neurology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Dermatology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Gilenya,

Fingolimod (hydrochloride)

Therapeutic area: Neurology (updated)
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Bempedoic acid (ETC-1002)

Therapeutic area: Cardiovascular diseases/Other
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): TOBI Podhaler,

Tobramycin

Therapeutic area: Infectious diseases
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): Striverdi, Respimat,

Olodaterol (hydrochloride)

Therapeutic area: Pneumology-allergology
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Prasugrel (hydrochloride) / acetylsalicylic acid

Therapeutic area: Cardiovascular diseases
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / perindopril

Therapeutic area: Cardiovascular diseases
29/05/2017Human medicines European public assessment report (EPAR): Nevanac,

nepafenac

Revision: 13, Authorised
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human fibrinogen concentrate (BT524)

Therapeutic area: Haematology-Hemostaseology
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Macimorelin

Therapeutic area: Diagnostic/Endocrinology, -gynacology-fertility-metabolism
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Entolimod

Therapeutic area: Other
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Candesartan / amlodipine

Therapeutic area: Cardiovascular diseases
29/05/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

rVSVΔG-ZEBOV-GP

Therapeutic area: Vaccines
29/05/2017Human medicines European public assessment report (EPAR): Eucreas,

vildagliptin / metformin

Revision: 16, Authorised
24/05/2017European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
24/05/2017Human medicines European public assessment report (EPAR): Cialis,

tadalafil

Revision: 26, Authorised
24/05/2017Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly),

tadalafil

Revision: 11, 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)
22/05/2017Electronic 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)
22/05/2017Annual report on deferral granted in the paediatric investigation plan - (PED6) 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 eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
22/05/2017Delegating the EudraVigilance registration process (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) routes of administration (updated)
22/05/2017EudraVigilance user declaration (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
22/05/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (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
22/05/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
22/05/2017Nominations to the European Union Telematics governance bodies (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
22/05/2017News and press releases: EMA website briefly unavailable on 23 May
22/05/2017Veterinary medicine European public assessment report (EPAR): Zactran,

gamithromycin

Revision: 9, Authorised
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 measures: questions and answers (updated)
16/05/2017Post-authorisation safety studies: questions and answers (updated)
16/05/2017Transparency: questions and answers (updated)
16/05/2017Human medicines European public assessment report (EPAR): Plavix,

clopidogrel

Revision: 34, Authorised
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): Pramipexole Accord,

pramipexole

Revision: 5, Authorised
16/05/2017Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
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
16/05/2017Human medicines European public assessment report (EPAR): Pantozol Control,

pantoprazole

Revision: 11, Authorised
16/05/2017Newsletter: News bulletin for small and medium-sized enterprises - Issue 39
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:

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

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

Emeramide

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

Rituximab

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:

Human normal immunoglobulin

for the: Treatment in solid organ transplantation
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:

Thymidine and deoxycytidine

for the: Treatment of mitochondrial DNA depletion syndrome, myopathic form
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:

Estetrol

for the: Treatment of neonatal encephalopathy
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:

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
15/05/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 May 2017
15/05/2017Pending EC decision: Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Opinion date: 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 and hybrid 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): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 25, Authorised
11/05/2017Human medicines European public assessment report (EPAR): Imprida,

amlodipine / valsartan

Revision: 20, Withdrawn
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): 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
10/05/2017Annex 10 – 2016 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
10/05/2017News and press releases: Progress on science, medicines and health
10/05/2017Annexes - 2016 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)
05/05/2017Orphan designation:

Acetylleucine

for the: Treatment of Niemann-Pick disease
05/05/2017Human medicines European public assessment report (EPAR): Movymia,

teriparatide

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

Ketoconazole

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

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

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

Inebilizumab

for the: Treatment of neuromyelitis optica spectrum disorders
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:

(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:

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
05/05/2017MRL report: Tiamulin: Summary Report (1) – Committee for Veterinary Medicinal Products (updated)
05/05/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

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

teriparatide

Revision: 1, Authorised
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): 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
02/05/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 April 2017 PRAC
02/05/2017PRAC recommendations on signals adopted at the PRAC meeting of 3-6 April 2017 , adopted
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