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29/03/2019 Human medicines European public assessment report (EPAR): Vantobra, Tobramycin, Cystic Fibrosis, Respiratory Tract Infections, 18/03/2015, 3, Withdrawn (updated)
29/03/2019 Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia, Gout, 28/03/2019, Generic, Authorised
29/03/2019 Other: About us - European Medicines Agency (EMA) (updated)
29/03/2019 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: January 2019
29/03/2019 Scientific guideline: Draft ICH guideline E19 on optimisation of safety data collection - Step 2b
29/03/2019 ICH guideline E19 on optimisation of safety data collection - Step 2b
29/03/2019 Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1
29/03/2019 ICH Q3D Elemental impurities (updated)
29/03/2019 Agenda: Agenda - PDCO agenda of the 26-29 March 2019 meeting (updated)
29/03/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019
29/03/2019 Summary of opinion: Zynteglo, autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, 28/03/2019, Positive
29/03/2019 Summary of opinion: Imnovid (previously Pomalidomide Celgene), pomalidomide, 28/03/2019, Positive
29/03/2019 Summary of opinion: Mozobil, plerixafor, 28/03/2019, Positive
29/03/2019 News and press releases: EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack
29/03/2019 Referral: Basiron AC and associated names , benzoyl peroxide , Article 13 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/03/2019
29/03/2019 News and press releases: New gene therapy to treat rare inherited blood condition
29/03/2019 Referral: Omega-3 fatty acid medicines , Omega-3 fatty acid ethyl esters , Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 13/12/2018, 29/03/2019 (updated)
29/03/2019 Summary of opinion: Revlimid, lenalidomide, 28/03/2019, Positive
29/03/2019 Referral: Septanest and associated names , articaine (hydrochloride)/ adrenaline (tartrate) , Article 30 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/06/2018, 28/03/2019, 29/03/2019 (updated)
29/03/2019 Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis, Respiratory Tract Infections, 25/03/2015, Additional monitoring, 9, Authorised (updated)
28/03/2019 Report: Medicinal products for human use: monthly figures - February 2019
28/03/2019 National registers of authorised medicines
28/03/2019 Referral: Metamizole containing medicinal products , metamizole , Article 31 referrals, European Commission final decision, 13/12/2018, 20/03/2019, 28/03/2019 (updated)
28/03/2019 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 4, Authorised (updated)
28/03/2019 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 8, Authorised (updated)
28/03/2019 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 41, Authorised (updated)
28/03/2019 News and press releases: 20 years of sampling and testing programme for medicines authorised for the EU
28/03/2019 Sampling and testing (updated)
28/03/2019 Report: 20 years of sampling and testing of centrally authorised products: 1998 – 2017
28/03/2019 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, Additional monitoring, 5, Authorised (updated)
28/03/2019 Human medicines European public assessment report (EPAR): Repaglinide Accord, repaglinide, Diabetes Mellitus, Type 2, 22/12/2011, Generic, 5, Authorised (updated)
28/03/2019 Orphan designation: Methylthioninium for the: treatment of frontotemporal dementia with parkinsonism-17, 26/11/2010, Positive (updated)
28/03/2019 Orphan designation: Methylthioninium for the: treatment of progressive non-fluent aphasia, 26/11/2010, Positive (updated)
28/03/2019 Orphan designation: Methylthioninium for the: treatment of behavioural variant frontotemporal dementia, 26/11/2010, Positive (updated)
28/03/2019 Orphan designation: Methylthioninium for the: Treatment of progressive supranuclear palsy, 26/11/2010, Positive (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Ulunar Breezhaler, Glycopyrronium bromide, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 23/04/2014, Additional monitoring, 10, Authorised (updated)
27/03/2019 Orphan designation: Mercaptamine-pantetheine disulfide for the: Treatment of Rett syndrome, 11/01/2019, Positive
27/03/2019 Veterinary medicines European public assessment report (EPAR): Fungitraxx, Itraconazole, 12/03/2014, 2, Authorised (updated)
27/03/2019 Orphan designation: miglustat for the: Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive
27/03/2019 Human medicines European public assessment report (EPAR): Infanrix Hexa, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type-b polysaccharide, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 23/10/2000, 40, Authorised (updated)
27/03/2019 Orphan designation: Ralinepag for the: Treatment of pulmonary arterial hypertension, 11/01/2019, Positive
27/03/2019 Orphan designation: Rozanolixizumab for the: Treatment of immune thrombocytopenia, 11/01/2019, Positive
27/03/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: March 2019
27/03/2019 Orphan designation: Vinorelbine tartrate for the: Treatment of soft tissue sarcoma, 11/01/2019, Positive
27/03/2019 Veterinary medicines European public assessment report (EPAR): BTVPUR, bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen , 17/12/2010, 8, Authorised (updated)
27/03/2019 Periodic safety update single assessment: Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807
27/03/2019 Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 27/11/1995, 44, Authorised (updated)
27/03/2019 Orphan designation: melatonin for the: Treatment of perinatal asphyxia, 11/01/2019, Positive
27/03/2019 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for the: Treatment of beta-thalassaemia intermedia and major, 11/01/2019, Positive
27/03/2019 Orphan designation: Acetylleucine for the: Treatment of ataxia telangiectasia, 11/01/2019, Positive
27/03/2019 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 16, Authorised (updated)
27/03/2019 Orphan designation: Benserazide hydrochloride for the: The treatment of sickle cell disease, 11/01/2019, Positive
27/03/2019 Veterinary medicines European public assessment report (EPAR): Inflacam, meloxicam, 09/12/2011, Generic, 8, Authorised (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 11, Authorised (updated)
27/03/2019 News and press releases: New EudraVigilance system improves reporting of side effects and detection of safety signals
27/03/2019 Template or form: Template for letter from marketing-authorisation holder (MAH) permitting the Agency to send certificates elsewhere than to MAH address (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Zerit, stavudine, HIV Infections, 08/05/1996, 31, Authorised (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 3, Authorised (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, Generic, 2, Authorised (updated)
27/03/2019 Orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment for the: Treatment of short bowel syndrome, 11/01/2019, Positive
27/03/2019 Human medicines European public assessment report (EPAR): Carbaglu, carglumic acid, Amino Acid Metabolism, Inborn Errors, Propionic Acidemia, 24/01/2003, Orphan, 17, Authorised (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Epilepsy, 03/10/2011, Generic, 9, Authorised (updated)
27/03/2019 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 7, Authorised (updated)
27/03/2019 Orphan designation: L-cystine bis(N-methylpiperazide) for the: Treatment of cystinuria, 27/06/2018, Positive (updated)
27/03/2019 Orphan designation: Pegylated recombinant arginine deiminase for the: Treatment of malignant mesothelioma, 15/01/2015, Positive (updated)
27/03/2019 List of medicines under additional monitoring (updated)
27/03/2019 Medicine for use outside EU: List of medicinal products under additional monitoring (updated)
27/03/2019 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
27/03/2019 Medicines under additional monitoring: Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
27/03/2019 Medicines under additional monitoring: Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (updated)
27/03/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin) (updated)
26/03/2019 Human medicines European public assessment report (EPAR): Pramipexole Accord, pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome, 29/09/2011, Generic, 8, Authorised (updated)
26/03/2019 Orphan designation: Human coagulation factor X for the: Treatment of hereditary factor X deficiency, 14/09/2007, Positive (updated)
26/03/2019 Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia, Iron Overload, 25/08/1999, 23, Authorised (updated)
26/03/2019 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 1, Authorised (updated)
26/03/2019 Periodic safety update single assessment: Paracetamol / tramadol: List of nationally authorised medicinal products - PSUSA/00002310/201808
26/03/2019 Periodic safety update single assessment: Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201808
26/03/2019 Periodic safety update single assessment: Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201808
26/03/2019 News and press releases: Questions & answers: EU actions to prevent medicine shortages due to Brexit
26/03/2019 Human medicines European public assessment report (EPAR): Rebetol, Ribavirin, Hepatitis C, Chronic, 06/05/1999, 34, Authorised (updated)
26/03/2019 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised (updated)
26/03/2019 Human medicines European public assessment report (EPAR): Tolucombi, telmisartan, hydrochlorothiazide, Hypertension, 13/03/2013, Generic, 7, Authorised (updated)
26/03/2019 News and press releases: IT systems unavailable from 30 March to 1 April 2019
25/03/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 January 2019 , European Medicines Agency, London, UK, from 14/01/2019 to 17/01/2019 (updated)
25/03/2019 Paediatric Committee (PDCO): 13-16 November 2018 , European Medicines Agency, London, UK, from 13/11/2018 to 16/11/2018 (updated)
25/03/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 5, Authorised (updated)
25/03/2019 Minutes: Minutes - PDCO minutes of the 13-16 November 2018 meeting
25/03/2019 Minutes: Minutes of the PRAC meeting 14-17 January 2019
25/03/2019 Work programme: Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2019
25/03/2019 Brexit-related guidance for companies (updated)
25/03/2019 Veterinary medicines European public assessment report (EPAR): Suvaxyn Circo+MH RTU, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein/Inactivated Mycoplasma hyopneumoniae, strain P-5722-3., 06/11/2015, 5, Authorised (updated)
25/03/2019 Agenda: Agenda - CHMP agenda of the 25-28 March 2019 meeting
25/03/2019 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 2, Authorised (updated)
25/03/2019 Agenda: Agenda - CAT agenda of the 20-22 March 2019 meeting
25/03/2019 Human medicines European public assessment report (EPAR): Xadago, safinamide methanesulfonate, Parkinson Disease, 23/02/2015, Additional monitoring, 9, Authorised (updated)
25/03/2019 Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Head and Neck Neoplasms, Colorectal Neoplasms, 29/06/2004, 26, Authorised (updated)
25/03/2019 Human medicines European public assessment report (EPAR): Temozolomide Sun, temozolomide, Glioma, Glioblastoma, 13/07/2011, Generic, 13, Authorised (updated)
25/03/2019 Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Mucopolysaccharidosis VII, 23/08/2018, Orphan, Additional monitoring, Exceptional circumstances, 1, Authorised (updated)
22/03/2019 Report: Summary of transfers of appropriations in budget 2018 - Management Board meeting of 21 March 2019
22/03/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019
22/03/2019 Summary of opinion: Afoxolaner Merial, afoxolaner, 21/03/2019, Positive
22/03/2019 Summary of opinion: Baycox Iron, toltrazuril / iron(iii) ion, 21/03/2019, Positive
22/03/2019 Summary of opinion: Innovax-ND-IBD, cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 21/03/2019, Positive
22/03/2019 Summary of opinion: ProZinc, insulin human, 21/03/2019, Positive
22/03/2019 Summary of opinion: Vectra 3D, dinotefuran, permethrin, and pyriproxyfen, 21/03/2019, Positive
22/03/2019 Other: Decision on amending budget No 1-2019
22/03/2019 Regulatory and procedural guideline: Rules for reimbursement of expenses for delegates attending meetings with effect from 30 March 2019
22/03/2019 Report: MUMS/limited market scheme for veterinary medicines - 9th Annual report (01/01/2018 – 31/12/2018)
22/03/2019 Agenda: Agenda for the 103rd meeting of the Management Board
22/03/2019 Human medicines European public assessment report (EPAR): Intrarosa, Prasterone, Menopause, 08/01/2018, Additional monitoring, 2, Authorised
22/03/2019 Press Release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019
22/03/2019 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, 5, Authorised
22/03/2019 Human medicines European public assessment report (EPAR): Zeffix, lamivudine, Hepatitis B, Chronic, 28/07/1999, 23, Authorised
22/03/2019 Clinical Trial Regulation
22/03/2019 News and press releases: EMA Management Board: highlights of March 2019 meeting
22/03/2019 Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 2, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Orgalutran, ganirelix, Reproductive Techniques, Assisted, Ovulation Induction, 16/05/2000, 18, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 17, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, 26/07/2018, Additional monitoring, Biosimilar, 2, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Axumin, Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging, 21/05/2017, Additional monitoring, 6, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Bortezomib Hospira, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 6, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative, 13/08/1999, 53, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, Additional monitoring, 7, Authorised
21/03/2019 News and press releases: Management Board re-elects Christa Wirthumer-Hoche as chair
21/03/2019 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 17, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Invirase, saquinavir, HIV Infections, 03/10/1996, 46, Authorised
21/03/2019 Veterinary medicines European public assessment report (EPAR): Longrange, eprinomectin, Refused
21/03/2019 Human medicines European public assessment report (EPAR): Silapo, epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic, 18/12/2007, Biosimilar, 14, Authorised
21/03/2019 Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, Generic, 7, Authorised
20/03/2019 Human medicines European public assessment report (EPAR): Bortezomib Sun, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 6, Authorised
20/03/2019 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 27, Authorised
20/03/2019 Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine hydrochloride, Cystinosis, 18/01/2017, Orphan, 4, Authorised
20/03/2019 Management Board meeting: 21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019
20/03/2019 Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 18/11/2008, 18, Authorised
20/03/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2019 to 21/03/2019
20/03/2019 Agenda: Agenda - CVMP agenda of the 19-21 March 2019 meeting
20/03/2019 Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 1, Authorised
20/03/2019 News and press releases: Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis
20/03/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 4, Authorised
20/03/2019 Agenda: Agenda - COMP agenda of the 19-21 March 2019 meeting
20/03/2019 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma, Urticaria, 25/10/2005, 35, Authorised
20/03/2019 Orphan designation: Terguride for the: Treatment of systemic sclerosis, 24/01/2013, Positive
20/03/2019 Referrals document: Fenspiride containing medicinal products Article-107i referral - Annex I
20/03/2019 Template or form: Enpr-EMA networks funding sources form
20/03/2019 Transferring an orphan designation
20/03/2019 Changing the name or address of a sponsor
20/03/2019 Template or form: Template - Translations required with the submission of an application for transfer of orphan medicinal product designation
20/03/2019 Regulatory and procedural guideline: Checklist for sponsors applying for the transfer of orphan medicinal product designation
20/03/2019 Template or form: PDCO opinion template (annex I and II)
20/03/2019 Template or form: European Medicines Agency / PDCO summary-report template
20/03/2019 Template or form: Template letter for applicant - waiving right for a re-examination request
20/03/2019 Template or form: Request for confirmation of the applicability of the Agency's decision on class waivers
20/03/2019 Template or form: Template for scientific document (part B-F)
20/03/2019 Periodic safety update single assessment: Amlodipine / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010434/201807
20/03/2019 Other: EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list
20/03/2019 Other: Important medical event terms list version 22.0 (IME-List)
20/03/2019 Periodic safety update single assessment: Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015
20/03/2019 Periodic safety update single assessment: Domperidone: CMDh Scientific conclusions and grounds for variation, conditions and timetable for the implementation - EMEA/H/N/PSR/J/0015
19/03/2019 Human medicines European public assessment report (EPAR): Palonosetron Accord, Palonosetron, Vomiting, Nausea, Cancer, 26/05/2016, Generic, 2, Authorised
19/03/2019 Veterinary medicines European public assessment report (EPAR): Reconcile, fluoxetine, 08/07/2008, 10, Authorised
19/03/2019 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 31, Authorised
19/03/2019 Herbal medicinal product: Malvae sylvestris flos, Malvae sylvestris flos, F: Assessment finalised
19/03/2019 Human medicines European public assessment report (EPAR): Harvoni, ledispavir 90 mg, sofosbuvir 400 mg, Hepatitis C, Chronic, 17/11/2014, Additional monitoring, 16, Authorised
19/03/2019 Referral: Quinolone- and fluoroquinolone-containing medicinal products , nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin , Article 31 referrals, European Commission final decision, 15/11/2018, 11/03/2019, 19/03/2019
19/03/2019 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Authorised
19/03/2019 Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, 18/06/2009, Biosimilar, 21, Authorised
19/03/2019 Periodic safety update single assessment: Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804
19/03/2019 Periodic safety update single assessment: Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804
19/03/2019 Referrals document: Quinolone and fluoroquinolone Article-31 referral - Annex I
19/03/2019 Veterinary medicines European public assessment report (EPAR): Zulvac BTV, One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004, 25/04/2017, 1, Authorised
18/03/2019 Search tips
18/03/2019 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 2, Authorised
18/03/2019 Orphan designation: Amikacin sulfate (liposomal) for the: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive
18/03/2019 Orphan designation: Amikacin sulfate for the: Treatment of nontuberculous mycobacterial lung disease, 08/04/2014, Positive
18/03/2019 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, Positive
18/03/2019 Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the: Treatment of primary myelofibrosis, 05/08/2011, Positive
18/03/2019 Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the: Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive
18/03/2019 Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the: Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive
18/03/2019 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for the: Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive
18/03/2019 Orphan designation: Glucagon for the: Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive
18/03/2019 Orphan designation: Triheptanoin for the: Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive
18/03/2019 Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo- for the: Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive
18/03/2019 Orphan designation: Acebutolol hydrochloride for the: Treatment of Smith-Magenis syndrome, 14/10/2016, Positive
18/03/2019 Orphan designation: 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 for the: Treatment of primary hyperoxaluria, 31/07/2018, Positive
18/03/2019 Periodic safety update single assessment: Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807
18/03/2019 Orphan designation: Human haptoglobin for the: Treatment of sickle cell disease, 09/12/2011, Positive
18/03/2019 Periodic safety update single assessment: Inosine dimepranol acedoben: List of nationally authorised medicinal products - PSUSA/00010425/201808
18/03/2019 Orphan designation: Setmelanotide for the: Treatment of leptin receptor deficiency, 19/11/2018, Positive
18/03/2019 Orphan designation: Lomitapide for the: Treatment of familial chylomicronaemia, 17/12/2010, Positive
18/03/2019 Orphan designation: Setmelanotide for the: Treatment of Prader-Willi syndrome, 27/06/2016, Positive
18/03/2019 Orphan designation: Setmelanotide for the: Treatment of pro-opiomelanocortin deficiency, 14/07/2016, Positive
15/03/2019 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, 14, Authorised
15/03/2019 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 62, Authorised
15/03/2019 Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain for the: Treatment of glioma, 16/12/2014, Positive
15/03/2019 Orphan designation: Dantrolene sodium for the: Treatment of Wolfram syndrome, 12/12/2016, Positive
15/03/2019 Orphan designation: Hydroxy-propyl-beta-cyclodextrin for the: Treatment of Niemann-Pick disease, type C, 30/08/2011, Positive
15/03/2019 Orphan designation: exenatide for the: Treatment of idiopathic intracranial hypertension, 21/03/2016, Positive
15/03/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019
15/03/2019 Human medicines European public assessment report (EPAR): Altargo, retapamulin, Impetigo, Staphylococcal Skin Infections, 24/05/2007, 15, Withdrawn
15/03/2019 Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Hemophilia A, 08/01/2018, Additional monitoring, 2, Authorised
15/03/2019 Supply shortage: Nulojix (belatacept) supply shortage
15/03/2019 Periodic safety update single assessment: Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807
15/03/2019 Human medicines European public assessment report (EPAR): Halaven, Eribulin, Breast Neoplasms, Liposarcoma, 17/03/2011, 20, Authorised
15/03/2019 Human medicines European public assessment report (EPAR): Ventavis, iloprost, Hypertension, Pulmonary, 15/09/2003, Orphan, 26, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection, Kidney Transplantation, 17/06/2011, 10, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, 35, Authorised
14/03/2019 Investigation of subgroups in confirmatory clinical trials
14/03/2019 Human medicines European public assessment report (EPAR): Varuby, rolapitant, Vomiting, Nausea, Cancer, 19/04/2017, Additional monitoring, 3, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Ivemend, fosaprepitant, Vomiting, Cancer, 11/01/2008, 21, Authorised
14/03/2019 Periodic safety update single assessment: Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806
14/03/2019 Periodic safety update single assessment: Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806
14/03/2019 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 37, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid, colecalciferol, Osteoporosis, Postmenopausal, 16/10/2009, 13, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 2, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Prevenar 13, pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18C / pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F / pneumococcal polysaccharide serotype 3 / pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6A, pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 7F / pneumococcal polysaccharide serotype 9V protein, Pneumococcal Infections, Immunization, 09/12/2009, 33, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Vabomere, meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated, 20/11/2018, Additional monitoring, 1, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Pregabalin Zentiva, pregabalin, Anxiety Disorders, Epilepsy, 17/07/2015, Generic, 5, Authorised
14/03/2019 Orphan designation: Treprostinil diethanolamine (oral use) for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive
14/03/2019 Orphan designation: Itraconazole for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive
14/03/2019 Orphan designation: Treprostinil diethanolamine for the: Treatment of systemic sclerosis, 15/05/2009, Positive
14/03/2019 Orphan designation: Entolimod for the: Treatment of acute radiation syndrome, 11/01/2016, Positive
14/03/2019 Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the: Treatment of acute myeloid leukaemia, 09/10/2015, Positive
14/03/2019 Orphan designation: Treprostinil sodium (inhalation use) for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive
14/03/2019 Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, 02/02/2001, 19, Authorised
14/03/2019 Periodic safety update single assessment: Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804
14/03/2019 Periodic safety update single assessment: Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804
14/03/2019 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, 2, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 08/09/2003, 73, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 35, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Sutent, sunitinib, Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Neuroendocrine Tumors, 19/07/2006, 36, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 1, Authorised
14/03/2019 Human medicines European public assessment report (EPAR): Evotaz, atazanavir sulfate, cobicistat, HIV Infections, 13/07/2015, Additional monitoring, 7, Authorised
14/03/2019 ICH M10 on bioanalytical method validation
14/03/2019 Scientific guideline: Draft ICH guideline M10 on bioanalytical method validation - Step 2b
13/03/2019 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 33, Authorised
13/03/2019 Human medicines European public assessment report (EPAR): Zytiga, abiraterone acetate, Prostatic Neoplasms, 05/09/2011, 21, Authorised
13/03/2019 Human medicines European public assessment report (EPAR): Tegsedi, inotersen sodium, Amyloidosis, 05/07/2018, Orphan, Additional monitoring, 2, Authorised
13/03/2019 Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia, 09/06/2015, Additional monitoring, 9, Authorised
13/03/2019 Periodic safety update single assessment: Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805
13/03/2019 Periodic safety update single assessment: Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805