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28/02/2020 Leaflet: Leaflet - Orphan medicines in the EU
28/02/2020 Minutes: Minutes of the PRAC meeting 28-31 October 2019
28/02/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020
28/02/2020 Summary of opinion: Otezla, apremilast, 27/02/2020, Positive
28/02/2020 Withdrawn application: Axumin, fluciclovine (18F), Date of withdrawal: 11/02/2020, Post-authorisation
28/02/2020 Referral: Yondelis , trabectedin , Article 20 procedures, Procedure started, 27/02/2020
28/02/2020 Summary of opinion: Emgality, galcanezumab, 27/02/2020, Negative
28/02/2020 Summary of opinion: Ofev, nintedanib, 27/02/2020, Positive
28/02/2020 Summary of opinion: Alunbrig, brigatinib, 27/02/2020, Positive
28/02/2020 Veterinary medicines European public assessment report (EPAR): Aservo EquiHaler, ciclesonide, 28/01/2020, Authorised
27/02/2020 Veterinary medicines European public assessment report (EPAR): Halagon, halofuginone lactate, 13/12/2016, Generic, 3, Authorised
27/02/2020 Management Board meeting: 10-11 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 10/06/2020 to 11/06/2020
27/02/2020 Management Board meeting: 1 October 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 01/10/2020 to 01/10/2020
27/02/2020 Management Board meeting: 16-17 December 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 16/12/2020 to 17/12/2020
27/02/2020 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 11, Authorised
27/02/2020 Human medicines European public assessment report (EPAR): Tovanor Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 14, Authorised
27/02/2020 Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Mucopolysaccharidosis VII, 23/08/2018, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised
27/02/2020 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 18, Authorised
27/02/2020 Other: Emerging safety issues (ESI) contact points at the national competent authority (NCA) level
27/02/2020 Template or form: Standalone signal notification form
27/02/2020 Other: National contact points for standalone signal notifications
27/02/2020 Human medicines European public assessment report (EPAR): Leganto, rotigotine, Restless Legs Syndrome, Parkinson Disease, 16/06/2011, 18, Authorised
27/02/2020 Human medicines European public assessment report (EPAR): Neupro, rotigotine, Restless Legs Syndrome, Parkinson Disease, 15/02/2006, 29, Authorised
27/02/2020 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 23, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 14/02/2019, Additional monitoring, Biosimilar, 4, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Recarbrio, imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections, 13/02/2020, Additional monitoring, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Adrovance, alendronate sodium trihydrate, colecalciferol, Osteoporosis, Postmenopausal, 04/01/2007, 20, Authorised
26/02/2020 Veterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, 16/12/2008, 13, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 15, Authorised
26/02/2020 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, 25, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 19/05/2006, 19, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Baraclude, Entecavir, Hepatitis B, Chronic, 26/06/2006, 25, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal, 15/03/2010, 17/12/2009, 29, Authorised
26/02/2020 Human medicines European public assessment report (EPAR): Episalvan, betulae cortex dry extract  (5-10 : 1); extraction solvent: n-heptane 95% (w/w), Wounds and Injuries, Wound Healing, 14/01/2016, Additional monitoring, 4, Authorised
25/02/2020 Eligible patients and consumers organisations
25/02/2020 Recruitment: Careers at EMA user-guide
25/02/2020 Paediatric Committee (PDCO): 25-28 February 2020 , European Medicines Agency, Amsterdam, The Netherlands, from 25/02/2020 to 28/02/2020
25/02/2020 Paediatric Committee (PDCO): 24-27 March 2020 , European Medicines Agency, Amsterdam, The Netherlands, from 24/03/2020 to 27/03/2020
25/02/2020 Human medicines European public assessment report (EPAR): Cyramza, Ramucirumab, Stomach Neoplasms, 19/12/2014, 10, Authorised
25/02/2020 Agenda: Agenda - PDCO agenda of the 25-28 February 2020 meeting
25/02/2020 Template or form: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)
25/02/2020 Human medicines European public assessment report (EPAR): Aerinaze, desloratadine, pseudophedrine sulphate, Rhinitis, Allergic, Seasonal, 30/07/2007, 17, Authorised
25/02/2020 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 10, Authorised
25/02/2020 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesylate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, Additional monitoring, 9, Authorised
25/02/2020 Veterinary medicines European public assessment report (EPAR): Osurnia, terbinafine / florfenicol, betamethasone acetate, 31/07/2014, 8, Authorised
25/02/2020 Human medicines European public assessment report (EPAR): Ilaris, Canakinumab, Cryopyrin-Associated Periodic Syndromes, Arthritis, Juvenile Rheumatoid, Arthritis, Gouty, 23/10/2009, 24, Authorised
25/02/2020 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 10, Authorised
25/02/2020 Direct healthcare professional communication (DHPC): Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction, Active substance: mifamurtide, DHPC type: Quality defect, Last updated: 25/02/2020
25/02/2020 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 24, Authorised
25/02/2020 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against SERPINA1 mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues for the: Treatment of congenital alpha-1 antitrypsin deficiency, 16/12/2019, Positive
25/02/2020 Orphan designation: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate (tafamidis) for the: Treatment of familial amyloid polyneuropathy, 28/08/2006, Positive
25/02/2020 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 16, Authorised
25/02/2020 Orphan designation: tafamidis for the: Treatment of senile systemic amyloidosis, 08/11/2012, Positive
25/02/2020 Orphan designation: Pamrevlumab for the: Treatment of Duchenne muscular dystrophy, 16/12/2019, Positive
25/02/2020 Orphan designation: navitoclax for the: Treatment of myelofibrosis, 16/12/2019, Positive
25/02/2020 Orphan designation: Lactobacillus plantarum for the: Treatment of amyotrophic lateral sclerosis, 16/12/2019, Positive
25/02/2020 Herbal medicinal product: Agni casti fructus, Agni casti fructus, F: Assessment finalised
25/02/2020 Orphan designation: H-Leu-Pro-Pro-Leu-Pro-Tyr-Pro-OH for the: Treatment of amyotrophic lateral sclerosis, 16/12/2019, Positive
25/02/2020 Orphan designation: Efgartigimod alfa for the: Treatment of immune thrombocytopenia, 16/12/2019, Positive
25/02/2020 Committee for Medicinal Products for Human Use (CHMP): 24-27 February 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 24/02/2020 to 27/02/2020
25/02/2020 Human medicines European public assessment report (EPAR): Rebif, interferon beta-1a, Multiple Sclerosis, 03/05/1998, 37, Authorised
25/02/2020 Orphan designation: Adeno-associated virus vector encoding human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 16/12/2019, Positive
25/02/2020 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 28-31 January 2020
25/02/2020 Orphan designation: 5,7-dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)-one mesilate for the: Treatment of multiple system atrophy, 16/12/2019, Positive
25/02/2020 Agenda: Agenda - CHMP agenda of the 24-27 February 2020 meeting
25/02/2020 Medicine evaluation figures
25/02/2020 Report: Medicinal products for human use: monthly figures - January 2020
25/02/2020 European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting (Oct 2019) , European Medicines Agency, Amsterdam, the Netherlands, from 16/10/2019 to 16/10/2019
25/02/2020 Minutes: Minutes of the COMP meeting 5-7 November 2019
24/02/2020 Orphan designation: 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type, 16/12/2019, Positive
24/02/2020 Orphan designation: (E)-2-((2S,4S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-2-yl)-10-(carboxymethyl)-1-hydroxy-13-(2-(2-(2-((E)-3-(3-((3-hydroxy-3,3 diphosphonopropyl)(methyl)amino)propoxy)benzylidene)hydrazine-1-carbonothioyl)hydrazineyl)-2-oxoethyl)-8-oxo-5-thioxo-3,4,6,7,10,13-hexaazapentadec-2-en-15-oic acid for the: Treatment of osteosarcoma, 16/12/2019, Positive
24/02/2020 Orphan designation: Naltrexone for the: Treatment of fibromyalgia, 07/11/2020, Negative
24/02/2020 Human medicines European public assessment report (EPAR): Evenity, Romosozumab, Osteoporosis, 09/12/2019, Additional monitoring, Authorised
24/02/2020 Human medicines European public assessment report (EPAR): Pemetrexed Hospira, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 19/11/2015, Generic, 8, Authorised
24/02/2020 Human medicines European public assessment report (EPAR): Brilique, ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome, 03/12/2010, 15, Authorised
24/02/2020 Periodic safety update single assessment: Dienogest / estradiol (HRT indication): List of nationally authorised medicinal products - PSUSA/00010443/201906
24/02/2020 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major, 19/06/2015, Generic, 11, Authorised
24/02/2020 Human medicines European public assessment report (EPAR): Levemir, Insulin detemir, Diabetes Mellitus, 01/06/2004, 27, Authorised
21/02/2020 Maximum Residue Limits - Summary of opinion: Bupivacaine - Summary opinion of the CVMP on the establishment of maximum residue limits
21/02/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020
21/02/2020 Summary of opinion: Clynav, Salmon pancreas disease vaccine (recombinant DNA plasmid), 20/02/2020, Positive
21/02/2020 Summary of opinion: Vectormune FP ILT + AE, fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live), 20/02/2020, Positive
21/02/2020 Summary of opinion: Tulissin, tulathromycin, 20/02/2020, Positive
21/02/2020 Summary of opinion: Tulaven, tulathromycin, 20/02/2020, Positive
21/02/2020 Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Epilepsy, 03/10/2011, Generic, 11, Authorised
21/02/2020 Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 16, Authorised
21/02/2020 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 13/02/2020, Generic, Authorised
21/02/2020 Human medicines European public assessment report (EPAR): Hexyon, diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 20, Authorised
21/02/2020 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 12, Authorised
21/02/2020 Hexaxim H-W-2495
21/02/2020 Human medicines European public assessment report (EPAR): Hexacima, diphtheria toxoid / tetanus toxoid, two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein, hepatitis-B surface antigen, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 19, Authorised
21/02/2020 Periodic safety update single assessment: Clebopride: List of nationally authorised medicinal products - PSUSA/00000789/201906
20/02/2020 Human medicines European public assessment report (EPAR): Lifmior, etanercept, Arthritis, Psoriatic, Spondylitis, Ankylosing, Psoriasis, 13/02/2017, Additional monitoring, 8, Withdrawn
20/02/2020 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 19, Authorised
20/02/2020 Direct healthcare professional communication: Risks associated with systemic exposure to estradiol creams
20/02/2020 Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams, Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020
20/02/2020 Human medicines European public assessment report (EPAR): Cialis, tadalafil, Erectile Dysfunction, 12/11/2002, 27, Authorised
20/02/2020 Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis, Respiratory Tract Infections, 25/03/2015, Additional monitoring, 10, Authorised
20/02/2020 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201907
19/02/2020 Report: Applications for new human medicines under evaluation by the CHMP: February 2020
19/02/2020 Committee for Advanced Therapies (CAT): 19-21 February 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 19/02/2020 to 21/02/2020
19/02/2020 Agenda: Agenda - CAT agenda of the 19-21 February 2020 meeting
19/02/2020 Pharmacovigilance Risk Assessment Committee (PRAC): 30 September-3 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 30/09/2019 to 03/10/2019
19/02/2020 Minutes: Minutes of the PRAC meeting 30 September-03 October 2019
19/02/2020 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, Exceptional circumstances, 3, Authorised
19/02/2020 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 32, Authorised
19/02/2020 Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, 22/03/2017, 2, Authorised
19/02/2020 Other: European Medicines Agency’s privacy statement for the pre-employment medical examination
19/02/2020 Orphan designation: Combretastatin A1 diphosphate- for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive
19/02/2020 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive
19/02/2020 Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the: Treatment of fragile X syndrome, 20/04/2017, Positive
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 08/02/2013, Positive
19/02/2020 Orphan designation: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol (fosbretabulin tromethamine) for the: Treatment of anaplastic thyroid cancer, 14/04/2004, Positive
19/02/2020 Orphan designation: Ovine specific immunoglobulin (Fab) fragments raised against Vipera berus veno for the: Treatment of snakebite envenomation, 09/10/2015, Positive
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene for the: Treatment of congenital alpha-1 antitrypsin deficiency, 20/03/2007, Positive
19/02/2020 Orphan designation: Fosbretabulin tromethamine for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 21/03/2016, Positive
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human retinoschisin gene for the: Treatment of X-linked juvenile retinoschisis, 12/03/2013, Positive
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive
19/02/2020 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary sclerosing cholangitis, 14/12/2015, Positive
19/02/2020 Orphan designation: Fosbretabulin tromethamine for the: Treatment of ovarian cancer, 17/07/2013, Positive
19/02/2020 Orphan designation: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha) for the: Treatment of glioma, 19/02/2014, Positive
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene, 30/05/2016, Positive
19/02/2020 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, Authorised
18/02/2020 Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 30/11/2009, 16, Authorised
18/02/2020 Veterinary medicines European public assessment report (EPAR): Vectormune ND, cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, 08/09/2015, 5, Authorised
18/02/2020 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 15, Authorised
18/02/2020 Human medicines European public assessment report (EPAR): Iblias, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 4, Withdrawn
18/02/2020 ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5
18/02/2020 Scientific guideline: ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5 - Revision 3
18/02/2020 ICH E9 statistical principles for clinical trials
18/02/2020 Scientific guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials Step 5
18/02/2020 Agenda: Agenda - CVMP agenda of the 18-20 February 2020 meeting
18/02/2020 Other: EU Innovation Network: E-mail addresses for users
18/02/2020 Human medicines European public assessment report (EPAR): Nonafact, human coagulation factor IX, Hemophilia B, 03/07/2001, 9, Withdrawn
18/02/2020 Human medicines European public assessment report (EPAR): Beovu, brolucizumab, Wet Macular Degeneration, 13/02/2020, Additional monitoring, Authorised
18/02/2020 Orphan designation: Milatuzumab for the: Treatment of chronic lymphocytic leukaemia, 19/01/2009, Withdrawn
18/02/2020 Orphan designation: Milatuzumab for the: Treatment of multiple myeloma, 19/01/2009, Withdrawn
18/02/2020 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 6, Authorised
18/02/2020 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Additional monitoring, Authorised
18/02/2020 Regulatory and procedural guideline: Checklist for sponsors applying for the transfer of orphan medicinal product designation
17/02/2020 Other: European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs)
17/02/2020 Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
17/02/2020 Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation
17/02/2020 Agenda: Agenda - COMP agenda of the 18-20 February 2020 meeting
17/02/2020 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 15, Authorised
17/02/2020 Template or form: Mutual-recognition, decentralised and referral product-information template version 4.1
17/02/2020 Human medicines European public assessment report (EPAR): Sycrest, asenapine maleate , Bipolar Disorder, 01/09/2010, 16, Authorised
17/02/2020 Withdrawn application: Opsumit, macitentan, Date of withdrawal: 08/11/2019, Post-authorisation
17/02/2020 Periodic safety update single assessment: Ganciclovir: List of nationally authorised medicinal products - PSUSA/00001516/201906
17/02/2020 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 19, Authorised
17/02/2020 Periodic safety update single assessment: Human plasma proteins with not less than 95% albumin: List of nationally authorised medicinal products - PSUSA/00010605/201907
17/02/2020 Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 15, Authorised
17/02/2020 Periodic safety update single assessment: Octenidine: List of nationally authorised medicinal products - PSUSA/00010748/201907
14/02/2020 Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa, 13/02/2020, Additional monitoring, Biosimilar, Authorised
14/02/2020 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 7, Authorised
14/02/2020 Other: European Medicines Agency’s privacy statement public and targeted consultations
14/02/2020 Use of herbal medicinal products containing estragole
14/02/2020 Other: Second draft - Revision 1: Public statement on the use of herbal medicinal products containing estragole
14/02/2020 Overview of comments: Overview of comments received on the draft revised Public statement on the use of herbal medicinal products containing estragole (EMA/HMPC/137212/2005 Rev 1)
14/02/2020 News and press releases: Restrictions in use of cyproterone due to meningioma risk
14/02/2020 Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy, Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020
14/02/2020 Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen, Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020
14/02/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020
14/02/2020 Direct healthcare professional communications
14/02/2020 Human medicines European public assessment report (EPAR): Zalmoxis, Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, 18/08/2016, Conditional approval, 1, Withdrawn
14/02/2020 Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 7, Authorised
14/02/2020 Periodic safety update single assessment: Rocuronium : List of nationally authorised medicinal products - PSUSA/00002656/201902
14/02/2020 Periodic safety update single assessment: Rocuronium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002656/201902
13/02/2020 Periodic safety update single assessment: Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): List of nationally authorised medicinal products - PSUSA/00010593/201903
13/02/2020 Periodic safety update single assessment: Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implem - PSUSA/00010593/201903
13/02/2020 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib s-malate, Carcinoma, Renal Cell, 09/09/2016, Accelerated assessment, Additional monitoring, 7, Authorised
13/02/2020 Report: Information Management Strategy 2020-2022
13/02/2020 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 12, Authorised
13/02/2020 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 6, Authorised
13/02/2020 Human medicines European public assessment report (EPAR): Seebri Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 10, Authorised
13/02/2020 Template or form: Connecting to the Agency ESTRI Gateway using an AS2 compatible product
13/02/2020 Veterinary medicines European public assessment report (EPAR): Draxxin, tulathromycin, 11/11/2003, 22, Authorised
13/02/2020 Orphan designation: Replication-incompetent, non-integrating, herpes simplex virus 1 vector expressing the human transglutaminase-1 enzyme for the: Treatment of autosomal recessive congenital ichthyosis, 13/11/2019, Positive
13/02/2020 Orphan designation: Ganaxolone for the: Treatment of CDKL5 deficiency disorder, 13/11/2019, Positive
13/02/2020 Orphan designation: Exendin (9-39) for the: Treatment of congenital hyperinsulinism, 13/11/2019, Positive
13/02/2020 Orphan designation: Chimeric fibril-reactive IgG1k monoclonal antibody 11-1F4 for the: Treatment of AL amyloidosis, 13/11/2019, Positive
13/02/2020 Orphan designation: Camsirubicin for the: Treatment of soft tissue sarcoma, 13/11/2019, Positive
13/02/2020 Orphan designation: Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19) for the: Treatment of mantle cell lymphoma, 13/11/2019, Positive
12/02/2020 Orphan designation: (2S,3R,4R,5S)-2-(hydroxymethyl)-1-pentylpiperidine-3,4,5-triol for the: Treatment of GM2 gangliosidosis, 13/11/2019, Positive
12/02/2020 Orphan designation: 4-((E)-(5-(2-(2-((S)-2-((S)-1-(L-threonyl-L-lysyl)pyrrolidine-2-carboxamido)-5-guanidinopentanamido)acetamido)-2-carboxyethyl)-2-hydroxyphenyl)diazenyl)phenyl (2-(trimethylammonio)ethyl) phosphate for the: Treatment of non-infectious uveitis, 13/11/2019, Positive
12/02/2020 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 3, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 13, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 14, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 15, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Temybric Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 12/06/2019, Additional monitoring, 1, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 4, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 16, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 15, Authorised
12/02/2020 EudraVigilance Veterinary
12/02/2020 News and press releases: Public access to suspected side effect reports of veterinary medicines
12/02/2020 Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome, Dwarfism, Pituitary, 15/02/2001, 17, Authorised
12/02/2020 Veterinary medicines European public assessment report (EPAR): Inflacam, meloxicam, 09/12/2011, Generic, 10, Authorised
12/02/2020 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 13, Authorised
12/02/2020 Substances and products data management services
12/02/2020 Human medicines European public assessment report (EPAR): Zoledronic acid Teva, zoledronic acid, Fractures, Bone, Cancer, 16/08/2012, Generic, 12, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 4, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 8, Authorised
12/02/2020 Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase for the: Treatment of limb-girdle muscular dystrophy, 27/02/2017, Withdrawn
12/02/2020 Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase for the: treatment of facioscapulohumeral muscular dystrophy, 12/02/2015, Withdrawn
12/02/2020 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 1, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 07/11/2001, Additional monitoring, 37, Authorised
12/02/2020 Orphan designation: 2-Hydroxyoleic acid for the: Treatment of glioma, 27/10/2011, Positive
12/02/2020 Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo for the: Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Withdrawn
12/02/2020 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 24, Authorised
12/02/2020 Human medicines European public assessment report (EPAR): Votubia, everolimus, Tuberous Sclerosis, 02/09/2011, Orphan, 25, Authorised
12/02/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2020
11/02/2020 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 19, Authorised
11/02/2020 Human medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, Hypogonadism, 20/10/1995, 23, Authorised
11/02/2020 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 22, Authorised
11/02/2020 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility, Hypogonadism, 02/05/1996, 27, Authorised
11/02/2020 Orphan designation: lenalidomide for the: Treatment of follicular lymphoma, 24/01/2013, Withdrawn
11/02/2020 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 18, Authorised
11/02/2020 Orphan designation: Beraprost sodium for the: Treatment of pulmonary arterial hypertension, 10/07/2008, Withdrawn
11/02/2020 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes, 14/06/2007, Additional monitoring, 40, Authorised
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
11/02/2020 Regulatory and procedural guideline: Product Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 6
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7
11/02/2020 Regulatory and procedural guideline: Substances, Products, Organisations, Referentials (SPOR): SPOR API v2 Specification
11/02/2020 Regulatory and procedural guideline: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide
11/02/2020 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 14, Authorised
11/02/2020 Other: Information Technology Directors Group - List of nominated members (alphabetically by country)
11/02/2020 ICH M9 on biopharmaceutics classification system based biowaivers
11/02/2020 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 27-30 January 2020
11/02/2020 Withdrawn application: Xyndari, glutamine, Date of withdrawal: 18/09/2019, Initial authorisation
11/02/2020 Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 18/09/2013, 14, Authorised
11/02/2020 Rewards and incentives for paediatric medicines
11/02/2020 Template or form: Dossier administrative validation checklist
11/02/2020 Work programme: CHMP work plan 2020
10/02/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 13-16 January 2020 PRAC meeting
10/02/2020 Newsletter: Human medicines highlights - February 2020
10/02/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2019
10/02/2020 Agenda: Agenda - PRAC draft agenda of meeting 10-13 February 2020
10/02/2020 Minutes: Minutes - PDCO minutes of the 23-26 July 2019 meeting
10/02/2020 Minutes: Minutes - PDCO minutes of the 17-20 September 2019 meeting
10/02/2020 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 17, Authorised
10/02/2020 Regulatory and procedural guideline: Member states contact points for translations review
10/02/2020 Report: Final programming document 2020-2022
10/02/2020 Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, 18/05/2018, Additional monitoring, Biosimilar, 5, Authorised
07/02/2020 Template or form: Day 80 assessment report - Clinical template with guidance rev.02.20
07/02/2020 Other: European Medicines Agency's privacy statement for the organisation of meetings and events
07/02/2020 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, 17, Authorised
07/02/2020 Withdrawn application: Idhifa, enasidenib, Date of withdrawal: 06/12/2019, Initial authorisation
07/02/2020 Application withdrawal assessment report: Withdrawal assessment report for Idhifa
06/02/2020 Human medicines European public assessment report (EPAR): Baqsimi, Glucagon, Diabetes Mellitus, 16/12/2019, Authorised