What's new

RSS
Date Content
31/08/2018 News and press releases: Development of medicines for rare diseases
31/08/2018 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, 50, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 30, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 9, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Luveris, lutropin alfa, Ovulation Induction, Infertility, Female, 29/11/2000, 19, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Ciambra, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 02/12/2015, Generic, 2, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Brilique, ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome, 03/12/2010, 11, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Hypertension, 29/09/2010, Generic, 9, Authorised
31/08/2018 Human medicines European public assessment report (EPAR): Cotellic, cobimetinib hemifumarate, Melanoma, 20/11/2015, Additional monitoring, 6, Authorised
31/08/2018 Periodic safety update single assessment: Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712
31/08/2018 Periodic safety update single assessment: Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712
31/08/2018 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 22, Authorised
31/08/2018 Other: Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions
31/08/2018 Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 13, Authorised
31/08/2018 Template or form: Application for the establishment of maximum residue limits for an active substance to be used in veterinary medicinal products in accordance with Regulation (EC) No. 470/2009
31/08/2018 Periodic safety update single assessment: Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711
31/08/2018 Periodic safety update single assessment: Rosuvastatin: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002664/201711
31/08/2018 Human medicines European public assessment report (EPAR): Zalmoxis, Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, 18/08/2016, Orphan, Additional monitoring, Conditional approval, 1, Authorised
30/08/2018 Agenda: Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
30/08/2018 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, Additional monitoring, 12, Authorised
29/08/2018 Medicine shortages
29/08/2018 News and press releases: Towards improving the availability of medicines in the EU
29/08/2018 Work programme: Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
29/08/2018 Other: EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use
29/08/2018 Recommendation on medication errors: Guide to be given to prescribers to ensure Amglidia is used correctly
29/08/2018 Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 32, Authorised
28/08/2018 Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
28/08/2018 News and press releases: Fostering medicines for children
28/08/2018 Minutes: Minutes - PDCO minutes of the 24-27 July 2018 meeting
28/08/2018 Agenda: Agenda - PDCO agenda of the 21-24 August 2018 meeting
28/08/2018 Business hours and holidays
24/08/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, Portugal , Lisbon, Portugal, from 26/11/2018 to 28/11/2018
24/08/2018 Agenda: Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, October 2018
24/08/2018 Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Glioma, 07/09/2007, Orphan, 4, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): Duzallo, allopurinol, lesinurad, Gout, 23/08/2018, Additional monitoring, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): HyQvia, Human normal immunoglobulin, Immunologic Deficiency Syndromes, 16/05/2013, Additional monitoring, 12, Authorised
24/08/2018 The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, Spain , MSL Formacion, Madrid, Spain, from 15/10/2018 to 18/10/2018
24/08/2018 Agenda: Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, October 2018
24/08/2018 Human medicines European public assessment report (EPAR): Temozolomide Sandoz, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 15, Authorised
24/08/2018 Veterinary medicines European public assessment report (EPAR): VarroMed, oxalic acid dihydrate, formic acid, 02/02/2017, 1, Authorised
24/08/2018 Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Cholestasis, Vitamin E Deficiency, 23/07/2009, Additional monitoring, Exceptional circumstances, 12, Authorised
23/08/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts
23/08/2018 Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene
23/08/2018 Other: Organisation Management Services (OMS) operating model
23/08/2018 Management Board meeting: 6-7 June 2018 , European Medicines Agency, London, UK, from 06/06/2018 to 07/06/2018
23/08/2018 Minutes: Minutes of the 100th meeting of the Management Board: 6-7 June 2018
23/08/2018 Minutes: Minutes of the CAT meeting 18-20 April 2018
23/08/2018 Minutes: Minutes of the CAT meeting 23-25 May 2018
23/08/2018 News and press releases: European Medicines Agency closed 27 August 2018
23/08/2018 Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Melanoma, 17/02/2012, 18, Authorised
22/08/2018 News and press releases: Keeping medicines safe
22/08/2018 Orphan designation: Omaveloxolone for the: Treatment of Friedreich's ataxia, 27/06/2018, Positive
22/08/2018 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting, Cancer, 20/04/2012, 11, Authorised
22/08/2018 Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene for the: Treatment of mucopolysaccharidosis type I, 27/06/2018, Positive
22/08/2018 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 24, Authorised
21/08/2018 Orphan designation: Palovarotene for the: Treatment of multiple osteochondromas, 27/06/2018, Positive
21/08/2018 Orphan designation: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles for the: Treatment of ornithine transcarbamylase deficiency, 27/06/2018, Positive
21/08/2018 Orphan designation: 20-hydroxyecdysone for the: Treatment of Duchenne muscular dystrophy, 27/06/2018, Positive
21/08/2018 Orphan designation: Efpegsomatropin for the: Treatment of growth hormone deficiency, 27/06/2018, Positive
21/08/2018 Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Tomography, Emission-Computed, Single-Photon, Lewy Body Disease, Parkinson Disease, Alzheimer Disease, 27/07/2000, 20, Authorised
21/08/2018 Orphan designation: carmustine for the: Treatment in haematopoietic stem cell transplantation, 27/06/2018, Positive
21/08/2018 Orphan designation: Deferiprone for the: Treatment of neurodegeneration with brain iron accumulation, 27/06/2018, Positive
21/08/2018 Orphan designation: 2-[(2S)-2-methyl-1,4-dioxa-8-azaspiro[4.5]dec-8-yl]-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one for the: Treatment of tuberculosis, 27/06/2018, Positive
21/08/2018 Orphan designation: R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride for the: Treatment of hereditary angioedema, 27/06/2018, Positive
20/08/2018 Report: Report on budgetary and financial management: financial year 2017
20/08/2018 Report: Report on budgetary and financial management: financial year 2016
20/08/2018 News and press releases: Update on medicines containing valsartan from Zhejiang Tianyu: company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA
20/08/2018 Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Cataplexy, Narcolepsy, 13/10/2005, 28, Authorised
20/08/2018 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, Patient safety, 8, Authorised
20/08/2018 Other: Overview of OMS change request process
20/08/2018 Human medicines European public assessment report (EPAR): Myocet, doxorubicin hydrochloride, Breast Neoplasms, 13/07/2000, 20, Authorised
20/08/2018 Template or form: Annex 1 - Report template for the review of a European Union herbal monograph
17/08/2018 Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, 10/01/2008, 20, Authorised
17/08/2018 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 7, Authorised
17/08/2018 Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3
17/08/2018 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Osteoporosis, 16/12/2014, 7, Authorised
17/08/2018 Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 July 2018 , European Medicines Agency, London, UK, from 17/07/2018 to 19/07/2018
17/08/2018 Committee for Orphan Medicinal Products (COMP): 22-24 May 2018 , European Medicines Agency, London, UK, from 22/05/2018 to 24/05/2018
17/08/2018 Committee for Orphan Medicinal Products (COMP): 19-21 June 2018 , European Medicines Agency, London, UK, from 19/06/2018 to 21/06/2018
17/08/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2018
17/08/2018 Minutes: Minutes of the COMP meeting of 19-21 June 2018
17/08/2018 Minutes: Minutes of the COMP meeting of 22-24 May 2018
17/08/2018 Withdrawn application: Sutent, sunitinib, Date of withdrawal: 26/06/2018, Post-authorisation
17/08/2018 Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), Thalidomide, Multiple Myeloma, 16/04/2008, Orphan, 22, Authorised
16/08/2018 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 35, Authorised
16/08/2018 Periodic safety update single assessment: Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709
16/08/2018 Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, Additional monitoring, 7, Authorised
16/08/2018 Herbal medicinal product: Polypodii rhizoma, Polypodii rhizoma, F: Assessment finalised
15/08/2018 Clinical data publication
15/08/2018 Support for industry on clinical data publication
15/08/2018 Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3
15/08/2018 Scientific guideline: Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3
15/08/2018 Other: HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population
15/08/2018 Human medicines European public assessment report (EPAR): Memantine ratiopharm, memantine hydrochloride, Alzheimer Disease, 12/06/2013, Generic, 6, Authorised
15/08/2018 News and press releases: How are new medicines approved by EMA?
15/08/2018 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 23-24 July 2018
15/08/2018 Report: Medicinal products for human use: monthly figures - July 2018
15/08/2018 Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)
15/08/2018 Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1
15/08/2018 Template or form: Formatted table template to be inserted in each procedural submission cover letter
15/08/2018 Veterinary medicines European public assessment report (EPAR): Pexion, imepitoin, 25/02/2013, 6, Authorised
14/08/2018 Veterinary medicines European public assessment report (EPAR): Ubac, Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616, 26/07/2018, Authorised
14/08/2018 Periodic safety update single assessment: Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710
14/08/2018 Periodic safety update single assessment: Epinastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001231/201710
14/08/2018 Periodic safety update single assessment: Dutasteride, dutasteride / tamsulosine: List of nationally authorised medicinal products - PSUSA/00010506/201711
14/08/2018 Periodic safety update single assessment: Antithrombin iii: List of nationally authorised medicinal products - PSUSA/00003159/201712
14/08/2018 Periodic safety update single assessment: Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201711
14/08/2018 Periodic safety update single assessment: Alfuzosin: List of nationally authorised medicinal products -
14/08/2018 Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2
14/08/2018 Overview of comments: Overview of comments received on 'Procedure for the review and revision of European Union herbal monographs and European Union list entries' - Revision 2
14/08/2018 Periodic safety update single assessment: Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710
14/08/2018 Periodic safety update single assessment: Deoxycholic acid: List of nationally authorised products - PSUSA/00010525/201710
14/08/2018 Veterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine hydrochloride, 10/06/2015, 6, Authorised
14/08/2018 Veterinary medicines European public assessment report (EPAR): Suvaxyn PRRS MLV, Modified live porcine respiratory and reproductive syndrome virus, 24/08/2017, 2, Authorised
13/08/2018 Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
13/08/2018 Periodic safety update single assessment: Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710
13/08/2018 Veterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, 16/12/2008, 11, Authorised
13/08/2018 Scientific guideline: Guideline on core summary for product characteristics for human albumin solution - Revision 3
13/08/2018 Clinical investigation of recombinant and human plasma-derived factor VIII products
13/08/2018 Scientific guideline: Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2
13/08/2018 Scientific guideline: Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3
10/08/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 July 2018
10/08/2018 Report: Applications for new human medicines under evaluation by the CHMP: August 2018
10/08/2018 Other: CVMP meeting dates 2019, 2020 and 2021
10/08/2018 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, Additional monitoring, 27, Authorised
10/08/2018 News and press releases: Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan produced by another company Zhejiang Tianyu
10/08/2018 Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018 , European Medicines Agency, London, UK, from 11/06/2018 to 14/06/2018
10/08/2018 Minutes: Minutes of the PRAC meeting 11-14 June 2018
10/08/2018 Human medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, Hypogonadism, 20/10/1995, 22, Authorised
10/08/2018 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis, 15/06/2017, Additional monitoring, Biosimilar, 2, Authorised
10/08/2018 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 10, Authorised
09/08/2018 Newsletter: News bulletin for small and medium-sized enterprises - Issue 44
09/08/2018 Human medicines European public assessment report (EPAR): Numient, levodopa, carbidopa, Parkinson Disease, 19/11/2015, 3, Authorised
09/08/2018 Human medicines European public assessment report (EPAR): Fampyra, Fampridine, Multiple Sclerosis, 20/07/2011, 12, Authorised
09/08/2018 Periodic safety update single assessment: Prulifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002569/201710
09/08/2018 Periodic safety update single assessment: Prulifloxacin: List of nationally authorised medicinal products - PSUSA/00002569/201710
09/08/2018 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 2, Authorised
09/08/2018 Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, 26/07/2018, Generic, Authorised
08/08/2018 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, Authorised
08/08/2018 News and press releases: EMA: working for every patient in Europe
08/08/2018 News and press releases: Esmya: new measures to minimise risk of rare but serious liver injury
08/08/2018 Human medicines European public assessment report (EPAR): Zometa, zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone, 20/03/2001, 32, Authorised
08/08/2018 Human medicines European public assessment report (EPAR): Mavenclad, Cladribine, Multiple Sclerosis, 22/08/2017, 2, Authorised
08/08/2018 Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Orphan, Additional monitoring, Exceptional circumstances, 15, Authorised
07/08/2018 Human medicines European public assessment report (EPAR): Ariclaim, duloxetine, Diabetic Neuropathies, 11/08/2004, 26, Withdrawn
07/08/2018 Other: Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
07/08/2018 Other: Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
07/08/2018 Presentation: Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Session 1.2: Registration with EudraVigilance
07/08/2018 Other: Electronic submission of Article 57(2) data: questions and answers
07/08/2018 Other: Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
07/08/2018 Other: Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
07/08/2018 Human medicines European public assessment report (EPAR): DuoResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 6, Authorised
07/08/2018 Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 42, Authorised
07/08/2018 Human medicines European public assessment report (EPAR): Toviaz, fesoterodine fumarate, Urinary Bladder, Overactive, 20/04/2007, 20, Authorised
07/08/2018 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
07/08/2018 Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, 15/06/2017, Additional monitoring, Biosimilar, 2, Authorised
07/08/2018 Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, Generic, 10, Authorised
06/08/2018 Newsletter: Human medicines highlights - August 2018
06/08/2018 Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies
06/08/2018 Orphan designation: Metreleptin for the: Treatment of familial partial lipodystrophy, 17/07/2012, Positive
06/08/2018 Orphan designation: Metreleptin for the: Treatment of Barraquer-Simons syndrome, 17/07/2012, Positive
06/08/2018 Orphan designation: Metreleptin for the: Treatment of Berardinelli-Seip syndrome, 17/07/2012, Positive
06/08/2018 Orphan designation: Metreleptin for the: Treatment of Lawrence syndrome, 17/07/2012, Positive
06/08/2018 Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version
06/08/2018 Recommendation on medication errors: Myalepta: Educational material for patients and healthcare professionals to ensure Myalepta is used correctly
06/08/2018 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised
06/08/2018 Supply shortage: Cinryze (C1 inhibitor, human) supply shortage
06/08/2018 Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017
06/08/2018 Minutes: Minutes - PDCO minutes of the 26-29 June 2018 meeting
06/08/2018 Human medicines European public assessment report (EPAR): Revatio, sildenafil, Hypertension, Pulmonary, 28/10/2005, Orphan, 36, Authorised
06/08/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC meeting
06/08/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC
06/08/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC meeting
06/08/2018 Withdrawn application: Restaysis, ciclosporin, Date of withdrawal: 25/04/2018, Initial authorisation
06/08/2018 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 3, Authorised
03/08/2018 Human medicines European public assessment report (EPAR): Metalyse, tenecteplase, Myocardial Infarction, 23/02/2001, 17, Authorised
03/08/2018 Human medicines European public assessment report (EPAR): Ristfor, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/03/2010, 18, Authorised
03/08/2018 Antimicrobial resistance in veterinary medicine
03/08/2018 Report: European Medicines Agency’s interaction with industry stakeholders - Annual report 2017
03/08/2018 Periodic safety update single assessment: Morphine morphine-cyclizine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010549/201710
03/08/2018 Periodic safety update single assessment: Morphine morphine-cyclizine: List of nationally authorised medicinal products - PSUSA/00010549/201710
03/08/2018 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 14, Authorised
03/08/2018 Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 13, Authorised
03/08/2018 Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance
03/08/2018 Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance
03/08/2018 Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance
03/08/2018 Human medicines European public assessment report (EPAR): Cystadane, Betaine anhydrous, Homocystinuria, 14/02/2007, 11, Authorised
03/08/2018 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, Additional monitoring, 6, Authorised
03/08/2018 Human medicines European public assessment report (EPAR): Forsteo, teriparatide, Osteoporosis, Osteoporosis, Postmenopausal, 10/06/2003, 20, Authorised
03/08/2018 Overview of comments: Overview of comments received on 'Vismodegib hard capsule 150 mg product-specific bioequivalence guidance'
03/08/2018 Scientific guideline: Vismodegib hard capsule 150 mg product-specific bioequivalence guidance
03/08/2018 Human medicines European public assessment report (EPAR): Zydelig, Idelalisib, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 18/09/2014, Additional monitoring, 14, Authorised
03/08/2018
03/08/2018 Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance
03/08/2018 Overview of comments: Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’
02/08/2018 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2018
02/08/2018 Periodic safety update single assessment: Treprostinil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003013/201711
02/08/2018 Periodic safety update single assessment: Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201711
02/08/2018 Orphan designation: lenalidomide for the: Treatment of chronic lymphocytic leukaemia, 19/11/2007, Positive
02/08/2018 Orphan designation: lenalidomide for the: Treatment of diffuse large B-cell lymphoma, 13/05/2011, Positive
02/08/2018 Orphan designation: Pomalidomide for the: Treatment of multiple myeloma, 08/10/2009, Positive
02/08/2018 Report: Medicinal products for human use: monthly figures - June 2018
02/08/2018 Other: Outcome of public consultation on 'Questions and answers on implementation of risk-based prevention of cross contamination in production 'and ‘Guideline on setting health based exposure limits for use in risk identificat...
02/08/2018 Overview of comments: Overview of comments received on 'Questions and answers on implementation of risk based prevention of cross contamination in production' and ‘Guideline on setting health based exposure limits for use in risk identificati...
02/08/2018 Orphan designation: lenalidomide for the: Treatment of follicular lymphoma, 24/01/2013, Positive
02/08/2018 Orphan designation: lenalidomide for the: Treatment of marginal zone lymphoma, 24/04/2015, Positive
02/08/2018 News and press releases: Update on review of recalled valsartan medicines: preliminary assessment of possible risk to patients
02/08/2018 EudraVigilance Veterinary
02/08/2018 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 6, Authorised
02/08/2018 Human medicines European public assessment report (EPAR): Ribavirin Teva Pharma B.V., Ribavirin, Hepatitis C, Chronic, 01/07/2009, Generic, 13, Authorised
02/08/2018 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias, Hypercholesterolemia, 17/07/2015, Additional monitoring, 8, Authorised
01/08/2018 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, 16, Authorised
01/08/2018 Scientific guideline: Draft questions and answers on Data Monitoring Committees issues
01/08/2018 Human medicines European public assessment report (EPAR): Aplidin, Plitidepsin, Multiple Myeloma, 17/07/2018, Orphan, Refused
01/08/2018 Human medicines European public assessment report (EPAR): Ceplene, Histamine dihydrochloride, Leukemia, Myeloid, Acute, 07/10/2008, Additional monitoring, Exceptional circumstances, 12, Authorised
01/08/2018 News and press releases: Brexit preparedness: EMA to further temporarily scale back and suspend activities
01/08/2018 Veterinary medicines European public assessment report (EPAR): Apoquel, oclacitinib maleate, 12/09/2013, 4, Authorised
01/08/2018 Maximum Residue Limits - Report: Porcine prolactin (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
01/08/2018 Maximum Residue Limits - Report: Eprinomectin (Fin fish; extrapolation to horses and rabbits): European public maximum-residue-limit assessment report (EPMAR) - CVMP
01/08/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 July 2018
01/08/2018 Human medicines European public assessment report (EPAR): Janumet, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 18/02/2009, 23, Authorised
01/08/2018 Inspections, Human Medicines Pharmacovigilance and Committees
01/08/2018 Human Medicines Evaluation
01/08/2018 Human medicines European public assessment report (EPAR): Clopidogrel HCS, clopidogrel hydrochloride, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, 28/10/2010, Generic, 8, Authorised
01/08/2018 Human medicines European public assessment report (EPAR): Zinplava, bezlotoxumab, Enterocolitis, Pseudomembranous, 18/01/2017, Additional monitoring, 4, Authorised