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31/07/2018 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 25, Authorised
31/07/2018 Human medicines European public assessment report (EPAR): Victrelis, Boceprevir, Hepatitis C, Chronic, 18/07/2011, 22, Withdrawn
31/07/2018 Minutes: CHMP ORGAM minutes for the meeting on 16 July 2018
31/07/2018 Agenda: CHMP ORGAM agenda for the meeting on 16 July 2018
31/07/2018 Herbal medicinal product: Glycini semen, Glycini semen, F: Assessment finalised
31/07/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2018
31/07/2018 Minutes: CHMP ORGAM minutes for the meeting on 18 June 2018
31/07/2018 Agenda: CHMP ORGAM agenda for the meeting on 18 June 2018
31/07/2018 Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
31/07/2018 Human medicines European public assessment report (EPAR): Alsitek, masitinib mesylate, Amyotrophic Lateral Sclerosis, 26/07/2018, Orphan, Refused
31/07/2018 Veterinary medicines European public assessment report (EPAR): Vectormune ND, cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, 08/09/2015, 3, Authorised
31/07/2018 Newsletter: What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018
30/07/2018 Minutes: Minutes of the CHMP meeting 28-31 May 2018
30/07/2018 Trainee programme
30/07/2018 Human medicines European public assessment report (EPAR): Ultibro Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 19/09/2013, Additional monitoring, 9, Authorised
30/07/2018 Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 23, Authorised
30/07/2018 Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury
27/07/2018 Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version
27/07/2018 Scientific guideline: VICH GL56 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods -...
27/07/2018 Veterinary medicines European public assessment report (EPAR): Certifect, fipronil / amitraz / (S)-methoprene, 06/05/2011, 5, Withdrawn
27/07/2018 Withdrawn application: Raligize, axalimogene filolisbac, Date of withdrawal: 10/07/2018, Initial authorisation
27/07/2018 Dose optimisation of established veterinary antibiotics in the context of summary of product characteristic (SPC) harmonisation
27/07/2018 Scientific guideline: Draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation - First version
27/07/2018 Scientific guideline: Second draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals
27/07/2018 Overview of comments: Overview of comments received on draft 'Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals' (E...
27/07/2018 EudraVigilance training and support
27/07/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
27/07/2018 News and press releases: New medicine for hereditary rare disease
27/07/2018 News and press releases: Two new paediatric-use marketing authorisations recommended by CHMP
27/07/2018 News and press releases: EMA restricts use of prostate cancer medicine Xofigo
27/07/2018 Summary of opinion: Xarelto, rivaroxaban, 26/07/2018, Positive
27/07/2018 Summary of opinion: Binocrit, epoetin alfa, 26/07/2018, Positive
27/07/2018 Summary of opinion: Epoetin Alfa Hexal, epoetin alfa, 26/07/2018, Positive
27/07/2018 Summary of opinion: Symkevi, tezacaftor / ivacaftor, 26/07/2018, Positive
27/07/2018 Summary of opinion: Abseamed, epoetin alfa, 26/07/2018, Positive
27/07/2018 Annex to CHMP highlights: Start of community reviews - CHMP meeting of 23-26 July 2018
27/07/2018 Scientific guideline: Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats
27/07/2018 Referrals document: Hydroxyethyl starch Article-107i referral - Annex I
27/07/2018 Referral: Hydroxyethyl starch (HES) containing medicinal products , hydroxyethyl starch (HES) , Article 107i procedures, European Commission final decision, 26/10/2017, 17/07/2018, 27/07/2018
27/07/2018 Human medicines European public assessment report (EPAR): Udenyca, pegfilgrastim, Neutropenia, 20/09/2018, Additional monitoring, Biosimilar, Authorised
27/07/2018 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism, 30/09/2008, Additional monitoring, 27, Authorised
26/07/2018 EudraVigilance: how to register
26/07/2018 Herbal medicinal product: Sambuci flos, Sambuci flos, F: Assessment finalised
26/07/2018 Herbal medicinal product: Cimicifugae rhizoma, Cimicifugae rhizoma, F: Assessment finalised
26/07/2018 Orphan designation: Peretinoin for the: Treatment of hepatocellular carcinoma, 05/08/2011, Positive
26/07/2018 Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, 19/07/2006, Orphan, 27, Authorised
26/07/2018 Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 20, Authorised
26/07/2018 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 11, Authorised
26/07/2018 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 20, Authorised
26/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, W: decision granting a waiver in all age groups for all conditions/indications, P/0131/2018
26/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Rosuvastatin, W: decision granting a waiver in all age groups for all conditions/indications, P/0126/2018
26/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus H1 haemagglutinin,influenza virus H3 haemagglutinin /influenza virus haemagglutinin from strain B Victoria lineage,influenza virus haemagglutinin from strain B Yamagata lineage (expressed as virus-like particle [VLP]), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0118/2018
26/07/2018 Assessment templates and guidance
26/07/2018 Template or form: Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 07.18
26/07/2018 Template or form: Day 80 assessment report - Non-clinical template with guidance rev. 07.18
26/07/2018 Template or form: Day 180 joint response assessment report - Overview template rev. 07.18
26/07/2018 Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance rev. 07.18
26/07/2018 Template or form: CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products
26/07/2018 Template or form: Day 150 joint assessment report - Quality template rev. 07.18
26/07/2018 Template or form: Generics - Day 80 assessment report overview and D 120 list of outstanding issues template with guidance rev. 07.18
26/07/2018 Template or form: Day 80 assessment report - Quality template with guidance rev. 07.18
26/07/2018 Template or form: Day 80 assessment report - Clinical template with guidance rev.07.18
26/07/2018 Template or form: PRAC D94 Rapporteur RMP assessment report template rev. 07.18
26/07/2018 Template or form: Generics - Day 80 assessment report - Non-clinical and clinical template with guidance rev. 07.18
26/07/2018 Template or form: Generics - Day 80 assessment report - Quality template with guidance rev. 07.18
26/07/2018 Template or form: CHMP and rapporteurs' joint assessment report template and assessment on similarity rev. 07.18
26/07/2018 Template or form: Generics - Day 150 joint report assessment report - Overview and D180 list of outstanding issues template with guidance rev. 07.18
26/07/2018 Template or form: Day 150 joint response assessment report - Overview and list of outstanding issues template rev. 07.18
26/07/2018 Template or form: Generics - Day 180 joint response assessment report - Overview template rev. 07.18
26/07/2018 Presentation: EudraVigilance reporting process for users: Introduction to EVWEB - Training Module EV-M3b
26/07/2018 Regulatory and procedural guideline: How to register with EudraVigilance and EVDAS - Training module EV-M1
26/07/2018 Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.5
26/07/2018 Other: Interactive tour on EudraVigilance registration
26/07/2018 Other: Introduction of a 'regulatory contact point' for marketing authorisation holders
26/07/2018 Human medicines European public assessment report (EPAR): TachoSil, human fibrinogen, human thrombin, Hemostasis, Surgical, 08/06/2004, 22, Authorised
25/07/2018 Human medicines European public assessment report (EPAR): Daklinza, daclatasvir dihydrochloride, Hepatitis C, Chronic, 22/08/2014, Additional monitoring, 13, Authorised
25/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes, W: decision granting a waiver in all age groups for all conditions/indications, P/0115/2018
25/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Enfortumab vedotin, W: decision granting a waiver in all age groups for all conditions/indications, P/0114/2018
25/07/2018 Other: Extended Telematics strategy and implementation roadmap 2018-2019
25/07/2018 Herbal medicinal product: Verbasci flos, Verbasci flos, F: Assessment finalised
25/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0104/2018
25/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ponesimod, PM: decision on the application for modification of an agreed PIP, P/0128/2018
25/07/2018 PIP decision: P/0132/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for testosterone (EMEA-001529-PIP02-14-M01)
25/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501), PM: decision on the application for modification of an agreed PIP, P/0130/2018
25/07/2018 Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Parkinson Disease, 12/01/2015, 5, Authorised
25/07/2018 Paediatric Committee (PDCO): 29 May – 1 June 2018 , European Medicines Agency, London, UK, from 29/05/2018 to 01/06/2018
25/07/2018 Minutes: Minutes - PDCO minutes of the 29 May-01 June 2018 meeting
25/07/2018 Other: Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004 on the potential risk for the consumer resulting from the use of diethanolamine as an excipient ...
25/07/2018 Report: CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004 in relation to the potential risk for the consumer resulting from the use of diethanolamine as an excipient ...
25/07/2018 Veterinary medicines European public assessment report (EPAR): Innovax-ILT, Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus, 03/07/2015, 1, Authorised
25/07/2018 News and press releases: IT systems unavailable from 27 to 30 July 2018
24/07/2018 Paediatric Committee (PDCO): 24-27 July 2018 , European Medicines Agency, London, UK, from 24/07/2018 to 27/07/2018
24/07/2018 Agenda: Agenda - PDCO agenda of the 24-27 July 2018 meeting
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene, PM: decision on the application for modification of an agreed PIP, P/0121/2018
24/07/2018 Orphan designation: Itraconazole for the: Prevention of invasive aspergillosis, 25/05/2018, Positive
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (JCAR017), PM: decision on the application for modification of an agreed PIP, P/0119/2018
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): tilmanocept, PM: decision on the application for modification of an agreed PIP, P/0106/2018
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Repatha, Evolocumab, PM: decision on the application for modification of an agreed PIP, P/0104/2018
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, Dalbavancin, PM: decision on the application for modification of an agreed PIP, P/0113/2018
24/07/2018 Orphan designation: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-225-Actinium for the: Treatment of glioma, 25/05/2018, Positive
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain, PM: decision on the application for modification of an agreed PIP, P/0112/2018
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Tapentadol (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0111/2018
24/07/2018 Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, Orphan, Additional monitoring, Exceptional circumstances, 18, Authorised
24/07/2018 Orphan designation: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin for the: Prevention of haemolytic uraemic syndrome, 25/05/2018, Positive
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane, PM: decision on the application for modification of an agreed PIP, P/0110/2018
24/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab, PM: decision on the application for modification of an agreed PIP, P/0109/2018
24/07/2018 Orphan designation: Ambroxol hydrochloride for the: Treatment of amyotrophic lateral sclerosis, 25/05/2018, Positive
24/07/2018 Other: Involvement of patient representatives in scientific advice procedures at the European Medicines Agency
24/07/2018 Other: Involvement of patient representatives in scientific advisory groups at the European Medicines Agency
23/07/2018 Agenda: Agenda - HMPC agenda of the 23-24 July 2018 meeting
23/07/2018 Orphan designation: Daratumumab for the: Treatment of AL amyloidosis, 25/05/2018, Positive
23/07/2018 Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues for the: Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis), 25/05/2018, Positive
23/07/2018 Orphan designation: 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4- c]pyridin-6-yl)ethan-1-one for the: Treatment of Stargardt's disease, 25/05/2018, Positive
23/07/2018 Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles for the: Treatment of methylmalonic acidaemia, 25/05/2018, Positive
23/07/2018 Orphan designation: Adeno-associated viral vector serotype 9 containing the human CLN1 gene for the: Treatment of neuronal ceroid lipofuscinosis, 25/05/2018, Positive
23/07/2018 Orphan designation: Bardoxolone methyl for the: Treatment of Alport syndrome, 25/05/2018, Positive
23/07/2018 Orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein for the: Treatment of Ebola virus disease, 25/05/2018, Positive
23/07/2018 Minutes: Minutes of the CVMP meeting of 19-21 June 2018
23/07/2018 Access to EudraVigilance data
23/07/2018 Report: Annual accounts: Financial year 2017
23/07/2018 Scientific guideline: Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1
23/07/2018 Development of new medicinal products for the treatment of ulcerative colitis
23/07/2018 Overview of comments: Overview of comments received on ''Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis' (EMA/CHMP/EWP/18463/2006 Rev. 1)
23/07/2018 Clinical investigation of medicinal products for the management of Crohn's disease
23/07/2018 Scientific guideline: Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2
23/07/2018 Overview of comments: Overview of comments received on 'draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease' (EMA/CPMP/EWP/2284/99 Rev. 2)
23/07/2018 Scientific guideline: Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins - Revision 1
23/07/2018 Similar biological medicinal products containing recombinant erythropoietins
20/07/2018 Orphan designation: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide for the: treatment of acute pancreatitis, 18/11/2016, Positive
20/07/2018 Similar medicinal products containing somatropin (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)
20/07/2018 Scientific guideline: Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1
20/07/2018 Overview of comments: Overview of comments received on ‘the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)’ (EMA/CHMP/BPWP/94033/2007), Rev.3
20/07/2018 Scientific guideline: Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 5
20/07/2018 Scientific guideline: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 3
20/07/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018
20/07/2018 Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting
20/07/2018 Other: List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders
20/07/2018 Human medicines European public assessment report (EPAR): Insulatard, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised
19/07/2018 Overview of comments: Overview of comments on 'Draft qualification opinion on molecular neuroimaging of the dopamine transporter as biomarker to identify patients with early manifest Parkinsonism in Parkinson’s disease'
19/07/2018 Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms
19/07/2018 Periodic safety update single assessment: Levocabastine: List of nationally authorised medicinal products - PSUSA/00001849/201711
19/07/2018 Periodic safety update single assessment: Amlodipine / indapamide, amlodipine / indapamide / perindopril: List of nationally authorised medicinal products - PSUSA/00010358/201711
19/07/2018 Human medicines European public assessment report (EPAR): Aloxi, palonosetron hydrochloride, Vomiting, Cancer, 22/03/2005, 21, Authorised
19/07/2018 Minutes: Minutes of the CAT meeting 14-16 March 2018
19/07/2018 Periodic safety update single assessment: Abciximab: List of nationally authorised medicinal products - PSUSA/00000014/201711
19/07/2018 Periodic safety update single assessment: Fludeoxyglucose (18f): List of nationally authorised medicinal products - PSUSA/00001437/201711
19/07/2018 Periodic safety update single assessment: Tafluprost / timolol: List of nationally authorised medicinal products - PSUSA/00010324/201712
19/07/2018 Periodic safety update single assessment: Diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001124/201711
19/07/2018 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 11, Authorised
19/07/2018 Periodic safety update single assessment: Caffeine / drotaverine hydrochloride / metamizol sodium: List of nationally authorised medicinal products - PSUSA/00001996/201711
19/07/2018 Committee for Advanced Therapies (CAT) expert meeting on scientific and regulatory considerations for adeno-associated viral vector (AVV)-based gene therapy , European Medicines Agency, London, UK, from 06/09/2017 to 06/09/2017
19/07/2018 Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018
19/07/2018 Chemistry of active substances for veterinary medicinal products
18/07/2018 Agenda: Agenda - CVMP agenda of the 17-19 July 2018 meeting
18/07/2018 Periodic safety update single assessment: Cetirizine: List of nationally authorised medicinal products - PSUSA/00000628/201711
18/07/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 26-29 June 2018
18/07/2018 Orphan designation: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII for the: Treatment of haemophilia A, 25/05/2018, Positive
18/07/2018 Periodic safety update single assessment: Bambuterol: List of nationally authorised medicinal products - PSUSA/00000295/201712
18/07/2018 Referrals document: Quinolone and fluoroquinolone Article-31 referral - Timetable for the procedure
18/07/2018 Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, Authorised
18/07/2018 Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, 24/06/2009, 12, Authorised
18/07/2018 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201711
18/07/2018 Periodic safety update single assessment: Econazole, econazole nitrate / triamcinolone acetonide, econazole nitrate / zinc oxide: List of nationally authorised medicinal products - PSUSA/00001195/201711
18/07/2018 Periodic safety update single assessment: Amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - only for the drug Numeta: List of nationally a...
18/07/2018 Orphan designation: Gevokizumab for the: Treatment of Schnitzler syndrome, 22/08/2014, Withdrawn
18/07/2018 Periodic safety update single assessment: Rupatadine: List of nationally authorised medicinal products - PSUSA/00002673/201712
18/07/2018 Orphan designation: Gevokizumab for the: Treatment of chronic non-infectious uveitis, 12/03/2013, Withdrawn
18/07/2018 Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the: Treatment of Behçet's Disease, 01/10/2010, Withdrawn
18/07/2018 Report: EMA communication perception survey report 2017
18/07/2018 Orphan designation: ambrisentan for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 11/04/2005, Withdrawn
18/07/2018 Orphan designation: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (avelumab) for the: Treatment of Merkel cell carcinoma, 14/12/2015, Positive
18/07/2018 Orphan designation: avelumab for the: treatment of gastric cancer, 12/12/2016, Positive
18/07/2018 Orphan designation: Thalidomide for the: Treatment of multiple myeloma, 20/11/2001, Withdrawn
18/07/2018 Human medicines European public assessment report (EPAR): Aerinaze, desloratadine, pseudophedrine sulphate, Rhinitis, Allergic, Seasonal, 30/07/2007, 16, Authorised
18/07/2018 News and press releases: EU and Japan reinforce their collaboration on inspections of medicine manufacturers
18/07/2018 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, Additional monitoring, 6, Authorised
18/07/2018 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 10, Authorised
18/07/2018 Human medicines European public assessment report (EPAR): Seebri Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 8, Authorised
17/07/2018 Periodic safety update single assessment: Methylprednisolone: List of nationally authorised medicinal products - PSUSA/00002026/201711
17/07/2018 News and press releases: Update on review of valsartan medicines following detection of impurity in active substance: assessing potential impact on patients is priority
17/07/2018 Periodic safety update single assessment: Bromperidol: List of nationally authorised medicinal products - PSUSA/00000439/201711
17/07/2018 Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting
17/07/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 June 2018
17/07/2018 Periodic safety update single assessment: Diacerein: List of nationally authorised medicinal products - PSUSA/00001026/201712
17/07/2018 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2018
17/07/2018 Follow up information session on the TransCelerate initiative , European Medicines Agency, London, UK, from 17/07/2018 to 17/07/2018
17/07/2018 Agenda: Agenda - Follow up information session on the TransCelerate initiative, 17 July 2018
17/07/2018 Veterinary medicines European public assessment report (EPAR): Dany's BienenWohl, oxalic acid dihydrate, 14/06/2018, Authorised
16/07/2018 Opinion/decision on a Paediatric investigation plan (PIP): Rasilez, aliskiren, PM: decision on the application for modification of an agreed PIP, P/0227/2014
16/07/2018 Orphan designation: Arsenic trioxide for the: Treatment of graft-versus-host disease, 12/12/2016, Positive
16/07/2018 News and press releases: EMA's proactive publication of clinical data a success
16/07/2018 Report: Clinical data publication (Policy 0070) report Oct 2016-Oct 2017
16/07/2018 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, Additional monitoring, 5, Authorised
16/07/2018 Human medicines European public assessment report (EPAR): Somac Control, pantoprazole, Gastroesophageal Reflux, 12/06/2009, 11, Authorised
16/07/2018 Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 12, Authorised
16/07/2018 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene for the: Treatment of adenosine-deaminase-deficient severe combined immunodeficiency, 07/06/2013, Positive
13/07/2018 Scientific guideline: Guideline on good pharmacogenomic practice - First version
13/07/2018 Template or form: Template for requesting orphan industry user admin role
13/07/2018 Template or form: Template for registering new active substance on EUTCT
13/07/2018 Human medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Hepatitis B, Chronic, 23/10/2009, Generic, 8, Authorised
13/07/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Human foetal neural stem cells
13/07/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Exosomes carrying recombinant mRNA encoding for the cystic fibrosis transmembrane conductance regulator protein and microRNA-17
13/07/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Human foetal neural stem cells
13/07/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose cells
13/07/2018 Report: Applications for new human medicines under evaluation by the CHMP: July 2018
13/07/2018 Human medicines European public assessment report (EPAR): Topotecan Teva, topotecan, Ovarian Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 21/09/2009, Generic, 8, Authorised
13/07/2018 Scientific guideline: Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products
13/07/2018 Overview of comments: Overview of comments on 'Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products' (EMA/CAT/80183/2014)'
13/07/2018 Quality, preclinical and clinical aspects of gene therapy medicinal products
13/07/2018 Scientific guideline: Guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1
13/07/2018 Human medicines European public assessment report (EPAR): Temomedac, temozolomide, Glioma, Glioblastoma, 25/01/2010, Generic, 11, Authorised
13/07/2018 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018
13/07/2018 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 32, Authorised
13/07/2018 Human medicines European public assessment report (EPAR): Xultophy, insulin degludec, liraglutide, Diabetes Mellitus, Type 2, 18/09/2014, Additional monitoring, 10, Authorised
12/07/2018 Periodic safety update single assessment: Calcium carbonate / famotidine / magnesium hydroxide: List of nationally authorised medicinal products - PSUSA/00001351/201709
12/07/2018 Orphan designation: ciclosporin for the: Treatment of vernal keratoconjunctivitis, 06/04/2006, Positive
12/07/2018 Periodic safety update single assessment: Famotidine: List of nationally authorised medicinal products - PSUSA/00001350/201709
12/07/2018 Periodic safety update single assessment: Famotidine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/201709
12/07/2018 Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, 22/09/1998, 23, Authorised
12/07/2018 Periodic safety update single assessment: Adapalene / benzoyl peroxide: List of nationally authorised medicinal products - PSUSA/00000059/201709
12/07/2018 Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz), levodopa, carbidopa, entacapone, Parkinson Disease, 11/11/2013, 5, Authorised
12/07/2018 Periodic safety update single assessment: Etomidate: List of nationally authorised medicinal products - PSUSA/00001330/20170
12/07/2018 Periodic safety update single assessment: Etomidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001330/20170
12/07/2018 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 11, Authorised
12/07/2018 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 11, Authorised
12/07/2018 Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/07/2016, Generic, 4, Authorised
11/07/2018 News and press releases: EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair
11/07/2018 Report: Report from EMA industry survey on Brexit preparedness
11/07/2018 Human medicines European public assessment report (EPAR): Azilect, rasagiline, Parkinson Disease, 21/02/2005, 20, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 1, Authorised
11/07/2018 Withdrawn application: Rotigotine Mylan, rotigotine, Date of withdrawal: 22/12/2017, Initial authorisation
11/07/2018 Human medicines European public assessment report (EPAR): Azarga, brinzolamide, timolol maleate, Glaucoma, Open-Angle, Ocular Hypertension, 25/11/2008, 12, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Azopt, brinzolamide, Glaucoma, Open-Angle, Ocular Hypertension, 09/03/2000, 24, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Mimpara, cinacalcet hydrochloride, Hypercalcemia, Parathyroid Neoplasms, Hyperparathyroidism, 22/10/2004, 20, Authorised
11/07/2018 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 19, Authorised
10/07/2018 News and press releases: EMA identifies gaps in industry preparedness for Brexit
10/07/2018 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 6, Authorised
10/07/2018 Minutes: Minutes - PDCO minutes of the 24-27 April 2018 meeting
10/07/2018 Other: Table of European Paediatric Research Nurse Networks and Groups provided by the Enpr-EMA Research Nurse Training Group
10/07/2018 Other: Sample eligibility form - Healthcare professionals
10/07/2018 Other: Sample eligibility form - Patients and consumers
10/07/2018 Report: Annual activity report 2017
10/07/2018 Newsletter: Human medicines highlights - July 2018
10/07/2018 Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 41, Authorised
10/07/2018 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 14, Authorised
10/07/2018 Human medicines European public assessment report (EPAR): Axura, memantine hydrochloride, Alzheimer Disease, 17/05/2002, 24, Authorised
09/07/2018 Agenda: Agenda - PRAC draft agenda of meeting 9-12 July 2018
09/07/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC
09/07/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC meeting
09/07/2018 Minutes: Minutes of the PRAC meeting 14-17 May 2018