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August 2016

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24/08/2016Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 13, Authorised
24/08/2016Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 33, Authorised
24/08/2016Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 9, Authorised
24/08/2016Questions and answers on signal management (updated)
24/08/2016Presentation - Introduction to training offering by EMA: Training module PhV-M0 (updated)
23/08/2016Human medicines European public assessment report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 25, Authorised
23/08/2016Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 13, Authorised
22/08/2016Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene),

pomalidomide

Revision: 8, Authorised
22/08/2016Human medicines European public assessment report (EPAR): PritorPlus,

telmisartan / hydrochlorothiazide

Revision: 29, Authorised
22/08/2016Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 21, Authorised
22/08/2016Human medicines European public assessment report (EPAR): Rapamune,

sirolimus

Revision: 34, Authorised
22/08/2016Minutes - PDCO minutes of the 20-22 July 2016 meeting
22/08/2016Annual reports for the period from 2012 to 2015 on staff engaging in an occupational activity within two years of leaving the service (article 16 of the staff regulations) (updated)
22/08/2016Agenda: Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 15 June 2016 (updated)
22/08/2016Medical literature monitoring workshop, European Medicines Agency, London, UK, From: 13-Sep-2016, To: 13-Sep-2016
22/08/2016Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 8, Authorised
22/08/2016Veterinary medicine European public assessment report (EPAR): Loxicom,

meloxicam

Revision: 12, Authorised
19/08/2016Orphan designation:

Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis (thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione

for the: The treatment of pancreatic cancer (updated)
19/08/2016Orphan designation:

Isofagomine tartrate

for the: Treatment of Gaucher disease (updated)
19/08/2016Orphan designation:

Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F

for the: Treatment of glioma (updated)
19/08/2016Orphan designation:

Milatuzumab

for the: Treatment of multiple myeloma (updated)
19/08/2016Orphan designation:

Yttrium (90Y)-DOTA-radiolabelled humanized monoclonal antibody against mucin 1

for the: Treatment of pancreatic cancer (updated)
19/08/2016Orphan designation:

Veltuzumab

for the: Treatment of chronic lymphocytic leukaemia (updated)
19/08/2016Orphan designation:

Milatuzumab

for the: Treatment of chronic lymphocytic leukaemia (updated)
19/08/2016Orphan designation:

Veliparib

for the: Treatment of ovarian cancer (updated)
19/08/2016Orphan designation:

4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

for the: Treatment of chronic lymphocytic leukaemia (updated)
19/08/2016Orphan designation:

Mogamulizumab

for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated) (updated)
19/08/2016Orphan 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)
19/08/2016Orphan designation:

N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N'-(2-fluoro-5-methylphenyl) urea

for the: Treatment of hepatocellular carcinoma (updated)
19/08/2016Orphan designation:

Fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol

for the: Treatment of Charcot-Marie-Tooth disease type 1A (updated)
19/08/2016Orphan designation:

Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA

for the: Treatment of Huntington’s disease (updated)
19/08/2016Human medicines European public assessment report (EPAR): Zontivity,

vorapaxar

Revision: 2, Authorised
19/08/2016EudraVigilance - Inclusion/exclusion criteria for the “Important Medical Events” list
19/08/2016Human medicines European public assessment report (EPAR): Macugen,

pegaptanib

Revision: 15, Authorised
19/08/2016EudraVigilance training on electronic reporting of individual case safety reports (ICSRs) in the European Economic Area (Vienna), Austrian Agency for Health and Food Safety (AGES), From: 23-Nov-2016, To: 25-Nov-2016
19/08/2016Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 6, Authorised
19/08/2016EudraVigilance training on electronic reporting of individual case safety reports (ICSRs) in the European Economic Area (Madrid), Agencia Espanola Medicamentos y Productos Sanitarios (AEMPS), From: 28-Sep-2016, To: 30-Sep-2016
19/08/2016Orphan designation:

Obinutuzumab

for the: Treatment of follicular lymphoma (updated)
19/08/2016eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, Agencia Espanola Medicamentos y Productos Sanitarios (AEMPS), From: 26-Sep-2016, To: 27-Sep-2016
19/08/2016Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 26, Authorised
19/08/2016EudraVigilance training (updated)
19/08/2016Human medicines European public assessment report (EPAR): Dasselta,

desloratadine

Revision: 7, Authorised
19/08/2016Human medicines European public assessment report (EPAR): Halaven,

eribulin

Revision: 14, Authorised
19/08/2016Veterinary medicine European public assessment report (EPAR): Sevohale (previously known as Sevocalm),

sevoflurane

Revision: 1, Authorised
19/08/2016Orphan designation:

Pegylated recombinant phenylalanine ammonia lyase

for the: Treatment of hyperphenylalaninaemia (updated)
19/08/2016Report: Medicinal products for human use: monthly figures - July 2016
19/08/2016Human medicines European public assessment report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 19, Authorised
19/08/2016Human medicines European public assessment report (EPAR): Repaglinide Krka,

repaglinide

Revision: 4, Authorised
18/08/2016Designated Medical Event (DME) list
18/08/2016Signal management (updated)
18/08/2016Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 28, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Emselex,

darifenacin hydrobromide

Revision: 19, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 25, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Desloratadine Teva,

desloratadine

Revision: 9, Authorised
18/08/2016Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD,

live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009

Revision: 3, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 8, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 17, Authorised
18/08/2016Human medicines European public assessment report (EPAR): Enyglid,

repaglinide

Revision: 6, Authorised
18/08/2016Orphan designation:

Phosphorothioate oligonucleotide targeted to apolipoprotein C-III

for the: Treatment of familial chylomicronaemia syndrome (updated)
18/08/2016Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 26, Authorised
18/08/2016Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
18/08/2016Orphan designation:

Antisense oligonucleotide targeted to the SMN2 gene

for the: Treatment of 5q spinal muscular atrophy (updated)
18/08/2016Orphan designation:

Phosphorothioate oligonucleotide targeted to transthyretin

for the: Treatment of ATTR amyloidosis (updated)
17/08/2016Orphan designation:

Recombinant antibody construct against human CD30 and CD16A

for the: Treatment of Hodgkin’s lymphoma (updated)
17/08/2016Omarigliptin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
17/08/2016Orphan designation:

Defibrotide

for the: Treatment of hepatic veno-occlusive disease (updated)
17/08/2016Orphan designation:

Defibrotide

for the: Prevention of hepatic veno-occlusive disease (updated)
17/08/2016Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2016
17/08/2016Agenda: Agenda - PDCO agenda of the 17-19 August 2016 meeting
17/08/2016Orphan designation:

Defibrotide

for the: Prevention of graft-versus-host disease (updated)
17/08/2016Human medicines European public assessment report (EPAR): Vidaza,

azacitidine

Revision: 14, Authorised
17/08/2016EudraVigilance - Key project milestones and summary of associated ADR communications (updated)
17/08/2016Member States involved in the European Medicines Agency-European Union Member states-Food and Drug Administration initiative on inspections for generic applications (updated)
17/08/2016Veterinary medicine European public assessment report (EPAR): Nobivac L4,

Vaccine to prevent Leptospira infections in dogs

Revision: 2, Authorised
16/08/2016Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 8, Authorised
16/08/2016Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 5, Authorised
16/08/2016Human medicines European public assessment report (EPAR): Triumeq,

abacavir sulfate / dolutegravir sodium / lamivudine

Revision: 5, Authorised
16/08/2016Registration form - Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
16/08/2016Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products, European Medicines Agency, London, UK, From: 15-Nov-2016, To: 16-Nov-2016
16/08/2016Agenda: Programme of the Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
16/08/2016News and press releases: Addressing challenges of innovative cancer immunotherapy medicines
16/08/2016Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 28, Authorised
16/08/2016Orphan designation:

3-Pentylbenzeneacetic acid sodium salt

for the: Treatment of idiopathic pulmonary fibrosis (updated)
16/08/2016Orphan designation:

Obeticholic acid

for the: Treatment of primary sclerosing cholangitis (updated)
16/08/2016Orphan designation:

(1-Methyl-2-nitro-1H-imidazole-5-yl)methyl N,N’-bis(2-bromoethyl)diamidophosphate

for the: Treatment of pancreatic cancer (updated)
16/08/2016Orphan designation:

Human heterologous liver cells (for infusion)

for the: Treatment of carbamoyl-phosphate synthase-1 deficiency (updated)
16/08/2016Orphan designation:

Human heterologous liver cells (for infusion)

for the: Treatment of argininosuccinic aciduria (updated)
16/08/2016Orphan designation:

Human heterologous liver cells (for infusion)

for the: Treatment of citrullinaemia type 1 (updated)
16/08/2016Orphan designation:

Human heterologous liver cells (for infusion)

for the: Treatment of hyperargininaemia (updated)
16/08/2016Orphan designation:

68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid

for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours (updated)
16/08/2016Orphan designation:

Sodium ascorbate and menadione sodium bisulfite

for the: Treatment of autosomal dominant polycystic liver disease (updated)
16/08/2016Implementing ISO IDMP: introduction to SPOR data services, European Medicines Agency, London, UK, From: 04-Aug-2016, To: 04-Aug-2016 (updated)
16/08/2016Human medicines European public assessment report (EPAR): Epivir,

lamivudine

Revision: 38, Authorised
16/08/2016Eighth industry stakeholder platform: operation of the European Union (EU) pharmacovigilance legislation, European Medicines Agency, London, UK, From: 01-Jul-2016, To: 01-Jul-2016 (updated)
16/08/2016Highlights from the eighth European Medicines Agency Industry Platform meeting on the operation of European Union pharmacovigilance legislation - 1 July 2016
16/08/2016Human medicines European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers),

ribavirin

Revision: 9, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Cialis,

tadalafil

Revision: 24, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD),

caspofungin

Revision: 21, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Teysuno,

tegafur / gimeracil / oteracil

Revision: 11, Authorised
15/08/2016Orphan designation:

Beloranib

for the: Treatment of craniopharyngioma (updated)
15/08/2016Orphan designation:

Beloranib

for the: Treatment of Prader-Willi syndrome (updated)
15/08/2016Orphan designation:

Recombinant human ADAMTS-13

for the: Treatment of thrombotic thrombocytopenic purpura (updated)
15/08/2016Orphan designation:

Human heterologous liver cells (for infusion)

for the: Treatment of acute liver failure (updated)
15/08/2016Orphan designation:

Human apotransferrin

for the: Treatment of congenital hypotransferrinaemia (updated)
15/08/2016Orphan designation:

[Gly2]-recombinant human glucagon-like peptide

for the: Treatment of short-bowel syndrome (updated)
15/08/2016Orphan designation:

humanised monoclonal antibody of the IgG4 kappa isotype targeting CD47

for the: treatment of acute myeloid leukaemia (updated)
15/08/2016Orphan designation:

Pro-Pro-Thr-Val-Pro-Thr-Arg

for the: Treatment of xeroderma pigmentosum (updated)
15/08/2016Orphan designation:

Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin

for the: Treatment of malignant mesothelioma (updated)
15/08/2016Orphan designation:

Two allogeneic irradiated pancreatic tumour cell lines

for the: Treatment of pancreatic cancer (updated)
15/08/2016Orphan designation:

Tideglusib

for the: Treatment of fragile X syndrome (updated)
15/08/2016Orphan designation:

Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene

for the: Treatment of high-grade glioma with subsequent use of ganciclovir sodium (updated)
15/08/2016Human medicines European public assessment report (EPAR): Oncaspar,

pegaspargase

Revision: 2, Authorised
15/08/2016Orphan designation:

Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin

for the: Treatment of pancreatic cancer (updated)
15/08/2016Human medicines European public assessment report (EPAR): Byetta,

exenatide

Revision: 19, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Cerezyme,

imiglucerase

Revision: 20, Authorised
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of citrullinaemia type 2 (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of hyperargininaemia (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of argininosuccinic aciduria (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of citrullinaemia type 1 (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of ornithine carbamoyltransferase deficiency (updated)
15/08/2016Orphan designation:

Glyceryl tri-(4-phenylbutyrate)

for the: Treatment of carbamoyl-phosphate synthase-1 deficiency (updated)
15/08/2016Orphan designation:

pentetrazol

for the: Treatment of idiopathic hypersomnia (updated)
15/08/2016Orphan designation:

Yttrium (90Y) edotreotide

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumors (updated)
15/08/2016Orphan designation:

Antisense oligonucleotide targeting the F508delta mutation of CFTR

for the: Treatment of cystic fibrosis (updated)
15/08/2016Orphan designation:

Ciclosporin

for the: Treatment of vernal keratoconjunctivitis (updated)
15/08/2016Orphan designation:

Recombinant human parathyroid hormone

for the: Treatment of hypoparathyroidism (updated)
15/08/2016Orphan designation:

N,N'-bis(2-mercaptoethyl)isophthalamide

for the: Treatment of mercury toxicity (updated)
15/08/2016Orphan designation:

Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene

for the: Treatment of glycogen storage disease type II (Pompe's disease) (updated)
15/08/2016Veterinary medicine European public assessment report (EPAR): Canigen L4,

Canine leptospirosis vaccine (inactivated)

Revision: 1, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Zonegran,

zonisamide

Revision: 25, Authorised
15/08/2016Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 5, Authorised
15/08/2016Orphan designation:

Recombinant human lecithin cholesterol acyltransferase

for the: Treatment of lecithin-cholesterol-acyltransferase deficiency (updated)
15/08/2016Orphan designation:

Maribavir

for the: Prevention of cytomegalovirus disease in patients with impaired cell mediated immunity (updated)
15/08/2016Orphan designation:

N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate

for the: Treatment of renal-cell carcinoma (updated)
15/08/2016Orphan designation:

Alpha-1 antitrypsin (inhalation use)

for the: Treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency (updated)
15/08/2016Orphan designation:

Humanised IgG1 monoclonal antibody against human eotaxin-2

for the: Treatment of systemic sclerosis (updated)
15/08/2016Orphan designation:

Chimeric monoclonal antibody to O-acetyl-GD2 antigen

for the: Treatment of neuroblastoma (updated)
15/08/2016Orphan designation:

Allantoin

for the: Treatment of epidermolysis bullosa (updated)
15/08/2016Orphan designation:

Maribavir

for the: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity (updated)
15/08/2016Orphan designation:

Enzastaurin hydrochloride

for the: Treatment of glioma (updated)
15/08/2016Orphan designation:

Enzastaurin hydrochloride

for the: Treatment of diffuse large B cell lymphoma (updated)
15/08/2016Orphan designation:

Metronidazole

for the: Treatment of pouchitis (updated)
15/08/2016Human medicines European public assessment report (EPAR): Praluent,

alirocumab

Revision: 4, Authorised
15/08/2016Annex II - Concession specification: costing sheet (EMA/2016/43/RS)
15/08/2016Invitation to apply for a service concession in the area of meeting and training organisation (EMA/2016/43/RS)
15/08/2016Technical specifications for service concession: meeting and training organisation (EMA/2016/43/RS)
15/08/2016Appendix B - Estimated business requirements (EMA/2016/43/RS)
15/08/2016Annex VII - Draft concession contract (EMA/2016/43/RS)
15/08/2016Annex VI - Service concession: Checklist of documents which applicant must submit (EMA/2016/43/RS)
15/08/2016Annex V - Service concession: Subcontractors (EMA/2016/43/RS)
15/08/2016Annex IV - Service concession: Minimum technical requirements declaration (EMA/2016/43/RS)
15/08/2016Annex I - Concession information sheet and declaration on submission (EMA/2016/43/RS)
15/08/2016Annex III - Service concession: Declaration of honour on exclusion criteria and selection criteria (EMA/2016/43/RS)
15/08/2016Workshop on single-arm trials in oncology, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 30-Jun-2016 (updated)
15/08/2016Archive of development of good pharmacovigilance practices (updated)
15/08/2016Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changes
15/08/2016Good pharmacovigilance practices (updated)
15/08/2016Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with considerations P.II on biological medicinal products finalised post-public consultation
15/08/2016Scientific guideline: Comments received from public consultation on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products
15/08/2016Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products, adopted
15/08/2016News and press releases: Better monitoring of biological medicines
12/08/2016Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 21, Authorised
12/08/2016Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 5, Authorised
12/08/2016Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 14, Authorised
12/08/2016Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4R,

Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 2, Authorised
12/08/2016Human medicines European public assessment report (EPAR): Infanrix Hexa,

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

Revision: 26, Authorised
12/08/2016Veterinary medicine European public assessment report (EPAR): Ibraxion,

Inactivated and adjuvanted vaccine against Bovine Rhinotracheitis

Revision: 8, Authorised
12/08/2016Regulatory and procedural guideline: EudraVigilance auditable requirement project - EudraVigilance training plan, adopted (updated)
12/08/2016Regulatory and procedural guideline: EudraVigilance stakeholder change management plan (updated)
12/08/2016Veterinary medicine European public assessment report (EPAR): Recocam,

meloxicam

Revision: 3, Authorised
12/08/2016Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 8, Authorised
12/08/2016Orphan designation:

Triheptanoin

for the: Treatment of very-long-chain 3-hydroxyacyl-CoA-dehydrogenase deficiency (updated)
11/08/2016Human medicines European public assessment report (EPAR): Rapilysin,

reteplase

Revision: 22, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Clopidogrel Acino,

clopidogrel

Revision: 6, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 10, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 24, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Zypadhera,

olanzapine

Revision: 15, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 7, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Replagal,

agalsidase alfa

Revision: 20, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 31, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Vizarsin,

sildenafil

Revision: 12, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma,

telmisartan

Revision: 7, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Conbriza,

bazedoxifene

Revision: 9, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Elocta,

efmoroctocog alfa

Revision: 2, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Akynzeo,

netupitant / palonosetron

Revision: 1, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 7, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 28, Authorised
11/08/2016Human medicines European public assessment report (EPAR): RoActemra,

tocilizumab

Revision: 20, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 5, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Pioglitazone Accord,

pioglitazone

Revision: 3, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 6, Authorised
11/08/2016Human medicines European public assessment report (EPAR): Faslodex,

fulvestrant

Revision: 15, Authorised
11/08/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
11/08/2016Orphan designation:

Human anthrax monoclonal antibody

for the: For post-exposure prophylaxis of inhalation anthrax disease (updated)
11/08/2016News and press releases: Data integrity: key to public health protection
11/08/2016Orphan designation:

unoprostone isopropyl

for the: Treatment of retinitis pigmentosa (updated)
11/08/2016Orphan designation:

Triheptanoin

for the: Treatment of long-chain 3-hydroxyacyl-CoA-dehydrogenase deficiency (updated)
11/08/2016Orphan designation:

Human anthrax immunoglobulin

for the: Treatment of inhalation anthrax disease (updated)
11/08/2016Orphan designation:

17-(Dimethylaminoethylamino)-17-demethoxygeldanamycin (after administration of adeno-associated viral vector encoding an inducible short hairpin RNA targeting claudin-5)

for the: Treatment of retinitis pigmentosa (updated)
11/08/2016Orphan designation:

Human anthrax monoclonal antibody

for the: Treatment of inhalation anthrax disease (updated)
11/08/2016Human medicines European public assessment report (EPAR): Sycrest,

asenapine

Revision: 14, Authorised
11/08/2016Orphan designation:

Ramucirumab

for the: Treatment of hepatocellular carcinoma (updated)
11/08/2016Orphan designation:

Chimeric antibody to mesothelin

for the: Treatment of pancreatic cancer (updated)
11/08/2016Orphan designation:

Amrubicin hydrochloride

for the: Treatment of small cell lung cancer (updated)
11/08/2016Orphan designation:

Human anthrax immunoglobulin

for the: Post-exposure prophylaxis of inhalation anthrax disease (updated)
11/08/2016Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 5, Authorised
10/08/2016Human medicines European public assessment report (EPAR): Ratiograstim,

filgrastim

Revision: 8, Authorised
10/08/2016Human medicines European public assessment report (EPAR): Somavert,

pegvisomant

Revision: 14, Authorised
10/08/2016Principles for ensuring the confidentiality of data supplied to the European Surveillance of Veterinary Antimicrobial Agent Consumption (ESVAC) project (updated)
10/08/2016Report: Report on budgetary and financial management: financial year 2015
10/08/2016Orphan designation:

2-Chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine

for the: Treatment of acute lymphoblastic leukaemia (updated)
10/08/2016Orphan designation:

Homoharringtonine

for the: Treatment of acute myeloid leukaemia (updated)
10/08/2016Orphan designation:

Sorafenib tosylate

for the: Treatment of renal cell carcinoma (updated)
10/08/2016Orphan designation:

Homoharringtonine

for the: Treatment of chronic myeloid leukaemia (updated)
10/08/2016Orphan designation:

Recombinant human bile-salt-stimulated lipase

for the: Treatment of cystic fibrosis (updated)
10/08/2016Orphan designation:

Liarozole

for the: Treatment of congenital ichthyoses (updated)
10/08/2016Orphan designation:

Iodine (123I) Serum Amyloid P

for the: Diagnosis of the extent of histologically proven amyloidosis (updated)
10/08/2016Orphan designation:

Fumagillin

for the: Treatment of diarrhoea associated with intestinal microsporidial infection (updated)
10/08/2016Orphan designation:

Recombinant human acid alpha-glucosidase

for the: Treatment of glycogen storage disease type II (Pompe's disease) (updated)
10/08/2016Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 6, Authorised
10/08/2016Human medicines European public assessment report (EPAR): Desloratadine ratiopharm,

desloratadine

Revision: 5, Authorised
10/08/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: ivermectin (topical use) PSUSA/00010376/201510
10/08/2016List of nationally authorised medicinal products: acitretin PSUSA/00000051/201510
10/08/2016CMDh Scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation: acitretin PSUSA/00000051/201510
10/08/2016List of nationally authorised medicinal products: ivermectin (topical use) PSUSA/00010376/201510
09/08/2016Referral: Article 13 referrals, Levonelle 1500 microgram tablets and associated names,

levonorgestrel

(updated)
09/08/2016Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 13, Authorised
09/08/2016Implementation of the pharmacovigilance legislation (updated)
09/08/2016Newsletter: Human medicines highlights - July 2016
09/08/2016Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 19, Authorised
09/08/2016Report: Applications for new human medicines under evaluation by the CHMP: August 2016
09/08/2016Veterinary medicine European public assessment report (EPAR): Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Revision: 3, Authorised
09/08/2016Human medicines European public assessment report (EPAR): Biopoin,

epoetin theta

Revision: 11, Authorised
09/08/2016Human medicines European public assessment report (EPAR): Betaferon,

interferon beta-1b

Revision: 27, Authorised
09/08/2016Referral: Article 31 referrals, Factor VIII (updated)
09/08/2016Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 22, Authorised
08/08/2016Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
08/08/2016Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
08/08/2016Presubmission guidance: questions 24 to 33 (updated)
08/08/2016Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD,

live vaccine against infectious bursal disease and Marek's disease

Revision: 9, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Zoledronic acid Teva Generics,

zoledronic acid

Revision: 2, Withdrawn
08/08/2016News and press releases: EU collaboration strengthens safety monitoring of medicines
08/08/2016Maribavir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
08/08/2016Submission of comments on GVP Module IX – Signal management (EMA/827661/2011 Rev. 1)
08/08/2016Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2) (EMA/395730/2012)
08/08/2016Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII – Post-authorisation safety studies (Rev. 2) (EMA/813938/2011)
08/08/2016Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions, draft: consultation open
08/08/2016Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2), draft: consultation open
08/08/2016Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies with tracked changes (Rev. 2)
08/08/2016Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies with tracked changes (Rev. 2)
08/08/2016Scientific guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2), adopted (updated)
08/08/2016Scientific guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2), adopted (updated)
08/08/2016Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1), draft: consultation open
08/08/2016Submission of comments on GVP Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions (EMA/209012/2015)
08/08/2016Submission of comments on GVP Module VI – Management and reporting of adverse reactions to medicinal products (EMA/873138/2011 Rev. 2)
08/08/2016Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with draft revision 2 of module VI on management and reporting of adverse reactions and draft revision 1 of module IX on signal management with its addendum for public consultation, and final revision 2 of module VIII on post-authorisation studies with its addendum
08/08/2016Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 22, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 18, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen),

aripiprazole

Revision: 3, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 22, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Temozolomide Accord,

temozolomide

Revision: 14, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Benepali,

etanercept

Revision: 3, Authorised
08/08/2016Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 6, Authorised
08/08/2016Certification procedures for micro-, small- and medium-sized enterprises (SMEs) (updated)
08/08/2016Ex ante publicity of a negotiated procedure – EMA/2016/22/DF – Supply and disposal of catering equipment including appliances
05/08/2016Referral: Article 35, Colistin combinations,

colistin and amoxicillin; ampicillin; chlortetracycline; doxycycline; enrofloxacin; erythromycin; neomycin; oxytetracycline; spiramycin; sulfadimethoxine; sulfaguanidine; sulfamethoxypyridazine ...

05/08/2016Human medicines European public assessment report (EPAR): Memantine ratiopharm,

memantine

Revision: 3, Authorised
05/08/2016Human medicines European public assessment report (EPAR): Tobi Podhaler,

tobramycin

Revision: 12, Authorised
05/08/2016Human medicines European public assessment report (EPAR): Aldara,

imiquimod

Revision: 21, Authorised
05/08/2016Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 12, Authorised
05/08/2016Scientific guideline: Draft questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies, draft: consultation open
05/08/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: perindopril PSUSA/00002354/201510
05/08/2016List of nationally authorised medicinal products: perindopril PSUSA/00002354/201510
05/08/2016News and press releases: Transparency in drug regulation
05/08/2016Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 18, Authorised
05/08/2016Scientific guideline: Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer - Revision 1, adopted
05/08/2016Scientific guideline: Guideline on development, production, characterisation and specification for monoclonal antibodies and related products - Revision 1, adopted
05/08/2016Scientific guideline: Guideline on production and quality control of animal immunoglobulins and immunosera for human use - Revision 1, adopted
05/08/2016Production and quality control of animal immunoglobins and immunosera for human use (updated)
05/08/2016Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer (updated)
05/08/2016Development, production, characterisation and specifications for monoclonal antibodies and related products (updated)
04/08/2016Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 3, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 9, Authorised
04/08/2016Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 3, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Ovaleap,

follitropin alfa

Revision: 4, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 20, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Bortezomib Sun,

bortezomib

Revision: 0, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Ivabradine Anpharm,

ivabradine

Revision: 2, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Aclasta,

zoledronic acid

Revision: 22, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Aripiprazole Sandoz,

aripiprazole

Revision: 2, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Unituxin,

dinutuximab

Revision: 1, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Zyclara,

imiquimod

Revision: 4, Authorised
04/08/2016Agenda: Agenda - Workshop on measuring the impact of pharmacovigilance activities
04/08/2016Availability of veterinary vaccines
04/08/2016News and press releases: Increasing the availability of veterinary vaccines in the EU
04/08/2016Human medicines European public assessment report (EPAR): Kinzalkomb,

telmisartan / hydrochlorothiazide

Revision: 30, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Rasilez HCT,

aliskiren / hydrochlorothiazide

Revision: 10, Authorised
04/08/2016Human medicines European public assessment report (EPAR): Memantine LEK,

memantine

Revision: 3, Authorised
04/08/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 20-22 July 2016
04/08/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2016
04/08/2016Minutes - PDCO minutes of the 22-24 June 2016 meeting
04/08/2016Human medicines European public assessment report (EPAR): Levetiracetam Teva,

levetiracetam

Revision: 10, Authorised
04/08/2016Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
04/08/2016Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
04/08/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
04/08/2016Renewals: questions and answers (updated)
04/08/2016Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure
04/08/2016Regulatory and procedural guideline: Guideline on the processing of renewals in the centralised procedure , adopted
04/08/2016Application and Evaluation: Regulatory and procedural guidance (updated)
04/08/2016Pre-submission: Regulatory and procedural guidance (updated)
04/08/2016Generic / hybrid applications: questions 11 to 22 (updated)
04/08/2016Generic / hybrid applications: questions 1 to 10 (updated)
04/08/2016Worksharing: questions and answers (updated)
04/08/2016Grouping of variations: questions and answers (updated)
04/08/2016Extension applications: questions and answers (updated)
04/08/2016Transparency: questions and answers (updated)
04/08/2016Periodic safety update reports: questions and answers (updated)
04/08/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
04/08/2016Renewals: Regulatory and procedural guidance (updated)
04/08/2016Regulatory and procedural guideline: Guideline on the processing of renewals in the centralised procedure: document with track changes , draft: consultation closed (updated)
04/08/2016Post-authorisation safety studies: questions and answers (updated)
04/08/2016Transfer of marketing authorisation: questions and answers (updated)
04/08/2016Type-II variations: questions and answers (updated)
04/08/2016Human medicines European public assessment report (EPAR): Lonquex,

lipegfilgrastim

Revision: 10, Authorised
04/08/2016Type-IA variations: questions and answers (updated)
04/08/2016Type-IB variations: questions and answers (updated)
03/08/2016List of nationally authorised medicinal products: metoclopramide PSUSA/00002036/201510
03/08/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: metoclopramide PSUSA/00002036/201510
03/08/2016Veterinary medicine European public assessment report (EPAR): Osurnia,

terbinafine / florfenicol / betamethasone

Revision: 2, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 6, Authorised
03/08/2016Questions and answers: Good manufacturing practice (updated)
03/08/2016Human medicines European public assessment report (EPAR): Telmisartan Actavis,

telmisartan

Revision: 7, Authorised
03/08/2016Newsletter: News bulletin for small and medium-sized enterprises - Issue 36
03/08/2016Regulatory and procedural guideline: List of active substances subject to worksharing for signal management (updated)
03/08/2016Human medicines European public assessment report (EPAR): Tasmar,

tolcapone

Revision: 21, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Temozolomide Sun,

temozolomide

Revision: 9, Authorised
03/08/2016News and press releases: Adaptive pathways: key learnings and next steps
03/08/2016Regulatory and procedural guideline: Guidance for companies considering the adaptive pathways approach (updated)
03/08/2016Report: Final report on the adaptive pathways pilot
03/08/2016Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 9, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Eporatio,

epoetin theta

Revision: 9, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Iasibon,

ibandronic acid

Revision: 6, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Aripiprazole Accord,

aripiprazole

Revision: 2, Authorised
03/08/2016Human medicines European public assessment report (EPAR): MicardisPlus,

telmisartan / hydrochlorothiazide

Revision: 25, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 37, Authorised
03/08/2016Human medicines European public assessment report (EPAR): Caspofungin Accord,

caspofungin

Revision: 1, Authorised
03/08/2016Pending EC decision: Mysildecard,

sildenafil

Opinion date: 28-Jul-2016
03/08/2016Innovative Medicines Initiative WEB-RADR workshop: mobile technologies and social media as new tools in pharmacovigilance, European Medicines Agency, London, UK, From: 19-Oct-2016, To: 19-Oct-2016
02/08/2016Human medicines European public assessment report (EPAR): Avonex,

interferon beta-1a

Revision: 27, Authorised
02/08/2016Human medicines European public assessment report (EPAR): Nemdatine,

memantine

Revision: 5, Authorised
02/08/2016Human medicines European public assessment report (EPAR): Kovaltry,

octocog alfa

Revision: 1, Authorised
02/08/2016Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 10, Authorised
02/08/2016News and press releases: New layout for EMA scientific guidelines
02/08/2016Orphan designation:

Melatonin

for the: Treatment of necrotising enterocolitis
02/08/2016Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 38, Authorised
02/08/2016Recommendations on minor-use-minor-species and limited-market classifications (updated)
02/08/2016Human medicines European public assessment report (EPAR): Neofordex,

dexamethasone

Revision: 1, Authorised
02/08/2016Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 4, Authorised
02/08/2016Veterinary medicine European public assessment report (EPAR): Prac-tic,

pyriprole

Revision: 9, Authorised
02/08/2016Plasma-master-file certifications (updated)
02/08/2016New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC
02/08/2016PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016, adopted
01/08/2016Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products (updated)
01/08/2016Scientific guideline: Concept paper on revision of guidelines on the clinical investigation and core SmPC of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 rev. 1) (EMA/CHMP/BPWP/1619/1999 rev. 2), draft: consultation open
01/08/2016Clinical investigation of recombinant and human plasma-derived factor VIII products (updated)
01/08/2016Clinical development of medicinal products for the treatment of cystic fibrosis (updated)
01/08/2016Scientific guideline: Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/2008) - Revision 1, draft: consultation open
01/08/2016Annual report of the Good Clinical Practice Inspections Working Group 2015
01/08/2016List of signals discussed at the PRAC since September 2012 (updated)
01/08/2016Report: Workshop report - Developing a framework of collaboration between the European Medicines Agency (EMA) and academia
01/08/2016Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016 (updated)
01/08/2016Agenda: Agenda - Healthcare Professionals Organisations Working Party (HCPWP) workshop with academia (updated)
01/08/2016Scientific guideline: Draft abiraterone tablets 250 mg product-specific bioequivalence guidance, draft: consultation open
01/08/2016Scientific guideline: Draft exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance, draft: consultation open
01/08/2016Vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance
01/08/2016Vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance
01/08/2016Paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance
01/08/2016Scientific guideline: Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance, draft: consultation open
01/08/2016Scientific guideline: Draft paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance, draft: consultation open
01/08/2016Scientific guideline: Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance, draft: consultation open
01/08/2016Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis (updated)
01/08/2016News and press releases: Development of medicines to treat tuberculosis
01/08/2016Scientific guideline: Draft addendum to the 'guideline on the evaluation of medicinal products indicated for treatment of bacterial infections' to address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis - Revision 1, draft: consultation open
01/08/2016Agenda: Agenda - Patient registries workshop
01/08/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
01/08/2016Patient registries workshop, European Medicines Agency, London, UK, From: 28-Oct-2016, To: 28-Oct-2016
01/08/2016Identifying opportunities for ‘Big data’ in medicines development and regulation, European Medicines Agency, London, UK, From: 14-Nov-2016, To: 15-Nov-2016
01/08/2016Abiraterone tablets 250 mg product-specific bioequivalence guidance
01/08/2016Exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance
01/08/2016Development of new medicinal products for the treatment of ulcerative colitis (updated)
01/08/2016Clinical investigation of medicinal products for the management of Crohn's disease (updated)
01/08/2016Information Management (updated)
01/08/2016Scientific guideline: Draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2, draft: consultation open
01/08/2016Scientific guideline: Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1, draft: consultation open
01/08/2016Organisation chart: Information Management (updated)