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June 2018

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13/06/2018Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 10, Authorised
13/06/2018Human medicines European public assessment report (EPAR): Copalia HCT,

amlodipine / valsartan / hydrochlorothiazide

Revision: 11, Authorised
13/06/2018Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 12, Authorised
13/06/2018eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 20-Sep-2018, To: 21-Sep-2018
13/06/2018eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 15-Nov-2018, To: 16-Nov-2018
13/06/2018Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018
13/06/2018Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018
13/06/2018Evaluation of medicinal products indicated for treatment of bacterial infections (updated)
13/06/2018Procurement activities 2017 (updated)
13/06/2018Orphan designation:

Ivosidenib

for the: Treatment of acute myeloid leukaemia (updated)
13/06/2018Orphan designation:

2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (remdesivir)

for the: Treatment of Ebola virus disease (updated)
13/06/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s.,

pregabalin

Revision: 3, Authorised
13/06/2018Orphan designation:

Sialic acid (also known as aceneuramic acid)

for the: Treatment of GNE myopathy (updated)
13/06/2018Orphan designation:

Synthetic double-stranded RNA oligonucleotide specific to hydroxyacid oxidase 1 gene

for the: Treatment of primary hyperoxaluria type 1 (updated)
13/06/2018Human medicines European public assessment report (EPAR): Circadin,

melatonin

Revision: 27, Authorised
13/06/2018Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 9, Authorised
13/06/2018Orphan designation:

humanised fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain

for the: Prevention of graft-versus-host disease (updated)
13/06/2018Orphan designation:

Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor

for the: Treatment of retinitis pigmentosa (updated)
13/06/2018Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran)

for the: Treatment of haemophilia B (updated)
13/06/2018Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran)

for the: Treatment of haemophilia A (updated)
13/06/2018Orphan designation:

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel)

for the: Treatment of B-lymphoblastic leukaemia/lymphoma (updated)
13/06/2018Human medicines European public assessment report (EPAR): Zavesca,

miglustat

Revision: 27, Authorised
13/06/2018Orphan designation:

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel)

for the: Treatment of diffuse large B-cell lymphoma (updated)
13/06/2018Orphan designation:

Aztreonam lysinate (inhalation use)

for the: Treatment of Gram-negative bacterial lung infection in cystic fibrosis (updated)
13/06/2018Orphan designation:

Mexiletine hydrochloride

for the: Treatment of myotonic disorders (updated)
13/06/2018Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 10, Authorised
13/06/2018Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 48, Authorised
13/06/2018Applying for orphan designation (updated)
13/06/2018Human medicines European public assessment report (EPAR): Akynzeo,

netupitant / palonosetron

Revision: 3, Authorised
13/06/2018Human medicines European public assessment report (EPAR): NovoMix,

insulin aspart

Revision: 26, Authorised
13/06/2018Human medicines European public assessment report (EPAR): Eporatio,

epoetin theta

Revision: 11, Authorised
13/06/2018Orphan designation:

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

for the: Treatment of primary myelofibrosis (updated)
13/06/2018Orphan designation:

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

for the: Treatment of post-essential thrombocythaemia myelofibrosis (updated)
13/06/2018Orphan designation:

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

for the: Treatment of post-polycythaemia vera myelofibrosis (updated)
12/06/2018Human medicines European public assessment report (EPAR): Jalra,

vildagliptin

Revision: 15, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 23, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Temozolomide Teva,

temozolomide

Revision: 17, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Cuprymina,

copper (64Cu) chloride

Revision: 6, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Filgrastim Hexal,

filgrastim

Revision: 14, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Incresync,

alogliptin / pioglitazone

Revision: 6, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Pemetrexed medac,

pemetrexed

Revision: 2, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Grepid,

clopidogrel

Revision: 16, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Stocrin,

efavirenz

Revision: 38, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Trelegy Ellipta,

fluticasone furoate / umeclidinium / vilanterol

Revision: 1, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Temodal,

temozolomide

Revision: 30, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Zerbaxa,

ceftolozane / tazobactam

Revision: 7, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 13, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Elebrato Ellipta,

fluticasone furoate / umeclidinium / vilanterol

Revision: 1, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Quinsair,

levofloxacin

Revision: 7, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 21, Authorised
12/06/2018Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 15, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Neofordex,

dexamethasone

Revision: 3, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva,

lamivudine / zidovudine

Revision: 9, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi,

busulfan

Revision: 4, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 7, Authorised
12/06/2018Orphan designation:

A highly purified formulation of Staphylococcus aureus protein A

for the: Treatment of immune thrombocytopenia (updated)
12/06/2018Orphan designation:

Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl ethyl ester))-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-PEG1500-ester]

for the: Treatment of dengue (updated)
12/06/2018Orphan designation:

Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor

for the: Treatment in haematopoietic stem cell transplantation (updated)
12/06/2018Human medicines European public assessment report (EPAR): Emend,

aprepitant

Revision: 24, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 55, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 15, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Ritonavir Mylan,

ritonavir

Revision: 1, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 20, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 33, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 8, Authorised
12/06/2018Veterinary medicine European public assessment report (EPAR): NexGard,

afoxolaner

Revision: 5, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 12, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 27, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Effentora,

fentanyl

Revision: 19, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva,

pregabalin

Revision: 4, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Zutectra,

human hepatitis-B immunoglobulin

Revision: 12, Authorised
12/06/2018Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 26, Authorised
11/06/2018Minutes of the PRAC meeting 9-12 April 2018
11/06/2018Dexamfetamine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/201709
11/06/2018Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201709
11/06/2018Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria
11/06/2018Regulatory and procedural guideline: Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities (updated)
11/06/2018Management Board meeting: 15 March 2018, European Medicines Agency, London, UK, From: 15-Mar-2018, To: 15-Mar-2018 (updated)
11/06/2018Agenda: Agenda and list of speakers - Public Hearing: quinolone and fluoroquinolone medicines (updated)
11/06/2018PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC meeting, adopted
11/06/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC
11/06/2018List of signals discussed at the PRAC since September 2012 (updated)
11/06/2018Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 11, Authorised
11/06/2018Human medicines European public assessment report (EPAR): Abraxane,

paclitaxel

Revision: 21, Authorised
11/06/2018Committee for Herbal Medicinal Products (HMPC): 4-5 June 2018, European Medicines Agency, London, UK, From: 04-Jun-2018, To: 05-Jun-2018 (updated)
11/06/2018Agenda: Agenda - HMPC agenda of the 4-5 June 2018 meeting
11/06/2018Outcome of written procedures during the period 22 February 2018 to 21 May 2018
11/06/2018Report: Summary of transfers of appropriations in budget 2018
11/06/2018Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018, European Medicines Agency, London, UK, From: 11-Jun-2018, To: 14-Jun-2018 (updated)
11/06/2018Agenda: Agenda - PRAC draft agenda of meeting 11-14 June 2018
11/06/2018Management Board meeting: 6-7 June 2018, European Medicines Agency, London, UK, From: 06-Jun-2018, To: 07-Jun-2018 (updated)
11/06/2018Management Board meeting dates 2019 – 2021
11/06/2018Human medicines European public assessment report (EPAR): ATryn,

antithrombin alfa

Revision: 14, Authorised
11/06/2018Human medicines European public assessment report (EPAR): Mixtard,

insulin human (rDNA)

Revision: 17, Authorised
11/06/2018Human medicines European public assessment report (EPAR): Starlix,

nateglinide

Revision: 13, Authorised
11/06/2018Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 35, Authorised
11/06/2018Guidance on good manufacturing practice and good distribution practice: Questions and answers (updated)
11/06/2018Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 4, Authorised
08/06/2018EudraVigilance Operational Plan - milestones 2018 to 2020
08/06/2018Orphan designation:

Para-aminosalicylic acid

for the: Treatment of tuberculosis (updated)
08/06/2018Orphan designation:

(1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine

for the: Treatment of neurotrophic keratitis (updated)
08/06/2018EudraVigilance (updated)
08/06/2018Orphan designation:

Bitopertin

for the: Treatment of beta-thalassaemia intermedia and major (updated)
08/06/2018Orphan designation:

tiratricol

for the: Treatment of Allan-Herndon-Dudley syndrome (updated)
08/06/2018Orphan 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)
08/06/2018Human medicines European public assessment report (EPAR): Actraphane,

insulin human (rDNA)

Revision: 17, Authorised
08/06/2018Orphan designation:

Glibenclamide for the treatment of neonatal diabetes

for the: Treatment of neonatal diabetes (updated)
08/06/2018Human medicines European public assessment report (EPAR): Amglidia,

glibenclamide

Revision: 0, Authorised
08/06/2018Report: Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use: June 2018
08/06/2018Human medicines European public assessment report (EPAR): Jakavi,

ruxolitinib

Revision: 16, Authorised
08/06/2018CHMP ORGAM minutes for the meeting on 16 April 2018
08/06/2018Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018, European Medicines Agency, London, UK, From: 23-Apr-2018, To: 26-Apr-2018 (updated)
08/06/2018Human medicines European public assessment report (EPAR): Invanz,

ertapenem

Revision: 21, Authorised
08/06/2018SPOR user registration
08/06/2018Orphan designation:

(Manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-)

for the: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy (updated)
08/06/2018Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 11, Authorised
08/06/2018Orphan designation:

Mepolizumab

for the: Treatment of Churg-Strauss syndrome (updated)
08/06/2018Orphan designation:

Mepolizumab

for the: Treatment of hypereosinophilic syndrome (updated)
08/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Cadazolid

Therapeutic area: Infectious diseases (updated)
08/06/2018Cadazolid - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
08/06/2018Human medicines European public assessment report (EPAR): Pemetrexed Krka,

pemetrexed

Revision: 0, Authorised
07/06/2018News and press releases: Highlights of 100th Management Board meeting: June 2018
07/06/2018Clinical Trial Regulation (updated)
07/06/2018Referral: Article 31 referrals, Valproate and related substances,

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

(updated)
07/06/2018Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 14, Authorised
07/06/2018Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 13, Authorised
07/06/2018Permethrin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002355/201707
07/06/2018Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/201707
07/06/2018Human medicines European public assessment report (EPAR): Mirvaso,

brimonidine

Revision: 8, Authorised
07/06/2018Finasteride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001392/201708
07/06/2018Finasteride: List of nationally authorised medicinal products - PSUSA/00001392/201708
07/06/2018Human medicines European public assessment report (EPAR): Cabometyx ,

cabozantinib

Revision: 2, Authorised
07/06/2018Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 13, Authorised
07/06/2018Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/201708
07/06/2018Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708
07/06/2018News and press releases: Changes to submission and assessment of maximum residue limits of veterinary medicines in foods
07/06/2018Human medicines European public assessment report (EPAR): Remicade,

infliximab

Revision: 50, Authorised
07/06/2018News and press releases: Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience
07/06/2018Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 15, Authorised
06/06/2018Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop),

clopidogrel

Revision: 22, Authorised
06/06/2018Pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale cereal - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale cereale

Therapeutic area: Other (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pollen from Betula verrucosa

Therapeutic area: Pneumology-allergology (updated)
06/06/2018Pollen from Betula verrucosa - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pollen from Alnus glutinosa, Betula verrucosa and Corylus avellana

Therapeutic area: Pneumology-allergology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pollen from Phleum pratense

Therapeutic area: Other (updated)
06/06/2018Pollen from Alnus glutinosa, Betula verrucosa and Corylus avellana - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/06/2018Pollen from Phleum pratense - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/06/2018Allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae

Therapeutic area: Pneumology-allergology (updated)
06/06/2018Agenda: Agenda for the 100th meeting of the Management Board (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Quizartinib

Therapeutic area: Oncology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Orencia,

Abatacept

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Xgeva; Prolia,

Denosumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology/Endocrinology, -gynacology-fertility-metabolism (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pyridopyrimidione SMN2 splicing modifier

Therapeutic area: Neurology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Varuby,

Rolapitant

Therapeutic area: Haematology-Hemostaseology (updated)
06/06/2018List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Binimetinib

Therapeutic area: Oncology (updated)
06/06/2018Presentation - Understanding which technologies are coming into the healthcare systems (Michael Berntgen)
06/06/2018Presentation - Update on PRIME (Jordi Llinares and Zahra Hanaizi)
06/06/2018Presentation - Post licensing evidence generation (PLEG) (Jane Moseley)
06/06/2018Presentation - Follow-up from the EC/EMA workshop on paediatrics (Ralph Bax)
06/06/2018Presentation - EMA experience with the review of digital technology proposals in medicine development programmes (Francesca Cerreta)
06/06/2018Presentation - Experience with the review of the orphan designation in the context of extension of indication (Kristina Larsson)
06/06/2018Presentation - Evolving framework for the co-development of medicinal products with companion diagnostics (Falk Ehmann and Armin Ritzhaupt)
06/06/2018Presentation - Histology-independent indications (Kristina Larsson)
06/06/2018Presentation - Scientific and regulatory evaluation procedure support [S-REPS] pilot update / system preview (Sylvie Beausuroy, Paolo Tomasi, Bob Coggins)
06/06/2018Presentation - Targeting “histology-independent indications” and resulting challenges in the context of orphan designations (Francesco Pignatti)
06/06/2018Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 59, Authorised
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Encorafenib

Therapeutic area: Oncology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661) / ivacaftor

Therapeutic area: Pneumology-allergology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Erenumab

Therapeutic area: Neurology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Selumetinib

Therapeutic area: Oncology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene

Therapeutic area: Haematology-Hemostaseology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Iblias, Kovaltry,

Octocog alfa

Therapeutic area: Haematology-Hemostaseology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Afstyla,

Lonoctocog alfa

Therapeutic area: Haematology-Hemostaseology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Indacaterol (acetate) / mometasone (furoate)

Therapeutic area: Pneumology-allergology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Lanadelumab (DX-2930)

Therapeutic area: Other (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Lokelma,

Sodium zirconium cyclosilicate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Osilodrostat

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Simponi,

Golimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Rydapt,

Midostaurin

Therapeutic area: Oncology (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): Acarizax and associated names,

Dermatophagoides pteronyssinus / dermatophagoides farinae allergen extract

Therapeutic area: Pneumology-allergology (updated)
06/06/20182017 annual report of the European Medicines Agency (updated)
06/06/2018Application form for European Medicines Agency certificates of medicinal products (updated)
06/06/2018Human medicines European public assessment report (EPAR): Steglujan,

ertugliflozin / sitagliptin

Revision: 1, Authorised
06/06/2018Human medicines European public assessment report (EPAR): Vemlidy,

tenofovir alafenamide

Revision: 4, Authorised
06/06/2018Agenda: Programme - 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
06/06/20182018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018 (updated)
06/06/2018Agenda: CHMP ORGAM agenda for the meeting on 22 May 2018
06/06/2018Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 28-31 May 2018
06/06/2018Report: List of products granted eligibility to PRIME (updated)
06/06/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Crisaborole

Therapeutic area: Dermatology (updated)
06/06/2018Orphan designation:

Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein

for the: Treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome) (updated)
06/06/2018Statement of expenses for candidates (updated)
06/06/2018News and press releases: Towards improved safety monitoring of veterinary medicines
06/06/2018EudraVigilance Veterinary (updated)
05/06/2018Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 22, Authorised
05/06/2018Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 25, Authorised
05/06/2018Human medicines European public assessment report (EPAR): Travatan,

travoprost

Revision: 27, Authorised
05/06/2018Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 11, Authorised
05/06/2018Human medicines European public assessment report (EPAR): Levemir,

insulin detemir

Revision: 26, Authorised
05/06/2018Work instructions for preparation of a Withdrawal Assessment Report - Orphan Maintenance following the request of withdrawal of an orphan designation after COMP review at time of marketing authorisation or extension of indication, adopted
05/06/2018Work instructions for preparation of an Orphan Maintenance Assessment Report (OMAR) following a positive or negative opinion on the maintenance of the orphan designation criteria at time of marketing authorisation or extension of indication, adopted
05/06/2018Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi,

pemetrexed

Revision: 3, Authorised
05/06/2018Human medicines European public assessment report (EPAR): Farydak,

panobinostat

Revision: 4, Authorised
04/06/2018Human medicines European public assessment report (EPAR): Oslif Breezhaler,

indacaterol

Revision: 12, Authorised
04/06/2018Human medicines European public assessment report (EPAR): Steglatro,

ertugliflozin

Revision: 1, Authorised
04/06/2018Human medicines European public assessment report (EPAR): Insuman,

insulin human

Revision: 26, Authorised
04/06/2018Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 5, Authorised
04/06/2018Mandate, objectives and rules of procedure for the CVMP Immunologicals Working Party (IWP) (updated)
04/06/2018Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 19, Authorised
04/06/2018Orphan designation:

Mavoglurant 

for the: Treatment of fragile-X syndrome (updated)
04/06/2018Orphan designation:

Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor (lacnotuzumab)

for the: Treatment of tenosynovial giant cell tumour, localised and diffused type (updated)
04/06/2018Mandate, objectives and rules of procedure for the CVMP Environmental Risk Assessment Working Party (ERAWP) (updated)
04/06/2018Mandate, objectives and rules of procedure for the CVMP Safety Working Party (SWP-V) (updated)
04/06/2018Recommendation for the basic surveillance of Eudravigilance veterinary data (updated)
04/06/2018Mandate, objectives and rules of procedure for the CVMP Scientific Advice Working Party (SAWP-V) (updated)
04/06/2018Human medicines European public assessment report (EPAR): Semglee,

insulin glargine

Revision: 1, Authorised
04/06/2018Mandate, objectives and rules of procedure for the CVMP Efficacy Working Party (EWP-V) (updated)
04/06/2018Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) (updated)
04/06/2018Mandate, objectives and rules of procedure for the CVMP Antimicrobials Working Party (AWP) (updated)
04/06/2018Scientific publications (updated)
04/06/2018Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707
04/06/2018Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707
04/06/2018Quetiapine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002589/201707
04/06/2018Quetiapine: List of nationally authorised medicinal products - PSUSA/00002589/201707
04/06/2018Alprostadil (indicated in peripheral arterial occlusive diseases): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000111/201707
04/06/2018Alprostadil (indicated in peripheral arterial occlusive diseases): List of nationally authorised medicinal products - PSUSA/00000111/201707
04/06/2018Roxithromycin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002669/201612 (updated)
01/06/2018Human medicines European public assessment report (EPAR): Aubagio,

teriflunomide

Revision: 9, Authorised
01/06/2018Human medicines European public assessment report (EPAR): GONAL-f,

follitropin alfa

Revision: 21, Authorised
01/06/2018Human medicines European public assessment report (EPAR): Jylamvo,

methotrexate

Revision: 1, Authorised
01/06/2018Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 June 2018 (updated)
01/06/2018Mutual recognition agreements (updated)
01/06/2018News and press releases: Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
01/06/2018News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018
01/06/2018News and press releases: First monoclonal antibody therapy for prevention of migraine
01/06/2018News and press releases: New medicine for hereditary rare disease
01/06/2018News and press releases: Esmya: new measures to minimise risk of rare but serious liver injury
01/06/2018Pending EC decision: Rxulti,

brexpiprazole

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Hyrimoz,

adalimumab

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Translarna,

ataluren

Opinion date: 31-May-2018
01/06/2018News and press releases: EMA restricts use of Keytruda and Tecentriq in bladder cancer
01/06/2018Scientific advice and protocol assistance adopted during the CHMP meeting 28 – 31 May 2018, adopted
01/06/2018Pending EC decision: Exondys,

eteplirsen

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Alsitek,

masitinib

Opinion date: 18-Apr-2018 (updated)
01/06/2018Pending EC decision: Hefiya,

adalimumab

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Halimatoz,

adalimumab

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Xeljanz,

tofacitinib

Opinion date: 31-May-2018
01/06/2018Referral: Article 30 referrals, Scandonest and associated names,

mepivacaine

(updated)
01/06/2018Start of community reviews - CHMP meeting of 18-31 May 2018, adopted
01/06/2018Pending EC decision: Tegsedi,

inotersen

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Trazimera,

trastuzumab

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Myalepta,

metreleptin

Opinion date: 31-May-2018
01/06/2018Pending EC decision: Briviact (in Italy: Nubriveo),

brivaracetam

Opinion date: 31-May-2018
01/06/2018Withdrawn application: Restaysis,

ciclosporin

Initial authorisation
01/06/2018Pending EC decision: Nityr,

nitisinone

Opinion date: 31-May-2018
01/06/2018Referral: Article 20 procedures, Esmya,

ulipristal acetate

(updated)
01/06/2018Referral: Article 31 referrals, Metamizole containing medicinal products,

metamizole

01/06/2018Pending EC decision: Aimovig,

erenumab

Opinion date: 31-May-2018
01/06/2018Agenda: Agenda - Info day for micro, small and medium-sized enterprises: regulatory toolbox for medicines and combined devices developers (updated)
01/06/2018Info 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 (updated)
01/06/2018Procurement (updated)
01/06/2018Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (updated)