What's New?

  • Email
  • Help

January 2018

Filter by:
Date Content
31/01/2018Clinical pharmacology and pharmacokinetics: questions and answers (updated)
31/01/2018Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.5 release notes (updated)
31/01/2018MRL report: Alarelin (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
31/01/2018MRL report: Bromelain (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
31/01/2018Human medicines European public assessment report (EPAR): Mvasi,

bevacizumab

Revision: 0, Authorised
31/01/2018Minutes of the PRAC meeting 27-30 November 2017
31/01/2018Human medicines European public assessment report (EPAR): Jetrea,

ocriplasmin

Revision: 8, Authorised
31/01/2018Veterinary medicine European public assessment report (EPAR): Prevomax,

maropitant

Revision: 1, Authorised
31/01/2018Orphan designation:

Sorafenib tosylate

for the: Treatment of hepatocellular carcinoma (updated)
31/01/2018Human medicines European public assessment report (EPAR): Nplate,

romiplostim

Revision: 16, Authorised
31/01/2018Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka,

emtricitabine / tenofovir disoproxil

Revision: 2, Authorised
31/01/2018Human medicines European public assessment report (EPAR): Replagal,

agalsidase alfa

Revision: 21, Authorised
31/01/2018Template letter of intent for request of scientific advice or protocol assistance (updated)
31/01/2018Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 15, Authorised
31/01/2018News and press releases: How to better apply the paediatric legislation to boost development of medicines for children
31/01/2018Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation, European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018
31/01/2018Human medicines European public assessment report (EPAR): Ruconest,

conestat alfa

Revision: 8, Authorised
31/01/2018Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance
31/01/2018Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance
31/01/2018Agomelatine oral tablet 25 mg product-specific bioequivalence guidance
31/01/2018Vismodegib hard capsule 150 mg product-specific bioequivalence guidance
31/01/2018Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance
31/01/2018Scientific guideline: Draft vismodegib hard capsule 150 mg product-specific bioequivalence guidance, draft: consultation open
31/01/2018Scientific guideline: Draft ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, draft: consultation open
31/01/2018Scientific guideline: Draft posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, draft: consultation open
31/01/2018Scientific guideline: Draft cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, draft: consultation open
31/01/2018Scientific guideline: Draft agomelatine oral tablet 25 mg product-specific bioequivalence guidance, draft: consultation open
31/01/2018Plasma-master-file certifications (updated)
31/01/2018List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
31/01/2018Gentamicin (systemic use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009159/201703 (updated)
31/01/2018List of medicines under additional monitoring (updated)
31/01/2018Gentamicin (systemic use): List of nationally authorised medicinal products - PSUSA/00009159/201703 (updated)
31/01/2018List of medicinal products under additional monitoring (updated)
31/01/2018List of medicinal products under additional monitoring (updated)
31/01/2018Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (updated)
31/01/2018Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 40, Authorised
31/01/2018Human medicines European public assessment report (EPAR): Qtern,

saxagliptin / dapagliflozin

Revision: 2, Authorised
31/01/2018Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 14, Authorised
30/01/2018Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 13, Authorised
30/01/2018Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 11, Authorised
30/01/2018Human medicines European public assessment report (EPAR): Nucala,

mepolizumab

Revision: 5, Authorised
30/01/2018Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 11, Authorised
30/01/2018Human medicines European public assessment report (EPAR): Protopic,

tacrolimus

Revision: 22, Authorised
30/01/2018Questions and answers: implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines GL6 (phase I) and GL38 (phase II) (updated)
29/01/2018Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use (updated)
29/01/2018Minutes of the COMP meeting of 30-31 October 2017
29/01/2018Agenda: Agenda - HMPC agenda of the 29-30 January 2018 meeting
29/01/2018Orphan designation:

Methylthioninium

for the: treatment of behavioural variant frontotemporal dementia (updated)
29/01/2018Orphan designation:

Methylthioninium

for the: treatment of progressive non-fluent aphasia (updated)
29/01/2018Orphan designation:

Methylthioninium

for the: treatment of frontotemporal dementia with parkinsonism-17 (updated)
29/01/2018Orphan designation:

Methylthioninium

for the: treatment of progressive supranuclear palsy (updated)
29/01/2018Work plan for the CHMP Excipients Drafting Group (ExcpDG) for the revision of the EC guideline ‘Excipients in the labelling and package leaflet of medicinal products for human use’ for 2018
29/01/2018Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 41, Authorised
29/01/2018Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 20, Authorised
29/01/2018News and press releases: Statement by Executive Director Guido Rasi in The Hague
29/01/2018Human medicines European public assessment report (EPAR): Tesavel,

sitagliptin

Revision: 18, Authorised
29/01/2018Human medicines European public assessment report (EPAR): Xelevia,

sitagliptin

Revision: 24, Authorised
29/01/2018Helixate NexGen : EPAR - Procedural steps taken and scientific information after authorisation (updated)
29/01/2018Advate : EPAR - Procedural steps taken and scientific information after authorisation (updated)
29/01/2018Elocta : EPAR - Procedural steps taken and scientific information after authorisation (updated)
29/01/2018Human medicines European public assessment report (EPAR): Advagraf,

tacrolimus

Revision: 16, Authorised
29/01/2018Human medicines European public assessment report (EPAR): Januvia,

sitagliptin

Revision: 22, Authorised
29/01/2018Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 6, Authorised
29/01/2018Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis),

pemetrexed

Revision: 4, Authorised
29/01/2018Organisation chart: Information Management (updated)
26/01/2018Scientific guideline: Draft VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species, draft: consultation open
26/01/2018Scientific guideline: Concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open
26/01/2018VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
26/01/2018Human medicines European public assessment report (EPAR): Tacforius,

tacrolimus

Revision: 0, Authorised
26/01/2018Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, adopted (updated)
26/01/2018Human medicines European public assessment report (EPAR): Ontruzant,

trastuzumab

Revision: 0, Authorised
26/01/2018Human medicines European public assessment report (EPAR): Ibrance,

palbociclib

Revision: 3, Authorised
26/01/2018Human medicines European public assessment report (EPAR): Sustiva,

efavirenz

Revision: 42, Authorised
26/01/2018Human medicines European public assessment report (EPAR): Faslodex,

fulvestrant

Revision: 18, Authorised
26/01/2018Cefuroxime sodium (except for intracameral use): List of nationally authorised medicinal products - PSUSA/00000615/201704
26/01/2018Cefuroxime sodium (except for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000615/201704
26/01/2018Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 6, Authorised
26/01/2018Scientific publications (updated)
26/01/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for evaluation procedure for CVMP MUMS/limited market classification requests
26/01/2018News and press releases: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
26/01/2018Minutes of the CAT meeting 30-31 October 2017
26/01/2018Minutes of the CAT meeting 10-12 April 2017 (updated)
26/01/2018Veterinary innovation day, European Medicines Agency, London, UK, From: 19-Apr-2018, To: 19-Apr-2018
26/01/2018News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018
26/01/2018News and press releases: First-in-class medicine to prevent bleeding in haemophilia A patients with inhibitors
26/01/2018News and press releases: New enzyme replacement therapy to treat rare genetic disorder alpha-mannosidosis in children and adults
26/01/2018Pending EC decision: EnCyzix,

enclomifene

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Steglatro,

ertugliflozin

Opinion date: 25-Jan-2018
26/01/2018Withdrawn application: Rotigotine Mylan,

rotigotine

Initial authorisation
26/01/2018Pending EC decision: Relvar Ellipta,

fluticasone furoate / vilanterol

Opinion date: 25-Jan-2018
26/01/2018Referral: Article 107i procedures, Hydroxyethyl starch (HES) containing medicinal products,

hydroxyethyl starch (HES)

(updated)
26/01/2018Pending EC decision: Segluromet,

ertugliflozin / metformin

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Aplidin,

plitidepsin

Opinion date: 14-Dec-2017 (updated)
26/01/2018Pending EC decision: Semglee,

insulin glargine

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Lokelma,

sodium zirconium cyclosilicate

Opinion date: 23-Feb-2017 (updated)
26/01/2018Scientific advice and protocol assistance adopted during the CHMP meeting 22 – 25 January 2018
26/01/2018Pending EC decision: Revinty Ellipta,

fluticasone furoate / vilanterol

Opinion date: 25-Jan-2018
26/01/2018Withdrawn application: Opdivo,

nivolumab

Post-authorisation
26/01/2018Pending EC decision: Hizentra,

human normal immunoglobulin (SCIg)

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Hemlibra,

emicizumab

Opinion date: 25-Jan-2018
26/01/2018Withdrawn application: Balimek,

binimetinib

Initial authorisation
26/01/2018Pending EC decision: Lamzede,

velmanase alfa

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Shingrix,

herpes zoster vaccine (recombinant, adjuvanted)

Opinion date: 25-Jan-2018
26/01/2018Pending EC decision: Steglujan,

ertugliflozin / sitagliptin

Opinion date: 25-Jan-2018
25/01/2018Chimeric antigen receptor (CAR) T-cell therapy registries workshop, European Medicines Agency, London, UK, From: 02-Sep-2018, To: 02-Sep-2018
25/01/2018EudraVigilance Expert Working Group (EV-EWG) work programme 2018
25/01/2018Product Management Services and Substance Management Services projects
25/01/2018Substance and product data management services (updated)
25/01/2018Human medicines European public assessment report (EPAR): Pramipexole Teva,

pramipexole

Revision: 18, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 11, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Tecentriq,

atezolizumab

Revision: 1, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Darunavir Krka d.d.,

darunavir

Revision: 0, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 9, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Velphoro,

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

Revision: 4, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Elebrato Ellipta,

fluticasone furoate / umeclidinium / vilanterol

Revision: 0, Authorised
25/01/2018Regulatory and procedural guideline: Member states contact points for translation review (v.6.10) (updated)
25/01/2018Human medicines European public assessment report (EPAR): Tepadina,

thiotepa

Revision: 11, Authorised
25/01/2018Human medicines European public assessment report (EPAR): Stocrin,

efavirenz

Revision: 37, Authorised
25/01/2018Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
24/01/2018Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 8, Authorised
24/01/2018Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 8, Authorised
24/01/2018Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb
24/01/2018Scientific guideline: Draft guideline on core summary of products characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb, draft: consultation open
24/01/2018Regulatory and procedural guideline: Draft qualification opinion on molecular neuroimaging of the dopamine transporter as biomarker to identify patients with early manifest Parkinsonism in Parkinson’s disease, draft: consultation open
24/01/2018Orphan medicines figures 2000-2017 (updated)
24/01/2018Glucosamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001539/201703
24/01/2018Scientific guideline: Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote replacement, reduction, and refinement (3Rs) measures described in the European Pharmacopoeia - Applicable to human vaccines from 01/01/2018, adopted
24/01/2018Scientific guideline: Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs, adopted
24/01/2018Scientific guideline: Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote reduction, refinement and replacement (3Rs) measures described in the European Pharmacopoeia - Applicable to veterinary vaccines from 01/01/2017, adopted
24/01/2018Overview of comments received on 'Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs'
24/01/2018Glucosamine: List of nationally authorised medicinal products - PSUSA/00001539/201703
24/01/2018Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 41, Authorised
24/01/2018Simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002709/201704
24/01/2018Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/201704
24/01/2018Epoprostenol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001242/201703
24/01/2018Epoprostenol: List of nationally authorised medicinal products - PSUSA/00001242/201703
24/01/2018Human medicines European public assessment report (EPAR): Zyclara,

imiquimod

Revision: 6, Authorised
24/01/2018Report: Medicinal products for human use: monthly figures - December 2017
24/01/2018Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
24/01/2018Agenda: Agenda - PDCO agenda of the 23-26 January 2018 meeting
24/01/2018Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
24/01/2018Human medicines European public assessment report (EPAR): Marixino (previously Maruxa),

memantine

Revision: 5, Authorised
24/01/2018Human medicines European public assessment report (EPAR): Ledaga,

chlormethine

Revision: 2, Authorised
24/01/2018Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 10, Authorised
24/01/2018Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.,

emtricitabine / tenofovir disoproxil

Revision: 2, Authorised
24/01/2018Human medicines European public assessment report (EPAR): Cabometyx ,

cabozantinib

Revision: 1, Authorised
24/01/2018Orphan designation:

Adenovirus associated viral vector serotype 8 containing the human AIPL1 gene

for the: Treatment of Leber's congenital amaurosis
24/01/2018Orphan designation:

Acetylleucine

for the: Treatment of GM2 gangliosidosis
24/01/2018Orphan designation:

Agammaglobulinaemia tyrosine kinase

for the: Treatment of pemphigus
24/01/2018Orphan designation:

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

for the: Treatment of paroxysmal nocturnal haemoglobinuria
23/01/2018Human medicines European public assessment report (EPAR): Mimpara,

cinacalcet

Revision: 19, Authorised
23/01/2018Mutual recognition agreements (updated)
23/01/2018Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 19, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 27, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Votrient,

pazopanib

Revision: 19, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Lartruvo,

olaratumab

Revision: 3, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 12, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva,

irbesartan / hydrochlorothiazide

Revision: 13, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Actelsar HCT,

telmisartan / hydrochlorothiazide

Revision: 6, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Rilutek,

riluzole

Revision: 25, Authorised
23/01/2018Orphan designation:

1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea

for the: Ttreatment of gastrointestinal stromal tumours (updated)
23/01/2018Orphan designation:

Modified messenger ribonucleic acid encoding human argininosuccinate lyase enzyme encapsulated into lipid nanoparticles

for the: Treatment of argininosuccinic aciduria
23/01/2018Orphan designation:

4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl

for the: Treatment of familial cerebral cavernous malformation
23/01/2018News and press releases: EMA surveys pharma companies on their preparedness for Brexit
23/01/2018Orphan designation:

Pegunigalsidase alfa

for the: Treatment of Fabry disease
23/01/2018Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva,

emtricitabine / tenofovir disoproxil

Revision: 1, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Imlygic,

talimogene laherparepvec

Revision: 3, Authorised
23/01/2018Orphan designation:

2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione

for the: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
23/01/2018Authorisation of medicines (updated)
23/01/2018About us (updated)
23/01/2018News and press releases: Why EMA matters to European citizens
23/01/2018What we do (updated)
23/01/2018Orphan designation:

Venetoclax

for the: Treatment of mantle cell lymphoma
23/01/2018Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate),

clopidogrel

Revision: 11, Authorised
23/01/2018Agenda: Agenda - CHMP agenda of the 22-25 January 2018 meeting (updated)
23/01/2018Human medicines European public assessment report (EPAR): Targretin,

bexarotene

Revision: 16, Authorised
23/01/2018Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 8, Authorised
23/01/2018Orphan designation:

Naproxcinod

for the: Treatment of Duchenne muscular dystrophy (updated)
23/01/2018Orphan designation:

Tivantinib

for the: Treatment of hepatocellular carcinoma (updated)
23/01/2018Orphan designation:

Mixture of two allogeneic human pancreatic cancer cell lines stably transduced with a retroviral vector encoding the murine alpha-(1,3)-galactosyltransferase gene

for the: Treatment of pancreatic cancer (updated)
23/01/2018Orphan designation:

Allogeneic, umbilical cord blood-derived, ex vivo-expanded, haematopoietic CD133+ cells / allogeneic, umbilical cord blood-derived, non-expanded, haematopoietic CD133- cells

for the: Treatment of acute myeloid leukaemia (updated)
23/01/2018News and press releases: Human medicines: highlights of 2017
22/01/2018Orphan designation:

2-amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy)phenyl]thio]phenyl]ethyl]-1,3-propanediol hydrochloride

for the: Prevention of graft-versus-host disease (updated)
22/01/2018Orphan designation:

Temsirolimus

for the: Treatment of renal cell carcinoma (updated)
22/01/2018Human medicines European public assessment report (EPAR): Memantine ratiopharm,

memantine

Revision: 4, Authorised
22/01/2018Regulatory and procedural guideline: EudraVigilance user manual - Individual case safety report form - Version 1.1 (updated)
22/01/2018Agenda: Agenda - Second international awareness session for international regulators, academia and non-governmental organisations (updated)
22/01/2018CHMP ORGAM minutes for the meeting on 4 December 2017
22/01/2018Agenda: CHMP ORGAM agenda for the meeting on 15 January 2018
22/01/2018Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 23, Authorised
22/01/2018Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders (updated)
19/01/2018Olsalazine: List of nationally authorised medicinal products - PSUSA/00002213/201705
19/01/2018Lanthanum: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003175/201703
19/01/2018Lanthanum: List of nationally authorised medicinal products - PSUSA/00003175/201703
19/01/2018Human medicines European public assessment report (EPAR): NovoEight,

turoctocog alfa

Revision: 4, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Levitra,

vardenafil

Revision: 26, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Grepid,

clopidogrel

Revision: 15, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Kovaltry,

octocog alfa

Revision: 4, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Gazyvaro,

obinutuzumab

Revision: 5, Authorised
19/01/2018News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 January 2018
19/01/2018Pending EC decision: Vectormune ND,

Newcastle disease and Marek’s disease vaccine (live recombinant)

Opinion date: 18-Jan-2018
19/01/2018Pending EC decision: Advocate,

imidacloprid / moxidectin

Opinion date: 18-Jan-2018
19/01/2018Pending EC decision: Panacur AquaSol,

fenbendazole

Opinion date: 18-Jan-2019
19/01/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for requesting and recording of exceptions and non-compliance events (updated)
19/01/2018Minutes of the CVMP meeting of 5-7 December 2017
19/01/2018Overview of comments received on 'Draft guideline on the chemistry of active substances for veterinary medicinal products'
19/01/2018Scientific guideline: Guideline on the chemistry of active substances for veterinary medicinal products, adopted
19/01/2018Chemistry of active substances/new active substances (updated)
19/01/2018Extension of reserve lists for external selection procedures: Temporary Agent reserve lists expiring on 31 December 2017 (updated)
19/01/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for evaluation procedure for veterinary medicines initial marketing authorisation procedures and extensions
19/01/2018Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201705
19/01/2018Betaxolol: List of nationally authorised medicinal products - PSUSA/00000401/201705
19/01/2018Halofantrine: List of nationally authorised medicinal products - PSUSA/00001586/201705
19/01/2018Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 7, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 12, Authorised
19/01/2018Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 13, Authorised
18/01/2018Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 7, Authorised
18/01/2018Orphan designation:

Budesonide

for the: Treatment of eosinophilic oesophagitis (updated)
18/01/2018Human medicines European public assessment report (EPAR): Jorveza,

budesonide

Revision: 0, Authorised
18/01/2018Work plan of the CHMP Blood Products Working Party for 2018 (updated)
18/01/2018Work plan for the Biosimilar Medicinal Products Working Party 2018 (updated)
18/01/2018Work plan for the Infectious Diseases Working Party 2018 (updated)
18/01/2018Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 23, Authorised
18/01/2018Work plan for the CHMP Respiratory Drafting Group for 2018 (updated)
18/01/2018Agenda: Agenda - CAT agenda of the 17-19 January 2018 meeting
18/01/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 12-15 December 2017
18/01/2018Estradiol, estradiol /prednisolone (only cream/balm/emulsion for application in the female genital area): List of nationally authorised medicinal products - PSUSA/00010441/201704
18/01/2018Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201704
18/01/2018Ivermectin (topical use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010376/201704
18/01/2018Valsartan, hydrochlorothiazide / valsartan: List of nationally authorised medicinal products - PSUSA/00010396/201704
18/01/2018Orphan designation:

Recombinant human alpha 1 chain homotrimer of type VII collagen

for the: Treatment of epidermolysis bullosa (updated)
18/01/2018Human medicines European public assessment report (EPAR): Zonegran,

zonisamide

Revision: 28, Authorised
18/01/2018Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 26, Authorised
18/01/2018Veterinary medicine European public assessment report (EPAR): SevoFlo,

sevoflurane

Revision: 15, Authorised
18/01/2018Technetium (99mTc) hynic-octeotide: List of nationally authorised medicinal products - PSUSA/00010521/201706
18/01/2018Amlodipine/candesartan: List of nationally authorised medicinal products - PSUSA/00010191/201704
18/01/2018Formoterol: List of nationally authorised medicinal products - PSUSA/00001469/201705
18/01/2018Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201705
18/01/2018Strontium [89sr] chloride: List of nationally authorised medicinal products - PSUSA/00002795/201705
18/01/2018Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/201704
18/01/2018Human medicines European public assessment report (EPAR): BiResp Spiromax,

budesonide / formoterol

Revision: 5, Authorised
18/01/2018Amlodipine besilate/hydrochlorothiazide/olmesartan medoxomil: List of nationally authorised medicinal products - PSUSA/00002210/201704
18/01/2018Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 24, Authorised
18/01/2018Amlodipine/olmesartan: List of nationally authorised medicinal products - PSUSA/00002208/201704
18/01/2018Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 24, Authorised
18/01/2018Human medicines European public assessment report (EPAR): Kineret,

anakinra

Revision: 22, Authorised
18/01/2018Financial management and budgetary reporting (updated)
18/01/2018Management Board meeting: 13-14 December 2017, European Medicines Agency, London, UK, From: 13-Dec-2017, To: 14-Dec-2017 (updated)
18/01/2018Report: European Medicines Agency budget for 2018
17/01/2018Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 7, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Nuwiq,

simoctocog alfa (rFVIII)

Revision: 4, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Prialt,

ziconotide

Revision: 20, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Trumenba,

meningococcal group b vaccine (recombinant, adsorbed)

Revision: 1, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Bavencio,

avelumab

Revision: 1, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Praluent,

alirocumab

Revision: 8, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Erelzi,

etanercept

Revision: 2, Authorised
17/01/2018Human medicines European public assessment report (EPAR): VeraSeal,

human fibrinogen / human thrombin

Revision: 0, Authorised
17/01/2018Lanreotide: List of nationally authorised medicinal products - PSUSA/00001826/201705
17/01/2018Diltiazem: List of nationally authorised medicinal products - PSUSA/00001084/201705
17/01/2018Eprosartan / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00001244/201704
17/01/2018Cidofovir: List of nationally authorised medicinal products - PSUSA/00010558/201706
17/01/2018Orphan designation:

(S)-{8-Fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid (letermovir)

for the: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at... (updated)
17/01/2018Orphan designation:

Histamine dihydrochloride

for the: Treatment of acute myeloid leukaemia (updated)
17/01/2018News and press releases: Is an orphan medicine still an orphan once it gets on the market?
17/01/2018Human medicines European public assessment report (EPAR): Prevymis,

letermovir

Revision: 0, Authorised
17/01/2018indobufen: List of nationally authorised medicinal products - PSUSA/00001736/201705
17/01/2018Eprosartan: List of nationally authorised medicinal products - PSUSA/00001243/201704
17/01/2018Human medicines European public assessment report (EPAR): Amgevita,

adalimumab

Revision: 1, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 8, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan,

tenofovir disoproxil

Revision: 3, Authorised
17/01/2018Azithromycin (ocular use formulations): List of nationally authorised medicinal products - PSUSA/00010492/201704
17/01/2018Human medicines European public assessment report (EPAR): Desloratadine ratiopharm,

desloratadine

Revision: 7, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Lutathera,

lutetium (177Lu) oxodotreotide

Revision: 0, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella),

rituximab

Revision: 3, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Ritemvia,

rituximab

Revision: 2, Authorised
17/01/2018Orphan designation:

Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide (lutetium (177Lu) oxodotreotide)

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours (updated)
17/01/2018Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 10, Authorised
17/01/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
17/01/2018Human medicines European public assessment report (EPAR): CellCept,

mycophenolate mofetil

Revision: 27, Authorised
17/01/2018Human medicines European public assessment report (EPAR): Blitzima,

rituximab

Revision: 2, Authorised
17/01/2018Procurement (updated)
17/01/2018Human medicines European public assessment report (EPAR): Venclyxto,

venetoclax

Revision: 2, Authorised
16/01/2018Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/201705
16/01/2018Human rabies immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001639/201704
16/01/2018Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / human von willebrand factor

Revision: 9, Authorised
16/01/2018Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 22, Authorised
16/01/2018Human medicines European public assessment report (EPAR): Rasilez HCT,

aliskiren / hydrochlorothiazide

Revision: 13, Authorised
16/01/2018Human medicines European public assessment report (EPAR): ReFacto AF,

moroctocog alfa

Revision: 34, Authorised
16/01/2018European Union Network data board - Terms of reference (updated)
16/01/2018Agenda: Agenda - CVMP agenda of the 16-18 January 2018 meeting
16/01/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for evaluation procedure for CVMP scientific advice requests
16/01/2018Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 12, Authorised
16/01/2018Organisation chart: Stakeholders and Communication (updated)
16/01/2018Human medicines European public assessment report (EPAR): Viramune,

nevirapine

Revision: 35, Authorised
15/01/2018Cyproterone / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00000906/201705
15/01/2018Risperidone: List of nationally authorised medicinal products - PSUSA/00002649/201705
15/01/2018Olodaterol / tiotropium: List of nationally authorised medicinal products - PSUSA/00010489/201705
15/01/2018Chlorpromazine: List of nationally authorised medicinal products - PSUSA/00000715/201705
15/01/2018News and press releases: Defect with Buccolam oral syringes
15/01/2018Orphan 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
15/01/2018Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201705
15/01/2018Venlafaxine: List of nationally authorised medicinal products - PSUSA/00003104/201705
15/01/2018Piracetam: List of nationally authorised medicinal products - PSUSA/00002429/201704
15/01/2018Buspirone: List of nationally authorised medicinal products - PSUSA/00000463/201704
15/01/2018Orphan designation:

antisense oligonucleotide targeting exon 73 in the COL7A1 gene

for the: Treatment of epidermolysis bullosa
15/01/2018News and press releases: Chair of EMA’s committee for orphan medicines receives award for outstanding patient engagement
15/01/2018Orphan designation:

(R)-troloxamide quinone

for the: Treatment of amyotrophic lateral sclerosis
15/01/2018Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/201705
15/01/2018Glimepiride: List of nationally authorised medicinal products - PSUSA/00001534/201706
15/01/2018Technetium (99mTc) tetrofosmin, tetrofosmin: List of nationally authorised medicinal products - PSUSA/00002870/201705
15/01/2018Agenda: Agenda - COMP agenda of the 16-18 January 2018 meeting
15/01/2018Letter of support for the development of a needs-based quality of life Patient Reported Outcome (PRO) measure specific to adults with plexiform neurofibromas
15/01/2018Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm,

clopidogrel

Revision: 5, Authorised
15/01/2018Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 11, Authorised
15/01/2018Orphan designation:

Recombinant adeno-associated viral vector serotype 9 containing human iduronate-2-sulfatase gene

for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
15/01/2018Orphan designation:

tamoxifen citrate

for the: Treatment of Duchenne muscular dystrophy
15/01/2018Orphan designation:

tiratricol

for the: Treatment of Allan-Herndon-Dudley syndrome
15/01/2018Human medicines European public assessment report (EPAR): Helixate NexGen,

octocog alfa

Revision: 31, Authorised
15/01/2018Orphan designation:

N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin)benzamide

for the: Treatment of peripheral T-cell lymphoma
15/01/2018Human medicines European public assessment report (EPAR): Elocta,

efmoroctocog alfa

Revision: 3, Authorised
15/01/2018Orphan designation:

1,4-diamino-2,3-dicyano-1,4-bis[2-aminophenylthio] butadiene

for the: Treatment of non-traumatic subarachnoid haemorrhage
15/01/2018Human medicines European public assessment report (EPAR): Advate,

octocog alfa

Revision: 22, Authorised
15/01/2018Orphan 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
15/01/2018Human medicines European public assessment report (EPAR): Palonosetron Hospira,

palonosetron

Revision: 2, Authorised
15/01/2018Orphan designation:

Concizumab

for the: Treatment of haemophilia B
12/01/2018CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2017
12/01/2018Human medicines European public assessment report (EPAR): Zubsolv,

buprenorphine / naloxone

Revision: 0, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Trelegy Ellipta,

fluticasone furoate / umeclidinium / vilanterol

Revision: 0, Authorised
12/01/2018Orphan designation:

diazoxide choline

for the: treatment of Prader-Willi syndrome
12/01/2018Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 18, Authorised
12/01/2018Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201705
12/01/2018Orphan designation:

C1-esterase-inhibitor human

for the: Treatment in solid organ transplantation
12/01/2018Fluorescein (systemic use): List of nationally authorised medicinal products - PSUSA/00009153/201704
12/01/2018Esomeprazole / naproxen: List of nationally authorised medicinal products - PSUSA/00001270/201704
12/01/2018Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 10, Authorised
12/01/2018Veterinary medicine European public assessment report (EPAR): Bluevac BTV8,

bluetongue virus inactivated, serotype 8

Revision: 5, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Memantine Mylan,

memantine

Revision: 3, Authorised
12/01/2018News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2018
12/01/2018News and press releases: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
12/01/2018Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 24, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 21, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Spedra,

avanafil

Revision: 10, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Repaglinide Krka,

repaglinide

Revision: 5, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Brineura,

cerliponase alfa

Revision: 1, Authorised
12/01/2018Referral: Article 29(4) referrals, Alcover and associated names,

sodium oxybate

(updated)
12/01/2018Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 16, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Zepatier,

elbasvir / grazoprevir

Revision: 4, Authorised
12/01/2018Human medicines European public assessment report (EPAR): NeoRecormon,

epoetin beta

Revision: 24, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 38, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 22, Authorised
12/01/2018Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
12/01/2018Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 6, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 8, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Zavesca,

miglustat

Revision: 26, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Roteas,

edoxaban

Revision: 1, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Nemdatine,

memantine

Revision: 7, Authorised
12/01/2018Human medicines European public assessment report (EPAR): Kisplyx,

lenvatinib

Revision: 4, Authorised
11/01/2018Referral: Article 31 referrals, Flupirtine-containing medicinal products,

flupirtine

(updated)
11/01/2018Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 14, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 12, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 7, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Ocrevus,

ocrelizumab

Revision: 0, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 31, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Olanzapine Mylan,

olanzapine

Revision: 12, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Spinraza,

nusinersen

Revision: 1, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Rapiscan,

regadenoson

Revision: 8, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 30, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 9, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Ixiaro,

Japanese-encephalitis vaccine (inactivated, adsorbed)

Revision: 13, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 12, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Aerinaze,

desloratadine / pseudoephedrine

Revision: 15, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 9, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 19, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 10, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Evista,

raloxifene

Revision: 21, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Levetiracetam Sun,

levetiracetam

Revision: 9, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Neulasta,

pegfilgrastim

Revision: 29, Authorised
11/01/2018COOK IVF cell media - Procedural steps and scientific information after initial consultation (updated)
11/01/2018CHMP opinions on consultation procedures (updated)
11/01/2018Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 19, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Kengrexal,

cangrelor

Revision: 4, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 14, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Fycompa,

perampanel

Revision: 13, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Alecensa,

alectinib

Revision: 4, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 2, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Pemetrexed Hospira,

pemetrexed

Revision: 4, Authorised
11/01/2018Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 37, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Inovelon,

rufinamide

Revision: 15, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 15, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Aranesp,

darbepoetin alfa

Revision: 39, Authorised
10/01/2018Veterinary medicine European public assessment report (EPAR): Leucogen,

Adjuvanted vaccine against feline leukaemia

Revision: 4, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 11, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Praxbind,

idarucizumab

Revision: 4, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 18, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Blincyto,

blinatumomab

Revision: 6, Authorised
10/01/2018Human medicines European public assessment report (EPAR): HBVaxPro,

hepatitis-B vaccine (rDNA)

Revision: 24, Authorised
10/01/2018Human medicines European public assessment report (EPAR): Lymphoseek,

tilmanocept

Revision: 4, Authorised
10/01/2018Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis, adopted
10/01/2018Orphan designation:

Seladelpar

for the: Treatment of primary biliary cholangitis
10/01/2018Human medicines European public assessment report (EPAR): Esmya,

ulipristal

Revision: 11, Authorised
10/01/2018Orphan designation:

Autologous ex-vivo-expanded peripheral polyclonal lymphocytes enriched in activated natural killer cells

for the: Treatment of multiple myeloma
10/01/2018Orphan designation:

5-amino-1-(2-methyl-1H-benzo[d]imidazol-5-yl)-1H-pyrazol-4-yl 1H-indol-2-yl ketone mono[(S)-2-hydroxysuccinate]

for the: Treatment of biliary tract cancer
10/01/2018Work plan for the Gastroenterology Drafting Group 2018
10/01/2018Work plan for the Pharmacogenomics Working Party 2018
10/01/2018Work plan for the CHMP Oncology Working Party for 2018
10/01/2018Orphan designation:

Bitopertin

for the: Treatment of beta-thalassaemia intermedia and major
10/01/2018Human medicines European public assessment report (EPAR): Dexdor,

dexmedetomidine

Revision: 7, Authorised
09/01/2018Decision of the Executive Director on a 1-year initiative for fee reductions for notifications of parallel distribution (updated)
09/01/2018Joint Audit Programme (updated)
09/01/2018Orphan designation:

Adenoviral vector of serotype 5 modified to contain a chimeric sequence consisting of a minimal urokinase-type plasminogen activator receptor promoter preceded by three Notch-responsive elements, and coated with oligopeptide end-modified poly (beta-amino) esters

for the: Treatment of pancreatic cancer
09/01/2018Orphan designation:

Glasdegib maleate

for the: Treatment of acute myeloid leukaemia
09/01/2018Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 14, Authorised
09/01/2018Orphan designation:

Siplizumab

for the: Treatment in solid organ transplantation
09/01/2018Orphan designation:

Glucopyranosyl lipid A

for the: Treatment of follicular lymphoma
09/01/2018Orphan designation:

Pracinostat

for the: Treatment of acute myeloid leukaemia
09/01/2018National experts on secondment (updated)
09/01/2018Jobs@EMA User guide
09/01/2018A common data model in Europe? – Why? Which? How?, European Medicines Agency, London, UK, From: 11-Dec-2017, To: 12-Dec-2017 (updated)
09/01/2018Signal management (updated)
09/01/2018Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 29, Authorised
09/01/2018Quality of medicines questions and answers: Part 2 (updated)
08/01/2018Agenda: Agenda - PRAC draft agenda of meeting 8-11 January 2018
08/01/2018Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 31, Authorised
08/01/2018Orphan designation:

Cannabidivarin

for the: Treatment of Rett syndrome
08/01/2018Orphan designation:

Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8

for the: Treatment of mastocytosis
08/01/2018Compliance Group mandate
08/01/2018Orphan designation:

S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid

for the: Treatment of primary sclerosing cholangitis
08/01/2018Work plan for the Cardiovascular Working Party 2018 (updated)
08/01/2018Orphan designation:

Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F

for the: Treatment of multiple myeloma
08/01/2018Orphan designation:

Cannabidiol

for the: Treatment of West syndrome
08/01/2018Minutes of the CHMP meeting 06-09 November 2017
08/01/2018Report: Applications for new human medicines under evaluation by the CHMP: January 2018
08/01/2018Orphan designation:

Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin

for the: Treatment of Prader-Willi syndrome
08/01/2018Orphan designation:

Recombinant adeno-associated viral vector serotype 5 encoding Staphylococcus aureus Cas9 endonuclease and two guide RNAs complementary to two regions of intron 26 of the CEP290 gene

for the: Treatment of Leber’s congenital amaurosis
08/01/2018Orphan designation:

2-[N-(2-hydroxyethyl)]-N-(4-methoxybenzenesulfonyl)]amino-N-(4-chlorocinnamyl)-N-methylbenzylamine

for the: Treatment of Charcot-Marie-Tooth disease
08/01/2018Orphan designation:

Entospletinib

for the: Treatment of acute myeloid leukaemia
08/01/2018Orphan designation:

Ofranergene obadenovec

for the: Treatment of ovarian cancer
05/01/2018Herbal medicinal products: Vitis , Vitis viniferae folium, Vitis vinifera L. (updated)
05/01/2018Minutes of the PRAC meeting 23-26 October 2017
05/01/2018Work plan for the Rheumatology-Immunology Working Party 2017
05/01/2018Veterinary medicine European public assessment report (EPAR): Sevohale (previously known as Sevocalm),

sevoflurane

Revision: 2, Authorised
05/01/2018Work plan for the Central Nervous System Working Party 2018
05/01/2018Work plan for the Pharmacokinetics Working Party 2018
05/01/2018Minutes - PDCO minutes of the 7-10 November 2017 meeting
05/01/2018Newsletter: Human medicines highlights - January 2018
05/01/2018Frequently asked questions about parallel distribution (updated)
05/01/2018Herbal medicinal products: Glycine, Lecithinum ex soya, Glycine max (L.) Merr. (updated)
05/01/2018Veterinary medicine European public assessment report (EPAR): Coxevac,

inactivated Coxiella burnetii vaccine

Revision: 6, Authorised
04/01/2018Herbal medicinal products: Olea, Oleae folium, Olea europaea L. (updated)
04/01/2018Human medicines European public assessment report (EPAR): Clopidogrel Acino,

clopidogrel

Revision: 6, Withdrawn
04/01/2018Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 13, Authorised
04/01/2018Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union, European Medicines Agency, London, UK, From: 24-Nov-2017, To: 24-Nov-2017
04/01/2018Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 26, Authorised
04/01/2018Human medicines European public assessment report (EPAR): Karvezide,

irbesartan / hydrochlorothiazide

Revision: 34, Authorised
04/01/2018Human medicines European public assessment report (EPAR): Imbruvica,

ibrutinib

Revision: 11, Authorised
04/01/2018PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017, adopted
04/01/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 25-30 November 2017 PRAC
04/01/2018List of signals discussed at the PRAC since September 2012 (updated)
04/01/2018Sodium iodide (131i): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002753/201703
04/01/2018Sodium iodide (131i): List of nationally authorised medicinal products - PSUSA/00002753/201703
04/01/2018Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX,

avian infectious bronchitis vaccine (live)

Revision: 2, Authorised
03/01/2018Fluticasone propionate: List of nationally authorised medicinal products- PSUSA/00001454/201702
03/01/2018Fluticasone propionate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation- PSUSA/00001454/201702
03/01/2018Veterinary medicine European public assessment report (EPAR): Kexxtone,

monensin

Revision: 4, Authorised
03/01/2018Orphan designation:

Sodium chlorite

for the: Treatment of amyotrophic lateral sclerosis (updated)
03/01/2018Veterinary medicine European public assessment report (EPAR): Eravac,

Rabbit haemorrhagic disease vaccine (inactivated)

Revision: 2, Authorised
03/01/2018Mefloquine: List of nationally authorised medicinal products - PSUSA/00001955/201702
03/01/2018Mefloquine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001955/201702
03/01/2018Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous stromal vascular fraction
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous human mesenchymal stem cells present in bone marrow cells suspension
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded polyclonal CD4+CD25+CD127lo/-FOXP3+ regulatory T cells
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Viable autologous adipose-derived regenerative cells
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Pro-inflammatory dendritic cells
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: DNA plasmid encoding for the extracellular domain of human TNFα p55 receptor linked to the human IgG1 Fc domain
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 2/1 vector encoding human β-hexosaminidase alpha and beta subunits
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured dental pulp stem cells
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous dental pulp stem cells
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Freshly isolated autologous CD34+
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogenic adipose-derived stem cells differentiated in vitro towards the cardiovascular lineage
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated viral vector serotype 8 containing the human low-density lipoprotein receptor (LDLR) gene
03/01/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Full-thickness human skin substitute composed of an epidermal layer of fully-stratified human keratinocytes and a collagen-rich dermal equivalent containing human dermal fibroblasts
03/01/2018Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010345/201702
03/01/2018Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus): List of nationally authorised medicinal products - PSUSA/00010345/201702