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June 2017

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30/06/2017Scientific guideline: Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration, adopted
30/06/2017Overview of comments received on 'Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration' (EMA/44410/2014)
30/06/2017Agenda: Agenda – 4th industry stakeholder platform on the operation of the centralised procedure for human medicinal products
30/06/2017Human medicines European public assessment report (EPAR): Imbruvica,

ibrutinib

Revision: 9, Authorised
30/06/2017United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
30/06/2017Minutes of the PRAC meeting 2-5 May 2017
30/06/2017Cetirizine / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00000629/201608
30/06/2017Cetirizine / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000629/201608
30/06/2017Human medicines European public assessment report (EPAR): Ucedane,

carglumic acid

Revision: 0, Authorised
30/06/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
30/06/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
30/06/2017Regulatory and procedural guideline: Guidance for applicants for the preparation of the precise scope section of the variation application form
30/06/2017Classification of changes: questions and answers (updated)
30/06/2017Pre-notification check for type IA/IAIN variations (updated)
30/06/2017European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated)
30/06/2017Orphan designation:

225Ac-lintuzumab

for the: Treatment of acute myeloid leukaemia
30/06/2017Regulatory and procedural guideline: Pre-submission checklist for type II variation applications
30/06/2017Type-II variations: questions and answers (updated)
30/06/2017Improving quality of submissions (updated)
30/06/2017Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 25, Authorised
30/06/2017Human medicines European public assessment report (EPAR): Levetiracetam Teva,

levetiracetam

Revision: 11, Authorised
30/06/2017Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 21, Authorised
30/06/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn Aujeszky 783 + O/W,

live attenuated Aujeszky's disease virus

Revision: 14, Authorised
30/06/2017Veterinary medicine European public assessment report (EPAR): Naxcel,

ceftiofur

Revision: 13, Authorised
30/06/2017Veterinary medicine European public assessment report (EPAR): Cardalis,

benazepril hydrochloride / spironolactone

Revision: 3, Authorised
30/06/2017Notices of calls for tender - 2017 (updated)
29/06/2017Orphan designation:

Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII

for the: Treatment of haemophilia A
29/06/2017Orphan designation:

Ursodeoxycholic acid

for the: Treatment of Niemann-Pick disease
29/06/2017Orphan designation:

Recombinant human interleukin-7 fused to a hybrid crystallisable fragment region of a human antibody-

for the: Treatment of idiopathic CD4 lymphocytopenia
29/06/2017Orphan designation:

Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain

for the: Treatment of paroxysmal nocturnal haemoglobinuria
29/06/2017Orphan designation:

Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p

for the: Treatment of cutaneous T-cell lymphoma
29/06/2017Orphan designation:

Tamoxifen citrate

for the: Treatment of cystic fibrosis
29/06/2017DepoCyte (cytarabine) supply shortage (updated)
29/06/2017Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 8, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Erelzi,

etanercept

Revision: 0, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 11, Authorised
29/06/2017Orphan designation:

Chenodeoxycholic acid

for the: Treatment of inborn errors in primary bile acid synthesis (updated)
29/06/2017Plasma-master-file certifications (updated)
29/06/2017Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 21, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Kevzara,

sarilumab

Revision: 0, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau),

chenodeoxycholic acid

Revision: 1, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Afinitor,

everolimus

Revision: 18, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Vidaza,

azacitidine

Revision: 16, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Oprymea,

pramipexole

Revision: 16, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Nimenrix,

meningococcal group A, C, W 135 and Y conjugate vaccine

Revision: 18, Authorised
29/06/2017Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 15, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Sabervel,

irbesartan

Revision: 2, Withdrawn
29/06/2017Human medicines European public assessment report (EPAR): Rekovelle,

follitropin delta

Revision: 1, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 36, Authorised
29/06/2017Human medicines European public assessment report (EPAR): Atriance,

nelarabine

Revision: 17, Authorised
29/06/2017COMP meeting report on the review of applications for orphan designation: June 2017
29/06/2017Cinryze (C1 inhibitor, human) supply shortage
29/06/2017Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 10, Authorised
29/06/2017Antimicrobial resistance (updated)
29/06/2017Newsletter: Human medicines highlights - June 2017
29/06/2017Type-IA variations: questions and answers (updated)
29/06/2017Type-IB variations: questions and answers (updated)
29/06/2017Second paediatric strategy forum on medicine development for mature B cell malignancies in children, European Medicines Agency, London, UK, From: 13-Nov-2017, To: 14-Nov-2017 (updated)
29/06/2017Orphan designation:

Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide

for the: Treatment of acute myeloid leukaemia
28/06/2017Annex VIII - List of cilostazol-containing medicinal products in the European Union (updated)
28/06/2017List of medicinal products under additional monitoring (updated)
28/06/2017List of medicinal products under additional monitoring (updated)
28/06/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
28/06/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
28/06/2017Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
28/06/2017List of medicines under additional monitoring (updated)
28/06/2017Annex XIII - List of Valproate and related substances in the European Union (updated)
28/06/2017Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
28/06/2017Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
28/06/2017Annex VIII - List of cilostazol-containing medicinal products in the European Union (updated)
28/06/2017Annex VI - List of flupirtine-containing medicinal products in the EU (updated)
28/06/2017Annex VI - List of flupirtine-containing medicinal products in the EU (updated)
28/06/2017Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (updated)
28/06/2017Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (updated)
28/06/2017Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
28/06/2017Report: List of products granted eligibility to PRIME (updated)
28/06/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 June 2017, adopted
28/06/2017Agenda: Programme and registration form - Joint European Medicines Agency / Drug Information Association information day on measuring the impact of pharmacovigilance activities, 14 November 2017 (updated)
28/06/2017Annual list of contractors 2016 - contract values: €15,000 to €134,999
28/06/2017Annual list of specific contracts based on framework contracts - 2016
28/06/2017Annual list of contractor modifications 2016
27/06/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
27/06/2017VICH GL55 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use - First version
27/06/2017Scientific guideline: VICH GL55: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use - First version, adopted
27/06/2017VICH GL50 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
27/06/2017Scientific guideline: VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - Revision 1, adopted
27/06/2017Withdrawn application: Cavoley,

pegfilgrastim

Initial authorisation (updated)
27/06/2017Withdrawn application: Efgratin,

pegfilgrastim

Initial authorisation (updated)
27/06/2017Human medicines European public assessment report (EPAR): Optaflu,

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Revision: 16, Withdrawn
27/06/2017Human medicines European public assessment report (EPAR): Trisenox,

arsenic trioxide

Revision: 23, Authorised
27/06/2017Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 51, Authorised
27/06/2017Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan,

emtricitabine / tenofovir disoproxil

Revision: 1, Authorised
27/06/2017New vacancy: Temporary Agent (AST3), Communication Assistants
27/06/2017Human medicines European public assessment report (EPAR): Nexium Control,

esomeprazole

Revision: 9, Authorised
27/06/2017Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 4, Authorised
27/06/2017Human medicines European public assessment report (EPAR): Glyxambi,

empagliflozin / linagliptin

Revision: 1, Authorised
27/06/2017Annual report 2016 on staff engaging in an occupational activity within two years of leaving the service (article 16 of the staff regulations)
26/06/2017Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 9, Authorised
26/06/2017Pharmacovigilance (updated)
26/06/2017Final summary record – EDC systems and risk-based monitoring in Clinical Trials
26/06/2017Checklist for prioritisation of EU regulatory network collaborative impact research
26/06/2017Minutes - PDCO minutes of the 18-21 April 2017 meeting
26/06/2017Regulatory and procedural guideline: EudraVigilance stakeholder change management plan (updated)
26/06/2017Connecting to the Agency ESTRI Gateway using an AS1 or AS2 compatible product
26/06/2017EV Human (encryption certificate)
26/06/2017EV Test (encryption certificate)
26/06/2017Regulatory and procedural guideline: EudraVigilance - Marketing authorisation holders - Adobe connect invitation
26/06/2017Regulatory and procedural guideline: EudraVigilance - National competent authorities - Adobe connect invitation
26/06/2017EudraVigilance system overview (updated)
26/06/2017Regulatory and procedural guideline: EudraVigilance auditable requirement project - EudraVigilance training plan - Version 4, adopted (updated)
26/06/2017EudraVigilance - Key milestones and summary of associated EudraVigilance auditable requirements project communications (updated)
26/06/2017Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.0
26/06/2017Regulatory and procedural guideline: Instruction guide to support the e-learning training module IT-M2 - E2B(R3)/E2B(R2) XML testing - Version 1.0
26/06/2017Regulatory and procedural guideline: EudraVigilance user manual - Individual case safety report form - Version 1.0
26/06/2017Regulatory and procedural guideline: How to register with EudraVigilance and EVDAS - Training module EV-M1
26/06/2017Regulatory and procedural guideline: Medical literature monitoring by EMA - Training module EV-M7
26/06/2017Regulatory and procedural guideline: Testing the electronic reporting of ICSRs/SUSARs to EudraVigilance - Training module IT-M2
26/06/2017Regulatory and procedural guideline: EudraVigilance technical support plan for national competent authorities in the EEA
26/06/2017Regulatory and procedural guideline: EudraVigilance checklist for national competent authorities in the EEA
26/06/2017EudraVigilance: electronic reporting (updated)
26/06/2017EudraVigilance training and support (updated)
26/06/2017EudraVigilance: how to register (updated)
26/06/2017Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure
26/06/2017Regulatory and procedural guideline: Connection template - EMA ESTRI Gateway using an AS1 or AS2 compatible product
26/06/2017Regulatory and procedural guideline: EudraVigilance checklist and technical support plan for marketing authorisation holders and sponsors of clinical trials in the EEA
26/06/2017Regulatory and procedural guideline: EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 1.0
26/06/2017EudraVigilance change management (updated)
26/06/2017EudraVigilance (updated)
26/06/2017Marketing authorisation holders invited to register EudraVigilance Data Analysis System (EVDAS) users - timeslots to register (updated)
23/06/2017Scientific guideline: Concept paper on revision of the guideline on clinical development of vaccines, draft: consultation open
23/06/2017News and press releases: First ever guidance for stem cell therapies in animals published
23/06/2017Report: Medicinal products for human use: monthly figures - May 2017
23/06/2017Stem cell-based products for veterinary use: specific questions on sterility to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) (updated)
23/06/2017Scientific guideline: Questions and Answers on allogenic stem cell-based products for veterinary use: specific questions on sterility, adopted
23/06/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
23/06/2017News and press releases: Two new medicines recommended for the treatment of chronic hepatitis C
23/06/2017News and press releases: EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
23/06/2017Pending EC decision: Mimpara,

cinacalcet

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Stivarga,

regorafenib

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Nitisinone MendeliKABS, Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Adlumiz,

anamorelin

Opinion date: 18-May-2017 (updated)
23/06/2017Pending 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 (updated)
23/06/2017Pending EC decision: Victoza,

liraglutide

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Masipro,

masitinib

Opinion date: 18-May-2017 (updated)
23/06/2017Pending EC decision: Fotivda,

tivozanib

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Mavenclad,

cladribine

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Orencia,

abatacept

Opinion date: 22-Jun-2017
23/06/2017Overview of invented names reviewed in September 2016 by the Name Review Group adopted at the CHMP meeting of 19-22 June 2017, adopted
23/06/2017Scientific advice and protocol assistance adopted during the CHMP meeting 19–22 June 2017, adopted
23/06/2017Pending EC decision: Imraldi,

adalimumab

Opinion date: 22-Jun-2017
23/06/2017Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
23/06/2017Pending EC decision: Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Opinion date: 22-Jun-2017
23/06/2017Referral: Article 29(4) referrals, Alcover and associated names,

sodium oxybate

23/06/2017Pending EC decision: Soliris,

eculizumab

Opinion date: 22-Jun-2017
23/06/2017Withdrawn application: Zafiride,

ngr-human tumour necrosis factor alpha

Initial authorisation
23/06/2017Pending EC decision: Kisqali,

ribociclib

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan,

efavirenz / emtricitabine / tenofovir disoproxil

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Vosevi, Opinion date: 22-Jun-2017
23/06/2017Withdrawn application: Elmisol,

levamisole

Initial authorisation
23/06/2017Pending EC decision: Kaletra,

lopinavir / ritonavir

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: SonoVue,

sulphur hexafluoride

Opinion date: 22-Jun-2017
23/06/2017Pending EC decision: Maviret, Opinion date: 22-Jun-2017
22/06/2017Recommendation for maintenance of orphan designation at the time of marketing authorisation: Brineura (cerliponase alfa) for the treatment of neuronal ceroid lipofuscinosis
22/06/2017Human medicines European public assessment report (EPAR): Brineura,

cerliponase alfa

Revision: 0, Authorised
22/06/2017Pending EC decision: Faslodex,

fulvestrant

Opinion date: 22-Jun-2017
22/06/2017Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma),

clopidogrel

Revision: 13, Authorised
21/06/2017Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 28, Authorised
21/06/2017Human medicines European public assessment report (EPAR): M-M-RVaxPro,

measles, mumps and rubella vaccine (live)

Revision: 19, Authorised
21/06/2017Orphan designation:

Antisense oligonucleotide targeted to the SMN2 gene (nusinersen)

for the: Treatment of 5q spinal muscular atrophy (updated)
21/06/2017Recommendation for maintenance of orphan designation at the time of marketing authorisation: Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy
21/06/2017Template of the request to the CVMP to (re)classify a veterinary medicinal product as minor use minor species (MUMS) / intended for use in a limited market (updated)
21/06/2017Classifications as minor-use-minor-species and limited-market (updated)
21/06/2017Human medicines European public assessment report (EPAR): Spinraza,

nusinersen

Revision: 0, Authorised
21/06/2017Minutes of the CAT meeting 10-12 April 2017
21/06/2017Human medicines European public assessment report (EPAR): Ferriprox,

deferiprone

Revision: 21, Authorised
21/06/2017Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 23, Authorised
21/06/2017Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 10, Authorised
21/06/2017Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 11, Authorised
21/06/2017Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 2, Authorised
20/06/2017Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1, Revision: 0, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Lumigan,

bimatoprost

Revision: 28, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Evarrest,

human fibrinogen / human thrombin

Revision: 4, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 30, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 9, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Vaxelis,

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

Revision: 3, Authorised
20/06/2017Agenda: Agenda - PDCO agenda of the 20-23 June 2017 meeting
20/06/2017Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 21, Authorised
20/06/2017Human medicines European public assessment report (EPAR): Intuniv,

guanfacine

Revision: 4, Authorised
20/06/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
20/06/2017EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension, European Medicines Agency, London, UK, From: 12-Jun-2017, To: 13-Jun-2017 (updated)
20/06/2017Human medicines European public assessment report (EPAR): Elmiron,

pentosan polysulfate sodium

Revision: 0, Authorised
20/06/2017Register of deadlines to put a medicinal product on the market in accordance with Article 33 of the Paediatric Regulation (updated)
20/06/2017Human medicines European public assessment report (EPAR): Capecitabine Medac,

capecitabine

Revision: 7, Authorised
20/06/2017Informed consent for paediatric clinical trials in Europe 2015 (updated)
20/06/2017Human medicines European public assessment report (EPAR): Yondelis,

trabectedin

Revision: 21, Authorised
19/06/2017Agenda: Agenda - CAT agenda of the 15-16 June 2017 meeting
19/06/2017Human medicines European public assessment report (EPAR): Sirturo,

bedaquiline

Revision: 11, Authorised
19/06/2017Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 13, Authorised
19/06/2017Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 4, Authorised
19/06/2017Agenda: Workshop on generation and use of Health Based Exposure Limits (HBEL)
19/06/2017Workshop on generation and use of Health Based Exposure Limits (HBEL), European Medicines Agency, London, UK, From: 20-Jun-2017, To: 21-Jun-2017
19/06/2017Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 9, Authorised
19/06/2017Human medicines European public assessment report (EPAR): Aubagio,

teriflunomide

Revision: 7, Authorised
19/06/2017Opinion/decision on a Paediatric investigation plan (PIP): Katclari,

L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L-aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, acetate salt / L-glutamyl-L-glutaminyl-L-valyl-L-alanyl-Lglutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanine, acetate salt / L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanyl-L-arginyl-L-isoleucyl-L-leucyl-L-lysyl-L-asparaginyl-L-cysteinyl-L-valine, acetate salt...

Therapeutic area: Pneumology-allergology/Oto-rhino-laryngology (updated)
19/06/2017Katclari - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
19/06/2017Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 13, Authorised
19/06/2017Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 13, Authorised
19/06/2017Agenda: Agenda - CHMP agenda of the 19-22 June 2017 meeting
19/06/2017Human medicines European public assessment report (EPAR): Mirvaso,

brimonidine

Revision: 7, Authorised
19/06/2017Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 6, Authorised
19/06/2017Report: Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States (updated)
19/06/2017Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (updated)
19/06/2017HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population (updated)
19/06/2017HMPC: overview of assessment work – priority list (updated)
19/06/2017Human medicines European public assessment report (EPAR): Senshio,

ospemifene

Revision: 4, Authorised
19/06/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: natural killer cells derived from human induced pluripotent stem cells transduced to express high-affinity non-cleavable CD16 (hnCD16) Fc receptor
19/06/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: genetically modified oncolytic adenovirus coated with oligopeptide-end modified Poly (β-amino) esters
16/06/2017Agenda: CHMP ORGAM agenda for the meeting on 12 June 2017
16/06/2017Minutes of the CVMP meeting of 10-11 May 2017
16/06/2017Pending EC decision: Innovax-ND-IBD,

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus

Opinion date: 15-Jun-2017
16/06/2017Pending EC decision: Suvaxyn PRRS MLV,

porcine respiratory and reproductive syndrome virus, live

Opinion date: 15-Jun-2017
16/06/2017Pending EC decision: Exzolt,

fluralaner

Opinion date: 15-Jun-2017
16/06/2017Pending EC decision: Vepured,

recombinant verotoxin 2e

Opinion date: 15-Jun-2017
16/06/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 13-15 June 2017
16/06/2017Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 10, Authorised
16/06/2017Veterinary Medicines (updated)
16/06/2017Organisation chart: Stakeholders and Communication (updated)
16/06/2017Organisation chart: Veterinary Medicines (updated)
16/06/2017Organisation chart: Human Medicines Evaluation (updated)
16/06/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 9, Authorised
16/06/2017News and press releases: EMA Management Board: highlights of June 2017 meeting
16/06/2017Report: Summary of transfers of appropriations in budget 2017
16/06/2017Report: European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016
16/06/2017Management Board meeting dates 2017 – 2019
16/06/2017Press release: EMA Management Board: highlights of June 2017 meeting
16/06/2017Management Board meeting: 14-15 June 2017, European Medicines Agency, London, UK, From: 14-Jun-2017, To: 15-Jun-2017 (updated)
16/06/2017Outcome of written procedures finalised during the period from 14 February 2017 to 11 May 2017
16/06/2017Report: European Medicines Agency’s interaction with industry stakeholders - Annual report 2016
16/06/2017Delivery time frame for the EU portal and EU database (updated)
16/06/2017EMA working group on committees’ operational preparedness for veterinary medicines
16/06/2017EMA working group on committees’ operational preparedness for human medicines
15/06/2017Human medicines European public assessment report (EPAR): Pemetrexed Lilly,

pemetrexed

Revision: 3, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Ravicti,

 glycerol phenylbutyrate

Revision: 5, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 10, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 9, Authorised
15/06/2017Human medicines European public assessment report (EPAR): DuoTrav,

travoprost / timolol

Revision: 14, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 2, Authorised
15/06/2017Electronic submission of veterinary dossiers: Questions and answers (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (updated)
15/06/2017Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 7, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Inductos,

dibotermin alfa

Revision: 21, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Pemetrexed Hospira,

pemetrexed

Revision: 3, Authorised
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Madrid) (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Lisbon) (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Prague) (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Vienna) (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Amsterdam) (updated)
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of individual case safety report (ICSRs) in the ISO/ICH E2B(R3) format: hands-on training course (updated)
15/06/2017Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 18, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 40, Authorised
15/06/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo+MH RTU,

Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)

Revision: 3, Authorised
15/06/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 6, Authorised
15/06/2017Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201609
15/06/2017Hydrochlorothiazide / olmesartan: List of nationally authorised medicinal products - PSUSA/00002209/201610
15/06/2017Olmesartan: List of nationally authorised medicinal products - PSUSA/00002207/201610
15/06/2017Agenda: Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (London) (updated)
15/06/2017Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201609
15/06/2017Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201609
15/06/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 11, Authorised
15/06/2017Veterinary medicine European public assessment report (EPAR): Veraflox,

pradofloxacin

Revision: 5, Authorised
14/06/2017Agenda: Agenda for the 96th meeting of the Management Board (updated)
14/06/2017Brimonidine (except for the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00000430/201609
14/06/2017Tetrabenazine: List of nationally authorised medicinal products - PSUSA/00002911/201610
14/06/2017Brimonidine / timolol: List of nationally authorised medicinal products - PSUSA/00000431/201609
14/06/2017Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

(updated)
14/06/2017Presentation - Role of OMCLs for control of emergency vaccines (Julie Baré)
14/06/2017Presentation - Lessons learnt by EU regulators from the authorisations of foot-and-mouth disease, avian influenza, bluetongue and schmallenberg vaccines in the EU (Dr Esther Werner)
14/06/2017Human medicines European public assessment report (EPAR): Helixate NexGen,

octocog alfa

Revision: 30, Authorised
14/06/2017Human medicines European public assessment report (EPAR): Lynparza,

olaparib

Revision: 3, Authorised
14/06/2017Aminosalicylate sodium : List of nationally authorised medicinal products - PSUSA/00000165/201610
14/06/2017Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 September 2017, European Medicines Agency, London, UK, From: 25-Sep-2017, To: 28-Sep-2017 (updated)
14/06/2017Human medicines European public assessment report (EPAR): Aripiprazole Sandoz,

aripiprazole

Revision: 4, Authorised
14/06/2017Pharmacovigilance fees: questions and answers (updated)
13/06/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
13/06/2017Human medicines European public assessment report (EPAR): Ocaliva,

obeticholic acid

Revision: 1, Authorised
13/06/2017Human medicines European public assessment report (EPAR): Qtern,

saxagliptin / dapagliflozin

Revision: 1, Authorised
13/06/2017SME info day "Supporting innovative medicines' development and early access", European Medicines Agency, London, UK, From: 17-Nov-2017, To: 17-Nov-2017
13/06/2017Human medicines European public assessment report (EPAR): Olanzapine Mylan,

olanzapine

Revision: 11, Authorised
13/06/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for recovery of amounts wrongly paid, off-setting / correction to salaries, off-setting of amounts wrongly paid – expenditure operations (updated)
13/06/2017European medicines agency Standard operating procedure (SOP): Amendment, cancellation, waiver or partial waiver of amounts receivable - revenue operations
13/06/2017Minutes of the COMP meeting 10-11 April 2017
13/06/2017European medicines agency Standard operating procedure (SOP): Review of the period of market exclusivity of orphan medicinal products in accordance with Art. 8(2) of Regulation (EC) 141/2000
13/06/2017Work instructions on orphan electronic product folders, adopted (updated)
13/06/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: May 2017
13/06/2017Technetium (99mTc) bicisate : List of nationally authorised medicinal products - PSUSA/00002856/201610
13/06/2017Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 24, Authorised
13/06/2017Erythromycin / tretinoin : List of nationally authorised medicinal products - PSUSA/00001259/201610
13/06/2017Timolol (systemic use) : List of nationally authorised medicinal products - PSUSA/00010432/201610
13/06/2017Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics),

tadalafil

Revision: 1, Authorised
13/06/2017Acitretin :List of nationally authorised medicinal products - PSUSA/00000051/201610
13/06/2017Artemether / lumefantrin (apart from the dispersible tablet) : List of nationally authorised medicinal products - PSUSA/00000236/201610
13/06/2017Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
13/06/2017Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201610
13/06/2017Regulatory and procedural guideline: Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures (updated)
13/06/2017Agenda: Agenda - COMP agenda of the 13-15 June 2017 meeting
13/06/2017Agenda: Agenda - CVMP agenda of the 13-15 June 2017 meeting
13/06/2017Agenda: CHMP ORGAM agenda for the meeting on 8 May 2017
13/06/2017CHMP ORGAM minutes for the meeting on 8 May 2017
12/06/2017Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 16, Authorised
12/06/2017Levosimendan : List of nationally authorised medicinal products - PSUSA/00001858/201609
12/06/2017News and press releases: Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12/06/2017Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 34, Authorised
12/06/2017Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201610
12/06/2017Amlodipine / perindopril: List of nationally authorised medicinal products - PSUSA/00000179/201610
12/06/2017Tiotropium: List of nationally authorised medicinal products - PSUSA/00002972/201610
12/06/2017Bromhexine: List of nationally authorised medicinal products - PSUSA/00000437/201609
09/06/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2017
09/06/2017Referral: Article 20 procedures, Zinbryta,

daclizumab

09/06/2017Referral: Article 31 referrals, Factor VIII (updated)
09/06/2017News and press releases: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
09/06/2017Introduction to the European Union (EU) regulatory system and EMA for international regulators and non-governmental organisations, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017
09/06/2017Withdrawn application: Enpaxiq,

pacritinib

Initial authorisation (updated)
09/06/2017Human medicines European public assessment report (EPAR): Orencia,

abatacept

Revision: 24, Authorised
09/06/2017Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 41, Authorised
09/06/2017Human medicines European public assessment report (EPAR): Circadin,

melatonin

Revision: 26, Authorised
09/06/2017Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.,

emtricitabine / tenofovir disoproxil

Revision: 0, Authorised
08/06/2017Orphan designation:

Chimeric monoclonal antibody against claudin 6

for the: Treatment of ovarian cancer (updated)
08/06/2017Orphan designation:

Chimaeric monoclonal antibody against claudin-18 splice variant 2

for the: Treatment of pancreatic cancer (updated)
08/06/2017Orphan designation:

Chimeric monoclonal antibody against claudin-18 splice variant 2

for the: treatment of gastric cancer (updated)
08/06/2017Veterinary medicine European public assessment report (EPAR): Suprelorin,

deslorelin acetate

Revision: 8, Authorised
08/06/2017European Union example instances - E2B(R3) testing files (updated)
08/06/2017Veterinary medicine European public assessment report (EPAR): Ingelvac PCV FLEX,

Porcine circovirus vaccine (inactivated)

Revision: 0, Authorised
08/06/2017Pre-authorisation guidance (updated)
08/06/2017Human medicines European public assessment report (EPAR): Laventair,

umeclidinium bromide / vilanterol

Revision: 6, Authorised
08/06/2017Veterinary medicine European public assessment report (EPAR): Osurnia,

terbinafine / florfenicol / betamethasone

Revision: 3, Authorised
08/06/2017Human medicines European public assessment report (EPAR): Strensiq,

asfotase alfa

Revision: 4, Authorised
08/06/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 16-19 May 2017
08/06/2017Report: Applications for new human medicines under evaluation by the CHMP: June 2017
08/06/2017Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 14, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Desloratadine Teva,

desloratadine

Revision: 10, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Azopt,

brinzolamide

Revision: 23, Authorised
07/06/2017Minutes of the CHMP meeting 18-21 April 2017
07/06/2017First anniversary of PRIME: experience so far, European Medicines Agency, London, UK, From: 19-May-2017, To: 19-May-2017 (updated)
07/06/2017Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 38, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 33, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Orphacol,

cholic acid

Revision: 3, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Spedra,

avanafil

Revision: 9, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Azarga,

brinzolamide / timolol

Revision: 10, Authorised
07/06/2017Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane),

para-aminosalicylic acid

Revision: 4, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 3, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 6, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 10, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Iblias,

octocog alfa

Revision: 3, Authorised
06/06/2017Availability of veterinary vaccines (updated)
06/06/2017Joint EMA/HMA Veterinary Vaccine Availability Action Plan - Analysis of industry recommendations
06/06/2017Human medicines European public assessment report (EPAR): Kogenate Bayer,

octocog alfa

Revision: 29, Authorised
06/06/2017Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines, European Medicines Agency, London, UK, From: 22-Jun-2017, To: 23-Jun-2017
06/06/2017Human medicines European public assessment report (EPAR): Nuwiq,

simoctocog alfa (rFVIII)

Revision: 2, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Simbrinza,

brinzolamide / brimonidine tartrate

Revision: 3, Authorised
06/06/2017Agenda: Agenda - PRAC draft agenda of meeting 6-9 June 2017
06/06/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 24, Authorised
06/06/2017EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 27-Jun-2017, To: 28-Jun-2017
06/06/2017Human medicines European public assessment report (EPAR): Zoledronic acid Mylan,

zoledronic acid

Revision: 6, Authorised
06/06/2017Eleventh industry stakeholder platform on the operation of pharmacovigilance in the European Union, European Medicines Agency, London, UK, From: 02-Jun-2017, To: 02-Jun-2017
06/06/2017Human medicines European public assessment report (EPAR): Gardasil,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 36, Authorised
06/06/2017Referral: Article 30 referrals, Saroten and associated names,

amitriptyline

(updated)
06/06/2017Human medicines European public assessment report (EPAR): NovoEight,

turoctocog alfa

Revision: 3, Authorised
06/06/2017Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 5, Authorised
02/06/2017Minutes of the PRAC meeting 3-6 April 2017
02/06/2017Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 14, Authorised
02/06/2017Human medicines European public assessment report (EPAR): Emadine,

emedastine

Revision: 20, Authorised
02/06/2017Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 1, Authorised
02/06/2017Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 34, Authorised
02/06/2017Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 16, Authorised
02/06/2017Withdrawn application: Solithromycin Triskel EU Services,

solithromycin

Initial authorisation (updated)
02/06/2017Veterinary medicine European public assessment report (EPAR): Novem,

meloxicam

Revision: 10, Authorised
02/06/2017Trainee programme (updated)
01/06/2017Human medicines European public assessment report (EPAR): Ganfort,

bimatoprost / timolol

Revision: 15, Authorised
01/06/2017Template letter of intent work sharing procedure (updated)
01/06/2017Human medicines European public assessment report (EPAR): Ivabradine Accord,

ivabradine

Revision: 0, Authorised
01/06/2017Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 10, Authorised
01/06/2017Human medicines European public assessment report (EPAR): Imlygic,

talimogene laherparepvec

Revision: 2, Authorised
01/06/2017News and press releases: European Medicines Agency closed 5 June 2017
01/06/2017Report: Report - Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations)
01/06/2017Minutes of the COMP meeting 14-15 March 2017
01/06/2017Human medicines European public assessment report (EPAR): Hycamtin,

topotecan

Revision: 27, Authorised
01/06/2017Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 24, Authorised
01/06/2017Human medicines European public assessment report (EPAR): Myclausen,

mycophenolate mofetil

Revision: 12, Authorised
01/06/2017Human medicines European public assessment report (EPAR): PritorPlus,

telmisartan / hydrochlorothiazide

Revision: 30, Authorised
01/06/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure on how to conduct a procurement procedure (updated)
01/06/2017Human medicines European public assessment report (EPAR): Infanrix Hexa,

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Revision: 33, Authorised
01/06/2017Human medicines European public assessment report (EPAR): Pemetrexed medac,

pemetrexed

Revision: 1, Authorised
01/06/2017Need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
01/06/2017Scientific guideline: Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), draft: consultation open
01/06/2017Organisation chart of the European Medicines Agency (updated)
01/06/2017Organisation chart: Human Medicines Research and Development Support (updated)
01/06/2017Organisation chart: Information Management (updated)
01/06/2017Explanatory note on general fees payable to the European Medicines Agency as of 1 June 2017