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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 Human medicines European public assessment report (EPAR): Odomzo, sonidegib diphosphate, Carcinoma, Basal Cell, 14/08/2015, Additional monitoring, 6, 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report (EPAR): Ivabradine JensonR, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 11/11/2016, Generic, Withdrawn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 Scientific guideline: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1
19/12/2018 Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances
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 Scientific guideline: Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
19/12/2018 Conduct of bioequivalence studies for veterinary medicinal products
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 News and press releases: Regulatory Science to 2025 – launch of six-month public consultation
19/12/2018 Advanced therapy classification
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 Human medicines European public assessment report (EPAR): Dengvaxia, chimeric yellow fever dengue virus serotype 1 (live, attenuated) / chimeric yellow fever dengue virus serotype 2 (live, attenuated) / chimeric yellow fever dengue virus serotype 3 (live, attenuated) / chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue, 12/12/2018, Additional monitoring, Authorised
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 Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, Additional monitoring, 5, Authorised
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 Human medicines European public assessment report (EPAR): Olazax Disperzi, olanzapine, Schizophrenia, Bipolar Disorder, 10/12/2009, Generic, 9, Authorised
17/12/2018 Deputy Executive Director and support services
17/12/2018 Other: Organisation chart: Deputy Executive Director support services
17/12/2018 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Additional monitoring, Authorised
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 Ezetimibe 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 Other: Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC
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
13/12/2018 Human medicines European public assessment report (EPAR): Rebif, interferon beta-1a, Multiple Sclerosis, 03/05/1998, 33, Authorised
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 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 11, Authorised
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 Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures
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
11/12/2018 Privacy statement
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 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 18, Authorised
10/12/2018 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 7, Authorised
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 Human medicines European public assessment report (EPAR): Savene, dexrazoxane hydrochloride, Extravasation of Diagnostic and Therapeutic Materials, 27/07/2006, 13, 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 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis, 25/10/2005, 23, 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
07/12/2018 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, Orphan, 33, Authorised
07/12/2018 Veterinary medicines European public assessment report (EPAR): Econor, valnemulin, 12/03/1999, 20, Authorised
06/12/2018 Veterinary medicines European public assessment report (EPAR): Easotic, hydrocortisone aceponate / miconazole nitrate, gentamicin sulphate, 19/11/2008, 7, Authorised
06/12/2018 Periodic safety update single assessment: Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803
06/12/2018 Procurement: Ex ante publicity of a negotiated procedure: bank accounts for the deposit of surplus funds in euro
06/12/2018 Template or form: Application form - User guide for the electronic application form for a marketing authorisation
06/12/2018 Regulatory and procedural guideline: Draft quality review of documents (QRD) guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (D...
06/12/2018 Report: Applications for new human medicines under evaluation by the CHMP: December 2018
06/12/2018 Periodic safety update single assessment: Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803
06/12/2018 Work Instruction - WIN: Work instructions for validation of signals from the review of individual cases
06/12/2018 Standard Operating Procedure - SOP: Standard operating procedure for handling of safety information from non-EEA regulatory authorities
06/12/2018 Committee for Orphan Medicinal Products (COMP): 11-13 September 2018 , European Medicines Agency, London, UK, from 11/09/2018 to 13/09/2018
06/12/2018 Minutes: Minutes of the COMP meeting 11-13 September 2018
06/12/2018 Regulatory and procedural guideline: EudraVigilance registration frequently asked questions
06/12/2018 Overview of comments: Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use
06/12/2018 Overview of comments: Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use
06/12/2018 Report: Medicinal products for human use: monthly figures - November 2018
06/12/2018 Human medicines European public assessment report (EPAR): ProQuad, virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox, Rubella, Measles, Mumps, Immunization, 05/04/2006, 24, Authorised
06/12/2018 Overview of comments: Overview of comments received on the draft policy/0043: European Medicines Agency policy on access to documents
06/12/2018 Human medicines European public assessment report (EPAR): DuoTrav, travoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 23/04/2006, 16, Authorised
05/12/2018 Human medicines European public assessment report (EPAR): Plavix, clopidogrel hydrogen sulfate, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 15/07/1998, 38, Authorised
05/12/2018 Human medicines European public assessment report (EPAR): Zomarist, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 18, Authorised
05/12/2018 Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 14/07/1998, 39, Authorised
05/12/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 13-16 November 2018
05/12/2018 Human medicines European public assessment report (EPAR): Venclyxto, Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, 04/12/2016, Additional monitoring, Conditional approval, 7, Authorised
05/12/2018 Periodic safety update single assessment: Foscarnet: List of nationally authorised medicinal products - PSUSA/00001472/201803
05/12/2018 Human medicines European public assessment report (EPAR): Lamzede, velmanase alfa, alpha-Mannosidosis, 23/03/2018, Orphan, Additional monitoring, Exceptional circumstances, 1, Authorised
05/12/2018 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel hydrogen sulphate, Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 12, Authorised
05/12/2018 Human medicines European public assessment report (EPAR): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 21/09/2017, Additional monitoring, 6, Authorised
05/12/2018 Periodic safety update single assessment: Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802
05/12/2018 Periodic safety update single assessment: Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802
05/12/2018 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 50, Authorised
05/12/2018 Orphan designation: Paclitaxel (micellar) for the: Treatment of ovarian cancer, 17/12/2006, Withdrawn
04/12/2018 16th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting , European Medicines Agency, London, UK, from 07/12/2018 to 07/12/2018
04/12/2018 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018
04/12/2018 Agenda: Agenda - Enpr-EMA Coordinating Group and networks meeting on 22 October 2018
04/12/2018 Minutes: Minutes of the Enpr-EMA Coordinating Group and networks meeting on 22 October 2018
04/12/2018 Other: Mandate of the European network of paediatric research-European Medicines Agency working groups
04/12/2018 Scientific guideline: Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance
04/12/2018 Other: Launch of the new EudraVigilance system: questions and answers from stakeholders
04/12/2018 Report: Meeting summary - EMA Human Scientific’ Committees Working Party with Healthcare Professionals’ Organisations (HCPWP) 26 September 2018
04/12/2018 Human medicines European public assessment report (EPAR): Vipdomet, alogliptin benzoate, metformin hydrochloride, Diabetes Mellitus, Type 2, 18/09/2013, 6, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Crixivan, indinavir sulfate ethanolate, HIV Infections, 04/10/1996, 39, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 14, Authorised
04/12/2018 Report: Report - Data anonymisation: a key enabler for clinical data sharing
04/12/2018 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 35, Authorised
04/12/2018 Scientific guideline: Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance
04/12/2018 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 37, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Rivastigmine Sandoz, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 10/12/2009, 11, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, 22/07/2007, 16, Authorised
04/12/2018 Scientific guideline: Overview of comments received on ' Draft Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken’ (EMA/CHMP/CVMP/JEG-3R
04/12/2018 Scientific guideline: Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken
04/12/2018 Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken
04/12/2018 Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, 22/04/2013, 22/02/2013, Generic, 8, Authorised
04/12/2018 Agenda: Agenda - CVMP agenda of the 4-6 December 2018 meeting
04/12/2018 Periodic safety update reports: questions and answers
04/12/2018 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride / tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 21, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 28, Authorised
04/12/2018 Human medicines European public assessment report (EPAR): Sildenafil Actavis, sildenafil, Erectile Dysfunction, 10/12/2009, Generic, 12, Authorised
03/12/2018 Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation