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May 2016

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31/05/2016Human medicines European public assessment report (EPAR): Levetiracetam Sun,

levetiracetam

Revision: 6, Authorised
31/05/2016Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 14, Authorised
31/05/2016Orphan designation:

Recombinant fusion protein linking human coagulation factor IX with human albumin

for the: Treatment of haemophilia B (updated)
31/05/2016Referral: Article 78, Closamectin Pour-on Solution and associated names,

Ivermectin, closantel

31/05/2016Rewards and incentives for paediatric medicines (updated)
31/05/2016Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 10, Authorised
31/05/2016Presentation - Session 3: Extrapolation plan and PK/PD studies Panel Discussion (Martin Posch)
31/05/2016Presentation - Supporting a Pediatric Investigational Plan for Everolimus - Defining the extrapolation plan (Thomas Dumortier, Mick Looby)
31/05/2016Presentation - On the road to clinical extrapolation (Kristina Weber, Armin Koch)
31/05/2016Presentation - Paediatric Pulmonary arterial hypertension - Regulatory Perspective (Amany El-gazayerly)
31/05/2016Presentation - Extrapolation challenges in pediatric PAH - Possible solutions for a feasible, global study (M. Bacchi, A. Morganti, P. Cornelisse, J. Bolognese, C. Lesage, A. Kümmel, P. Nilsson)
31/05/2016Presentation - Extrapolation plan and statistical tools - Panel discussion (Flora Musuamba, Alexander Staab)
31/05/2016Presentation - Validating the extrapolation concept – methodological considerations (Andrew Thomson)
31/05/2016Presentation - Confirmation of extrapolation based on PK/PD data and modeling (Jacob Brogren)
31/05/2016Presentation - General framework on managing uncertainties (Kevin Blake)
31/05/2016Presentation - Decision making, revisited
31/05/2016Presentation - Regulatory interactions: Expectations on extrapolation approaches (Lynne Yao)
31/05/2016Presentation - Considerations for Implementing the EMA Extrapolation Approach: A Global Drug Developer’s Perspective (Christina Bucci-Rechtweg)
31/05/2016Presentation - EMA Extrapolation Framework Regulatory tools (Paolo Tomasi)
31/05/2016Presentation - Design of PK/PD Studies (Mats Karlsson)
31/05/2016Presentation - Model Informed Drug Discovery and Development (MID3) Good Practice: use of prior knowledge and setting up assumptions (Scott Marshall, Lutz Harnisch)
31/05/2016EMA public workshop on extrapolation of efficacy and safety in medicine development, European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016 (updated)
31/05/2016Presentation - Extrapolation of dosing, efficacy and safety of biologics in JIA, IBD and psoriasis - EMA history (Richard Veselý)
31/05/2016Presentation - Case study Brivact UCB
31/05/2016Presentation - Extrapolation in paediatric juvenile idiopathic arthritis: case study (Ruth Oliver, Laura Shaughnessy, Philippa Charlton)
31/05/2016Presentation - Extrapolation & Pediatric Development: A case study from pediatric Ulcerative Colitis (Richard Strauss)
31/05/2016Presentation - POS (Partial onset seizures) Extrapolation from adults to children Clinical setting (Catherine Chiron, Gerard Pons)
31/05/2016Presentation - Methodology for extrapolation in the EU FP7 ASTERIX, IDeAl and InSPiRe projects (Nigel Stallard, Ralf-Dieter Hilgers, Kit Roes)
31/05/2016Presentation - (One) Statistician(’)s perspectives on extrapolation (Rob Hemmings)
31/05/2016Presentation - A modelling and simulation perspective on extrapolation (Ine Skottheim Rusten)
31/05/2016Presentation - Extrapolation: which is the patient perspective? (Marco Greco)
31/05/2016Presentation - Paediatric medicines development - The need for different approaches (Sam Maldonado)
31/05/2016Presentation - When do clinicians usually extrapolate in their practice? (Daniel Brasseur, Christoph Male)
31/05/2016Presentation - Bayesian prior elicitation: an application to the MYPAN trial in childhood polyarteritis nodosa (Lisa Hampson, John Whitehead, Despina Eleftheriou, Paul Brogan)
31/05/2016Presentation - EMA extrapolation framework (Christoph Male)
31/05/2016Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 13, Authorised
31/05/2016Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 27, Authorised
31/05/2016Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 12, Authorised
31/05/2016Educational brochure for healthcare professionals and diary for patients using Uptravi
31/05/2016Veterinary medicine European public assessment report (EPAR): Kexxtone,

monensin

Revision: 3, Authorised
31/05/2016Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 14, Authorised
31/05/2016Agenda: Agenda - Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance
31/05/2016Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance, European Medicines Agency, London, UK, From: 13-Jun-2016, To: 13-Jun-2016
31/05/2016Orphan designation:

Autologous stromal vascular cell fraction from adipose tissue

for the: Treatment of systemic sclerosis
31/05/2016Orphan designation:

Antisense oligonucleotide complementary to the exonic splicer enhancer sequence at intron 26 of the centrosomal protein 290 pre-mRNA

for the: Treatment of Leber’s congenital amaurosis
31/05/2016Orphan designation:

Resiquimod

for the: Treatment of cutaneous T-cell lymphoma
31/05/2016Orphan designation:

2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate

for the: Treatment of acute myeloid leukaemia
31/05/2016Scientific guideline: ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers, draft: consultation open
31/05/2016Orphan designation:

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

for the: Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy’s disease)
31/05/2016Orphan designation:

Combination of 4-hydroxyandrostenedione, Serenoa serrulata fruit extract and alpha lipoic acid

for the: Treatment of multiple symmetric lipomatosis
31/05/2016Orphan designation:

S-acetyl-(S)-4'-phosphopantetheine, calcium salt

for the: Treatment of pantothenate-kinase-associated neurodegeneration
30/05/2016Orphan designation:

Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase

for the: Treatment of Angelman syndrome
30/05/2016Orphan designation:

Cannabidiol

for the: Prevention of graft-versus-host disease
30/05/2016Orphan designation:

Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly

for the: Treatment of malignant mesothelioma
30/05/2016Orphan designation:

N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-L-arginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine N-hexadecylamide

for the: Treatment of beta thalassaemia intermedia and major
30/05/2016Orphan designation:

Recombinant human cerebral dopamine neurotrophic factor

for the: Treatment of amyotrophic lateral sclerosis
30/05/2016Orphan designation:

Humanised recombinant IgG4 anti-human tau antibody

for the: Treatment of progressive supranuclear palsy
30/05/2016Orphan designation:

Brincidofovir

for the: Prevention of cytomegalovirus disease
30/05/2016Orphan designation:

Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly

for the: Treatment of acute myeloid leukaemia
30/05/2016Orphan designation:

Fluocinolone acetonide

for the: Treatment of non-infectious uveitis
30/05/2016Orphan designation:

Autologous dermal fibroblasts genetically modified ex vivo with a lentiviral vector containing the human COL7A1 gene

for the: Treatment of epidermolysis bullosa
30/05/2016Orphan designation:

Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1

for the: Treatment of haemophilia B (congenital factor IX deficiency) (updated)
30/05/2016Orphan designation:

Human/murine chimeric monoclonal antibody against endoglin

for the: Treatment of soft tissue sarcoma
30/05/2016Human medicines European public assessment report (EPAR): Cayston,

aztreonam

Revision: 14, Authorised
30/05/2016Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 16, Authorised
30/05/2016Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 1, Authorised
30/05/2016List of nationally authorised medicinal products: carmustine (implant) PSUSA/00010348/201509
30/05/2016Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 7, Authorised
30/05/2016Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 2, Authorised
30/05/2016Veterinary medicine European public assessment report (EPAR): RevitaCAM,

meloxicam

Revision: 5, Withdrawn
27/05/2016Pending EC decision: Sialanar,

glycopyrronium bromide

Opinion date: 28-Apr-2016 (updated)
27/05/2016Informed consent for paediatric clinical trials in Europe 2015 (updated)
27/05/2016Agenda: Agenda - HMPC agenda of the 30-31 May 2016 meeting
27/05/2016Annexes - 2015 annual report of the European Medicines Agency (updated)
27/05/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2016 meeting
27/05/2016Scientific guideline: Draft guideline on the plant testing strategy for veterinary medicinal products, draft: consultation open
27/05/2016Scientific guideline: Draft reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media), draft: consultation open
27/05/2016European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines, European Medicines Agency, London, UK, From: 15-Apr-2016, To: 15-Apr-2016 (updated)
27/05/2016Plasma-master-file certifications (updated)
27/05/2016Human medicines European public assessment report (EPAR): Evra,

norelgestromin / ethinyl estradiol

Revision: 17, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Tepadina,

thiotepa

Revision: 9, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 16, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Myfenax,

mycophenolate mofetil

Revision: 17, Authorised
27/05/2016Overview of comments received on 'Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission'
27/05/2016Pending EC decision: Zepatier,

elbasvir / grazoprevir

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Qtern,

saxagliptin / dapagliflozin

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Revestive,

teduglutide

Opinion date: 26-May-2016
27/05/2016Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 May 2016
27/05/2016Pending EC decision: Ninlaro,

ixazomib

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Epclusa,

sofosbuvir / velpatasvir

Opinion date: 26-May-2016
27/05/2016Withdrawn application: Xegafri,

rociletinib

Initial authorisation
27/05/2016Pending EC decision: Humira,

adalimumab

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Kyprolis,

carfilzomib

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Adcetris,

brentuximab vedotin

Opinion date: 26-May-2016
27/05/2016Report: CHMP statistics: May 2016
27/05/2016Human medicines European public assessment report (EPAR): Idelvion,

albutrepenonacog alfa

Revision: 0, Authorised
27/05/2016News and press releases: Two new combination therapies against chronic hepatitis C
27/05/2016Pending EC decision: Tysabri,

natalizumab

Opinion date: 26-May-2016
27/05/2016Referral: Article 13 referrals, Levonelle 1500 microgram tablets and associated names,

levonorgestrel

27/05/2016Withdrawn application: Opsiria,

sirolimus

Initial authorisation
27/05/2016Pending EC decision: Bortezomib Sun,

bortezomib

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Pemetrexed Fresenius Kabi,

pemetrexed

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Bortezomib Hospira,

bortezomib

Opinion date: 26-May-2016
27/05/2016Pending EC decision: Simponi,

golimumab

Opinion date: 26-May-2016
27/05/2016Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 5, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 7, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 0, Authorised
27/05/2016Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Copper carbonate, adopted
27/05/2016News and press releases: Improving safety of first-in-human clinical trials
27/05/2016List of nationally authorised medicinal products: desogestrel / ethinylestradiol PSUSA/00000967/201509
27/05/2016List of nationally authorised medicinal products: chlorquinadol (vaginal tablet) promestriene PSUSA/00009272/201509
27/05/2016List of nationally authorised medicinal products: phloroglucinol, phloroglucinol / trimethylphloroglucinol PSUSA/00010355/201509
27/05/2016Human medicines European public assessment report (EPAR): Harvoni,

sofosbuvir / ledipasvir

Revision: 5, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 12, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 2, Authorised
27/05/2016Human medicines European public assessment report (EPAR): Zerbaxa,

ceftolozane / tazobactam

Revision: 3, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 6, Authorised
26/05/2016MRL report: Copper carbonate: European public maximum-residue-limit assessment report (EPMAR) - CVMP
26/05/2016Recommendations on the use of antibiotics in animals (updated)
26/05/2016Scientific guideline: Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health, draft: consultation open
26/05/2016News and press releases: European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance
26/05/2016Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 0, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 2, Authorised
26/05/2016Veterinary medicine European public assessment report (EPAR): Proteq West Nile,

West Nile recombinant canarypox virus (vCP2017 virus)

Revision: 2, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Glustin,

pioglitazone

Revision: 23, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 6, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 4, Authorised
26/05/2016Hexaxim H-W-2495 (updated)
26/05/2016Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 6, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 1, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Actos,

pioglitazone

Revision: 23, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Caelyx,

doxorubicin

Revision: 26, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Ovaleap,

follitropin alfa

Revision: 3, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 20, Authorised
26/05/2016Human medicines European public assessment report (EPAR): Tamiflu,

oseltamivir

Revision: 27, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Temozolomide Teva,

temozolomide

Revision: 15, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 4, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 45, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Abilify Maintena,

aripiprazole

Revision: 10, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Alprolix,

eftrenonacog alfa

Revision: 0, Authorised
25/05/2016Human medicines European public assessment report (EPAR): Trajenta,

linagliptin

Revision: 8, Authorised
25/05/2016Human medicines European public assessment report (EPAR): TachoSil,

human fibrinogen / human thrombin

Revision: 20, Authorised
25/05/2016List of nationally authorised medicinal products: latanoprost (products with paediatric indication) PSUSA/00001834/201510
25/05/2016List of nationally authorised medicinal products: lactitol PSUSA/00001819/201509
25/05/2016List of nationally authorised medicinal products: bisoprolol PSUSA/00000419/201509
25/05/2016Veterinary medicine European public assessment report (EPAR): MS-H Vaccine,

Mycoplasma synoviae strain MS-H

Revision: 2, Authorised
25/05/2016List of medicinal products under additional monitoring (updated)
25/05/2016List of medicinal products under additional monitoring (updated)
25/05/2016List of medicines under additional monitoring (updated)
25/05/2016(R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
25/05/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

(R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124)

Therapeutic area: Psychiatry/Neurology (updated)
25/05/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

(S)-1-{5-Phenyl-4-[(pyridin-2-ylmethyl)-amino]-thieno[2,3-d]pyrimidin-2-yl}-piperidine-3-carboxylic acid (2-hydroxy-ethyl)-amide

Therapeutic area: Cardiovascular diseases (updated)
25/05/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Abrilumab

Therapeutic area: Gastroentology-Hepatology (updated)
25/05/2016(S)-1-{5-Phenyl-4-[(pyridin-2-ylmethyl)-amino]-thieno[2,3-d]pyrimidin-2-yl}-piperidine-3-carboxylic acid (2-hydroxy-ethyl)-amide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
25/05/2016Abrilumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
25/05/2016Day 80 assessment report generics quality template rev. 3.16 (updated)
25/05/2016Regulatory and procedural guideline: Day 80 assessment report overview guidance - generics rev. 3.16 (updated)
25/05/2016Regulatory and procedural guideline: Day 80 assessment report generics quality guidance rev. 3.16 (updated)
25/05/2016Day 80 assessment report non-clinical and clinical - generic template rev. 3.16 (updated)
25/05/2016Regulatory and procedural guideline: Day 80 assessment report non-clinical and clinical guidance - generics rev. 3.16 (updated)
25/05/2016Day 120 list of questions - generics template rev. 3.16 (updated)
25/05/2016Day 180 list of outstanding issues generics template rev. 3.16 (updated)
25/05/2016Day 80 assessment report overview - generics template rev. 3.16 (updated)
25/05/2016Day 150 joint report assessment report overview generics template rev. 3.16 (updated)
25/05/2016Day 180 joint assessment report generics template rev. 3.16 (updated)
25/05/2016Day 150 joint response assessment report - Overview template re. 3.16 (updated)
25/05/2016Day 150 joint response assessment report - Clinical template rev. 3.16 (updated)
25/05/2016Day 150 joint response assessment report - Quality template rev. 3.16 (updated)
25/05/2016Day 80 assessment report - New active substance status template rev. 3.16 (updated)
25/05/2016Day 80 assessment report - Clinical template rev. 3.16 (updated)
25/05/2016Day 80 assessment report - Quality template rev. 3.16 (updated)
25/05/2016Regulatory and procedural guideline: D80 assessment report - Overview guidance rev. 3.16
25/05/2016Day 120 list of questions template rev. 3.16 (updated)
25/05/2016Day 80 assessment report - Non-clinical template rev. 3.16 (updated)
25/05/2016Regulatory and procedural guideline: D80 assessment report - Clinical guidance rev. 3.16
25/05/2016Regulatory and procedural guideline: D80 assessment report - Non-clinical guidance rev. 3.16
25/05/2016Regulatory and procedural guideline: Day 80 assessment report - Quality guidance (updated)
25/05/2016Day 180 list of outstanding issues template rev. 3.16 (updated)
25/05/2016Day 180 joint response assessment report - Overview template rev. 3.16 (updated)
25/05/2016Day 180 joint response assessment report - Non-clinical template rev. 3.16 (updated)
25/05/2016Day 180 joint response assessment report - Quality template rev. 3.16 (updated)
25/05/2016Day 180 joint response assessment report - Clinical template rev. 3.16 (updated)
25/05/2016Day 150 joint response assessment report - Non-clinical template rev. 3.16 (updated)
25/05/2016Report: Report on ESVAC trial for collecting data on consumption of antimicrobial agents in pigs
25/05/2016European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
25/05/2016Day 80 assessment report - Overview template rev 3.16 (updated)
24/05/2016Human medicines European public assessment report (EPAR): Telmisartan Teva,

telmisartan

Revision: 9, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Sprycel,

dasatinib

Revision: 26, Authorised
24/05/2016Agenda: Agenda - PDCO agenda of the 25-27 May 2016 meeting
24/05/2016Timetable initial (full) marketing authorisation application - Accelerated assessment
24/05/2016Human medicines European public assessment report (EPAR): Ivemend,

fosaprepitant

Revision: 15, Authorised
24/05/2016Timetable accelerated assessment request for initial marketing authorisation applications
24/05/2016Human medicines European public assessment report (EPAR): Lysodren,

mitotane

Revision: 12, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Rilutek,

riluzole

Revision: 24, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 5, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 42, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 7, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 4, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Ruconest,

conestat alfa

Revision: 5, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Baraclude,

entecavir

Revision: 21, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 2, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma,

telmisartan

Revision: 6, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Blincyto,

blinatumomab

Revision: 1, Authorised
24/05/2016Veterinary medicine European public assessment report (EPAR): Poulvac E. coli,

Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens

Revision: 6, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 5, Authorised
24/05/2016Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 10, Authorised
23/05/2016List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
23/05/2016Final assessment report on Polygonum aviculare L., herba , adopted
23/05/2016Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba, adopted
23/05/2016Final list of references supporting the assessment of Polygonum aviculare L., herba, adopted
23/05/2016Final European Union herbal monograph on Polygonum aviculare L., herba, adopted
23/05/2016Herbal medicinal products: Polygonum, Polygoni avicularis herba, Polygonum aviculare L. (updated)
23/05/2016Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 36, Authorised
23/05/2016Agenda: Agenda - CHMP agenda of the 23-26 May 2016 meeting
23/05/2016Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 5, Authorised
23/05/2016Final European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos, adopted
23/05/2016Herbal medicinal products: Helichrysum, Helichrysi flos, Helichrysum arenarium (L.) Moench (updated)
23/05/2016Final list of references supporting the assessment of Helichrysum arenarium (L.) Moench, flos , adopted
23/05/2016Final assessment report on Helichrysum arenarium (L.) Moench, flos , adopted
23/05/2016Opinion of the HMPC on a European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos , adopted
23/05/2016Orphan designation:

Elotuzumab

for the: Treatment of multiple myeloma (updated)
23/05/2016Orphan designation:

Allopurinol sodium

for the: Treatment of perinatal asphyxia (updated)
23/05/2016Report: Highlights from the 7th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 4 April 2016
20/05/2016Guidelines and concept papers adopted during the CHMP meeting 25-28 April 2016, adopted
20/05/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
20/05/2016Minutes of the CVMP meeting of 19-21 April 2016
20/05/2016Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 10, Authorised
20/05/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 2016
20/05/2016MRL pending EC decision: Monepantel - Summary opinion of the CVMP on the establishment of maximum residue limits
20/05/2016Pending EC decision: Draxxin,

tulathromycin

Opinion date: 19-May-2016
20/05/2016Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva,

mycophenolate mofetil

Revision: 17, Authorised
20/05/2016Minutes - PDCO minutes of the 30 March-1 April 2016 meeting
20/05/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: thiocolchicoside PSUSA/00002927/201507
20/05/2016List of nationally authorised medicinal products: influenza vaccine (surface antigen, inactivated, adjuvanted) PSUSA/00010300/201508
20/05/2016List of nationally authorised medicinal products: influenza vaccine (surface antigen, inactivated) PSUSA/00001744/201508
20/05/2016List of nationally authorised medicinal products: influenza vaccine (surface antigen, inactivated, virosome) PSUSA/00001746/201508
20/05/2016List of nationally authorised medicinal products: thiocolchicoside PSUSA/00002927/201507
20/05/2016List of nationally authorised medicinal products: cilostazol PSUSA/00010209/201508
20/05/2016List of nationally authorised medicinal products: beractant PSUSA/00000384/201510
20/05/2016List of nationally authorised medicinal products: fenoterol (obstetric indications) PSUSA/00010001/201509
20/05/2016List of nationally authorised medicinal products: levofloxacin PSUSA/00001854/201510
20/05/2016List of nationally authorised medicinal products: manidipine PSUSA/00001932/201506
20/05/2016List of nationally authorised medicinal products: rupatadine PSUSA/00002673/201506
20/05/2016List of nationally authorised medicinal products: urapidil PSUSA/00003078/201507
20/05/2016List of nationally authorised medicinal products: ketoprofen (topical use only PSUSA/00009205/201509
20/05/2016Regulatory and procedural guideline: Guidance for implementation of eligibility requirements (updated)
20/05/2016Workshop on single-arm trials (SAT) in oncology, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 30-Jun-2016
20/05/2016List of nationally authorised medicinal products: chloroquine PSUSA/00000685/201508
20/05/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: chloroquine PSUSA/00000685/201508
20/05/2016List of nationally authorised medicinal products: acetylcysteine PSUSA/00000034/201509
20/05/2016News and press releases: Accessing key EMA information on human medicines
20/05/2016Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins, European Medicines Agency, London, UK, From: 09-Mar-2016, To: 09-Mar-2016 (updated)
20/05/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4R,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 2, Authorised
20/05/2016Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4R,

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

Revision: 1, Authorised
20/05/2016Agenda: Draft agenda - Workshop on single-arm trials (SAT) in oncology
19/05/2016Human medicines European public assessment report (EPAR): Briviact,

brivaracetam

Revision: 1, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Actelsar HCT,

telmisartan / hydrochlorothiazide

Revision: 5, Authorised
19/05/2016Taxotere (docetaxel) supply shortage
19/05/2016Human medicines European public assessment report (EPAR): Orgalutran,

ganirelix

Revision: 15, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Zalviso,

sufentanil

Revision: 1, Authorised
19/05/2016Agenda: Agenda - CAT agenda of the 18-20 May 2016 meeting
19/05/2016Referral: Article 30 referrals, Amoxil,

amoxicillin

(updated)
19/05/2016Agenda: Agenda - Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects
19/05/2016Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects, European Medicines Agency, London, UK, From: 03-Oct-2016, To: 03-Oct-2016
19/05/2016Human medicines European public assessment report (EPAR): Empliciti,

elotuzumab

Revision: 0, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 20, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 15, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 2, Authorised
19/05/2016Letter of support for Patient Data Platform for capturing patient-reported outcome measures for Dravet syndrome
19/05/20162015 annual report of the European Medicines Agency (updated)
19/05/2016Third industry stakeholder platform on the operation of the centralised procedure for human medicinal products, European Medicines Agency, London, UK, From: 21-Apr-2016, To: 21-Apr-2016 (updated)
19/05/2016Decision on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment (updated)
19/05/2016Human medicines European public assessment report (EPAR): Zyprexa,

olanzapine

Revision: 36, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Rezolsta,

darunavir / cobicistat

Revision: 2, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 16, Authorised
19/05/2016Agenda: Agenda - CVMP agenda of the 17-19 May 2016 meeting
19/05/2016Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 9, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 5, Authorised
19/05/2016Agenda: Agenda - COMP agenda of the 17-19 May 2016 meeting
19/05/2016Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 29, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 3, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 4, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 3, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 4, Authorised
19/05/2016Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 4, Authorised
18/05/2016Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 7, Authorised
18/05/2016Human medicines European public assessment report (EPAR): Bonviva,

ibandronic acid

Revision: 21, Authorised
18/05/2016Human medicines European public assessment report (EPAR): Ribavirin Teva,

ribavirin

Revision: 12, Authorised
18/05/2016Referral: Article 20 procedures, SGLT2 inhibitors,

canagliflozin, dapagliflozin, empagliflozin

(updated)
18/05/2016Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when
17/05/2016Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 53, Authorised
17/05/2016Annex 10 - 2015 annual report of the European Medicines Agency - Positive negative and negative opinions; Withdrawn applications
17/05/2016News and press releases: Progress in science, medicine and health
17/05/2016Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 2, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Sildenafil Teva,

sildenafil

Revision: 13, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 9, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 10, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Nevirapine Teva,

nevirapine

Revision: 7, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Vaniqa,

eflornithine

Revision: 20, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Bronchitol,

mannitol

Revision: 9, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Obizur,

susoctocog alfa

Revision: 1, Authorised
17/05/2016Human medicines European public assessment report (EPAR): Levemir,

insulin detemir

Revision: 24, Authorised
17/05/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Dermatology (updated)
17/05/2016Human medicines European public assessment report (EPAR): Insuman,

insulin human

Revision: 23, Authorised
17/05/2016Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91,

live attenuated vaccine against avian infectious bronchitis

Revision: 10, Authorised
17/05/2016Referral: Article 31 referrals, Dienogest / Ethinylestradiol containing medicinal products indicated in acne,

dienogest/ethinylestradiol

(updated)
17/05/2016Human medicines European public assessment report (EPAR): Entyvio,

vedolizumab

Revision: 5, Authorised
13/05/2016Human medicines European public assessment report (EPAR): Ribavirin Teva Pharma B.V.,

ribavirin

Revision: 12, Authorised
13/05/2016Newsletter: Human medicines highlights - April 2016
13/05/2016Human medicines European public assessment report (EPAR): Kiovig,

human normal immunoglobulin

Revision: 17, Authorised
13/05/2016Human medicines European public assessment report (EPAR): Duavive,

oestrogens conjugated / bazedoxifene

Revision: 5, Authorised
13/05/2016Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 2, Authorised
13/05/2016Report: Public summary report - Inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products
13/05/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016
13/05/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for type IB variations to centralised marketing authorisations (medicines for veterinary use) (updated)
13/05/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure on annual re-assessment of centrally authorised veterinary medicinal products under exceptional circumstances (updated)
13/05/2016PRAC: meeting archive 2014-2015
13/05/2016Human medicines European public assessment report (EPAR): Envarsus,

tacrolimus

Revision: 3, Authorised
13/05/2016List of nationally authorised medicinal products: everolimus (indicated for rejection of transplanted organs) PSUSA/00010269/201507
13/05/2016List of nationally authorised medicinal products: fluocinolone acetonide (intravitreal implant in applicator) PSUSA/00010224/201508
13/05/2016CMDh scientific conclusions, amendments to product information and implementation timetable: everolimus (indicated for rejection of transplanted organs) PSUSA/00010269/2
13/05/2016CAT meeting dates 2016, 2017 and 2018
13/05/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2016 meeting
13/05/2016Report: Medicinal products for human use: monthly figures - April 2016
13/05/2016Report: Applications for new human medicines under evaluation by the CHMP: May 2016
13/05/2016Scientific guideline: Draft reflection paper on the dissolution specification for generic oral immediate release products, draft: consultation open
13/05/2016Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe, European Medicines Agency, London, UK, From: 27-May-2016, To: 27-May-2016
13/05/2016Monthly report on application procedures guidelines and related documents for veterinary medicines: April 2016
13/05/2016Agenda: Agenda - Workshop on extrapolation of efficacy and safety in medicine development across age groups (updated)
13/05/2016Human medicines European public assessment report (EPAR): Nemdatine,

memantine

Revision: 4, Authorised
13/05/2016Human medicines European public assessment report (EPAR): Bondronat,

ibandronic acid

Revision: 23, Authorised
13/05/2016News and press releases: European Medicines Agency closed 16 May 2016
12/05/2016Adaptive pathways (updated)
12/05/2016Human medicines European public assessment report (EPAR): Lonsurf,

trifluridine / tipiracil

Revision: 0, Authorised
12/05/2016Referral: Article 20 procedures, Tysabri,

natalizumab

(updated)
12/05/2016Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 22, Authorised
12/05/2016Human medicines European public assessment report (EPAR): Ibandronic Acid Teva,

ibandronic acid

Revision: 7, Authorised
12/05/2016Agenda: Programme - Targeted consultation on development of new medicinal products for the treatment of rheumatoid arthritis
12/05/2016Report: Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States (updated)
12/05/2016Presentation - Session 3 – ISO ICSR Implementation technical aspects - Part 2
12/05/2016Presentation - Session 2 – ISO ICSR Implementation technical aspects - Part 1
12/05/2016Presentation - Session 1 – Documentation, resources and implementation milestones
12/05/2016Presentation - Session 4 – Testing with EMA new process
12/05/2016Publications (updated)
12/05/2016News and press releases: Can regulators influence the affordability of medicines?
11/05/2016Human medicines European public assessment report (EPAR): Zyprexa Velotab,

olanzapine

Revision: 25, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Edarbi,

azilsartan medoxomil

Revision: 5, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 2, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Abseamed,

epoetin alfa

Revision: 16, Authorised
11/05/2016Inventory of paediatric therapeutic needs - Respiratory
11/05/2016Needs for paediatric medicines (updated)
11/05/2016Opinions on safety variations/Periodic Safety Update Reports (PSURs) adopted at the CHMP meeting of 25-28 April 2016, adopted
11/05/2016Organisational matters - CHMP meeting 25-28 April 2016, adopted
11/05/2016Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 25-28 April 2016, adopted
11/05/2016Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm,

levetiracetam

Revision: 5, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 21, Authorised
11/05/2016Imatinib Teva : EPAR - Product Information (updated)
11/05/2016Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 13, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Imatinib Teva,

imatinib

Revision: 6, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Intelence,

etravirine

Revision: 20, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm,

clopidogrel

Revision: 3, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 15, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 4, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Insulin Human Winthrop,

insulin human

Revision: 15, Authorised
11/05/2016Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 7, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis),

pemetrexed

Revision: 2, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 38, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 6, Authorised
11/05/2016Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 10, Authorised
11/05/2016News and press releases: Supporting innovative SMEs as major drivers of new pharmaceutical developments
11/05/2016Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005
11/05/2016Report: Report on the 10th anniversary of the SME initiative
11/05/2016Human medicines European public assessment report (EPAR): Lucentis,

ranibizumab

Revision: 24, Authorised
10/05/2016Agenda: Agenda - PRAC draft agenda of meeting 10-13 May 2016
10/05/2016European Union Network data board - Terms of reference (updated)
10/05/2016Frequently asked questions - Trainees at the European Medicines Agency (updated)
10/05/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 27-29 April 2016
10/05/2016PRAC recommendations on signals adopted at the PRAC meeting of 11-14 April 2016, adopted
10/05/2016Minutes of the COMP meeting 21-23 March 2016
10/05/2016EudraVigilance support guide
10/05/2016Ex ante publicity of a negotiated procedure: EMA/2016/42/COM – Promotional products
10/05/2016Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD),

alendronic acid / colecalciferol

Revision: 10, Authorised
10/05/2016Human medicines European public assessment report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 24, Authorised
10/05/2016Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 31, Authorised
10/05/2016Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 15, Authorised
04/05/2016Referral: Article 29(4) referrals, Tobramycin VVB and associated names,

tobramycin

(updated)
04/05/2016List of nationally authorised medicinal products: paracetamol / tramadol PSUSA/00002310/201508
04/05/2016Referral: Article 30 referrals, Novantrone and associated names,

mitoxantrone

(updated)
04/05/2016Orphan designation:

Sindbis virus envelope pseudotyped lentiviral vector encoding New York oesophageal squamous cell carcinoma-1 protein

for the: Treatment of soft tissue sarcoma
04/05/2016Orphan designation:

Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene

for the: Treatment of haemophilia A
04/05/2016Orphan designation:

Acalabrutinib

for the: Treatment of lymphoplasmacytic lymphoma
04/05/2016Orphan designation:

Acalabrutinib

for the: Treatment of mantle cell lymphoma
04/05/2016Scientific guideline: Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
04/05/2016Scientific guideline: Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
04/05/2016Scientific guideline: Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1), draft: consultation open
04/05/2016Human medicines European public assessment report (EPAR): Lyxumia ,

lixisenatide

Revision: 6, Authorised
04/05/2016Orphan designation:

Adeno-associated viral vector serotype 8 encoding human ornithine transcarbamylase

for the: Treatment of ornithine transcarbamylase deficiency
04/05/2016Orphan designation:

Fosbretabulin tromethamine

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours
04/05/2016Report: Human adult allogenic mesodermal progenitor cells
04/05/2016Report: Adeno-associated virus serotype 2 based vector containing the human RPE65 gene expression cassette
04/05/2016Report: Human autologous stromal vascular fraction (SVF) cells and human autologous adipose-derived mesenchymal stem cells (ADSC) cells
04/05/2016Report: Adenovirus serotype 5 expressing the Core protein, the Polymerase protein and selected domains of the Envelope protein of Hepatitis B Virus
04/05/2016Report: Two irradiated allogeneic pancreatic tumour cell lines, genetically engineered to secrete human granulocyte macrophage-colony stimulating factor (GM-CSF)
04/05/2016Report: Autologous blood-derived cells filtered to remove other blood components
04/05/2016Orphan designation:

N-acetyl-D-mannosamine monohydrate

for the: Treatment of GNE myopathy
04/05/2016Report: Ex vivo expanded autologous Epstein-Barr Virus specific T-cells derived from peripheral blood mononuclear cells
04/05/2016Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 48, Authorised
04/05/2016Scientific guideline: Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use', draft: consultation open
03/05/2016Orphan designation:

Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes

for the: Treatment of post-transplant lymphoproliferative disorder
03/05/2016Orphan designation:

Fenretinide

for the: Treatment of cutaneous T-cell lymphoma
03/05/2016Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis,

inactivated bluetongue virus, serotype 1

Revision: 5, Authorised
03/05/2016Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 3, Authorised
03/05/2016Orphan designation:

Hydrocortisone (modified-release tablet)

for the: Treatment of adrenal insufficiency (updated)
03/05/2016News and press releases: European Medicines Agency closed 5-9 May 2016
03/05/2016Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 2, Authorised
03/05/2016Minutes of the CAT meeting 22-23 March 2016
03/05/2016Human medicines European public assessment report (EPAR): Ciambra,

pemetrexed

Revision: 0, Authorised
03/05/2016Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis, European Medicines Agency, London, UK, From: 07-Jun-2016, To: 07-Jun-2016
03/05/2016Minutes of the PRAC meeting 14-17 March 2016
03/05/2016Minutes of the CHMP meeting 29 March - 1 April 2016
03/05/2016Human medicines European public assessment report (EPAR): Binocrit,

epoetin alfa

Revision: 15, Authorised
03/05/2016Human medicines European public assessment report (EPAR): Azilect,

rasagiline

Revision: 16, Authorised
03/05/2016MRL report: Rafoxanide: European public maximum-residue-limit assessment report (EPMAR) - CVMP
03/05/2016Ex ante publicity of a negotiated procedure: EMA/2016/13/FI - Physical inventory of fixed assets
03/05/2016Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis,

inactivated bluetongue virus, serotype-1

Revision: 4, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Ozurdex,

dexamethasone

Revision: 7, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 11, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 0, Authorised
02/05/2016Ancillary - Day 80 Quality template (updated)
02/05/2016Ancillary - Day 150 JAR Quality template (updated)
02/05/2016Ancillary - CHMP Day 120 LoQ (updated)
02/05/2016Ancillary - Day 150 JAR Overview template (updated)
02/05/2016Ancillary - Day 150 JAR Non-clinical and clinical template (updated)
02/05/2016Ancillary - CHMP Day 180 LoQ (updated)
02/05/2016Ancillary - Day 180 JAR Quality template (updated)
02/05/2016Human medicines European public assessment report (EPAR): Mirapexin,

pramipexole

Revision: 29, Authorised
02/05/2016Ancillary - Day 180 JAR Overview template (updated)
02/05/2016Ancillary - Day 80 Overview template (updated)
02/05/2016Ancillary - Day 180 JAR Non-clinical and clinical template (updated)
02/05/2016Veterinary medicine European public assessment report (EPAR): Activyl,

indoxacarb

Revision: 6, Authorised
02/05/2016Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues

for the: Treatment of primary hyperoxaluria
02/05/2016Orphan designation:

Glucopyranosyl lipid A stable emulsion and recombinant New York oesophageal squamous cell carcinoma-1 protein

for the: Treatment of soft tissue sarcoma
02/05/2016Orphan designation:

Florilglutamic acid (18F)

for the: Diagnosis of glioma
02/05/2016Orphan designation:

Florilglutamic acid (18F)

for the: Diagnosis of hepatocellular carcinoma
02/05/2016Orphan designation:

Acalabrutinib

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
02/05/2016Orphan designation:

Exenatide

for the: Treatment of idiopathic intracranial hypertension
02/05/2016Orphan designation:

Diaspirin cross-linked haemoglobin

for the: Treatment of oesophageal cancer
02/05/2016Orphan designation:

Ubenimex

for the: Treatment of pulmonary arterial hypertension
02/05/2016Human medicines European public assessment report (EPAR): Esmya,

ulipristal

Revision: 9, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Gardasil,

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

Revision: 32, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 8, Authorised
02/05/2016Scientific guideline: Draft guideline on good pharmacogenomic practice, draft: consultation open
02/05/2016Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 4, Authorised
02/05/2016Human medicines European public assessment report (EPAR): Orencia,

abatacept

Revision: 21, Authorised
02/05/2016Referral: Article 20 procedures, Zydelig,

idelalisib

(updated)
02/05/2016Scientific guideline: Draft Everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg product-specific bioequivalence guidance, draft: consultation open
02/05/2016Scientific guideline: Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance, draft: consultation open
02/05/2016Scientific guideline: Draft Paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance, draft: consultation open
02/05/2016Scientific guideline: Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance, draft: consultation open
02/05/2016Scientific guideline: Draft Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg product-specific bioequivalence guidance, draft: consultation open