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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public assessment report (EPAR): Vantobra, Tobramycin, Cystic Fibrosis, Respiratory Tract Infections, 18/03/2015, 3, Withdrawn
29/03/2019 Other: About us - European Medicines Agency (EMA)
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: 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
29/03/2019 Scientific guideline: Draft ICH guideline E19 on optimisation of safety data collection - Step 2b
29/03/2019 Agenda: Agenda - PDCO agenda of the 26-29 March 2019 meeting
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 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 News and press releases: New gene therapy to treat rare inherited blood condition
29/03/2019 Summary of opinion: Mozobil, plerixafor, 28/03/2019, Positive
29/03/2019 Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis, Respiratory Tract Infections, 25/03/2015, Additional monitoring, 9, Authorised
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
28/03/2019 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 41, Authorised
28/03/2019 Sampling and testing
28/03/2019 News and press releases: 20 years of sampling and testing programme for medicines authorised for the EU
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): Repaglinide Accord, repaglinide, Diabetes Mellitus, Type 2, 22/12/2011, Generic, 5, Authorised
28/03/2019 Orphan designation: Methylthioninium for the: treatment of frontotemporal dementia with parkinsonism-17, 26/11/2010, Positive
28/03/2019 Orphan designation: Methylthioninium for the: treatment of progressive non-fluent aphasia, 26/11/2010, Positive
28/03/2019 Orphan designation: Methylthioninium for the: treatment of behavioural variant frontotemporal dementia, 26/11/2010, Positive
28/03/2019 Orphan designation: Methylthioninium for the: Treatment of progressive supranuclear palsy, 26/11/2010, Positive
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
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
27/03/2019 Orphan designation: Rozanolixizumab for the: Treatment of immune thrombocytopenia, 11/01/2019, Positive
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
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
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: 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, 9, Authorised
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
27/03/2019 Human medicines European public assessment report (EPAR): Zerit, stavudine, HIV Infections, 08/05/1996, 31, Authorised
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, 18, Authorised
27/03/2019 Orphan designation: L-cystine bis(N-methylpiperazide) for the: Treatment of cystinuria, 27/06/2018, Positive
27/03/2019 Orphan designation: Pegylated recombinant arginine deiminase for the: Treatment of malignant mesothelioma, 15/01/2015, Positive
27/03/2019 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
27/03/2019 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
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
26/03/2019 Orphan designation: Human coagulation factor X for the: Treatment of hereditary factor X deficiency, 14/09/2007, Positive
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): Tolucombi, telmisartan, hydrochlorothiazide, Hypertension, 13/03/2013, Generic, 7, Authorised
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
25/03/2019 Paediatric Committee (PDCO): 13-16 November 2018 , European Medicines Agency, London, UK, from 13/11/2018 to 16/11/2018
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 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
25/03/2019 Agenda: Agenda - CHMP agenda of the 25-28 March 2019 meeting
25/03/2019 Agenda: Agenda - CAT agenda of the 20-22 March 2019 meeting
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 Other: Decision on amending budget No 1-2019
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 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): Zeffix, lamivudine, Hepatitis B, Chronic, 28/07/1999, 23, Authorised
22/03/2019 News and press releases: EMA Management Board: highlights of March 2019 meeting
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): 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
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): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 18/11/2008, 18, Authorised
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 Agenda: Agenda - COMP agenda of the 19-21 March 2019 meeting
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 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 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 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, Additional monitoring, 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 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: 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: Lomitapide for the: Treatment of familial chylomicronaemia, 17/12/2010, Positive
18/03/2019 Orphan designation: Setmelanotide for the: Treatment of leptin receptor deficiency, 19/11/2018, 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 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's 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 Supply shortage: Nulojix (belatacept) supply shortage
15/03/2019 Periodic safety update single assessment: Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807
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): 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 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): Evotaz, atazanavir sulfate, cobicistat, HIV Infections, 13/07/2015, Additional monitoring, 7, Authorised
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): Zytiga, abiraterone acetate, Prostatic Neoplasms, 05/09/2011, Accelerated assessment, 21, 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
13/03/2019 Herbal medicinal product: Cynarae folium, Cynarae folium, F: Assessment finalised
13/03/2019 Human medicines European public assessment report (EPAR): Adcetris, Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease, 25/10/2012, Orphan, Additional monitoring, Conditional approval, 24, Authorised
13/03/2019 Template or form: Innovation Task Force (ITF) briefing meeting request form
12/03/2019 Agenda: Agenda - PRAC draft agenda of meeting 12-15 March 2019
12/03/2019 Human medicines European public assessment report (EPAR): Cholib, fenofibrate, simvastatin, Dyslipidemias, 26/08/2013, 9, Authorised
12/03/2019 Agenda: Agenda - CAT agenda of the 20-22 February 2019 meeting
12/03/2019 Orphan designation: C1 esterase inhibitor (human) for the: Treatment in solid organ transplantation, 14/12/2018, Positive
12/03/2019 Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole for the: Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive
12/03/2019 Orphan designation: 6,8-bis(benzylthio)octanoic acid for the: Treatment of acute myeloid leukaemia, 14/12/2018, Positive
12/03/2019 Orphan designation: 6,8-bis(benzylthio)octanoic acid for the: Treatment of pancreatic cancer, 14/12/2018, Positive
12/03/2019 Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for the: Treatment of biliary atresia, 14/12/2018, Positive
12/03/2019 Orphan designation: Pevonedistat for the: Treatment of myelodysplastic syndromes, 14/12/2018, Positive
12/03/2019 Orphan designation: Marizomib for the: Treatment of glioma, 14/12/2018, Positive
11/03/2019 News and press releases: EMA now operating from Amsterdam
11/03/2019 Veterinary medicines European public assessment report (EPAR): Aftovaxpur DOE, Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia  ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., 15/07/2013, 16/05/2013, 6, Authorised
11/03/2019 Referral: Fortekor , benazepril hydrochloride , Article 34, European Commission final decision, 10/11/2011, 06/02/2012, 11/03/2019
11/03/2019 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 17, Authorised
11/03/2019 Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)) for the: Treatment of C3 glomerulopathy, 14/12/2018, Positive
11/03/2019 Veterinary pre-submission Q&A: Introduction
11/03/2019 Template or form: Marketing authorisation application (MAA) - pre-submission meeting request form (veterinary)
11/03/2019 Orphan designation: Allogeneic ABCB5-positive limbal stem cells for the: Treatment of limbal stem cell deficiency, 14/12/2018, Positive
11/03/2019 Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1 for the: Treatment of biliary tract cancer, 14/12/2018, Positive
11/03/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the PRAC meeting of 11-14 February 2019
08/03/2019 Sterilisation of the medicinal product, active substance, excipient and primary container
08/03/2019 Scientific guideline: Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance
08/03/2019 Report: Applications for new human medicines under evaluation by the CHMP: February 2019
08/03/2019 Report: Applications for new human medicines under evaluation by the CHMP: January 2019
08/03/2019 Other: Information management strategy
08/03/2019 Information management
08/03/2019 Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive
08/03/2019 Other: Table of the amounts in euro of basic monthly salaries for contract agents for each grade and step
08/03/2019 Other: Table of the amounts in euro of basic monthly salaries for temporary agents for each grade and step
08/03/2019 Orphan designation: Acetylcysteine for the: Treatment of pseudomyxoma peritonei, 14/12/2018, Positive
08/03/2019 Orphan designation: Venglustat for the: Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive
08/03/2019 Orphan designation: Bromelain for the: Treatment of pseudomyxoma peritonei, 14/12/2018, Positive
08/03/2019 Orphan designation: Sodium 2-hydroxylinoleate for the: Treatment of biliary tract cancer, 14/12/2018, Positive
08/03/2019 Template or form: Application form for European Medicines Agency certificates of medicinal products
08/03/2019 Orphan designation: afatinib for the: Treatment of Fanconi anaemia, 14/12/2018, Positive
08/03/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/87/2009
08/03/2019 Newsletter: News bulletin for small and medium-sized enterprises - Issue 46
07/03/2019 Other: European Medicines Agency process for engaging in externally funded regulatory sciences and process improvement research activities for public and animal health
07/03/2019 Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase for the: Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive
07/03/2019 Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor for the: Treatment of cystic fibrosis, Positive
07/03/2019 Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor for the: Treatment of cystic fibrosis, 14/12/2018, Positive
07/03/2019 Orphan designation: Human anti-promyostatin monoclonal antibody for the: Treatment of spinal muscular atrophy, 14/12/2018, Positive
07/03/2019 Human medicines European public assessment report (EPAR): Topotecan Actavis, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 24/07/2009, Generic, 6, Withdrawn
07/03/2019 EPAR - All authorised presentations: Stocrin : EPAR - All Authorised presentations
06/03/2019 Other: Mandate, objectives and rules of procedure for the joint CHMP/CVMP Quality Working Party
06/03/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2019
06/03/2019 Referrals document: Bacterial lysate medicines Article 31 referral - Timetable for the procedure
06/03/2019 Newsletter: Human medicines highlights - March 2019
06/03/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 February 2019
06/03/2019 Veterinary medicines European public assessment report (EPAR): Acticam, meloxicam, 09/12/2008, Generic, 7, Authorised
06/03/2019 Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan) for the: Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive
06/03/2019 Orphan designation: Avacopan for the: Treatment of C3 glomerulopathy, 20/06/2017, Positive
06/03/2019 Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide for the: Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive
06/03/2019 Work programme: PDCO work plan 2019
06/03/2019 Human medicines European public assessment report (EPAR): Cyltezo, adalimumab, Hidradenitis Suppurativa, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, 10/11/2017, Additional monitoring, Biosimilar, 2, Withdrawn
05/03/2019 Veterinary medicines European public assessment report (EPAR): Halagon, halofuginone lactate, 13/12/2016, Generic, 2, Authorised
05/03/2019 Human medicines European public assessment report (EPAR): Sildenafil ratiopharm, sildenafil, Erectile Dysfunction, 23/12/2009, Generic, 16, Authorised
05/03/2019 Other: Timetable: Type II variation and worksharing application monthly assessment
05/03/2019 Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension, Glaucoma, Open-Angle, 18/07/2014, 6, Authorised
05/03/2019 Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Opioid-Related Disorders, Constipation, 01/07/2008, 15, Authorised
05/03/2019 Human medicines European public assessment report (EPAR): Solymbic, adalimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Crohn Disease, Colitis, Ulcerative, Hidradenitis Suppurativa, Psoriasis, Arthritis, Rheumatoid, 22/03/2017, Additional monitoring, Biosimilar, 2, Withdrawn
05/03/2019 Veterinary medicines European public assessment report (EPAR): Clynav, pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins, 26/06/2017, 4, Authorised
05/03/2019 Other: European Medicines Agency terms and conditions for the payment of Agency's invoices
04/03/2019 Report: Annual report on the use of the special contribution for orphan medicinal products - 2018
04/03/2019 Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA for the: Treatment of adrenoleukodystrophy, 06/06/2012, Positive
04/03/2019 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (lumasiran) for the: Treatment of primary hyperoxaluria, 21/03/2016, Positive
04/03/2019 Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for the: Treatment of retinitis pigmentosa, 28/07/2015, Positive
04/03/2019 Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for the: Treatment of Leber's congenital amaurosis, 02/04/2012, Positive
04/03/2019 Veterinary medicines European public assessment report (EPAR): Porcilis ColiClos, Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT, 14/06/2012, 4, Authorised
04/03/2019 Human medicines European public assessment report (EPAR): Kuvan, Sapropterin dihydrochloride, Phenylketonurias, 02/12/2008, Orphan, 18, Authorised
04/03/2019 Other: From laboratory to patient: the journey of a centrally authorised medicine
04/03/2019 Other: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive
01/03/2019 News and press releases: Regulatory information – adjusted fees for applications to EMA from 1 April 2019
01/03/2019 Veterinary medicines European public assessment report (EPAR): Evant, Eimeria acervulina, strain 003, Eimeria maxima, strain 013, Eimeria mitis, strain 006, Eimeria praecox, strain 007, Eimeria tenella, strain 004, 05/02/2019, Authorised
01/03/2019 Agenda: CHMP ORGAM agenda for the meeting on 21 January 2019
01/03/2019 Human medicines European public assessment report (EPAR): Emgality, Galcanezumab, Migraine Disorders, 14/11/2018, Additional monitoring, 1, Authorised
01/03/2019 EMA in London (1995-2019)
01/03/2019 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 25-28 February 2019
01/03/2019 Summary of opinion: Trydonis, beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive
01/03/2019 Summary of opinion: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive
01/03/2019 Withdrawn application: Epjevy, pacritinib, Date of withdrawal: 07/02/2019, Initial authorisation
01/03/2019 News and press releases: New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
01/03/2019 News and press releases: First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
01/03/2019 News and press releases: CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease
01/03/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019
01/03/2019 News and press releases: First treatment for rare disease characterised by high levels of triglycerides in blood
01/03/2019 News and press releases: Change of time zone due to EMA's relocation in March 2019
01/03/2019 Minutes: Minutes of the CVMP meeting of 22-24 January 2019
01/03/2019 News and press releases: New add-on treatment for patients with severe asthma
01/03/2019 Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, 08/02/2019, Generic, Authorised
01/03/2019 Other: Orientation guide for industry - Spark building