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31/10/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet,Ledertrexate,Maxtrex,Metex,Metoject, Article 31 referrals, European Commission final decision, 22/08/2019, 21/10/2019, 31/10/2019
31/10/2019 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 5, Authorised
31/10/2019 Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia, Kidney Failure, Chronic, 28/08/2007, Biosimilar, 20, Authorised
31/10/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019
31/10/2019 News and press releases: EMA closed 1 November 2019
31/10/2019 Other: Electronic registration process – EudraVigilance registration phases I, II and III
31/10/2019 Other: Required registration documents for EudraVigilance XCOMP
31/10/2019 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 13, Authorised
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/201812
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000427/201812
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gilteritinib (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0194/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imipenem (monohydrate),cilastatin (sodium),relebactam (MK-7655A), PM: decision on the application for modification of an agreed PIP, P/0173/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, PM: decision on the application for modification of an agreed PIP, P/0196/2019
30/10/2019 ICH guideline E19 on optimisation of safety data collection - Step 2b
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, PM: decision on the application for modification of an agreed PIP, P/0172/2019
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline E19 on optimisation of safety data collection - Step 2b'
30/10/2019 ICH M10 on bioanalytical method validation
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0165/2019
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline M10 on bioanalytical method validation - Step 2b'
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Deferiprone, PM: decision on the application for modification of an agreed PIP, P/0189/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, PM: decision on the application for modification of an agreed PIP, P/0195/2019
30/10/2019 Human medicines European public assessment report (EPAR): Xadago, safinamide methanesulfonate, Parkinson Disease, 23/02/2015, 10, Authorised
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa, PM: decision on the application for modification of an agreed PIP, P/0176/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0190/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab, PM: decision on the application for modification of an agreed PIP, P/0174/2019
30/10/2019 Other: Informed consent for paediatric clinical trials in Europe 2015
30/10/2019 Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma, Glioblastoma, 26/01/1999, 32, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, 1, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 4, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Sildenafil Teva, sildenafil, Erectile Dysfunction, 30/11/2009, Generic, 14, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 18, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): colecalciferol, W: decision granting a waiver in all age groups for all conditions or indications, P/0182/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Amoxicillin (in combination with pantoprazole + clarithromycin), W: decision granting a waiver in all age groups for all conditions or indications, P/0184/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Clarithromycin (in combination with pantoprazole + amoxicillin), W: decision granting a waiver in all age groups for all conditions or indications, P/0183/2019
29/10/2019 Agenda: Agenda - CHMP agenda of the 14-17 October 2019 meeting
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Seladelpar, W: decision granting a waiver in all age groups for all conditions or indications, P/0192/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): salbutamol sulfate,budesonide, W: decision granting a waiver in all age groups for all conditions or indications, P/0185/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Candesartan,Atorvastatin,amlodipine, W: decision granting a waiver in all age groups for all conditions or indications, P/0187/2019
29/10/2019 Template or form: Day 80 assessment report - Non-clinical template with guidance rev. 10.19
29/10/2019 Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance rev. 10.19
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate),Olopatadine (hydrochloride) (GSP 301 NS), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0170/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pantoprazole (in combination with amoxicillin + clarithromycin), W: decision granting a waiver in all age groups for all conditions or indications, P/0188/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human lecithin cholesterol acyltransferase, W: decision granting a waiver in all age groups for all conditions or indications, P/0175/2019
29/10/2019 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 12, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanized antibody targeting B cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F, W: decision granting a waiver in all age groups for all conditions or indications, P/0168/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0191/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): ofatumumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0122/2019
29/10/2019 Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia, Gout, 28/03/2019, Generic, 1, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibandronic acid (in the form of ibandronate sodium monohydrate), W: decision granting a waiver in all age groups for all conditions or indications, P/0180/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dusquetide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0177/2019
29/10/2019 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2019 by end of November 2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib, W: decision granting a waiver in all age groups for all conditions or indications, P/0167/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Efpeglenatide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0181/2019
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00010631/201812
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010631/201812
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0178/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib, W: decision granting a waiver in all age groups for all conditions or indications, P/0171/2019
29/10/2019 Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid, 01/07/2013, Orphan, Accelerated assessment, Additional monitoring, 20, Authorised
29/10/2019 Overview of comments: Overview of comments received on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Report: Outcome of public consultation on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Leaflet: Biosimilars in the EU - Information guide for healthcare professionals
28/10/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 28/10/2019 to 31/10/2019
28/10/2019 Agenda: Agenda - PRAC draft agenda of meeting 28-31 October 2019
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/201812
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002908/201812
28/10/2019 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 11, Authorised
28/10/2019 Other: The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees
28/10/2019 Other: PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 30 September-3 October 2019
28/10/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
28/10/2019 Periodic safety update single assessment: Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812
28/10/2019 Notifying a change of marketing status
28/10/2019 Worksharing: questions and answers
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 2 - Nitrosamine detected response template
28/10/2019 Template or form: Step 2 Nitrosamine detected response template
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812
25/10/2019 News and press releases: Dialogue with Chinese authorities on medicine regulation
24/10/2019 Human medicines European public assessment report (EPAR): Thorinane, enoxaparin sodium, Venous Thromboembolism, 14/09/2016, Additional monitoring, Biosimilar, 2, Withdrawn
24/10/2019 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, Authorised
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of salivary gland cancer, 21/03/2018, Withdrawn
24/10/2019 Orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib) for the: Treatment of soft tissue sarcoma, 11/01/2016, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of glioma, 19/11/2018, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of papillary thyroid cancer, 19/11/2018, Withdrawn
23/10/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1+8 Bovis, inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, 08/03/2012, Accelerated assessment, 6, Authorised
23/10/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1+8 Ovis, inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 /inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02, 14/03/2011, 6, Authorised
23/10/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 14-17 October 2019
23/10/2019 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 13, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 18, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis, 25/10/2005, 26, Authorised
22/10/2019 Report: Medicinal products for human use: monthly figures - September 2019
22/10/2019 Regulatory and procedural guideline: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes
22/10/2019 Regulatory and procedural guideline: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
22/10/2019 Other: Mandate, objectives and rules of procedure for the Name Review Group (NRG)
21/10/2019 News and press releases: Enhancing consistency in wording of therapeutic indications to support healthcare decision-making
21/10/2019 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 13, Authorised
21/10/2019 Regulatory and procedural guideline: Wording of therapeutic indication - A guide for assessors of centralised applications
21/10/2019 Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 17, Authorised
21/10/2019 Other: Quality Review of Documents (QRD) working group plenary meeting dates
21/10/2019 Committee for Herbal Medicinal Products (HMPC): 14-16 January 2019 , European Medicines Agency, London, UK, from 14/01/2019 to 16/01/2019
21/10/2019 Minutes: Minutes of the HMPC 14-16 January 2019 meeting
18/10/2019 Scientific guideline: CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
18/10/2019 CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
18/10/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019
18/10/2019 Summary of opinion: Ervebo, Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), 17/10/2019, Positive
18/10/2019 Summary of opinion: Revolade, eltrombopag, 17/10/2019, Negative
18/10/2019 News and press releases: First non-injectable treatment for severe low blood sugar levels
17/10/2019 Procurement: Ex ante publicity of a negotiated procedure : EMA/2019/32/LD – Legal advice in relation to Dutch law on real estate and building maintenance
17/10/2019 Minutes: Minutes of the PRAC meeting 13-16 May 2019
17/10/2019 Human medicines European public assessment report (EPAR): Efavirenz Teva, efavirenz, HIV Infections, 09/01/2012, Generic, 9, Authorised
17/10/2019 Minutes: Minutes of the CVMP meeting of 10-12 September 2019
17/10/2019 Minutes: Minutes of the CVMP meeting of 16-18 July 2019
17/10/2019 Minutes: Minutes of the CVMP meeting of 18-20 June 2019
17/10/2019 Human medicines European public assessment report (EPAR): Duloxetine Lilly, duloxetine, Neuralgia, Diabetic Neuropathies, Depressive Disorder, Major, 08/12/2014, 6, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 12, Authorised
17/10/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC
17/10/2019 Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - July 2019
17/10/2019 Human medicines European public assessment report (EPAR): Anoro Ellipta (previously Anoro), umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 13, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Pemetrexed medac, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 26/11/2015, Generic, 5, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Imatinib medac, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, 25/09/2013, Generic, 5, Withdrawn
16/10/2019 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 15, Authorised
16/10/2019 Orphan designation: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class (atinumab) for the: Treatment of spinal cord injury, 19/01/2009, Withdrawn
16/10/2019 Orphan designation: Aztreonam lysinate (inhalation use) for the: Treatment of Gram-negative bacterial lung infection in cystic fibrosis, 21/06/2004, Expired
16/10/2019 Orphan designation: Recombinant human soluble Fc-gamma receptor II b for the: Treatment of idiopathic thrombocytopenic purpura, 02/08/2007, Withdrawn
16/10/2019 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 64, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Dectova, Zanamivir, Influenza, Human, 26/04/2019, Additional monitoring, 1, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative, 13/08/1999, 55, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 24, Authorised
16/10/2019 Orphan designation: pentetrazol for the: Treatment of idiopathic hypersomnia, 11/11/2015, Positive
16/10/2019 Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, Additional monitoring, 10, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Exforge, amlodipine (as besylate), valsartan, Hypertension, 16/01/2007, 25, Authorised
16/10/2019 Orphan designation: Recombinant human acid ceramidase for the: Treatment of Farber disease, 19/02/2014, Positive
16/10/2019 Orphan designation: Recombinant human acid ceramidase for the: Treatment of cystic fibrosis, 10/08/2015, Positive
16/10/2019 Orphan designation: Ibudilast for the: Treatment of amyotrophic lateral sclerosis, 12/12/2016, Positive
16/10/2019 Agenda: Agenda - PDCO agenda of the 15-18 October 2019 meeting
15/10/2019 Gefitinib product-specific bioequivalence guidance
15/10/2019 Ezetimibe product-specific bioequivalence guidance
15/10/2019 Cabozantinib product-specific bioequivalence guidance
15/10/2019 Palbociclib product-specific bioequivalence guidance
15/10/2019 Colchicine product-specific bioequivalence guidance
15/10/2019 Apixaban product-specific bioequivalence guidance
15/10/2019 Human medicines European public assessment report (EPAR): Comtess, entacapone, Parkinson Disease, 16/09/1998, 26, Authorised
15/10/2019 Human medicines European public assessment report (EPAR): Stivarga, regorafenib, Colorectal Neoplasms, 26/08/2013, 15, Authorised
15/10/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: October 2019
15/10/2019 Report: Sales of veterinary antimicrobial agents in 31 European countries in 2017
15/10/2019 News and press releases: European countries increase commitment to responsible antibiotic use in animals
15/10/2019 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
15/10/2019 Committee for Orphan Medicinal Products (COMP): 8-10 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 08/10/2019 to 10/10/2019
15/10/2019 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 30, Authorised
15/10/2019 Orphan designation: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (avelumab) for the: Treatment of Merkel cell carcinoma, 14/12/2015, Withdrawn
15/10/2019 Orphan designation: avelumab for the: Treatment of gastric cancer, 12/12/2016, Withdrawn
15/10/2019 Orphan designation: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F(depatuxizumab mafodotin for the: Treatment of glioma, 29/07/2014, Withdrawn
15/10/2019 Orphan designation: Glucopyranosyl lipid A for the: Treatment of follicular lymphoma, 16/10/2017, Withdrawn
15/10/2019 Orphan designation: Glucopyranosyl lipid A stable emulsion and recombinant New York oesophageal squamous cell carcinoma-1 protein for the: Treatment of soft tissue sarcoma, 21/03/2016, Withdrawn
15/10/2019 Orphan designation: Sindbis virus envelope pseudotyped lentiviral vector encoding New York oesophageal squamous cell carcinoma-1 protein for the: Treatment of soft tissue sarcoma, 21/03/2016, Withdrawn
15/10/2019 Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ), docetaxel trihydrate, Stomach Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, 28/08/2015, Generic, 8, Withdrawn
15/10/2019 Human medicines European public assessment report (EPAR): Optruma, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 23, Authorised
15/10/2019 Periodic safety update single assessment: Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201902
15/10/2019 Human medicines European public assessment report (EPAR): Bortezomib Sun, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 7, Authorised
15/10/2019 Committee for Herbal Medicinal Products (HMPC): 13-15 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 13/05/2019 to 15/05/2019
15/10/2019 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 13-15 May 2019
15/10/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Rhamnus purshiana DC., cortex - Revision 1
15/10/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix - Revision 1
15/10/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Tanacetum parthenium (L.) Schultz Bip., herba - Revision 1
15/10/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1
15/10/2019 Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
15/10/2019 Herbal medicinal product: Tanaceti parthenii herba, Tanaceti parthenii herba, F: Assessment finalised
15/10/2019 Herbal medicinal product: Rhamni purshianae cortex, Rhamni purshianae cortex, F: Assessment finalised
15/10/2019 Herbal medicinal product: Thymi aetheroleum, Thymi aetheroleum, F: Assessment finalised
14/10/2019 Human medicines European public assessment report (EPAR): Temozolomide Sandoz, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 16, Authorised
14/10/2019 Human medicines European public assessment report (EPAR): Somac Control, pantoprazole, Gastroesophageal Reflux, 12/06/2009, 13, Authorised
14/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, Generic, 12, Authorised
14/10/2019 Veterinary medicines European public assessment report (EPAR): Simparica Trio, moxidectin, sarolaner, pyrantel embonate, 17/09/2019, Authorised
14/10/2019 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 37, Authorised
14/10/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 17-20 September 2019
14/10/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of hyperargininaemia, 28/06/2019, Positive
14/10/2019 Minutes: Minutes of the CHMP meeting 22-25 July 2019
14/10/2019 Human medicines European public assessment report (EPAR): Nuceiva, Botulinum toxin type A, Skin Aging, 27/09/2019, Additional monitoring, Authorised
14/10/2019 Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/07/2019 to 25/07/2019
14/10/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of argininosuccinic aciduria, 28/06/2019, Positive
14/10/2019 Orphan designation: regorafenib for the: Treatment of glioma, 28/06/2019, Positive
14/10/2019 Orphan designation: Recombinant human coagulation factor VIII Fc - von Willebrand factor - XTEN fusion protein for the: Treatment of haemophilia A, 28/06/2019, Positive
14/10/2019 News and press releases: European Network of Paediatric Research at EMA elects new chair
11/10/2019 Human medicines European public assessment report (EPAR): Truxima, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Wegener Granulomatosis, Leukemia, Lymphocytic, Chronic, B-Cell, Microscopic Polyangiitis, 17/02/2017, Additional monitoring, Biosimilar, 9, Authorised
11/10/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019
11/10/2019 Maximum Residue Limits - Summary of opinion: Dicyclanil - Summary opinion of the CVMP on the establishment of maximum residue limits
11/10/2019 Template or form: Letter of recommendations - Template
11/10/2019 Human medicines European public assessment report (EPAR): EndolucinBeta, lutetium (177 Lu) chloride, Radionuclide Imaging, 06/07/2016, Additional monitoring, 5, Authorised
11/10/2019 Human medicines European public assessment report (EPAR): Desloratadine Actavis, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 13/01/2012, Generic, 12, Authorised
11/10/2019 Human medicines European public assessment report (EPAR): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 21/09/2017, Additional monitoring, 7, Authorised
11/10/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 2-5 September 2019 PRAC meeting
11/10/2019 Orphan designation: Dry extract from birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the: Treatment of epidermolysis bullosa, 23/02/2011, Positive
11/10/2019 Regulatory and procedural guideline: PRIME eligibility requests: 2020 deadlines for submission and timetable for assessment
11/10/2019 Template or form: European Medicines Agency active-substance-master-file-number request form
11/10/2019 Agenda: Agenda - CAT agenda of the 9-11 October 2019 meeting
11/10/2019 Supply shortage: Maci (matrix applied characterised autologous cultured chondrocytes) implant supply shortage
10/10/2019 Human medicines European public assessment report (EPAR): Entacapone Orion, entacapone, Parkinson Disease, 18/08/2011, 8, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 16, Authorised
10/10/2019 Periodic safety update single assessment: Mesterolone: List of nationally authorised medicinal products - PSUSA/00010551/201901
10/10/2019 Human medicines European public assessment report (EPAR): Giapreza, Angiotensin II acetate, Hypotension, Shock, 23/08/2019, Additional monitoring, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 5, Authorised
10/10/2019 Periodic safety update single assessment: Interferon gamma: List of nationally authorised medicinal products - PSUSA/00001760/201901
10/10/2019 Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid serotype AAV-rh74 and a codon-optimised expression cassette to drive the expression of a secretable form of human acid alpha-glucosidase for the: Treatment of glycogen storage disease type II (Pompe's disease), 28/06/2019, Positive
10/10/2019 Orphan designation: rasagiline for the: Treatment of Duchenne muscular dystrophy, 28/06/2019, Positive
10/10/2019 Periodic safety update single assessment: Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201903
10/10/2019 Human medicines European public assessment report (EPAR): Ventavis, iloprost, Hypertension, Pulmonary, 15/09/2003, 27, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Hyperammonemia, Amino Acid Metabolism, Inborn Errors, 23/06/2017, Generic, 5, Authorised
10/10/2019 Periodic safety update single assessment: Trandolapril: List of nationally authorised medicinal products - PSUSA/00003004/201902
09/10/2019 Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis, Respiratory Tract Infections, 20/07/2011, Orphan, 15, Authorised
09/10/2019 Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia, Bipolar Disorder, 06/10/2008, Generic, 15, Authorised
09/10/2019 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 12, Authorised
09/10/2019 Periodic safety update single assessment: Dorzolamide / timolol: List of nationally authorised medicinal products - PSUSA/00001166/201902
09/10/2019 Human medicines European public assessment report (EPAR): Pemetrexed Accord, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, Generic, 4, Authorised
09/10/2019 Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, Biosimilar, 22, Authorised
09/10/2019 Periodic safety update single assessment: Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201902
09/10/2019 Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi, busulfan, Hematopoietic Stem Cell Transplantation, 22/09/2014, Generic, 6, Authorised
09/10/2019 Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 30/06/2013, Generic, 15, Authorised
09/10/2019 Report: Applications for new human medicines under evaluation by the CHMP: October 2019
09/10/2019 Human medicines European public assessment report (EPAR): Mixtard, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised
09/10/2019 Human medicines European public assessment report (EPAR): Fosavance, alendronic acid, colecalciferol, Osteoporosis, Postmenopausal, 24/08/2005, 22, Authorised
09/10/2019 Periodic safety update single assessment: Octenidine dihydrochloride 1-propanol 2-propanol: List of nationally authorised medicinal products - PSUSA/00010417/201901
09/10/2019 Periodic safety update single assessment: Ethanol-orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010416/201902
09/10/2019 Periodic safety update single assessment: Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201902
09/10/2019 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 17, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Protaphane, insulin human, Diabetes Mellitus, 07/10/2002, 17, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, 1, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Imatinib Actavis, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 17/04/2013, Generic, 12, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 25, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Duzallo, allopurinol, lesinurad, Gout, 23/08/2018, Additional monitoring, 1, Authorised
08/10/2019 Veterinary medicines European public assessment report (EPAR): Cytopoint, lokivetmab, 25/04/2017, 4, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Savene, dexrazoxane hydrochloride, Extravasation of Diagnostic and Therapeutic Materials, 27/07/2006, 14, Authorised
08/10/2019 Agenda: Agenda - HMPC agenda of the 23-25 September 2019 meeting
08/10/2019 Agenda: Agenda - CVMP agenda of the 8-10 October 2019 meeting
08/10/2019 Minutes: Minutes - PDCO minutes of the 26-29 March 2019 meeting
08/10/2019 Agenda: Agenda - COMP agenda of the 8-10 October 2019 meeting
08/10/2019 Procurement: Ex ante publicity of a negotiated procedure : EMA/2019/35/ED – Executive driver services
08/10/2019 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 3, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 14, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, 18/06/2009, Biosimilar, 22, Authorised
08/10/2019 Health technology assessment bodies
08/10/2019 Minutes: Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2018
08/10/2019 Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 17, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Giant Lymph Node Hyperplasia, 22/05/2014, Orphan, Accelerated assessment, 10, Authorised
08/10/2019 Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, 24/05/2018, Orphan, 3, Authorised
07/10/2019 Other: Summary of transfers of appropriations in budget 2019
07/10/2019 Management Board meeting: 12-13 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 12/06/2019 to 13/06/2019
07/10/2019 Other: Outcome of written procedures finalised during the period from 17 May 2019 to 16 September 2019
07/10/2019 Other: Charter of tasks and responsibilities of the accounting officer