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20/12/2018 Minutes: Minutes of the PRAC meeting 29-31 October 2018
20/12/2018 Veterinary medicines European public assessment report (EPAR): Imrestor, Pegbovigrastim, 09/12/2015, 1, Authorised
20/12/2018 Other: Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities
20/12/2018 Human medicines European public assessment report (EPAR): Ivabradine JensonR, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 11/11/2016, Generic, Withdrawn
20/12/2018 Scientific guideline: Concept paper on a guideline for allergen products development in moderate to low-sized study populations
20/12/2018 Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt for the: Treatment of beta thalassaemia intermedia and major, 24/08/2018, Positive
20/12/2018 Orphan designation: bertilimumab for the: Treatment of bullous pemphigoid, 24/11/2018, Positive
20/12/2018 Agenda: Agenda - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)
20/12/2018 Orphan designation: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells for the: Treatment in solid organ transplantation, 24/08/2018, Positive
19/12/2018 Orphan designation: Obiltoxaximab for the: Treatment of anthrax, 24/08/2018, Positive
19/12/2018 Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid for the: Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive
19/12/2018 Orphan designation: Copanlisib for the: Treatment of marginal zone lymphoma, 24/08/2018, Positive
19/12/2018 Periodic safety update single assessment: Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803
19/12/2018 Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate for the: Treatment of glioma, 24/08/2018, Positive
19/12/2018 Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances
19/12/2018 Scientific guideline: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1
19/12/2018 Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor for the: Treatment of glioma, 24/08/2018, Positive
19/12/2018 Overview of comments: Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3
19/12/2018 Conduct of bioequivalence studies for veterinary medicinal products
19/12/2018 Scientific guideline: Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
19/12/2018 Scientific guideline: Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2
19/12/2018 Work Instruction - WIN: Work instructions for maintenance of signal management tracking table
19/12/2018 Standard Operating Procedure - SOP: Standard operating procedure for signal management
19/12/2018 Work Instruction - WIN: Work instructions for key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals
19/12/2018 Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2 for the: Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive
19/12/2018 Orphan designation: Somapacitan for the: Treatment of growth hormone deficiency, 24/08/2018, Positive
19/12/2018 Orphan designation: tilorone for the: Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive
19/12/2018 Orphan designation: pemigatinib for the: Treatment of biliary tract cancer, 24/08/2018, Positive
19/12/2018 Orphan designation: melatonin for the: Treatment of acute radiation syndrome, 26/10/2018, Positive
19/12/2018 Opinion/decision on a Paediatric investigation plan (PIP): Abraxane, paclitaxel, PM: decision on the application for modification of an agreed PIP, P/0257/2018
19/12/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018
19/12/2018 News and press releases: European Medicines Agency closed 21 December 2018 to 2 January 2019
19/12/2018 Advanced therapy classification
19/12/2018 News and press releases: Regulatory Science to 2025 – launch of six-month public consultation
19/12/2018 Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats
19/12/2018 Work programme: Committee for Medicinal Products for Veterinary Use (CVMP) Work Plan 2019
19/12/2018 Other: Mandate, objectives and rules of procedure for the CVMP Antimicrobials Working Party (AWP)
19/12/2018 Scientific guideline: Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Revision 1
18/12/2018 Periodic safety update single assessment: Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801
18/12/2018
18/12/2018 Other: Committee for Advanced Therapies (CAT) work programme 2019
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin
18/12/2018 Scientific guideline: Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)
18/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro
18/12/2018 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
18/12/2018 Report: Wheat starch (containing gluten) used as an excipient - Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’
18/12/2018 Orphan designation: Mercaptopurine (oral suspension) for the: Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive
18/12/2018 Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein for the: 23/08/2017, Positive
18/12/2018 Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide) for the: Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive
18/12/2018 Scientific guideline: Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)
18/12/2018 Q&A: Good clinical practice (GCP)
17/12/2018 Deputy Executive Director and support services
17/12/2018 Other: Organisation chart: Deputy Executive Director support services
17/12/2018 Other: Inventory of herbal substances for assessment
17/12/2018 Other: Health threat plan map - Annex to EMA plan for emerging health threats
17/12/2018 Other: EMA plan for emerging health threats
17/12/2018 Public health threats
17/12/2018 Pandemic influenza
17/12/2018 News and press releases: Responding to emerging health threats in the EU
17/12/2018 Orphan designation: Nanoliposomal irinotecan for the: Treatment of pancreatic cancer, 09/12/2011, Positive
17/12/2018 Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside for the: Treatment of anti-MAG neuropathy, 17/07/2017, Positive
17/12/2018 Overview of comments: Overview of comments on 'Draft guideline on clinical development of fixed combination medicinal products - Revision 2 (EMA/CHMP/281825/2015)'
17/12/2018 Scientific guideline: Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance
17/12/2018 Clinical development of fixed combination medicinal products
17/12/2018 Scientific guideline: Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance
17/12/2018 Scientific guideline: Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products
17/12/2018 Risk management requirements for elemental impurities in veterinary medicinal products
14/12/2018 Report: Final Guideline on Active Substance Master File Procedure - Revision 4
14/12/2018 Management Board meeting: 12-13 December 2018 , European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018
14/12/2018 Regulatory and procedural guideline: Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
14/12/2018 Report: Summary of transfers of appropriations in budget 2018 - Management Board meeting of 12-13 December 2018
14/12/2018 Other: Outcome of written procedures during the period 11 September 2018 to 23 November 2018
14/12/2018 Other: Financial compensation and workload estimation of the EMA organisation of translations of product related information
14/12/2018 Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
14/12/2018 Regulatory and procedural guideline: EudraVigilance access policy for medicines for veterinary use - Revision 1
14/12/2018 EudraVigilance access policy for medicines for veterinary use
14/12/2018 Agenda: Agenda for the 102nd meeting of the Management Board
14/12/2018 Summary of opinion: Adcetris, brentuximab vedotin, 13/12/2018, Positive
14/12/2018 Summary of opinion: Rapiscan, regadenoson, 13/12/2018, Positive
14/12/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
14/12/2018 Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation
14/12/2018 Summary of opinion: Trimbow, beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive
14/12/2018 Summary of opinion: Sprycel, dasatinib, 13/12/2018, Positive
14/12/2018 Annex to CHMP highlights: Start of community reviews - CHMP meeting of 10-13 December 2018
14/12/2018 Summary of opinion: Rubraca, rucaparib, 13/12/2018, Positive
14/12/2018 Report: Report on the EMA Management Board delegation visit to the future EMA premises
14/12/2018 Minutes: Minutes of the CAT meeting 12-14 September 2018
14/12/2018 Quality and equivalence of topical products
14/12/2018 Scientific guideline: Draft guideline on quality and equivalence of topical products
14/12/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: November 2018
14/12/2018 News and press releases: EMA Management Board: highlights of December 2018 meeting
13/12/2018 Overview of comments: Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)
13/12/2018 Scientific guideline: Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance
13/12/2018 Overview of comments: Overview of comments received on 'Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance' (EMA/CHMP/291450/2018)
13/12/2018 Aliskiren product-specific bioequivalence guidance
13/12/2018 Human medicines European public assessment report (EPAR): Entacapone Teva, entacapone, Parkinson Disease, 18/02/2011, Generic, 8, Authorised
13/12/2018 Scientific guideline: Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
13/12/2018 Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells
12/12/2018 Minutes: Minutes - PDCO minutes of the 18-21 September 2018 meeting
12/12/2018 Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, 06/12/2018, Orphan, Refused
12/12/2018 Human medicines European public assessment report (EPAR): Zoledronic acid Teva Pharma, zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal, 15/08/2012, Generic, 11, Withdrawn
12/12/2018 Other: Guide on access to unpublished documents
12/12/2018 Q&A: 1-20
12/12/2018 Other: Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016
12/12/2018 Periodic safety update single assessment: Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804
12/12/2018 Other: Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Live attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Collagenase enzyme from Clostridium histolyticum
12/12/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+
11/12/2018 The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course , Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019
11/12/2018 Periodic safety update single assessment: Ofloxacin (topical use): List of nationally authorised medicinal products - PSUSA/00002204/201804
11/12/2018 Periodic safety update single assessment: Felodipine / ramipril: List of nationally authorised medicinal products - PSUSA/00001358/201803
11/12/2018 Agenda: Agenda - PDCO agenda of the 11-14 December 2018 meeting
11/12/2018 Other: Timetable: Annual renewal application of conditional marketing authorisation
11/12/2018 Quality of medicines questions and answers: Part 2
11/12/2018 Article 30(3) opinions
11/12/2018 Public Statement: Public statement on the evaluation of the compliance of marketing authorisation holders with CVMP Risk Management Strategy with respect to potential presence of RD114 in feline and canine vaccines
11/12/2018 Human medicines European public assessment report (EPAR): PegIntron, peginterferon alfa-2b, Hepatitis C, Chronic, 24/05/2000, 36, Authorised
11/12/2018 Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation
11/12/2018 Periodic safety update single assessment: Methylphenobarbital: List of nationally authorised medicinal products - PSUSA/00002025/201803
11/12/2018 Periodic safety update single assessment: Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803
10/12/2018 Minutes: Minutes of the CVMP meeting of 6-8 November 2018
10/12/2018 Other: Enpr-EMA Working group on public-private partnership: Network consultation recommendation
10/12/2018 Agenda: Agenda - CHMP agenda of the 10-13 December 2018 meeting
10/12/2018 Minutes: Minutes of the 101st meeting of the Management Board: 4 October 2018
10/12/2018 Periodic safety update single assessment: Numeta: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0017
10/12/2018 Periodic safety update single assessment: Numeta: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0017
10/12/2018 Periodic safety update single assessment: Metamizole: List of nationally authorised medicinal products - PSUSA/00001997/201804
07/12/2018 Human medicines European public assessment report (EPAR): Emadine, emedastine, Conjunctivitis, Allergic, 26/01/1999, 23, Authorised
07/12/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 December 2018
07/12/2018 Newsletter: Human medicines highlights - December 2018
07/12/2018 Veterinary medicines European public assessment report (EPAR): Rhiniseng, inactivated Bordetella bronchiseptica, strain 833CER, recombinant type-D Pasteurella-multocida toxin (PMTr), 15/09/2010, 4, Authorised
07/12/2018 Human medicines European public assessment report (EPAR): Osseor, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Authorised
07/12/2018 Human medicines European public assessment report (EPAR): Protelos, strontium ranelate, Osteoporosis, Postmenopausal, 20/09/2004, 19, Authorised
07/12/2018 Periodic safety update single assessment: Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/201804
07/12/2018 Human medicines European public assessment report (EPAR): RotaTeq, rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization, Rotavirus Infections, 26/06/2006, 27, Authorised
07/12/2018 Human medicines European public assessment report (EPAR): Diacomit, stiripentol, Myoclonic Epilepsy, Juvenile, 03/01/2007, 11/02/2009, Orphan, 15, Authorised
07/12/2018 Periodic safety update single assessment: Chlorprothixene: List of nationally authorised medicinal products - PSUSA/00000717/201803
07/12/2018 Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione for the: Treatment of systemic sclerosis, 12/10/2017, Positive
07/12/2018 Periodic safety update single assessment: Ofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00002203/201804
07/12/2018 Orphan designation: tiratricol for the: Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive
07/12/2018 Regulatory and procedural guideline: Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products
07/12/2018 Periodic safety update single assessment: Nebivolol: List of nationally authorised medicinal products - PSUSA/00002129/201803
07/12/2018 Template or form: Request/declaration form for the provision of information via mobile scanning and other technologies in the centralised procedure
07/12/2018 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 12, Authorised
07/12/2018 Veterinary medicines European public assessment report (EPAR): Respiporc FLUpan H1N1, inactivated influenza A virus/humanstrain: A/Jena/VI5258/2009(H1N1)pdm09, 16/05/2017, 1, Authorised
07/12/2018 Periodic safety update single assessment: Dihydroergotoxine - List of nationally authorised medicinal products - PSUSA/0001079/201804
07/12/2018 Periodic safety update single assessment: Acarbose: List of nationally authorised medicinal products - PSUSA/0000017/201803