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31/01/2020 Herbal medicinal product: Agropyri repentis rhizoma, Agropyri repentis rhizoma, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1
31/01/2020 Herbal medicinal product: Caryophylii floris aetheroleum, Caryophylii floris aetheroleum, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Syzygium aromaticum (L.) Merill et L. M. Perry (Eugenia caryophyllus (C. Spreng.) Bull. et Harr.), aetheroleum - Revision 1
31/01/2020 Herbal medicinal product: Carvi fructus, Carvi fructus, F: Assessment finalised
31/01/2020 Herbal medicinal product: Carvi aetheroleum, Carvi aetheroleum, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Carum carvi L., aetheroleum - Revision 1
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Carum carvi L., fructus - Revision 1
31/01/2020 Template or form: Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
31/01/2020 Herbal medicinal product: Zingiberis rhizoma, Zingiberis rhizoma, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Zingiber officinale Roscoe, rhizoma - Revision 1
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Chamaemelum nobile (L.) All. (Anthemis nobilis L.), flos - Revision 1
31/01/2020 Herbal medicinal product: Chamomillae romanae flos, Chamomillae romanae flos, F: Assessment finalised
31/01/2020 Herbal medicinal product: Colae semen, Colae semen, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Cola nitida (Vent.) Schott et Endl. (C. vera K. Schum.); Cola acuminata (P. Beauv.) Schott et Endl. (Sterculia acuminata P. Beauv.), semen - Revision 1
31/01/2020 Herbal medicinal product: Millefolii herba, Millefolii herba, F: Assessment finalised
31/01/2020 Herbal medicinal product: Pelargonii radix, Pelargonii radix, F: Assessment finalised
31/01/2020 Herbal - Call for data: Call for scientific data for the revision of the monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix - Revision 1
31/01/2020 Herbal – European Union list entry: Draft European Union list entry on Achillea millefolium L., herba - Revision 1
31/01/2020 Herbal - HMPC opinion on a European Union herbal monograph: Draft European Union herbal monograph on Achillea millefolium L., herba - Revision 1
31/01/2020 Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products
31/01/2020 Scientific guideline: Question and answer document in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012)
31/01/2020 News and press releases: UK withdrawal from the EU on 31 January 2020
31/01/2020 Brexit: the United Kingdom's withdrawal from the European Union
31/01/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
31/01/2020 News and press releases: First treatment for acute hepatic porphyria
31/01/2020 News and press releases: First oral GLP-1 treatment for type 2 diabetes
30/01/2020 Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Gaucher Disease, 18/02/2019, Generic, 2, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa, 22/11/2018, Orphan, Additional monitoring, 2, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Melanoma, 17/02/2012, 19, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis, Hyperphosphatemia, 28/01/2000, 32, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis, 13/01/2016, Additional monitoring, Biosimilar, 11, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Esbriet, Pirfenidone, Idiopathic Pulmonary Fibrosis, 27/02/2011, Orphan, 25, Authorised
30/01/2020 Human medicines European public assessment report (EPAR): Zoledronic acid Actavis, zoledronic acid monohydrate, Fractures, Bone, 20/04/2012, Generic, 12, Authorised
30/01/2020 Agenda: Agenda - PDCO agenda of the 28-31 January 2020 meeting
30/01/2020 Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Head and Neck Neoplasms, Colorectal Neoplasms, 29/06/2004, 28, Authorised
30/01/2020 Agenda: Agenda - CHMP agenda of the 27-30 January 2020 meeting
29/01/2020 Minutes: Minutes of the COMP meeting 8-10 October 2019
29/01/2020 Veterinary medicines European public assessment report (EPAR): Coliprotec F4, live non-pathogenic Escherichia coli O8:K87, 16/03/2015, 2, Authorised
29/01/2020 Veterinary medicines European public assessment report (EPAR): Meloxoral, meloxicam, 19/11/2010, Generic, 6, Authorised
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, The Netherlands, from 04/03/2020 to 06/03/2020
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, Netherlands, from 06/05/2020 to 08/05/2020
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Vienna , Vienna, Austria, from 25/05/2020 to 27/05/2020
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Paris , Paris, France, from 08/06/2020 to 10/06/2020
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, Netherlands, from 15/06/2020 to 17/06/2020
29/01/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Munich , Munich, Germany, from 29/06/2020 to 01/07/2020
29/01/2020 Other: Electronic product information for human medicines in the European Union - Categorised comments received following public consultation (partially anonymised)
29/01/2020 Report: Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles'
29/01/2020 News and press releases: Key principles for the use of electronic product information for EU medicines
29/01/2020 Press Release: Key principles for the use of electronic product information for EU medicines
29/01/2020 Product-information requirements
29/01/2020 Electronic product information for human medicines in the European Union – key principles
29/01/2020 Regulatory and procedural guideline: Electronic product information for human medicines in the European Union - key principles
29/01/2020 Other: Electronic product information for human medicines in the European Union - Contributions received following public consultation (partially anonymised)
29/01/2020 Minutes: Minutes of the HMPC 13-15 May 2019 meeting
29/01/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: January 2020
29/01/2020 Newsletter: News bulletin for small and medium-sized enterprises - Issue 48
29/01/2020 Other: Extended Telematics strategy and implementation roadmap 2019-2020
29/01/2020 Minutes: Minutes of the HMPC 8-10 July 2019 meeting
29/01/2020 Minutes: Minutes of the CAT meeting 9-11 October 2019
29/01/2020 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
29/01/2020 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
29/01/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2019
28/01/2020 Human medicines European public assessment report (EPAR): HBVaxPro, hepatitis B, recombinant surface antigen, Hepatitis B, Immunization, 27/04/2001, 26, Authorised
28/01/2020 Periodic safety update single assessment: Measles vaccine (live attenuated): List of nationally authorised medicinal products - PSUSA/00001938/201905
28/01/2020 Periodic safety update single assessment: Fusidic acid (systemic use): List of nationally authorised medicinal products - PSUSA/00010226/201905
28/01/2020 News and press releases: Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health
28/01/2020 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 8, Authorised
28/01/2020 Press Release: Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health
28/01/2020 Overview of comments: Overview of comments - 'Categorisation of antibiotics in the European Union - Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals'
28/01/2020 Advice on impacts of using antimicrobials in animals
28/01/2020 Report: Categorisation of antibiotics in the European Union - Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals
28/01/2020 Human medicines European public assessment report (EPAR): Ultibro Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 19/09/2013, 11, Authorised
28/01/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2019
28/01/2020 Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 3, Authorised
28/01/2020 Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 12, Authorised
28/01/2020 Supporting SMEs
28/01/2020 Patients' and Consumers' Working Party
28/01/2020 Minutes: Minutes of the CHMP meeting 11-14 November 2019
28/01/2020 Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA for the: Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive
27/01/2020 Periodic safety update single assessment: Cidofovir : List of nationally authorised medicinal products - PSUSA/00010558/201906
27/01/2020 Periodic safety update single assessment: Ethinylestradiol / levonorgestrel: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001309/201904
27/01/2020 History of EMA
27/01/2020 Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Lymphoma, B-Cell, 16/01/2020, Orphan, Additional monitoring, Conditional approval, Authorised
27/01/2020 Orphan designation: polatuzumab vedotin for the: Treatment of diffuse large B-cell lymphoma, 16/04/2018, Positive
27/01/2020 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Nicardipine: List of nationally authorised medicinal products - PSUSA/00002149/201905
27/01/2020 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 December 2019
27/01/2020 Agenda: Agenda - CAT agenda of the 22-24 January 2020 meeting
27/01/2020 Human medicines European public assessment report (EPAR): Doptelet, avatrombopag, Thrombocytopenia, 20/06/2019, Additional monitoring, 1, Authorised
27/01/2020 Periodic safety update single assessment: Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201904
24/01/2020 Human medicines European public assessment report (EPAR): Caprelsa, Vandetanib, Thyroid Neoplasms, 16/02/2012, Additional monitoring, Conditional approval, 17, Authorised
24/01/2020 Newsletter: Enpr-EMA newsletter 2019
24/01/2020 Conduct of bioequivalence studies for veterinary medicinal products
24/01/2020 Scientific guideline: Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
24/01/2020 News and press releases: Martina Schüssler-Lenz re-elected as chair of Committee for Advanced Therapies
24/01/2020 Summary of opinion: Rabitec, Rabies vaccine (live, oral) for foxes and raccoon dogs, 23/01/2020, Positive
24/01/2020 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905
24/01/2020 Human medicines European public assessment report (EPAR): Vectibix, panitumumab, Colorectal Neoplasms, 03/12/2007, 31, Authorised
24/01/2020 EPAR - Overview: Vectibix : EPAR - Medicine overview
24/01/2020 Withdrawn application: Linhaliq, ciprofloxacin, Date of withdrawal: 29/10/2019, Initial authorisation
24/01/2020 Periodic safety update single assessment: Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201905
23/01/2020 Periodic safety update single assessment: Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904
23/01/2020 Periodic safety update single assessment: Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201905
23/01/2020 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905
23/01/2020 Periodic safety update single assessment: Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905
23/01/2020 Report: Human medicines highlights 2019
23/01/2020 Report: Veterinary medicines highlights 2019
23/01/2020 Orphan designation: propranolol hydrochloride for the: Treatment of retinopathy of prematurity, 17/10/2019, Positive
23/01/2020 Periodic safety update single assessment: Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905
23/01/2020 Orphan designation: pemigatinib for the: Treatment of myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK, 17/10/2019, Positive
23/01/2020 Orphan designation: paclitaxel for the: Treatment of soft tissue sarcoma, 17/10/2019, Positive
23/01/2020 Herbal - HMPC assessment report: Addendum to assessment report on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex
23/01/2020 Human medicines European public assessment report (EPAR): Eurartesim, piperaquine tetraphosphate / artenimol, Malaria, 27/10/2011, 11, Authorised
23/01/2020 Orphan designation: Nirogacestat for the: Treatment of soft tissue sarcoma, 17/10/2019, Positive
23/01/2020 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905
23/01/2020 Periodic safety update single assessment: Macrogol 4000, macrogol 4000 combinations (oral use): List of nationally authorised medicinal products - PSUSA/00010392/201905
22/01/2020 Other: Choice of timetable for type II variations and worksharing applications
22/01/2020 News and press releases: Court of Justice upholds EMA’s approach to transparency
22/01/2020 Agenda: Agenda - COMP agenda of the 20-22 January 2020 meeting
22/01/2020 Report: Medicinal products for human use: monthly figures - December 2019
22/01/2020 Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira, zoledronic acid monohydrate, Hypercalcemia, 19/11/2012, Generic, 16, Authorised
22/01/2020 Orphan designation: lonapegsomatropin for the: Treatment of growth hormone deficiency, 17/10/2019, Positive
22/01/2020 Periodic safety update single assessment: Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905
22/01/2020 Orphan designation: leriglitazone for the: Treatment of Friedreich’s ataxia, 17/10/2019, Positive
22/01/2020 Veterinary medicines European public assessment report (EPAR): Nobilis IB 4-91, live attenuated avian infectious bronchitis virus variant strain 4-91, 09/06/1998, 14, Authorised
22/01/2020 Orphan designation: besilesomab for the: Treatment in haematopoietic stem cell transplantation, 17/10/2019, Positive
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of primary biliary cirrhosis, 16/01/2014, Positive
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of Alagille syndrome, 16/01/2014, Positive
22/01/2020 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the: Treatment of primary sclerosing cholangitis, 16/01/2014, Positive
22/01/2020 Standard Operating Procedure - SOP: Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use)
22/01/2020 Template or form: Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) - Forms 1-7
22/01/2020 Type-IB variations: questions and answers
22/01/2020 Type-IA variations: questions and answers
22/01/2020 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, 13, Authorised
22/01/2020 Orphan designation: Autologous CD34+ haematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene for the: Treatment of beta-thalassaemia intermedia and major, 17/10/2019, Positive
22/01/2020 Orphan designation: Anti-neonatal Fc receptor human monoclonal antibody for the: Prevention of haemolytic disease of the foetus and newborn, 17/10/2019, Positive
22/01/2020 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 27, Authorised
22/01/2020 Orphan designation: Combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- half coding sequences of human ABCA4 fused to inteins for the: Treatment of Stargardt's disease, 17/10/2019, Positive
21/01/2020 Orphan designation: 4-oxo-4H-chromene-2-carboxylic acid (2-(2-4-(2-(6,7-dimethoxy-3,4-dihydro-1H-isoquinolin-2-yl)-ethyl)-phenyl-2H-tetrazol-5-yl)-4,5-dimethoxy-phenyl)-amide for the: Treatment of soft tissue sarcoma, 17/10/2019, Positive
21/01/2020 Orphan designation: 2'-O-(2-methoxyethyl)-D-ribose antisense oligonucleotide targeting glial fibrillary acidic protein messenger ribonucleic acid for the: Treatment of Alexander disease, 17/10/2019, Positive
21/01/2020 Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt for the: Treatment of graft-versus-host disease, 17/10/2019, Positive
21/01/2020 Orphan designation: 18-(p-(131I)-iodophenyl)octadecyl phosphocholine for the: Treatment of multiple myeloma, 17/10/2019, Positive
21/01/2020 Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} for the: Treatment of Netherton syndrome, 17/10/2019, Positive
21/01/2020 Referrals document: Picato Article-20 referral - Annex I - Scientific conclusions
21/01/2020 Other: Privacy Statement for the EMA individual experts’ stakeholder database
21/01/2020 Other: Privacy Statement concerning Public Hearings at the European Medicines Agency
21/01/2020 Regulatory and procedural guideline: EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1
21/01/2020 Agenda: Agenda - CVMP agenda of the 21-23 January 2020 meeting
21/01/2020 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 26, Authorised
21/01/2020 Human medicines European public assessment report (EPAR): Movymia, teriparatide, Osteoporosis, 11/01/2017, Additional monitoring, Biosimilar, 6, Authorised
20/01/2020 Orphan designation: nilotinib for the: Treatment of chronic myeloid leukaemia, 22/05/2006, Expired
20/01/2020 Human medicines European public assessment report (EPAR): Kengrexal, cangrelor, Acute Coronary Syndrome, Vascular Surgical Procedures, 23/03/2015, Additional monitoring, 8, Authorised
20/01/2020 Referral: Flurbiprofen Geiser , flurbiprofen , Flurbiprofen Sejmet,Mentocaína Spray,Flurbiprofeno Geiser, Article 29(4) referrals, European Commission final decision, 17/10/2019, 16/12/2019, 20/01/2020
20/01/2020 Periodic safety update single assessment: Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905
20/01/2020 Periodic safety update single assessment: Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905
20/01/2020 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 11, Authorised
20/01/2020 Other: Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency
20/01/2020 Periodic safety update single assessment: Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812
20/01/2020 News and press releases: Ten recommendations to unlock the potential of big data for public health in the EU
17/01/2020 Report: Applications for new human medicines under evaluation by the CHMP: January 2020
17/01/2020 Newsletter: Human medicines highlights - January 2020
17/01/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020
17/01/2020 News and press releases: EMA suspends Picato as a precaution while review of skin cancer risk continues
17/01/2020 News and press releases: PRAC confirms four-week limit for use of high-strength estradiol creams
17/01/2020 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 11, Authorised
17/01/2020 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism, 30/09/2008, Patient safety, Additional monitoring, 32, Authorised
17/01/2020 Periodic safety update single assessment: Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905
17/01/2020 Veterinary medicines European public assessment report (EPAR): Vaxxitek HVT+IBD, Recombinant turkey herpesvirus, strain vhvt013-69, live, 09/08/2002, 11, Authorised
17/01/2020 Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, 06/09/2010, 11, Authorised
17/01/2020 Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesylate, Melanoma, 26/08/2013, 21, Authorised
16/01/2020 Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for the: Treatment of C3 glomerulopathy, 21/08/2019, Positive
16/01/2020 Orphan designation: Adenoviral vector serotype 5 encoding the human interleukin-12 p70 transgene under the control of activator ligand veledimex for the: Treatment of glioma, 21/08/2019, Positive
16/01/2020 Orphan designation: Veledimex for the: Treatment of glioma, 21/08/2019, Positive
16/01/2020 Orphan designation: Clofazimine for the: Treatment of nontuberculous mycobacterial lung disease, 21/08/2019, Positive
16/01/2020 Applying for orphan designation
16/01/2020 Removing an orphan designation
16/01/2020 Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN6 gene for the: Treatment of neuronal ceroid lipofuscinosis, 21/08/2019, Positive
16/01/2020 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 4, Authorised
16/01/2020 Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene for the: Treatment of neuronal ceroid lipofuscinosis, 21/08/2019, Positive
16/01/2020 Orphan designation: 1-(2,2-diphenyltetrahydrofuran-3-yl)-N,N-dimethylmethanamine hydrochloride for the: Treatment of Rett syndrome, 21/08/2019, Positive
16/01/2020 Orphan designation: Herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes for the: Adjunctive treatment in haematopoietic cell transplantation, 20/10/2003, Withdrawn
16/01/2020 Orphan designation: Triheptanoin for the: Treatment of glucose transporter type-1 deficiency syndrome, 21/05/2015, Withdrawn
16/01/2020 Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile for the: Treatment of medullary thyroid carcinoma, 26/10/2018, Withdrawn
16/01/2020 News and press releases: EMA welcomes new Head of Information Management Division
15/01/2020 Human medicines European public assessment report (EPAR): Aerivio Spiromax, salmeterol xinafoate, fluticasone propionate, Pulmonary Disease, Chronic Obstructive, Asthma, 18/08/2016, 2, Withdrawn
15/01/2020 Leaflet: Responsible use of antibiotics protects animals and people - 2011-2017 Sales of antibiotics for veterinary use are down - Infographic
15/01/2020 Committee for Advanced Therapies (CAT): 11-13 September 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2019 to 13/09/2019
15/01/2020 Minutes: Minutes of the CAT meeting 11-13 September 2019
15/01/2020 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 12-15 November 2019
15/01/2020 Committee for Herbal Medicinal Products (HMPC): 13-15 January 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 13/01/2020 to 15/01/2020
15/01/2020 Agenda: Agenda - HMPC agenda of the 13-15 January 2020 meeting
15/01/2020 Veterinary medicines European public assessment report (EPAR): Zactran, gamithromycin, 24/07/2008, 11, Authorised
15/01/2020 Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics), tadalafil, Hypertension, Pulmonary, 09/01/2017, Generic, 4, Authorised
15/01/2020 Orphan designation: Olaratumab for the: Treatment of soft tissue sarcoma, 12/02/2015, Withdrawn
15/01/2020 News and press releases: Mandatory use of international standard for the reporting of side effects to improve safety of medicines
15/01/2020 Other: Announcement of the EMA Management Board - Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology
14/01/2020 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 11/11/2012, 17, Authorised
14/01/2020 Veterinary medicines European public assessment report (EPAR): ProZinc, insulin human, 12/07/2013, 9, Authorised
14/01/2020 Orphan designation: 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-(2-propynyl)-1,3-thiazol-2-amine for the: Treatment of congenital adrenal hyperplasia, 21/08/2019, Positive
14/01/2020 Periodic safety update single assessment: Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902
14/01/2020 Periodic safety update single assessment: Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902
14/01/2020 Orphan designation: acetazolamide for the: Treatment of periodic paralysis, 21/08/2019, Positive
14/01/2020 Other: Extension of reserve lists for external selection procedures: Contract Agent reserve list
14/01/2020 Periodic safety update single assessment: Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903
14/01/2020 Periodic safety update single assessment: Erythromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001257/201903
14/01/2020 Orphan designation: Relacorilant for the: Treatment of pancreatic cancer, 21/08/2019, Positive
14/01/2020 Orphan designation: Setmelanotide for the: Treatment of Bardet-Biedl syndrome, 21/08/2019, Positive
14/01/2020 Orphan designation: Peginterferon lambda-1a for the: Treatment of hepatitis D virus infection, 21/08/2019, Positive
14/01/2020 Orphan designation: temozolomide for the: Treatment of neuroblastoma, 21/08/2019, Positive
14/01/2020 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised
13/01/2020 Agenda: Agenda - PRAC draft agenda of meeting 13-16 January 2020
13/01/2020 Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, Additional monitoring, Biosimilar, 2, Authorised
13/01/2020 Orphan designation: lenalidomide for the: Treatment of marginal zone lymphoma, 24/04/2015, Withdrawn
13/01/2020 Orphan designation: lenalidomide for the: Treatment of diffuse large B-cell lymphoma, 13/05/2011, Withdrawn
13/01/2020 Orphan designation: lenalidomide for the: Treatment of chronic lymphocytic leukaemia, 19/11/2007, Withdrawn
13/01/2020 Orphan designation: lenalidomide for the: Treatment of mantle cell lymphoma, 27/10/2011, Withdrawn
13/01/2020 Orphan designation: "3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione (lenalidomide) for the: Treatment of myelodysplastic syndromes, 08/03/2004, Withdrawn
13/01/2020 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis, 15/06/2017, Additional monitoring, Biosimilar, 4, Authorised
13/01/2020 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic, 08/06/2001, 42, Authorised
13/01/2020 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Additional monitoring, Biosimilar, 8, Authorised
13/01/2020 Orphan designation: Two allogeneic irradiated pancreatic tumour cell lines for the: Treatment of pancreatic cancer, 11/01/2016, Withdrawn
13/01/2020 Orphan designation: Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin for the: Treatment of pancreatic cancer, 11/01/2016, Withdrawn
13/01/2020 Orphan designation: Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin for the: Treatment of malignant mesothelioma, 14/12/2015, Withdrawn
13/01/2020 Orphan designation: Ulocuplumab for the: Treatment of acute myeloid leukaemia, 12/02/2015, Withdrawn
13/01/2020 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for the treatment of sickle cell disease for the: The treatment of sickle cell disease, 29/04/2014, Positive
10/01/2020 Human medicines European public assessment report (EPAR): Zydelig, Idelalisib, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 18/09/2014, Additional monitoring, 16, Authorised
10/01/2020 Periodic safety update single assessment: Ezetimibe / simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001347/201903
10/01/2020 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome, Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 1, Authorised
10/01/2020 Human medicines European public assessment report (EPAR): Ketoconazole HRA, Ketoconazole, Cushing Syndrome, 18/11/2014, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised
10/01/2020 Regulatory and procedural guideline: IRIS guide for parallel distribution applicants
10/01/2020 Periodic safety update single assessment: Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903
10/01/2020 Other: Privacy Statement regarding the Experts database and the handling of competing interests of scientific committees’ members and experts
10/01/2020 News and press releases: Veterinary medicines: highlights of 2019
10/01/2020 Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 28/06/2017, Orphan, Additional monitoring, 6, Authorised
09/01/2020 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 16, Authorised
09/01/2020 Minutes: Minutes of the COMP meeting 10-12 September 2019
09/01/2020 News and press releases: Human medicines: highlights of 2019
09/01/2020 Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, 26/07/2018, Generic, 1, Authorised
08/01/2020 Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Osteoporosis, Postmenopausal, 17/04/2009, 13, Authorised
08/01/2020 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 7, Authorised
08/01/2020 Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity, Overweight, 23/03/2015, 8, Authorised
07/01/2020 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 4, Authorised
07/01/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 25-28 November 2019 PRAC meeting
07/01/2020 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 12, Authorised
07/01/2020 Other: Questions and answers on impact of European Union-United States mutual recognition agreement on marketing authorisation applications and relevant variations
07/01/2020 Human medicines European public assessment report (EPAR): TachoSil, human fibrinogen, human thrombin, Hemostasis, Surgical, 08/06/2004, 23, Authorised
06/01/2020 Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, 19/01/2015, Orphan, Additional monitoring, 11, Authorised
06/01/2020 Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 22, Authorised
06/01/2020 Orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein for the: Treatment of Ebola virus disease, 25/05/2018, Positive
06/01/2020 Orphan designation: Tipifarnib for the: Treatment of acute myeloid leukaemia, 10/03/2005, Positive