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31/08/2020 Agenda: Agenda - PRAC draft agenda of meeting 31 August - 3 September 2020
31/08/2020 Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised
31/08/2020 Minutes: Minutes of the PRAC meeting 9-12 March 2020
31/08/2020 Human medicines European public assessment report (EPAR): Nustendi, Bempedoic acid, Ezetimibe, Hypercholesterolemia, Dyslipidemias, 27/03/2020, Additional monitoring, 2, Authorised
31/08/2020 Enpr-EMA priority activities
31/08/2020 Other: Preparedness of medicines’ clinical trials in paediatrics: Recommendations by the Enpr-EMA working group on trial preparedness
31/08/2020 Herbal medicinal product: Menthae piperitae folium, Menthae piperitae folium, F: Assessment finalised
28/08/2020 Paediatric Committee (PDCO): 23-26 June 2020 , European Medicines Agency, Amsterdam, The Netherlands, from 23/06/2020 to 26/06/2020
28/08/2020 Minutes: Minutes - PDCO minutes of the 23-26 June 2020 meeting
28/08/2020 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 26-29 May 2020
28/08/2020 Minutes: Minutes - PDCO minutes of the 26-29 May 2020 meeting
28/08/2020 Paediatric Committee (PDCO): 25-28 February 2020 , European Medicines Agency, Amsterdam, The Netherlands, from 25/02/2020 to 28/02/2020
28/08/2020 Legal framework: orphan designation
28/08/2020 Paediatric Regulation
28/08/2020 ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers
28/08/2020 Patients and consumers
28/08/2020 Healthcare professionals
28/08/2020 Scientific guideline: ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b
28/08/2020 ICH E6(R3) good clinical practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties , Virtual meeting, from 03/06/2020 to 03/06/2020
28/08/2020 Minutes: Minutes - PDCO minutes of the 28-30 April 2020 meeting
28/08/2020 Minutes: Minutes - PDCO minutes of the 24-27 March 2020 meeting
28/08/2020 Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase) for the: Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive
28/08/2020 Human medicines European public assessment report (EPAR): Idefirix, Imlifidase, Desensitization, Immunologic, Kidney Transplantation, 25/08/2020, Orphan, Additional monitoring, Conditional approval, Authorised
28/08/2020 Periodic safety update single assessment: Pancuronium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002275/201912
28/08/2020 Periodic safety update single assessment: Pancuronium: List of nationally authorised medicinal products - PSUSA/00002275/201912
28/08/2020 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 28-30 April 2020
27/08/2020 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 38, Authorised
27/08/2020 Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 19/06/2015, Generic, 5, Authorised
27/08/2020 Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH, pregabalin, Anxiety Disorders, Epilepsy, 19/06/2015, Generic, 6, Authorised
27/08/2020 Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis), pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, 8, Authorised
27/08/2020 Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/09/2015, Generic, 5, Authorised
27/08/2020 Orphan designation: Rilzabrutinib for the: Treatment of immune thrombocytopenia, 04/06/2020, Positive
27/08/2020 Orphan designation: (16E)-14-methyl-20-oxa-5,7,14,26-tetraaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene–citric acid for the: Treatment of glioma, 17/10/2019, Positive
27/08/2020 Orphan designation: gallium citrate for the: Treatment of cystic fibrosis, 21/08/2019, Positive
27/08/2020 Orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the: Treatment of systemic sclerosis, 28/04/2016, Withdrawn
27/08/2020 Orphan designation: Autologous adult live cultured osteoblasts for the: Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive
27/08/2020 Orphan designation: Agammaglobulinaemia tyrosine kinase for the: Treatment of pemphigus, 12/12/2017, Positive
27/08/2020 Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide for the: Treatment of acute myeloid leukaemia, 14/10/2016, Positive
27/08/2020 Orphan designation: Recombinant human monoclonal antibody to insulin receptor for the: Treatment of congenital hyperinsulinism, 14/07/2016, Positive
27/08/2020 Orphan designation: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab) for the: Treatment of pneumonia caused by Staphylococcus aureus, 05/03/2012, Positive
27/08/2020 Veterinary medicines European public assessment report (EPAR): Zycortal, desoxycortone pivalate, 06/11/2015, 4, Authorised
27/08/2020 Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for the: Treatment of cystic fibrosis, 30/08/2011, Positive
27/08/2020 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for the: Prevention of delayed graft function after renal transplantation, 06/06/2010, Positive
27/08/2020 Orphan designation: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11 (Panobacumab) for the: Treatment of pneumonia caused by serotype O11 Pseudomonas aeruginosa, 29/06/2006, Positive
27/08/2020 Veterinary medicines European public assessment report (EPAR): Lydaxx, tulathromycin, 18/05/2020, Generic, Authorised
27/08/2020 Veterinary medicines European public assessment report (EPAR): Purevax FeLV, feline leukaemia virus recombinant canarypox virus (vCP97), 13/04/2000, 9, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone palmitate, Schizophrenia, 05/12/2014, 10, Authorised
26/08/2020 Orphan designation: Pevonedistat for the: Treatment of acute myeloid leukaemia, 25/07/2019, Positive
26/08/2020 Orphan designation: Pevonedistat for the: Treatment of myelodysplastic syndromes, 14/12/2018, Positive
26/08/2020 Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for the: Adjunctive treatment in haematopoietic cell transplantation, 15/01/2009, Positive
26/08/2020 Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for the: Treatment of peripheral T-cell lymphoma, 21/09/2019, Positive
26/08/2020 Orphan designation: Ixazomib for the: Treatment of systemic light chain amyloidosis, 08/11/2012, Positive
26/08/2020 Orphan designation: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel) for the: Treatment of anal fistula, 08/10/2009, Positive
26/08/2020 Orphan designation: Brentuximab vedotin for the: Treatment of cutaneous T-cell lymphoma, 11/01/2012, Positive
26/08/2020 Orphan designation: Balipodect for the: Adjunctive treatment in haematopoietic cell transplantation, 14/04/2019, Positive
26/08/2020 Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride for the: Treatment of Kabuki syndrome, 19/11/2018, Positive
26/08/2020 Minutes: Minutes of the CHMP meeting 25-28 May 2020
26/08/2020 Orphan designation: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid for the: Treatment of multiple myeloma, 27/09/2011, Positive
26/08/2020 Orphan designation: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate for the: Treatment of acute myeloid leukaemia, 22/02/2018, Positive
26/08/2020 Human medicines European public assessment report (EPAR): Rasilez HCT, aliskiren, hydrochlorothiazide, Hypertension, 16/01/2009, 17, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections, Bacteremia, Soft Tissue Infections, Endocarditis, Bacterial, 19/01/2006, 33, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, 9, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, Additional monitoring, 7, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections, 04/02/2002, 54, Authorised
26/08/2020 Human medicines European public assessment report (EPAR): Methylthioninium chloride Cosmo, methylthioninium chloride, Colorectal Neoplasms, Colonoscopy, 19/08/2020, Authorised
25/08/2020 Agenda: Agenda - CHMP agenda of the 17-20 August 2020 written procedure
25/08/2020 Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate for the: Treatment of mucopolysaccharidosis type I, 22/09/2016, Positive
25/08/2020 Veterinary medicines European public assessment report (EPAR): Naxcel, ceftiofur, 19/05/2005, 15, Authorised
25/08/2020 Human medicines European public assessment report (EPAR): Steglatro, ertugliflozin l-pyroglutamic acid, Diabetes Mellitus, Type 2, 21/03/2018, Additional monitoring, 6, Authorised
24/08/2020 Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, 22/07/2007, 17, Authorised
24/08/2020 Human medicines European public assessment report (EPAR): Accofil, filgrastim, Neutropenia, 17/09/2014, Biosimilar, 11, Authorised
24/08/2020 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma, Urticaria, 25/10/2005, 40, Authorised
24/08/2020 Human medicines European public assessment report (EPAR): Oprymea, pramipexole dihydrochloride monohydrate, Parkinson Disease, 12/09/2008, Generic, 20, Authorised
24/08/2020 Human medicines European public assessment report (EPAR): Fampyra, Fampridine, Multiple Sclerosis, 20/07/2011, 14, Authorised
21/08/2020 Human medicines European public assessment report (EPAR): Qutenza, capsaicin, Neuralgia, 15/05/2009, 14, Authorised
21/08/2020 Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel, Stroke, Peripheral Vascular Diseases, Myocardial Infarction, Acute Coronary Syndrome, 15/07/2008, 26, Authorised
21/08/2020 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 6, Authorised
21/08/2020 Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome, 14/07/1998, 43, Authorised
21/08/2020 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 23, Authorised
21/08/2020 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, 42, Authorised
20/08/2020 Veterinary medicines European public assessment report (EPAR): Eurican Herpes 205, Canine herpesvirus (F205 strain) antigens, 26/03/2001, 11, Authorised
20/08/2020 Summaries of scientific recommendations on classification of advanced therapy medicinal products
20/08/2020 Report: Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)
20/08/2020 Report: Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)
20/08/2020 Regulatory and procedural guideline: European Medicines Agency privacy statement for EnprEMA network database
20/08/2020 Veterinary medicines European public assessment report (EPAR): Oncept IL-2, vCP1338 virus, 03/05/2013, 5, Authorised
20/08/2020 Veterinary medicines European public assessment report (EPAR): Purevax Rabies, vCP65 virus, 18/02/2011, 6, Authorised
20/08/2020 Veterinary medicines European public assessment report (EPAR): Proteq West Nile, West Nile recombinant canarypox virus (vCP2017 virus), 05/08/2011, 14, Authorised
20/08/2020 Aluvia H-W-764
20/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Fevipiprant, PM: decision on the application for modification of an agreed PIP, P/0341/2019
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated viral vector encoding the human cytochrome P450 21-hydroxylase gene
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus serotype 5 encoding human retinal guanylate cyclase 1 gene
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cultured postnatal thymus tissue-derived product
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haematopoietic stem and progenitor cells treated ex vivo with a fusion protein
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human Wharton’s jelly-derived mesenchymal stem cells seeded onto decellularized dermal scaffold
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic natural killer cells expanded in vitro
20/08/2020 Report: Scientific recommendation on classification of ATMP: Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, & allogeneic, non-expanded, umbilical cord blood-derived,haematopoietic mature myeloid & lymphoid cells
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, and allogeneic, non-expanded, umbilical cord blood-derived...
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: DNA plasmid vector encoding human IL-12
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates
20/08/2020 Report: Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)
20/08/2020 Report: Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous skeletal muscle derived cells attached to poly(DL-lactide-co-glycolide) microparticles
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose-derived stem cells
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: DNA delivery vector with similar structure-function than bacteriophage capsids
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus type rh10 containing a transgene that encodes a microRNA targeting SOD1 messenger RNA under the control of an H1 promoter
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 containing a human α-L-iduronidase gene cassette
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 8 containing a codon optimised copy of the cDNA encoding human Retinitis Pigmentosa GTPase Regulator
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus (AAV), serotype 1 containing a transgene that encodes a microRNA targeting huntingtin messenger RNA
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector containing a human micro-dystrophin gene
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed messenger RNA molecules encoding IFNα2b, IL-12, IL-15sushi and GM-CSF cytokines
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Human bone marrow derived allogeneic mesenchymal stem cells expressing human alpha-1 antitrypsin
20/08/2020 Report: Scientific recommendation on classification of advanced therapy medicinal products: Ex-vivo expanded allogeneic bone marrow derived mesenchymal stromal cells
20/08/2020 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 41, Authorised
20/08/2020 Human medicines European public assessment report (EPAR): Nilemdo, Bempedoic acid, Hypercholesterolemia, Dyslipidemias, 01/04/2020, Additional monitoring, 2, Authorised
19/08/2020 Orphan designation: Adeno-associated virus serotype 9 containing the human ASPA gene for the: Treatment of Canavan disease, 04/06/2020, Positive
19/08/2020 Orphan designation: Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24 for the: Treatment of neonatal encephalopathy, 04/06/2020, Positive
19/08/2020 Orphan designation: Sodium phenylbutyrate, Tauroursodeoxycholic acid for the: Treatment of amyotrophic lateral sclerosis, 04/06/2020, Positive
19/08/2020 Orphan designation: 1-((2S,4S)-2-((((S)-(4-bromophenoxy)(((S)-1-oxo-1-(((S)-pentan-2-yl)oxy)propan-2-yl)amino)phosphoryl)oxy)methyl)-1,3-dioxolan-4-yl)-2-oxo-1,2-dihydropyrimidin-4-aminium chloride for the: Treatment of hepatocellular carcinoma, 04/06/2020, Positive
19/08/2020 Orphan designation: Autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4 for the: Treatment of soft tissue sarcoma, 04/06/2020, Positive
19/08/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 8, Authorised
19/08/2020 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 26, Authorised
19/08/2020 Withdrawn application: Xiidra, Date of withdrawal: 18/06/2020, Initial authorisation
19/08/2020 Report: Applications for new human medicines under evaluation by the CHMP: August 2020
19/08/2020 Orphan designation: Viltolarsen for the: Treatment of Duchenne muscular dystrophy, 04/06/2020, Positive
19/08/2020 Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)) for the: Treatment of paroxysmal nocturnal haemoglobinuria, 04/06/2020, Positive
19/08/2020 Orphan designation: Lutetium (177LU) lilotomab satetraxetan for the: Treatment of marginal zone lymphoma, 04/06/2020, Positive
19/08/2020 Orphan designation: Lumacaftor for the: Treatment of non-traumatic subarachnoid haemorrhage, 04/06/2020, Positive
19/08/2020 Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains for the: Treatment of multiple myeloma, 04/06/2020, Positive
19/08/2020 Orphan designation: Methotrexate for the: Treatment of retinal detachment, 04/06/2020, Positive
18/08/2020 Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
18/08/2020 Other: From laboratory to patient: the journey of a centrally authorised medicine
18/08/2020 Human medicines European public assessment report (EPAR): Evista, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 23, Authorised
18/08/2020 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 19, Authorised
18/08/2020 Human medicines European public assessment report (EPAR): Vargatef, nintedanib, Carcinoma, Non-Small-Cell Lung, 21/11/2014, 13, Authorised
18/08/2020 Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Schizophrenia, 26/07/2018, Additional monitoring, 3, Authorised
18/08/2020 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 5, Authorised
18/08/2020 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 19, Authorised
17/08/2020 Human medicines European public assessment report (EPAR): Azarga, brinzolamide, timolol maleate, Glaucoma, Open-Angle, Ocular Hypertension, 25/11/2008, 13, Authorised
17/08/2020 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010, Generic, 11, Authorised
17/08/2020 Human medicines European public assessment report (EPAR): Pramipexole Teva, pramipexole dihydrochloride monohydrate, Parkinson Disease, 18/12/2008, Generic, 20, Authorised
17/08/2020 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 16, Authorised
17/08/2020 Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, 22/08/2018, Orphan, Additional monitoring, 3, Authorised
14/08/2020 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, Additional monitoring, 21, Authorised
14/08/2020 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 4, Authorised
14/08/2020 Human medicines European public assessment report (EPAR): Signifor, pasireotide, Acromegaly, Pituitary ACTH Hypersecretion, 24/04/2012, Orphan, 13, Authorised
14/08/2020 Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
14/08/2020 Public Statement: Draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids - Revision 1
14/08/2020 Herbal - HMPC opinion on a European Union herbal monograph: Superseded opinion of the HMPC on a community herbal monograph on Tanacetum parthenium (L.) Shulz Bip., herba - First version
14/08/2020 Herbal - HMPC assessment report: Superseded final assessment report on Tanacetum parthenium (L.) Schulz Bip., herba -First version
14/08/2020 Herbal - Overview of comments received during consultation: Superseded overview of comments received on Community herbal monograph on Tanacetum parthenium (L) Schulz Bip., herba - First version
14/08/2020 Herbal - List of references supporting the assessment report: Superseded final list of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip., herba - First version
13/08/2020 Human medicines European public assessment report (EPAR): Nuceiva, Botulinum toxin type A, Skin Aging, 27/09/2019, Additional monitoring, 1, Authorised
13/08/2020 Human medicines European public assessment report (EPAR): Invega, paliperidone, Schizophrenia, Psychotic Disorders, 24/06/2007, 17, Authorised
13/08/2020 Human medicines European public assessment report (EPAR): Ciambra, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 02/12/2015, Generic, 4, Authorised
13/08/2020 Orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for the: Treatment of insulin autoimmune syndrome, 22/04/2020, Positive
13/08/2020 Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, Orphan, Accelerated assessment, 13, Authorised
13/08/2020 Periodic safety update single assessment: Lenograstim: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001839/201910
13/08/2020 Periodic safety update single assessment: Lenograstim: List of nationally authorised medicinal products - PSUSA/00001839/201910
13/08/2020 Orphan designation: adeno-associated virus vector serotype hu37 encoding human factor VIII for the: Treatment of haemophilia A, 22/04/2020, Positive
13/08/2020 Orphan designation: anti-(integrin beta-3) human monoclonal antibody for the: Prevention of fetal and neonatal alloimmune thrombocytopenia due to human platelet antigen-1a incompatibility, 22/04/2020, Positive
13/08/2020 Orphan designation: Rozanolixizumab for the: Treatment of myasthenia gravis, 22/04/2020, Positive
13/08/2020 Orphan designation: Methyl 3-((2R)-2-hydroxy-4-(((((S)-1-methoxy-1-oxopropan-2-yl) amino)(phenoxy)phosphoryl)oxy)-3,3-dimethylbutanamido)propanoate for the: Treatment of pantothenate-kinase-associated neurodegeneration, 17/02/2016, Withdrawn
13/08/2020 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular, Pain, Postoperative, 28/07/2015, 6, Authorised
13/08/2020 Report: Meeting summary - PCWP/HCPWP joint meeting on 2 June 2020
13/08/2020 Report: Meeting summary - PCWP/HCPWP joint meeting on 24 June 2020
13/08/2020 Other: Registration form - EMA Clinical Trial Information System (CTIS) webinar: Dynamic demo of sponsor workspace
12/08/2020 Orphan designation: "Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus (bulevirtide) for the: Treatment of hepatitis delta virus infection, 19/06/2015, Positive
12/08/2020 Orphan designation: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate for the: Treatment in haematopoietic stem cell transplantation, 20/04/2020, Positive
12/08/2020 Orphan designation: florbetaben (18F) for the: Diagnosis of AL amyloidosis, 22/04/2020, Positive
12/08/2020 Orphan designation: mitapivat sulfate for the: Treatment of pyruvate kinase deficiency, 22/04/2020, Positive
12/08/2020 Orphan designation: icatibant acetate for the: Treatment of angioedema, 18/02/2003, Expired
12/08/2020 Orphan designation: Trifarotene for the: Treatment of autosomal recessive congenital ichthyosis, 24/03/2020, Positive
12/08/2020 Orphan designation: Recombinant human galactocerebrosidase for the: Treatment of globoid cell leukodystrophy (Krabbe disease), 27/09/2011, Withdrawn
12/08/2020 Orphan designation: Losmapimod for the: treatment of facioscapulohumeral muscular dystrophy, 24/03/2020, Positive
12/08/2020 Orphan designation: Fosgemcitabine palabenamide for the: Treatment of biliary tract cancer, 24/03/2020, Positive
12/08/2020 Orphan designation: Cabiralizumab for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type, 12/12/2016, Withdrawn
12/08/2020 Orphan designation: N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino]isonicotinamide hydrochloride for the: Treatment of pancreatic cancer, 08/10/2009, Withdrawn
12/08/2020 Orphan designation: Asciminib for the: Treatment of chronic myeloid leukaemia, 24/03/2020, Positive
12/08/2020 Orphan designation: N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino]isonicotinamide hydrochloride for the: Treatment of acute myeloid leukaemia, 17/12/2010, Withdrawn
12/08/2020 Orphan designation: Allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus for the: Treatment in haematopoietic stem cell transplantation, 24/03/2020, Positive
12/08/2020 Orphan designation: 2-hydroxy-N,N,N-trimethylethan-1-aminium (Z)-4-(5-((3-benzyl-4-oxo-2-thioxothiazolidin-5-ylidene)methyl)furan-2-yl)benzoate for the: Treatment of pancreatic cancer, 24/03/2020, Positive
12/08/2020 Human medicines European public assessment report (EPAR): Olanzapine Glenmark, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 14, Authorised
11/08/2020 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 21, Authorised
11/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Captopril, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0206/2014
11/08/2020 Other: Records of data processing activity regarding the European Union electronic Register of Post-Authorisation Studies (EU PAS Register) (public)
11/08/2020 Other: Record of data processing activity regarding European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Resource Database (public)
11/08/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC
11/08/2020 Human medicines European public assessment report (EPAR): Orphacol, cholic acid, Digestive System Diseases, Metabolism, Inborn Errors, 12/09/2013, 25/05/2012, Orphan, Additional monitoring, Exceptional circumstances, 9, Authorised
11/08/2020 Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
11/08/2020 Orphan designation: Adeno-associated viral vector serotype 3B encoding human multidrug resistance protein 3A for the: Treatment of progressive familial intrahepatic cholestasis, 22/04/2020, Positive
11/08/2020 Orphan designation: DNA plasmid encoding IL-12 p35 and p40 genes for the: Treatment of ovarian cancer, 22/04/2020, Positive
11/08/2020 Orphan designation: cusatuzumab for the: Treatment of acute myeloid leukaemia, 22/04/2020, Positive
11/08/2020 Template or form: Template letter of intent for request of scientific advice or protocol assistance
11/08/2020 General privacy statement
11/08/2020 Orphan designation: Humanised monoclonal antibody to the folate receptor alpha for the: Treatment of ovarian cancer, 01/04/2008, Positive
11/08/2020 Orphan designation: Amatuximab for the: Treatment of malignant mesothelioma, 16/01/2014, Positive
11/08/2020 Orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide for the: Treatment of hepatocellular carcinoma, 23/08/2017, Positive
11/08/2020 Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid for the: Treatment of systemic sclerosis, 12/01/2017, Positive
11/08/2020 Human medicines European public assessment report (EPAR): Pretomanid FGK, Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, Orphan, Additional monitoring, Conditional approval, Authorised
11/08/2020 Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- for the: Treatment of cystic fibrosis, 14/10/2016, Positive
10/08/2020 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration
10/08/2020 News and press releases: Communication@EMA – how are we doing?
10/08/2020 Post-authorisation safety studies (PASS)
10/08/2020 Transfer of marketing authorisation: questions and answers
10/08/2020 Classification of changes: questions and answers
10/08/2020 Other: Validation issues frequently seen with initial marketing authorisation holders
10/08/2020 Template or form: Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human
07/08/2020 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 20, Authorised
07/08/2020 Minutes: Minutes of the COMP meeting 16-18 June 2020
07/08/2020 Newsletter: Human medicines highlights - August 2020
07/08/2020 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 5, Authorised
07/08/2020 Maximum Residue Limits - Report: Diflubenzuron (Salmonidae): Summary report - Committee for Medicinal Products for Veterinary Use
06/08/2020 Human medicines European public assessment report (EPAR): Duzallo, allopurinol, lesinurad, Gout, 23/08/2018, Additional monitoring, 2, Withdrawn
06/08/2020 Human medicines European public assessment report (EPAR): Xenleta, lefamulin acetate, Pneumonia, Bacterial, Community-Acquired Infections, 27/07/2020, Additional monitoring, Authorised
06/08/2020 Human medicines European public assessment report (EPAR): Apixaban Accord, Apixaban, Venous Thromboembolism, Stroke, Arthroplasty, 23/07/2020, Generic, Authorised
06/08/2020 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 16, Authorised
06/08/2020 Human medicines European public assessment report (EPAR): Fluenz Tetra, reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human, 04/12/2013, 19, Authorised
06/08/2020 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
05/08/2020 Human medicines European public assessment report (EPAR): Capecitabine Medac, capecitabine, Colorectal Neoplasms, 19/11/2012, Patient safety, Generic, 10, Authorised
04/08/2020 Withdrawn application: Tulatrixx , tulathromycin, Date of withdrawal: 01/04/2020, Initial authorisation
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Eladocagene exuparvovec, PM: decision on the application for modification of an agreed PIP, P/0080/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, PM: decision on the application for modification of an agreed PIP, P/0105/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), PM: decision on the application for modification of an agreed PIP, P/0088/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), PM: decision on the application for modification of an agreed PIP, P/0089/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], PM: decision on the application for modification of an agreed PIP, P/0084/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, PM: decision on the application for modification of an agreed PIP, P/0109/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, PM: decision on the application for modification of an agreed PIP, P/0092/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Avacopan, PM: decision on the application for modification of an agreed PIP, P/0103/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vadadustat, PM: decision on the application for modification of an agreed PIP, P/0074/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897), PM: decision on the application for modification of an agreed PIP, P/0082/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab, PM: decision on the application for modification of an agreed PIP, P/0093/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zinplava, bezlotoxumab, PM: decision on the application for modification of an agreed PIP, P/0104/2020
04/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, eluxadoline, PM: decision on the application for modification of an agreed PIP, P/0107/2020
04/08/2020 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 37, Authorised
03/08/2020 Veterinary medicines European public assessment report (EPAR): Simparica Trio, moxidectin, sarolaner, pyrantel embonate, 17/09/2019, 1, Authorised
03/08/2020 Template or form: Parallel consultation: briefing document template
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate, PM: decision on the application for modification of an agreed PIP, P/0069/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Idasanutlin, PM: decision on the application for modification of an agreed PIP, P/0081/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, PM: decision on the application for modification of an agreed PIP, P/0125/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa, PM: decision on the application for modification of an agreed PIP, P/0071/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): sonidegib, PM: decision on the application for modification of an agreed PIP, P/0111/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, PM: decision on the application for modification of an agreed PIP, P/0087/2020
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0075/2020
03/08/2020 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 12, Authorised
03/08/2020 Opinion/decision on a Paediatric investigation plan (PIP): Pegcetacoplan, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0149/2020