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May 2018

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23/05/2018Metronidazole / neomycin / nystatin: List of nationally authorised medicinal products - PSUSA/00010508/201709
23/05/2018Fluoxetine: List of nationally authorised medicinal products - PSUSA/00001442/201709
23/05/2018Modafinil: List of nationally authorised medicinal products - PSUSA/00010242/201708
23/05/2018Vigabatrin: List of nationally authorised medicinal products - PSUSA/00003112/201709
23/05/2018Etidronate: List of nationally authorised medicinal products - PSUSA/00001320/201709
23/05/2018Minocycline: List of nationally authorised medicinal products - PSUSA/00002065/201708
23/05/2018Bromazepam: List of nationally authorised medicinal products - PSUSA/00000435/201708
23/05/2018Treosulfan: List of nationally authorised medicinal products - PSUSA/00009319/201708
23/05/2018Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 28, Authorised
23/05/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion (updated)
23/05/2018Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 11, Authorised
23/05/2018Human medicines European public assessment report (EPAR): Jinarc,

tolvaptan

Revision: 4, Authorised
23/05/2018Orphan designation:

Modified mRNA encoding the UGT1A1 protein

for the: Treatment of Crigler-Najjar syndrome (updated)
23/05/2018Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 13, Authorised
23/05/2018Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consultation open
23/05/2018Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 66, Authorised
23/05/2018Human medicines European public assessment report (EPAR): Prometax,

rivastigmine

Revision: 34, Authorised
23/05/2018Human medicines European public assessment report (EPAR): Trulicity,

dulaglutide

Revision: 8, Authorised
23/05/2018Human medicines European public assessment report (EPAR): Desloratadine Teva,

desloratadine

Revision: 12, Authorised
23/05/2018Fenoterol (respiratory indications): List of nationally authorised medicinal products - PSUSA/00001366/201709
23/05/2018Human medicines European public assessment report (EPAR): Semglee,

insulin glargine

Revision: 0, Authorised
23/05/2018Orphan designation:

4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid 

for the: Treatment of acute myeloid leukaemia (updated)
23/05/2018Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 22, Authorised
23/05/2018Human medicines European public assessment report (EPAR): Symtuza,

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 3, Authorised
23/05/2018Sodium oxybate (intravenous use): List of nationally authorised medicinal products - PSUSA/00010613/201710
23/05/2018Losartan: List of nationally authorised medicinal products - PSUSA/00001912/201709
23/05/2018Human von willebrand factor: List of nationally authorised medicinal products - PSUSA/00001642/201709
23/05/2018Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 26, Authorised
23/05/2018List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
23/05/2018Desflurane: List of nationally authorised medicinal products - PSUSA/00000958/201709
23/05/2018Guidebook for Tenderers
23/05/2018Committee for Medicinal Products for Veterinary Use (CVMP): 23-25 May 2018, European Medicines Agency, London, UK, From: 23-May-2018, To: 25-May-2018 (updated)
23/05/2018Agenda: Agenda - CVMP agenda of the 23-25 May 2018 meeting
23/05/2018Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 13, Withdrawn
23/05/2018Work plan for the Pharmacovigilance Inspectors Working Group for 2018
23/05/2018Q&A: Good clinical practice (GCP) (updated)
23/05/2018Dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)
22/05/2018Plasma-master-file certifications (updated)
22/05/2018News and press releases: Working together for people with rare and complex diseases
22/05/2018EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research, European Medicines Agency, London, UK, From: 29-May-2018, To: 30-May-2018
22/05/2018Piperacillin / tazobactam: List of nationally authorised medicinal products - PSUSA/00002425/201709
22/05/2018Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 15, Authorised
22/05/2018Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 10, Authorised
22/05/2018Ropivacaine: List of nationally authorised medicinal products - PSUSA/00002662/201709
22/05/2018Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 26, Authorised
22/05/2018Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/201708
22/05/2018Human medicines European public assessment report (EPAR): Rapilysin,

reteplase

Revision: 24, Authorised
22/05/2018Human medicines European public assessment report (EPAR): Hexyon,

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: 18, Authorised
22/05/2018Agenda: Agenda - COMP agenda of the 22-24 May 2018 meeting
22/05/2018Report: Appendix 1: Proposed data elements relating to efficacy and to safety - CAR-T cell therapy registries workshop
22/05/2018Report: Appendix 2: Agenda and Participants - CAR-T cell therapy registries workshop
22/05/2018Report: Report - CAR-T cell therapy registries workshop
18/05/2018Human medicines European public assessment report (EPAR): Naglazyme,

galsulfase

Revision: 12, Authorised
18/05/2018Human medicines European public assessment report (EPAR): Simulect,

basiliximab

Revision: 22, Authorised
18/05/2018Agenda: Agenda - Third industry stakeholder platform on research and development support
18/05/2018Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018
18/05/2018Applying for orphan designation (updated)
18/05/2018Application form for European Medicines Agency certificates of medicinal products (updated)
18/05/2018News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018
18/05/2018Referral: Article 20 procedures, Esmya,

ulipristal acetate

(updated)
18/05/2018Human medicines European public assessment report (EPAR): Fasenra,

benralizumab

Revision: 1, Authorised
18/05/2018Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
18/05/2018News and press releases: PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
18/05/2018News and press releases: EMA review of Zinbryta confirms medicine’s risks outweigh its benefits
18/05/2018News and press releases: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir
18/05/2018Human medicines European public assessment report (EPAR): Myfenax,

mycophenolate mofetil

Revision: 19, Authorised
18/05/2018Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 13, Authorised
18/05/2018Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures): List of nationally authorised medicinal products - PSUSA/00002057/201709
18/05/2018Idebenone (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00001721/201709
18/05/2018Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709
18/05/2018News and press releases: European Medicines Agency closed 21 May 2018
18/05/2018Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 11, Authorised
18/05/2018Human medicines European public assessment report (EPAR): Edarbi,

azilsartan medoxomil

Revision: 7, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 13, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 10, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 30, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Invirase,

saquinavir

Revision: 44, Authorised
17/05/2018European Medicines Agency veterinary medicines innovation day, European Medicines Agency, London, UK, From: 19-Apr-2018, To: 19-Apr-2018 (updated)
17/05/2018Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 10, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Zarzio,

filgrastim

Revision: 14, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Arixtra,

fondaparinux sodium

Revision: 27, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Herzuma,

trastuzumab

Revision: 0, Authorised
17/05/2018Veterinary medicine European public assessment report (EPAR): Dexdomitor,

dexmedetomidine

Revision: 18, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 20, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Venclyxto,

venetoclax

Revision: 3, Authorised
17/05/2018List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
17/05/2018Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 12, Authorised
17/05/2018Human medicines European public assessment report (EPAR): Clopidogrel Mylan,

clopidogrel

Revision: 11, Authorised
17/05/2018Veterinary medicine European public assessment report (EPAR): BTVPUR AlSap 1,

bluetongue-virus serotype-1 antigen

Revision: 4, Withdrawn
17/05/2018Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 8, Authorised
17/05/2018Orphan designation:

adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1

for the: Treatment of amyotrophic lateral sclerosis
17/05/2018Orphan designation:

branaplam

for the: Treatment of spinal muscular atrophy
17/05/2018Orphan designation:

autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo

for the: Treatment of ovarian cancer
17/05/2018Orphan designation:

genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII

for the: Treatment of epidermolysis bullosa
17/05/2018Orphan designation:

burosumab

for the: Treatment of phosphaturic mesenchymal tumour
17/05/2018Orphan designation:

polatuzumab vedotin

for the: Treatment of diffuse large B-cell lymphoma
17/05/2018Orphan designation:

Efgartigimod alfa

for the: Treatment of myasthenia gravis
17/05/2018Orphan designation:

Recombinant modified ricin toxin A-chain subunit

for the: Prevention of ricin poisoning
17/05/2018Orphan designation:

Docosahexaenoic acid ethyl ester

for the: Treatment of sickle cell disease
17/05/2018Orphan designation:

Tazemetostat

for the: Treatment of malignant mesothelioma
17/05/2018Orphan designation:

Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA

for the: Treatment of haemophilia B
16/05/2018Veterinary medicine European public assessment report (EPAR): BTVPUR Alsap 8,

adjuvanted bluetongue virus vaccine

Revision: 5, Withdrawn
16/05/2018Paediatric Committee (PDCO): 20-23 March 2018, European Medicines Agency, London, UK, From: 20-Mar-2018, To: 23-Mar-2018 (updated)
16/05/2018Minutes - PDCO minutes of the 20-23 February 2018 meeting
16/05/2018Minutes - PDCO minutes of the 20-23 March 2018 meeting
16/05/2018List of eligible industry stakeholder organisations (updated)
16/05/2018Committee for Medicinal Products for Human Use (CHMP): Work Plan 2018 (updated)
16/05/2018Human medicines European public assessment report (EPAR): Afinitor,

everolimus

Revision: 20, Authorised
16/05/2018Human medicines European public assessment report (EPAR): Clopidogrel Krka,

clopidogrel

Revision: 11, Authorised
16/05/2018Human medicines European public assessment report (EPAR): Urorec,

silodosin

Revision: 14, Authorised
16/05/2018ICH S9 Non-clinical evaluation for anticancer pharmaceuticals (updated)
16/05/2018Scientific guideline: ICH guideline Q3D (R1) on elemental impurities - Step 2b, draft: consultation open
16/05/2018Scientific guideline: ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers - Step 5, adopted
16/05/2018Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 10, Withdrawn
16/05/2018Veterinary medicine European public assessment report (EPAR): Clevor,

ropinirole

Revision: 0, Authorised
16/05/2018Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 8, Authorised
16/05/2018Public statement: Public statement on Vibativ: Withdrawal of the marketing authorisation in the European Union
16/05/2018Human medicines European public assessment report (EPAR): Actelsar HCT,

telmisartan / hydrochlorothiazide

Revision: 7, Authorised
15/05/2018Human medicines European public assessment report (EPAR): Nordimet,

methotrexate

Revision: 4, Authorised
15/05/2018Report: Medicinal products for human use: monthly figures - April 2018
15/05/2018Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 16, Authorised
15/05/2018Human medicines European public assessment report (EPAR): Tamiflu,

oseltamivir

Revision: 31, Authorised
15/05/2018Orphan designation:

Recombinant human acid alpha-glucosidase

for the: Treatment of glycogen storage disease type II (Pompe's disease)
15/05/2018Orphan designation:

Melatonin

for the: Treatment of neonatal encephalopathy
15/05/2018Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 14, Authorised
15/05/2018Orphan designation:

Miransertib

for the: Treatment of Proteus syndrome
15/05/2018Human medicines European public assessment report (EPAR): Pregabalin Mylan,

pregabalin

Revision: 4, Authorised
15/05/2018Orphan designation:

Ribavirin

for the: Treatment of Lassa fever
15/05/2018Human medicines European public assessment report (EPAR): Zyllt,

clopidogrel

Revision: 10, Authorised
15/05/2018Orphan designation:

Ribavirin

for the: Treatment of Crimean-Congo haemorrhagic fever
15/05/2018Minutes of the COMP meeting of 13-15 February 2018 (updated)
15/05/2018Orphan designation:

Tazemetostat

for the: Treatment of follicular lymphoma
15/05/2018Human medicines European public assessment report (EPAR): Trumenba,

meningococcal group b vaccine (recombinant, adsorbed)

Revision: 3, Authorised
15/05/2018Human medicines European public assessment report (EPAR): Kineret,

anakinra

Revision: 23, Authorised
15/05/2018Human medicines European public assessment report (EPAR): Clopidogrel TAD,

clopidogrel

Revision: 8, Authorised
15/05/2018Orphan designation:

Dimethyl fumarate

for the: Treatment of Friedreich's ataxia
15/05/2018Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH,

pregabalin

Revision: 4, Authorised
15/05/2018Careers at European Medicines Agency (EMA) - External guidance with the general conditions for recruitment and employment at the EMA
14/05/2018Diclofenac / misoprostol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001040/201707 (updated)
14/05/2018Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 17, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Pregabalin Mylan Pharma,

pregabalin

Revision: 3, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Erelzi,

etanercept

Revision: 3, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Rivastigmine Actavis,

rivastigmine

Revision: 13, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Pemetrexed Accord,

pemetrexed

Revision: 2, Authorised
14/05/2018Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018, European Medicines Agency, London, UK, From: 14-May-2018, To: 17-May-2018 (updated)
14/05/2018Agenda: Agenda - PRAC draft agenda of meeting 14-17 May 2018
14/05/2018Report: Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use: May 2018
14/05/2018Orphan designation:

Gemfibrozil

for the: Treatment of neuronal ceroid lipofuscinosis
14/05/2018Agenda: Agenda - Info day for micro, small and medium-sized enterprises: regulatory toolbox for medicines and combined devices developers
14/05/2018Human medicines European public assessment report (EPAR): Leflunomide Winthrop,

leflunomide

Revision: 14, Authorised
14/05/2018Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, From: 26-Oct-2018, To: 26-Oct-2018
14/05/2018Human medicines European public assessment report (EPAR): Vivanza,

vardenafil

Revision: 24, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Imatinib medac,

imatinib

Revision: 5, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Prandin,

repaglinide

Revision: 16, Authorised
14/05/2018Newsletter: News bulletin for small and medium-sized enterprises - Issue 43
14/05/2018Human medicines European public assessment report (EPAR): Docetaxel Kabi,

docetaxel

Revision: 9, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 12, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Insulin lispro Sanofi,

insulin lispro

Revision: 2, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Velmetia,

sitagliptin / metformin

Revision: 23, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 26, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Ocaliva,

obeticholic acid

Revision: 2, Authorised
14/05/2018Methylaminolevulinate: List of nationally authorised medicinal products - PSUSA/00002019/201706
14/05/2018Methylaminolevulinate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002019/201706
14/05/2018Human medicines European public assessment report (EPAR): Strensiq,

asfotase alfa

Revision: 7, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 22, Authorised
14/05/2018Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders (updated)
14/05/2018Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 16, Authorised
14/05/2018Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS),

nitisinone

Revision: 1, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Oslif Breezhaler,

indacaterol

Revision: 11, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Ivemend,

fosaprepitant

Revision: 19, Authorised
08/05/2018Minutes of the PRAC meeting 5-8 March 2018
08/05/2018Human medicines European public assessment report (EPAR): Ivabradine Accord,

ivabradine

Revision: 1, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 16, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 22, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Imatinib Teva,

imatinib

Revision: 11, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH,

clopidogrel

Revision: 10, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Kinzalkomb,

telmisartan / hydrochlorothiazide

Revision: 33, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Atazanavir Mylan,

atazanavir

Revision: 2, Authorised
08/05/2018PRIME eligibility request: applicant’s justification (updated)
08/05/2018Human medicines European public assessment report (EPAR): Elmiron,

pentosan polysulfate sodium

Revision: 3, Authorised
08/05/2018Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 18, Authorised
08/05/2018Newsletter: Human medicines highlights - May 2018
08/05/2018Orphan designation:

Larotrectinib

for the: Treatment of salivary gland cancer
08/05/2018Orphan designation:

Tazemetostat

for the: Treatment of diffuse large B-cell lymphoma
08/05/2018Orphan designation:

Ivosidenib

for the: Treatment of biliary tract cancer
08/05/2018Orphan designation:

(2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide

for the: Treatment of C3 glomerulopathy
08/05/2018Questions and answers: Good manufacturing practice (updated)
08/05/2018Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm,

clopidogrel

Revision: 6, Authorised
08/05/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 April 2018
07/05/2018Human medicines European public assessment report (EPAR): Lacosamide Accord,

lacosamide

Revision: 1, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Stelara,

ustekinumab

Revision: 23, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Emadine,

emedastine

Revision: 21, Authorised
07/05/2018Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000788/201704 (updated)
07/05/2018Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma),

clopidogrel

Revision: 14, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 31, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Ionsys,

fentanyl

Revision: 1, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Filgrastim Hexal,

filgrastim

Revision: 13, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Axumin,

fluciclovine (18F)

Revision: 2, Authorised
07/05/2018Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/201707 (updated)
07/05/2018Human medicines European public assessment report (EPAR): Xermelo,

telotristat ethyl

Revision: 2, Authorised
07/05/2018European Medicines Agency guidance for applicants seeking access to PRIME scheme (updated)
07/05/2018Regulatory and procedural guideline: Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME), adopted (updated)
07/05/2018News and press releases: Two years of PRIME
07/05/2018Report: PRIME: a two-year overview
07/05/2018Human medicines European public assessment report (EPAR): Sildenafil Actavis,

sildenafil

Revision: 11, Authorised
07/05/2018European Medicines Agency guidance on interactions in the context of PRIME
07/05/2018Human medicines European public assessment report (EPAR): Ruconest,

conestat alfa

Revision: 9, Authorised
07/05/2018PRIME: priority medicines (updated)
07/05/2018Human medicines European public assessment report (EPAR): Arava,

leflunomide

Revision: 34, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 20, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Zykadia,

ceritinib

Revision: 9, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Levitra,

vardenafil

Revision: 27, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Vpriv,

velaglucerase alfa

Revision: 11, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Hemlibra,

emicizumab

Revision: 1, Authorised
07/05/2018Thirteenth industry stakeholder platform - operation of EU pharmacovigilance , European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018 (updated)
07/05/2018Report: Highlights from the 13th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 20 March 2018
07/05/2018Regulatory and procedural guideline: User guide on how to generate PDF versions of the product information - human (updated)
07/05/2018Information package for certificates of medicinal products issued by the European Medicines Agency (updated)
07/05/2018Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 19, Authorised
07/05/2018User safety of topically administered products (updated)
07/05/2018Scientific guideline: Guideline on user safety of topically administered veterinary medicinal products, adopted
07/05/2018Overview of comments received on 'Guideline on user safety of topically administered veterinary medicinal products'
07/05/2018Veterinary medicine European public assessment report (EPAR): Startvac,

adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci

Revision: 3, Authorised
07/05/2018Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 12, Authorised
07/05/2018List of signals discussed at the PRAC since September 2012 (updated)
07/05/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC
07/05/2018Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 14, Authorised
07/05/2018Orphan designation:

Bosutinib

for the: Treatment of chronic myeloid leukaemia (updated)
07/05/2018News and press releases: European Medicines Agency closed 9-11 May 2018
07/05/2018Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 21, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 19, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Atriance,

nelarabine

Revision: 19, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 17, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Ivabradine Anpharm,

ivabradine

Revision: 3, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Mylotarg,

gemtuzumab ozogamicin

Revision: 0, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 38, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Galvus,

vildagliptin

Revision: 15, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 8, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Alimta,

pemetrexed

Revision: 22, Authorised
04/05/2018Human medicines European public assessment report (EPAR): Biopoin,

epoetin theta

Revision: 13, Authorised
04/05/2018Referral: Article 31 referrals, Flupirtine-containing medicinal products,

flupirtine

(updated)
04/05/2018Eligible healthcare professionals' organisations (updated)
04/05/2018Opinion/decision on a Paediatric investigation plan (PIP): ,

Levofloxacin (hemihydrate)

Therapeutic area: Pneumology-allergology (updated)
04/05/2018Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 31, Authorised
04/05/2018Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
04/05/2018Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
04/05/2018Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
04/05/2018Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
04/05/2018Pre-authorisation guidance (updated)
04/05/2018Classification of changes: questions and answers (updated)
04/05/2018Grouping of variations: questions and answers (updated)
04/05/2018Type-IA variations: questions and answers (updated)
04/05/2018Submission of Article-46 paediatric studies: questions and answers (updated)
04/05/2018Human medicines European public assessment report (EPAR): Kogenate Bayer,

octocog alfa

Revision: 30, Authorised
03/05/2018Opinion of the CVMP on the establishment of maximum residue limits: Fluazuron, adopted
03/05/2018Divergent position on a CVMP opinion on the establishment of maximum residue limits: For extension of fluazuron for fin fish (automatic extrapolation to milk), adopted
03/05/2018Opinion of the CVMP on the establishment of maximum residue limits: Solvent naphtha, light aromatic, adopted
03/05/2018Administration and Corporate Management (updated)
03/05/2018Organisation chart: Administration and Corporate Management (updated)
03/05/2018Deputy Executive Director and support services (updated)
03/05/2018Orphan designation:

(1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione

for the: Treatment of systemic sclerosis (updated)
03/05/2018Orphan designation:

4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one

for the: Treatment of pancreatic cancer (updated)
03/05/2018Orphan designation:

Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene

for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome) (updated)
03/05/2018Orphan designation:

6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate

for the: Treatment of mucopolysaccharidosis type I (updated)
03/05/2018Orphan designation:

Tadekinig alfa

for the: Treatment of haemophagocytic lymphohistiocytosis (updated)
03/05/2018Orphan designation:

Recombinant human interleukin-12

for the: Treatment of acute radiation syndrome (updated)
03/05/2018Orphan designation:

Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene

for the: Treatment of mucopolysaccharidosis type I (updated)
03/05/2018Human medicines European public assessment report (EPAR): Lucentis,

ranibizumab

Revision: 27, Authorised
03/05/2018Orphan designation:

(1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione

for the: Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy’s disease) (updated)
03/05/2018Orphan designation:

2'-O-(2-Methoxyethyl) phosphorothioate antisense oligonucleotide targeting the growth hormone receptor

for the: Treatment of acromegaly (updated)
03/05/2018Orphan designation:

live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O

for the: Treatment of osteosarcoma (updated)
03/05/2018Orphan designation:

4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid

for the: Treatment of cystic fibrosis (updated)
03/05/2018Human medicines European public assessment report (EPAR): Natpar,

parathyroid hormone

Revision: 3, Authorised
03/05/2018Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work, adopted (updated)
03/05/2018Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.4 (updated)
03/05/2018Agenda: CHMP ORGAM agenda for the meeting on 16 April 2018
03/05/2018Haemophilia registries workshop, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018 (updated)
03/05/2018Agenda: Agenda – Haemophilia registries workshop
03/05/2018Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 April 2018
03/05/2018Report: List of products granted eligibility to PRIME (updated)
03/05/2018Regulatory and procedural guideline: How to use the defective product report to notify a quality defect to European Medicines Agency
03/05/2018Reporting a quality defect to EMA (updated)
03/05/2018Quality defects and recalls
03/05/2018Defective product report form
03/05/2018Veterinary medicine European public assessment report (EPAR): Ecoporc Shiga,

genetically modified Shiga-toxin-2e antigen

Revision: 3, Authorised
02/05/2018Human medicines European public assessment report (EPAR): Velphoro,

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

Revision: 5, Authorised
02/05/2018Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products, European Medicines Agency, London, UK, From: 23-Mar-2018, To: 23-Mar-2018 (updated)
02/05/2018Minutes - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products
02/05/2018Human medicines European public assessment report (EPAR): Fycompa,

perampanel

Revision: 14, Authorised
02/05/2018Human medicines European public assessment report (EPAR): Trydonis,

beclometasone / formoterol / glycopyrronium bromide

Revision: 0, Authorised
02/05/2018PSURs for centrally authorised veterinary medicinal products: procedure on PSUR submission and evaluation for non-marketed products (updated)
02/05/2018Human medicines European public assessment report (EPAR): Ultibro Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 7, Authorised
02/05/2018Annual reports and work programmes (updated)
02/05/2018News and press releases: EMA 2017 annual report published
02/05/2018HMPC: overview of assessment work – priority list (updated)
02/05/2018Presentation - Registry initiative - April 2018
02/05/2018Veterinary medicine European public assessment report (EPAR): Purevax RCPCh FeLV,

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukaemia and feline Chlamydophila virus infections

Revision: 9, Authorised
02/05/2018Candesartan, candesartan / hydrochlorothiazide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000527/201704 (updated)
02/05/2018Annexes - 2017 annual report of the European Medicines Agency
02/05/2018Agenda: Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges (updated)
02/05/2018Regulatory and procedural guideline: Qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects, adopted
02/05/2018Annex 10 – 2017 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
02/05/20182017 annual report of the European Medicines Agency
02/05/2018Regulatory and procedural guideline: Overview of comments on 'Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects'
02/05/2018Veterinary medicine European public assessment report (EPAR): Purevax RCPCh,

vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila virus infections

Revision: 11, Authorised
02/05/2018Nominations to the European Union Telematics governance bodies (updated)
02/05/2018Committee for Advanced Therapies (CAT): 15-16 February 2018, European Medicines Agency, London, UK, From: 15-Feb-2018, To: 16-Feb-2018 (updated)
02/05/2018Minutes of the CAT meeting 15-16 February 2018
02/05/2018Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 14, Authorised
02/05/2018MRL report: Fluazuron (All ruminants, except bovine and ovine, and fin fish): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/05/2018MRL report: Solvent naphtha, light aromatic (All food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/05/2018Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 18, Authorised
02/05/2018Veterinary medicine European public assessment report (EPAR): Purevax RCP FeLV,

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia

Revision: 9, Authorised
02/05/2018Human medicines European public assessment report (EPAR): Spedra,

avanafil

Revision: 11, Authorised
02/05/2018Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/201707
02/05/2018Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / human von willebrand factor

Revision: 10, Authorised
02/05/2018Human medicines European public assessment report (EPAR): Firazyr,

icatibant

Revision: 15, Authorised
02/05/2018Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 7, Withdrawn
02/05/2018Human medicines European public assessment report (EPAR): NeuroBloc,

botulinum toxin type B

Revision: 29, Authorised
02/05/2018Public statement: Public statement on Zinbryta: Withdrawal of the marketing authorisation in the European Union