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30/08/2019 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 13, Authorised
30/08/2019 Periodic safety update single assessment: Iron dextran: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010696/201901
30/08/2019 Periodic safety update single assessment: Iron dextran: List of nationally authorised medicinal products - PSUSA/00010696/201901
30/08/2019 Orphan designation: Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the: Treatment of acute myeloid leukaemia, 13/05/2011, Withdrawn
30/08/2019 Orphan designation: 2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}oxy)propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate for the: Treatment of acute myeloid leukaemia, 05/12/2008, Withdrawn
30/08/2019 Periodic safety update single assessment: Azathioprine: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00000275/201812
30/08/2019 Periodic safety update single assessment: Azathioprine: List of nationally authorised medicinal products - PSUSA/00000275/201812
30/08/2019 Orphan designation: Treosulfan for the: Conditioning treatment prior to haematopoietic-progenitor-cell transplantation, 22/02/2004, Withdrawn
30/08/2019 Orphan designation: 5'-CTG CCA CGT TCT CCT GC-(2' methoxy)A-(2' methoxy)C-(2' methoxy)C-3' for the: Treatment of myasthenia gravis, 21/06/2004, Withdrawn
30/08/2019 News and press releases: Global public meeting on draft ICH guideline on clinical trials
30/08/2019 Orphan designation: Eculizumab for the: Treatment of paroxysmal nocturnal haemoglobinuria, 17/10/2003, Expired
30/08/2019 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, Additional monitoring, 7, Authorised
30/08/2019 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, 1, Authorised
30/08/2019 Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, 18/12/2018, Orphan, 1, Authorised
30/08/2019 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride / tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 22, Authorised
30/08/2019 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, Additional monitoring, 18, Authorised
30/08/2019 Human medicines European public assessment report (EPAR): Thymanax, Agomelatine, Depressive Disorder, Major, 19/02/2009, 18/11/2006, 20, Authorised
30/08/2019 Committee for Advanced Therapies (CAT): 22-24 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/05/2019 to 24/05/2019
30/08/2019 Minutes: Minutes of the CAT meeting 22-24 May 2019
30/08/2019 Human medicines European public assessment report (EPAR): Daklinza, daclatasvir dihydrochloride, Hepatitis C, Chronic, 22/08/2014, Accelerated assessment, Additional monitoring, 15, Withdrawn
30/08/2019 Public Statement: Public statement on Daklinza: Expiry of the marketing authorisation in the European Union
29/08/2019 Human medicines European public assessment report (EPAR): Brimica Genuair, aclidinium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 11, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 1, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 10, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major, 17/12/2004, 28, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 14, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal, 15/03/2010, 17/12/2009, 28, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 21, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine, 31/07/2013, Additional monitoring, Exceptional circumstances, 14, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Sprycel, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 20/11/2006, 33, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 11, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 11/11/2012, 15, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 25, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 8, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 11, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, 23/08/2012, 17, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, Additional monitoring, 7, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Xeloda, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 02/02/2001, 24, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Posaconazole AHCL, posaconazole, Mycoses, 25/07/2019, Generic, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 2, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Vihuma, simoctocog alfa, Hemophilia A, 13/02/2017, Additional monitoring, 2, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, 7, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, 14, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis), pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, 6, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 17, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 10, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 4, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 3, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 5, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Cinryze, C1 inhibitor (human), Angioedemas, Hereditary, 15/06/2011, Additional monitoring, 17, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 51, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Xiapex, collagenase Clostridium histolyticum, Dupuytren Contracture, 28/02/2011, 19, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Dafiro HCT, Amlodipine besylate, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 18, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 27, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline tartrate, Parkinson Disease, 04/04/2016, Generic, 2, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 12, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Fiasp, insulin aspart, Diabetes Mellitus, 09/01/2017, Patient safety, Additional monitoring, 4, Authorised
26/08/2019 Template or form: CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46
26/08/2019 Template or form: CHMP rapporteurs' assessment report for post-authorisation measures (PAMs)
26/08/2019 Minutes: Minutes of the CAT meeting 16-17 April 2019
26/08/2019 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010, Generic, 8, Authorised
26/08/2019 Human medicines European public assessment report (EPAR): Doxolipad, doxorubicin hydrochloride, Breast Neoplasms, Ovarian Neoplasms, 08/08/2019, Refused
26/08/2019 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 10, Authorised
26/08/2019 Newsletter: News bulletin for small and medium-sized enterprises - Issue 47
26/08/2019 Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A, von Willebrand Diseases, 12/08/2013, 13, Authorised
23/08/2019 Human medicines European public assessment report (EPAR): Twynsta, telmisartan, amlodipine, Hypertension, 07/10/2010, 10, Authorised
23/08/2019 Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Hemophilia A, 08/01/2018, Additional monitoring, 3, Authorised
23/08/2019 Herbal medicinal product: Avenae fructus, Avenae fructus, F: Assessment finalised
23/08/2019 Herbal medicinal product: Avenae herba, Avenae herba, F: Assessment finalised
23/08/2019 Herbal medicinal product: Myrrha, gummi-resina, Myrrha, gummi-resina, F: Assessment finalised
23/08/2019 Herbal medicinal product: Bursae pastoris herba, Bursae pastoris herba, F: Assessment finalised
23/08/2019 Other: HMPC: overview of assessment work - priority list
23/08/2019 Committee for Advanced Therapies (CAT): 14-16 July 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 14/07/2019 to 16/07/2019
23/08/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2019
23/08/2019 Orphan designation: Imetelstat sodium for the: Treatment of myelofibrosis, 14/12/2015, Positive
23/08/2019 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 30, Authorised
23/08/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet,Ledertrexate,Maxtrex,Metex,Metoject, Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 22/08/2019, 23/08/2019
23/08/2019 News and press releases: New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
23/08/2019 Human medicines European public assessment report (EPAR): Venclyxto, Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, 04/12/2016, Additional monitoring, 8, Authorised
23/08/2019 Other: European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 4
23/08/2019 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 11, Authorised
22/08/2019 Herbal medicinal product: Polypodii rhizoma, Polypodii rhizoma, F: Assessment finalised
22/08/2019 Herbal medicinal product: Phaseoli fructus (sine semine), Phaseoli fructus (sine semine), F: Assessment finalised
22/08/2019 Herbal medicinal product: Rusci aculeati rhizoma, Rusci aculeati rhizoma, D: Draft under discussion
22/08/2019 Herbal medicinal product: Millefolii flos, Millefolii flos, F: Assessment finalised
22/08/2019 Herbal medicinal product: Leonuri cardiacae herba, Leonuri cardiacae herba, F: Assessment finalised
22/08/2019 Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Kidney Failure, Chronic, Anemia, Cancer, Blood Transfusion, Autologous, 16/07/1997, 28, Authorised
22/08/2019 Herbal medicinal product: Gentianae radix, Gentianae radix, F: Assessment finalised
22/08/2019 Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 24/04/2008, 24, Authorised
22/08/2019 Herbal medicinal product: Fragariae folium, Fragariae folium, F: Assessment finalised
22/08/2019 Human medicines European public assessment report (EPAR): Nevirapine Teva, nevirapine, HIV Infections, 30/11/2009, Generic, 9, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Zutectra, human hepatitis-B immunoglobulin, Immunization, Passive, Hepatitis B, Liver Transplantation, 30/11/2009, 13, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Carcinoma, Non-Small-Cell Lung, 21/09/2018, Additional monitoring, 1, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Onpattro, patisiran sodium, Amyloidosis, Familial, 27/08/2018, Orphan, Accelerated assessment, Additional monitoring, 3, Authorised
22/08/2019 Referral: Lartruvo , olaratumab , Article 20 procedures, European Commission final decision, 31/01/2019, 19/07/2019, 22/08/2019
22/08/2019 Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Cholestasis, Vitamin E Deficiency, 23/07/2009, Additional monitoring, Exceptional circumstances, 13, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 31, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 8, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Mimpara, cinacalcet hydrochloride, Hypercalcemia, Parathyroid Neoplasms, Hyperparathyroidism, 22/10/2004, 21, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Shingrix, Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster, 21/03/2018, Additional monitoring, 1, Authorised
22/08/2019 General privacy statement
21/08/2019 Agenda: Agenda - CHMP agenda of the 19-22 August 2019 written procedure
21/08/2019 Other: Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
21/08/2019 Human medicines European public assessment report (EPAR): Ratiograstim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 10, Authorised
21/08/2019 Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, Additional monitoring, Conditional approval, 1, Authorised
20/08/2019 Agenda: Agenda - PDCO agenda of the 20-23 August 2019 written procedure
20/08/2019 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 42, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, Orphan, 17, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Lifmior, etanercept, Arthritis, Psoriatic, Spondylitis, Ankylosing, Psoriasis, 13/02/2017, Additional monitoring, 7, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Waylivra, Volanesorsen sodium, Hyperlipoproteinemia Type I, 03/05/2019, Orphan, Additional monitoring, Conditional approval, 1, Authorised
20/08/2019 Other: Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
20/08/2019 Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, European Commission final decision, 31/01/2019, 02/04/2019, 20/08/2019
20/08/2019 Human medicines European public assessment report (EPAR): Cotellic, cobimetinib hemifumarate, Melanoma, 20/11/2015, Additional monitoring, 7, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 18, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 7, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Copalia, amlodipine (as besylate), valsartan, Hypertension, 15/01/2007, 23, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited), pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 24/04/2017, Generic, 6, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Hetlioz, tasimelteon, Sleep Disorders, Circadian Rhythm, 03/07/2015, Orphan, Additional monitoring, 4, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Zydelig, Idelalisib, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 18/09/2014, Additional monitoring, 15, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Ultibro Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 19/09/2013, Additional monitoring, 10, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization, Rotavirus Infections, 21/02/2006, 32, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Grepid, clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 27/07/2009, Generic, 19, Authorised
20/08/2019 European Medicines Agency and European Union payer community meeting , Zorginstituut Nederland, Diemen, The Netherlands, from 18/06/2019 to 18/06/2019
20/08/2019 Periodic safety update single assessment: Phloroglucinol, phloroglucinol trimethylphloroglucinol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010355/201809
20/08/2019 Periodic safety update single assessment: Phloroglucinol, phloroglucinol trimethylphloroglucinol: List of nationally authorised medicinal products - PSUSA/00010355/201809
19/08/2019 Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), Thalidomide, Multiple Myeloma, 16/04/2008, Orphan, 24, Authorised
19/08/2019 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 28/04/2017, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised
19/08/2019 Orphan designation: Lonafarnib for the: Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive
19/08/2019 Orphan designation: Exendin (9-39) for the: Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 14/10/2016, Positive
19/08/2019 Orphan designation: Ubenimex for the: Treatment of pulmonary arterial hypertension, 21/03/2016, Positive
19/08/2019 Orphan designation: Lonafarnib for the: Treatment of hepatitis delta virus infection, 16/01/2014, Positive
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2019
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: March 2019
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: February 2019
19/08/2019 Biosimilar medicines: marketing authorisation
19/08/2019 Generic and hybrid applications
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes)
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
19/08/2019 Orphan designation: Sodium benzoate for the: Treatment of hyperargininaemia, 11/01/2016, Positive
19/08/2019 Orphan designation: Sodium benzoate for the: Treatment of argininosuccinic aciduria, 11/01/2016, Positive
19/08/2019 Orphan designation: Sodium thiosulfate for the: Treatment for calciphylaxis, 15/01/2015, Positive
19/08/2019 Orphan designation: Sodium nitrite for the: Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive
19/08/2019 Orphan designation: Diacerein for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
19/08/2019 Orphan designation: Heat-killed Mycobacterium obuense (whole cell) for the: Treatment of pancreatic cancer, 16/12/2014, Positive
19/08/2019 Orphan designation: Recombinant fragment of human surfactant protein-D for the: Prevention of bronchopulmonary dysplasia, 23/08/2017, Positive
19/08/2019 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for the: Prevention of delayed graft function after renal transplantation, 06/06/2010, Positive
16/08/2019 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 25, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 6, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 27, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma, Urticaria, 25/10/2005, 38, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Mysildecard, sildenafil citrate, Hypertension, Pulmonary, 15/09/2016, Generic, 1, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Exforge HCT, Amlodipine besylate, valsartan, hydrochlorothiazide, Hypertension, 15/10/2009, 16, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 15, Authorised
16/08/2019 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, 74, Authorised
16/08/2019 News and press releases: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
16/08/2019 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, Additional monitoring, 5, Authorised
16/08/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
16/08/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances
16/08/2019 Report: Medicinal products for human use: monthly figures - July 2019
16/08/2019 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, Additional monitoring, 8, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests, Helicobacter Infections, 14/08/1997, 16, Authorised
16/08/2019 Template or form: Appendix V - Adverse-drug-reaction reporting details
16/08/2019 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, Additional monitoring, 14, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Dukoral, recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera, Immunization, 28/04/2004, 13, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Diabetes Mellitus, 09/09/2014, Additional monitoring, Biosimilar, 7, Authorised
14/08/2019 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 36, Authorised
14/08/2019 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Orphan, Additional monitoring, Exceptional circumstances, 14, Authorised
14/08/2019 Withdrawn application: Radicava, edaravone, Date of withdrawal: 24/05/2019, Initial authorisation
14/08/2019 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 25, Authorised
14/08/2019 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 6, Authorised
14/08/2019 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 12, Authorised
14/08/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2019
14/08/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 18/06/2019 to 20/06/2019
14/08/2019 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism, 30/09/2008, Additional monitoring, 30, Authorised
14/08/2019 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Enantone-Gyn Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leupro-Sandoz 3-Monats-Depot,Leuprostin,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, Under evaluation, 14/08/2019
14/08/2019 Human medicines European public assessment report (EPAR): Azacitidine Celgene, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 02/08/2019, Authorised
13/08/2019 Paediatric Committee (PDCO): 26 February-1 March 2019 , European Medicines Agency, from 26/02/2019 to 01/03/2019
13/08/2019 Minutes: Minutes - PDCO minutes of the 26 February-01 March 2019 meeting
13/08/2019 News and press releases: EMA closed 15 August 2019
13/08/2019 Newsletter: Human medicines highlights - August 2019
13/08/2019 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 25, Authorised
13/08/2019 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 11, Authorised
13/08/2019 Veterinary medicines European public assessment report (EPAR): Bovalto Ibraxion, inactivated IBR virus, 09/03/2000, 10, Withdrawn
13/08/2019 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 9, Authorised
12/08/2019 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 10, Authorised
12/08/2019 Human medicines European public assessment report (EPAR): Stocrin, efavirenz, HIV Infections, 28/05/1999, 41, Authorised
12/08/2019 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 13, Authorised
12/08/2019 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 18, Authorised
12/08/2019 Orphan designation: Zanubrutinib for the: Treatment of lymphoplasmacytic lymphoma, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of carbamoyl-phosphate synthase-1 deficiency, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of citrullinaemia type 1, 29/05/2019, Positive
12/08/2019 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 16, Authorised
12/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 April 2019
12/08/2019 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 36, Authorised
09/08/2019 Fingolimod product-specific bioequivalence guidance
09/08/2019 Scientific guideline: Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
09/08/2019 Newsletter: What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019
09/08/2019 Orphan designation: Relacorilant for the: Treatment of Cushing's syndrome, 29/05/2019, Positive
09/08/2019 Orphan designation: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide for the: Treatment of cystic fibrosis, 29/05/2019, Positive
09/08/2019 Orphan designation: Emixustat hydrochloride for the: Treatment of Stargardt's disease, 29/05/2019, Positive
09/08/2019 Orphan designation: Allogeneic skin-derived ABCB5-positive mesenchymal stem cells for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
09/08/2019 Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile for the: Treatment of acute myeloid leukaemia, 29/05/2019, Positive
09/08/2019 Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium for the: Treatment of pulmonary arterial hypertension, 29/05/2019, Positive
09/08/2019 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, Orphan, 15, Authorised
08/08/2019 Periodic safety update single assessment: Dextromethorphan: Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001009/201811
08/08/2019 Other: Coordinating group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
08/08/2019 Periodic safety update single assessment: Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201811
08/08/2019 Committee for Medicinal Products for Human Use (CHMP): 27-29 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 27/05/2019 to 29/05/2019
08/08/2019 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 1, Authorised
08/08/2019 Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal, 15/04/2005, 26, Authorised
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 15 July 2019
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 20 May 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 July 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 17 June 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 20 May 2019
08/08/2019 Minutes: Minutes - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2019 to 04/07/2019
08/08/2019 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 12, Authorised
08/08/2019 Human medicines European public assessment report (EPAR): Hepsera, adefovir dipivoxil, Hepatitis B, Chronic, 06/03/2003, 26, Authorised
07/08/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0298/2016
07/08/2019 Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of gout
07/08/2019 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 26/03/2013, Additional monitoring, Conditional approval, 18, Authorised
07/08/2019 Human medicines European public assessment report (EPAR): Kanuma, sebelipase alfa, Lipid Metabolism, Inborn Errors, 28/08/2015, Orphan, Accelerated assessment, Additional monitoring, 3, Authorised
06/08/2019 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Under evaluation, 06/08/2019
06/08/2019 Periodic safety update single assessment: Danaparoid: List of nationally authorised medicinal products - PSUSA/00000923/201812
06/08/2019 Periodic safety update single assessment: Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810
06/08/2019 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201810
06/08/2019 Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 19, Authorised
06/08/2019 Minutes: Minutes of the COMP meeting 15-17 April 2019
06/08/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC meeting
06/08/2019 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Additional monitoring, Biosimilar, 7, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, Additional monitoring, 3, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Docetaxel Teva, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 26/01/2010, Generic, 17, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 2, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 20/09/2006, 41, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir 90 mg, sofosbuvir 400 mg, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 17, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Aflunov, influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks, 28/11/2010, 11, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 8, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 18, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, Additional monitoring, 20, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Kanjinti, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 16/05/2018, Additional monitoring, Biosimilar, 5, Authorised
05/08/2019 Quality of medicines questions and answers: Part 1
05/08/2019 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 24, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, Additional monitoring, Conditional approval, 14, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Fabry Disease, 03/08/2001, Orphan, 26, Authorised
05/08/2019 Template or form: Template to report an allegation concerning an impropriety in an area of EMA’s responsibility (authorisation, supervision and maintenance of human and veterinary medicinal products)