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Date Content
08/04/2020 Report: Applications for new human medicines under evaluation by the CHMP: April 2020 (new)
08/04/2020 Template or form: Template letter of intent for request of scientific advice or protocol assistance (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Trepulmix, Treprostinil sodium, Hypertension, Pulmonary, 03/04/2020, Orphan, Authorised
08/04/2020 Orphan designation: Treprostinil sodium for the: Treatment of chronic thromboembolic pulmonary hypertension, 08/02/2013, Positive (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): Veraflox, pradofloxacin, 12/04/2011, 8, Authorised (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): Broadline, eprinomectin, fipronil, praziquantel, (S)-methoprene, 04/12/2013, 10, Authorised (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): Locatim (previously Serinucoli), Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, 29/03/1999, 11, Authorised (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): Nexgard Spectra, afoxolaner, milbemycin oxime, 15/01/2015, 8, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, Additional monitoring, Conditional approval, 3, Authorised (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): Profender, emodepside, praziquantel, 27/07/2005, 18, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, 15, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 44, Authorised (updated)
08/04/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC (updated)
08/04/2020 Veterinary medicines European public assessment report (EPAR): NexGard, afoxolaner, 11/02/2014, 11, Authorised (updated)
08/04/2020 Herbal medicinal product: Absinthii herba, Absinthii herba, F: Assessment finalised (updated)
08/04/2020 Herbal medicinal product: Taraxaci radix cum herba, Taraxaci radix cum herba, F: Assessment finalised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Revatio, sildenafil, Hypertension, Pulmonary, 28/10/2005, 39, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 42, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, Authorised
08/04/2020 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 30, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection, Kidney Transplantation, 17/06/2011, 13, Authorised (updated)
08/04/2020 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, 18, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s., pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 27/02/2017, Generic, 6, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
08/04/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC meeting (updated)
08/04/2020 Orphan designation: N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide for the: Treatment of pulmonary arterial hypertension, 22/02/2018, Positive (updated)
08/04/2020 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Position provided by CMDh, 30/01/2020, 08/04/2020 (updated)
08/04/2020 Orphan designation: Patidegib for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 21/03/2018, Positive (updated)
08/04/2020 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors, Radionuclide Imaging, 08/12/2016, Orphan, Additional monitoring, 5, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva, mycophenolate mofetil, Graft Rejection, 21/02/2008, Generic, 21, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 11, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 4, Authorised (updated)
08/04/2020 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, 28, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 13, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Emgality, Galcanezumab, Migraine Disorders, 14/11/2018, Additional monitoring, 3, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 28, Authorised (updated)
08/04/2020 Human medicines European public assessment report (EPAR): Beromun, tasonermin, Sarcoma, 12/04/1999, 13, Authorised (updated)
07/04/2020 Orphan designation: autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1 for the: Treatment of soft tissue sarcoma, 14/07/2016, Positive (updated)
07/04/2020 Orphan designation: Mepolizumab for the: Treatment of hypereosinophilic syndrome, 29/07/2004, Positive (updated)
07/04/2020 Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for the: Treatment of multiple myeloma, 16/10/2017, Positive (updated)
07/04/2020 Orphan designation: Mepolizumab for the: Treatment of Churg-Strauss syndrome, 12/03/2013, Positive (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 33, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, 13/09/1998, 35, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate, dolutegravir sodium, lamivudine, HIV Infections, 31/08/2014, Patient safety, 15, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis), pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, 7, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Kivexa, abacavir, lamivudine, HIV Infections, 16/12/2004, 30, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V., budesonide / formoterol fumarate dihydrate, Asthma, Pulmonary Disease, Chronic Obstructive, 03/04/2020, Authorised
07/04/2020 Regulatory and procedural guideline: Compilation of Quality Review of Documents decisions on stylistic matters in product information (updated)
07/04/2020 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
07/04/2020 Coronavirus disease (COVID-19) (updated)
07/04/2020 News and press releases: Global regulators discuss observational studies of real world data for COVID-19 medicines
07/04/2020 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 3, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine, tenofovir disoproxil phosphate, HIV Infections, 09/11/2016, Generic, 4, Authorised (updated)
07/04/2020 Periodic safety update single assessment: Pitavastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010502/201907 (new)
07/04/2020 Periodic safety update single assessment: Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201907 (new)
07/04/2020 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 3, Authorised (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Ruxience, rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus, 01/04/2020, Additional monitoring, Biosimilar, Authorised
07/04/2020 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 13, Authorised (updated)
07/04/2020 ICH E8 General considerations for clinical studies (updated)
07/04/2020 Human medicines European public assessment report (EPAR): Silapo, epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic, 18/12/2007, Biosimilar, 16, Authorised (updated)
07/04/2020 Veterinary medicines European public assessment report (EPAR): Baycox Iron, Iron(iii) ion / toltrazuril, 20/05/2019, Authorised (updated)
07/04/2020 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201907 (new)
07/04/2020 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the product Information and timetable for the implementation - PSUSA/00001711/201907 (new)
07/04/2020 EPAR - All authorised presentations: Silapo : EPAR - All Authorised presentations (updated)
06/04/2020 Frequently asked questions about parallel distribution (updated)
06/04/2020 News and press releases: EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
06/04/2020 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 7, Authorised (updated)
06/04/2020 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 32, Authorised (updated)
06/04/2020 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 32, Authorised (updated)
06/04/2020 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 7, Authorised (updated)
06/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Atorvastatin, W: decision granting a waiver in all age groups for all conditions/indications, P/0429/2019
06/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): sitravatinib (malate), W: decision granting a waiver in all age groups for all conditions/indications, P/0416/2019
06/04/2020 Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 April 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 14/04/2020 to 17/04/2020 (updated)
06/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): satoreotide trizoxetan, W: decision granting a waiver in all age groups for all conditions/indications, P/0390/2019
06/04/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
06/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): savolitinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0427/2019
06/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): loxoprofen (sodium hydrate), W: decision granting a waiver in all age groups for all conditions/indications, P/0417/2019
03/04/2020 Minutes: Minutes of the COMP meeting 20-22 January 2020 (new)
03/04/2020 Summary of opinion: Atectura Breezhaler, indacaterol, mometasone furoate, 26/03/2020, Positive (updated)
03/04/2020 Summary of opinion: Bemrist Breezhaler, indacaterol, mometasone furoate, 26/03/2020, Positive (updated)
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): (3S,7S)-22-(3-(((2-((5-(2-Carboxyethyl)-2-hydroxybenzyl)(carboxymethyl)amino)ethyl)(carboxymethyl)amino)methyl)-4-hydroxyphenyl)-5,13,20-trioxo-4,6,12,19-tetraazadocosane-1,3,7-tricarboxylic acid (PSMA-11), W: decision granting a waiver in all age groups for all conditions/indications, P/0393/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): A fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor complex and G Protein Coupled Receptor Family C Group 5 Member D (GPRC5D) (JNJ-64407564), W: decision granting a waiver in all age groups for all conditions/indications, P/0395/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): atazanavir (sulfate),ritonavir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0396/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): duvelisib, W: decision granting a waiver in all age groups for all conditions/indications, P/0428/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium),thiocolchicoside, W: decision granting a waiver in all age groups for all conditions/indications, P/0397/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Phenobarbital, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0422/2019
03/04/2020 Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features , European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019 (updated)
03/04/2020 Report: Report of the workshop on the use of registries in the monitoring of cancer therapies based on tumours’ genetic and molecular features - 29 November 2019 (new)
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues (DCR-PHXC), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0426/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2 (OMS721), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0400/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Marizomib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0403/2019
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Artesunate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0423/2019
03/04/2020 News and press releases: EMA provides recommendations on compassionate use of remdesivir for COVID-19
03/04/2020 Compassionate use (updated)
03/04/2020 Periodic safety update single assessment: Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201905 (new)
03/04/2020 Periodic safety update single assessment: Pholcodine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002396/201905 (new)
03/04/2020 News and press releases: International regulators discuss available knowledge supporting COVID-19 medicine development
03/04/2020 Herbal medicinal product: Arctii radix, Arctii radix, F: Assessment finalised (updated)
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): zanubrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0398/2019
03/04/2020 Periodic safety update single assessment: Iobitridol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001761/201904 (new)
03/04/2020 Periodic safety update single assessment: Iobitridol: List of nationally authorised medicinal products - PSUSA/00001761/201904 (new)
03/04/2020 Human medicines European public assessment report (EPAR): Dexdor, dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 12, Authorised (updated)
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone (hemisuccinate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0407/2019
03/04/2020 Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections, 04/02/2002, 53, Authorised (updated)
03/04/2020 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 39, Authorised (updated)
03/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): gefapixant (citrate), W: decision granting a waiver in all age groups for all conditions/indications, P/0380/2019
03/04/2020 Veterinary medicines European public assessment report (EPAR): Rabitec, attenuated live rabies vaccine virus, strain SPBN GASGAS, 01/12/2017, 1, Authorised (updated)
03/04/2020 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010, Generic, 9, Authorised (updated)
03/04/2020 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 9, Authorised (updated)
03/04/2020 Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, Orphan, 8, Authorised (updated)
03/04/2020 Minutes: Minutes of the HMPC 18-20 November 2019 meeting (new)
02/04/2020 Human medicines European public assessment report (EPAR): Incresync, alogliptin, pioglitazone, Diabetes Mellitus, Type 2, 19/09/2013, 7, Authorised (updated)
02/04/2020 Veterinary medicines European public assessment report (EPAR): ProteqFlu-Te, Clostridium tetani toxoid / Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus, 06/03/2003, 13, Authorised (updated)
02/04/2020 Veterinary medicines European public assessment report (EPAR): Oncept IL-2, vCP1338 virus, 03/05/2013, 4, Authorised (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Olazax Disperzi, olanzapine, Schizophrenia, Bipolar Disorder, 10/12/2009, Generic, 11, Authorised (updated)
02/04/2020 Regulatory and procedural guideline: PDCO rules of procedure (updated)
02/04/2020 Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised (updated)
02/04/2020 Orphan designation: Metreleptin for the: Treatment of familial partial lipodystrophy, 17/07/2012, Positive (updated)
02/04/2020 Orphan designation: Metreleptin for the: Treatment of Barraquer-Simons syndrome, 17/07/2012, Positive (updated)
02/04/2020 Orphan designation: Metreleptin for the: Treatment of Lawrence syndrome, 17/07/2012, Positive (updated)
02/04/2020 Orphan designation: Metreleptin for the: Treatment of Berardinelli-Seip syndrome, 17/07/2012, Positive (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Esmya, ulipristal acetate, Leiomyoma, 22/02/2012, Patient safety, 15, Suspended (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter, ulipristal acetate, Leiomyosarcoma, 27/08/2018, Patient safety, Suspended (updated)
02/04/2020 Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised (updated)
02/04/2020 Referral: Ulipristal acetate 5mg medicinal products , Ulipristal acetate , Article 31 referrals, Procedure started, 02/04/2020 (updated)
02/04/2020 Minutes: Minutes of the CHMP meeting 27-30 January 2020 (new)
02/04/2020 Other: CHMP rules of procedure (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 53, Authorised (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging, Alzheimer Disease, 22/08/2014, 10, Authorised (updated)
02/04/2020 Overview of comments: Analysis and summaries of public consultation results: EMA Regulatory Science to 2025 - Strategic reflection (updated)
02/04/2020 Veterinary medicines European public assessment report (EPAR): Neocolipor, E. coli F6 / E. coli field strain ag f41 / Recombinant e.coli ag k88 (or f4) (ab, ac, ad) / Recombinant e.coli ag k99 (or f5), 14/04/1998, 12, Authorised (updated)
02/04/2020 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Additional monitoring, Biosimilar, 2, Authorised (updated)
02/04/2020 Veterinary medicines European public assessment report (EPAR): Proteq West Nile, West Nile recombinant canarypox virus (vCP2017 virus), 05/08/2011, 13, Authorised (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0406/2019
02/04/2020 Veterinary medicines European public assessment report (EPAR): ProteqFlu, Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus, 06/03/2003, 13, Authorised (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0405/2019
02/04/2020 Regulatory and procedural guideline: CAT rules of procedure (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): 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 (bb2121), PM: decision on the application for modification of an agreed PIP, P/0387/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, PM: decision on the application for modification of an agreed PIP, P/0376/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Alunbrig, brigatinib, PM: decision on the application for modification of an agreed PIP, P/0430/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Bimekizumab, PM: decision on the application for modification of an agreed PIP, P/0375/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Itacitinib, PM: decision on the application for modification of an agreed PIP, P/0414/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0425/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, PM: decision on the application for modification of an agreed PIP, P/0379/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen, PM: decision on the application for modification of an agreed PIP, P/0404/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ajovy, fremanezumab, PM: decision on the application for modification of an agreed PIP, P/0411/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rivogenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0378/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, PM: decision on the application for modification of an agreed PIP, P/0418/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0424/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Orkambi, Lumacaftor,ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0431/2019 (updated)
02/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Maralixibat chloride (LUM001), PM: decision on the application for modification of an agreed PIP, P/0409/2019 (updated)
02/04/2020 Orphan designation: R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride (berotralstat) for the: Treatment of hereditary angioedema, 27/06/2018, Positive (updated)
02/04/2020 Public Statement: Public statement on Numient : Withdrawal of the marketing authorisation in the European Union (new)
02/04/2020 Orphan designation: Carboxypeptidase G2 for the: Adjunctive treatment in patients at risk of methotrexate toxicity, 03/02/2003, Positive (updated)
01/04/2020 Minutes: Minutes of the CVMP meeting of 18-20 February 2020 (new)
01/04/2020 Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 21, Authorised (updated)
01/04/2020 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
01/04/2020 Orphan designation: nitisinone for the: Treatment of alkaptonuria, 13/03/2002, Withdrawn (updated)
01/04/2020 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, 1, Authorised (updated)
01/04/2020 Veterinary medicines European public assessment report (EPAR): Zulvac 1 Ovis, inactivated bluetongue virus, serotype-1, 05/08/2011, Accelerated assessment, 6, Withdrawn (updated)
01/04/2020 Orphan designation: Humanised recombinant IgG4 anti-human tau antibody (tilavonemab) for the: Treatment of progressive supranuclear palsy, 28/04/2016, Withdrawn (updated)
01/04/2020 Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence (updated)
01/04/2020 Human medicines European public assessment report (EPAR): Azacitidine betapharm, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 24/03/2020, Generic, Authorised
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, PM: decision on the application for modification of an agreed PIP, P/0421/2019 (updated)
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zanamivir, PM: decision on the application for modification of an agreed PIP, P/0415/2019 (updated)
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Agomelatine, PM: decision on the application for modification of an agreed PIP, P/0432/2019 (updated)
01/04/2020 Report: List of products granted eligibility to PRIME (updated)
01/04/2020 Human medicines European public assessment report (EPAR): Synflorix, pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18c / pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f / pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 5 / pneumococcal polysaccharide serotype 6b / pneumococcal polysaccharide serotype 7f / pneumococcal polysaccharide serotype 9v, Pneumococcal Infections, Immunization, 29/03/2009, 32, Authorised (updated)
01/04/2020 News and press releases: COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
01/04/2020 News and press releases: Regulatory information - 1.6% increase in fees from 1 April 2020
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol, PM: decision on the application for modification of an agreed PIP, P/0381/2019 (updated)
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, PM: decision on the application for modification of an agreed PIP, P/0394/2019 (updated)
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir, W: decision granting a waiver in all age groups for all conditions/indications, P/0412/2019 (updated)
01/04/2020 Opinion/decision on a Paediatric investigation plan (PIP): Adasuve, loxapine, PM: decision on the application for modification of an agreed PIP, P/0385/2019 (updated)
01/04/2020 News and press releases: EU recommendations for 2020/2021 seasonal flu vaccine composition
01/04/2020 Regulatory and procedural guideline: Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021 (new)
01/04/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
01/04/2020 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 March 2020 (new)
01/04/2020 Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, Additional monitoring, Authorised
01/04/2020 Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, Generic, 5, Authorised (updated)
01/04/2020 Veterinary medicines European public assessment report (EPAR): Purevax Rabies, vCP65 virus, 18/02/2011, 5, Authorised (updated)
01/04/2020 ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 (updated)
01/04/2020 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Position provided by CMDh, 25/03/2020, 01/04/2020 (updated)
01/04/2020 Scientific guideline: ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 (new)
01/04/2020 Fees payable to the European Medicines Agency (updated)
01/04/2020 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2020 (new)
01/04/2020 Regulatory and procedural guideline: Council Regulation (EC) No 297/95 as amended by Commission Regulation (EU) 2020/422 of 19 March 2020 adjusting the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (new)
01/04/2020 Human medicines European public assessment report (EPAR): Tookad, padeliporfin di-potassium, Prostatic Neoplasms, 10/11/2017, Additional monitoring, 1, Authorised (updated)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Ilex paraguariensis St. Hilaire, folium (new)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Plantago lanceolata L., folium (new)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Solanum dulcamara L., stipites (new)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Urtica dioica L.; Urtica urens L., folium (new)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Urtica dioica L. and Urtica urens L., herba (new)
01/04/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore (new)