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28/09/2018 News and press releases: EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site
28/09/2018 Template or form: Applicant / marketing authorisation holder change of contact person for product invented name / product number template
28/09/2018 Template or form: Change of applicant - Cover letter standard text (human)
28/09/2018 Veterinary medicines European public assessment report (EPAR): Cortacare, hydrocortisone aceponate, 27/08/2018, Authorised
27/09/2018 News and press releases: Harnessing the potential of real world data through a ‘learning healthcare system’
26/09/2018 Periodic safety update reports
25/09/2018 News and press releases: EMA to launch new corporate website on 27 September 2018
21/09/2018 Approach towards harmonisation of withdrawal periods for edible tissues
21/09/2018 Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1
21/09/2018 Overview of comments: Overview of comments received on 'Guideline on approach towards harmonisation of withdrawal periods (EMA/CVMP/SWP/735325/2012)' - Revision 1
21/09/2018 Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1
21/09/2018 Scientific guideline: Draft reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version
21/09/2018 Scientific guideline: Reflection paper on resistance in ectoparasites
21/09/2018 Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health
21/09/2018 Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals
21/09/2018 Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device
21/09/2018 News and press releases: New gene therapy for rare inherited disorder causing vision loss recommended for approval
21/09/2018 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 17 – 20 September 2018
21/09/2018 Summary of opinion: Trelegy Ellipta, fluticasone furoate / umeclidinium / vilanterol, 20/09/2018, Positive
21/09/2018 Summary of opinion: Venclyxto, venetoclax, 20/09/2018, Positive
21/09/2018 Summary of opinion: RoActemra, tocilizumab, 20/09/2018, Positive
21/09/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
21/09/2018 News and press releases: Valsartan: review of impurities extended to other sartan medicines
21/09/2018 News and press releases: New medicine for the prevention of migraine
21/09/2018 News and press releases: New medicine to treat infections in adults
21/09/2018 Withdrawn application: Treprostinil SciPharm Sàrl , treprostinil, Date of withdrawal: 05/09/2018, Initial authorisation
21/09/2018 Orphan designation: Recombinant human von Willebrand factor for the: treatment of von Willebrand disease, 26/11/2010, Withdrawn
21/09/2018 Signal management
20/09/2018 Veterinary medicines European public assessment report (EPAR): Canigen L4, Inactivated Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain As-05-073); L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005), 03/07/2015, 3, Authorised
20/09/2018 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, Authorised
20/09/2018 News and press releases: Portugal to also benefit from EU-US mutual recognition agreement for inspections
19/09/2018 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 10, Authorised
19/09/2018 Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, 22/08/2018, Orphan, Additional monitoring, Authorised
19/09/2018 Applying for orphan designation
19/09/2018 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 4, Authorised
19/09/2018 Scientific guideline: Question and answer on the adequacy of the Mahalanobis distance to assess the comparability of drug dissolution profiles
18/09/2018 Third industry stakeholder platform on research and development support , European Medicines Agency, London, UK, from 18/05/2018 to 18/05/2018
18/09/2018 Template or form: Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations
18/09/2018 Template or form: Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations
18/09/2018 Template or form: One year of additional market protection for new indication assessment report template
18/09/2018 Template or form: One year extension of data protection for new indication of well-established use product assessment report template
18/09/2018 Template or form: Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs)
18/09/2018 Template or form: PRAC advice template
18/09/2018 Herbal medicinal product: Pelargonii radix, Pelargonii radix, F: Assessment finalised
18/09/2018 Minutes: Minutes - Third industry stakeholder platform on research and development support
18/09/2018 Herbal medicinal product: Avenae fructus, Avenae fructus, F: Assessment finalised
18/09/2018 Herbal medicinal product: Avenae herba, Avenae herba, F: Assessment finalised
18/09/2018 Human medicines European public assessment report (EPAR): Inductos, dibotermin alfa, Tibial Fractures, Fracture Fixation, Internal, Spinal Fusion, 09/09/2002, 22, Authorised
18/09/2018 Template or form: One year extension of data protection for legal status switch assessment report template
18/09/2018 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201801
18/09/2018 Human medicines European public assessment report (EPAR): Rapilysin, reteplase, Myocardial Infarction, 29/08/1996, 25, Authorised
18/09/2018 News and press releases: EMA's Committee for Medicinal Products for Human Use (CHMP) elects new chair
17/09/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 August 2018
17/09/2018 Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting
17/09/2018 Periodic safety update single assessment: 5 fluorouracil (topical application): List of nationally authorised medicinal products - PSUSA/00010000/201712
17/09/2018 Periodic safety update single assessment: Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712
17/09/2018 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 26, Authorised
17/09/2018 Scientific guideline: Draft concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1
17/09/2018 Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 30/11/2009, 14, Authorised
17/09/2018 Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Kidney Failure, Chronic, Anemia, Cancer, Blood Transfusion, Autologous, 16/07/1997, 27, Authorised
14/09/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018
14/09/2018 Summary of opinion: Respiporc FLUpan H1N1, inactivated influenza A virus/humanstrain: A/Jena/VI5258/2009(H1N1)pdm09, 13/09/2018, Positive
14/09/2018 Public Statement: Public statement on Angiox: Withdrawal of the marketing authorisation in the European Union
14/09/2018 Periodic safety update single assessment: Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201801
14/09/2018 Periodic safety update single assessment: Desmopressin: List of nationally authorised medicinal products - PSUSA/00000964/201712
14/09/2018 Periodic safety update single assessment: Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802
14/09/2018 Periodic safety update single assessment: Felodipine / metoprolol: List of nationally authorised medicinal products - PSUSA/00001357/201712
14/09/2018 Periodic safety update single assessment: Altizide / spironolactone: List of nationally authorised medicinal products - PSUSA/00002781/201801
14/09/2018 Human medicines European public assessment report (EPAR): Angiox, Bivalirudin, Acute Coronary Syndrome, 20/09/2004, 22, Withdrawn
14/09/2018 Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting
14/09/2018 Human medicines European public assessment report (EPAR): Alecensa, alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung, 16/02/2017, Additional monitoring, 7, Authorised
13/09/2018 Periodic safety update single assessment: Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801
13/09/2018 Overview of comments: Overview of comments received on 'the guideline Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 Rev. 5) - Revision 5
13/09/2018 Report: Medicinal products for human use: monthly figures - August 2018
13/09/2018 News and press releases: Committee for Orphan Medicinal Products (COMP) elects new chair
13/09/2018 Periodic safety update single assessment: Propofol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002555/201711
13/09/2018 Periodic safety update single assessment: Haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine: List of nationally...
13/09/2018 Periodic safety update single assessment: Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711
13/09/2018 Periodic safety update single assessment: Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712
13/09/2018 Periodic safety update single assessment: Amitriptyline/perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201801
13/09/2018 Periodic safety update single assessment: Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712
13/09/2018 Periodic safety update single assessment: Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712
13/09/2018 Periodic safety update single assessment: Hypericum perforatum L., herba: List of nationally authorised medicinal products - PSUSA/00001701/201801
13/09/2018 Biosimilar medicines: Overview
13/09/2018 News and press releases: Improving understanding of biosimilars in the EU
13/09/2018 News and press releases: Update on review of valsartan medicines: risk from NDMA remains low, a related substance NDEA also being investigated
13/09/2018 Periodic safety update single assessment: Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708
12/09/2018 Periodic safety update single assessment: Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801
12/09/2018 Periodic safety update single assessment: Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801
12/09/2018 Risk management plan information day , European Medicines Agency, London, UK, from 25/10/2018 to 25/10/2018
12/09/2018 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018 , European Medicines Agency, London, UK, from 11/09/2018 to 13/09/2018
11/09/2018 Periodic safety update single assessment: Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712
11/09/2018 Minutes: Minutes of the CHMP meeting 25-28 June 2018
11/09/2018 Periodic safety update single assessment: Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712
11/09/2018 Agenda: Draft agenda - Focus group meeting on the guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals
11/09/2018 Periodic safety update single assessment: Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712
11/09/2018 Periodic safety update single assessment: Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712
11/09/2018 Periodic safety update single assessment: Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712
11/09/2018 Human medicines European public assessment report (EPAR): Vectibix, panitumumab, Colorectal Neoplasms, 03/12/2007, 30, Authorised
11/09/2018 Periodic safety update single assessment: Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712
11/09/2018 Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting
10/09/2018 Periodic safety update single assessment: Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801
10/09/2018 Periodic safety update single assessment: Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712
10/09/2018 Periodic safety update single assessment: Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801
10/09/2018 Periodic safety update single assessment: Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711
10/09/2018 Periodic safety update single assessment: Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711
10/09/2018 Periodic safety update single assessment: Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711
10/09/2018 Periodic safety update single assessment: Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711
10/09/2018 Periodic safety update single assessment: Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707
10/09/2018 Periodic safety update single assessment: Azelastin: List of nationally authorised medicinal products - PSUSA/00000277/201712
10/09/2018 Periodic safety update single assessment: Hydrochlorothiazide / ramipril: List of nationally authorised medicinal products - PSUSA/00001660/201801
10/09/2018 Periodic safety update single assessment: Enalapril / nitrendipine: List of nationally authorised medicinal products - PSUSA/00001213/201801
10/09/2018 Periodic safety update single assessment: Ibutilide: List of nationally authorised medicinal products - PSUSA/00001713/201712
10/09/2018 Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for the: Treatment of primary mediastinal large B-cell lymphoma, 09/10/2015, Positive
10/09/2018 Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for the: Treatment of diffuse large B cell lymphoma, 16/12/2014, Positive
10/09/2018 Template or form: Architect/Building engineer - Exclusion criteria declaration form - EMA/CEI/2018-2
10/09/2018 Procurement: Architect/Building engineer - External expert contract - EMA/CEI/2018-2
10/09/2018 Procurement: Architect/Building engineer - Notice of call for expressions of interest (CEI) - EMA/CEI/2018-2
10/09/2018 Orphan designation: Nanobody directed towards the human A1 domain of von Willebrand factor (caplacizumab)  for the: Treatment of thrombotic thrombocytopenic purpura, 30/04/2009, Positive
07/09/2018 Newsletter: Human medicines highlights - September 2018
07/09/2018 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018
07/09/2018 Human medicines European public assessment report (EPAR): Tovanor Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 12, Authorised
07/09/2018 Periodic safety update single assessment: Tapentadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201711
07/09/2018 Periodic safety update single assessment: Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711
07/09/2018 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency, London, UK, from 08/06/2018 to 08/06/2018
07/09/2018 Report: Report of the 2018 annual face-to-face meeting of Enpr-EMA members and the Enpr-EMA Coordinating Group (CG)
07/09/2018 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) , European Medicines Agency, London, UK, from 07/06/2018 to 07/06/2018
07/09/2018 Report: Report of the tenth annual workshop (2018) of the European Network of Paediatric Research at the EMA (Enpr-EMA)
07/09/2018 Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medi...
06/09/2018 Supply shortage: Trisenox (arsenic trioxide) supply shortage
06/09/2018 Veterinary medicines European public assessment report (EPAR): Prac-tic, pyriprole, 18/12/2006, 10, Authorised
06/09/2018 Human medicines European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter, ulipristal acetate, Leiomyosarcoma, 27/08/2018, Authorised
06/09/2018 Human medicines European public assessment report (EPAR): Micardis, telmisartan, Hypertension, 16/12/1998, 23, Authorised
05/09/2018 Herbal medicinal product: Myrrha, gummi-resina, Myrrha, gummi-resina, F: Assessment finalised
05/09/2018 Orphan designation: Thymidine and deoxycytidine for the: Treatment of mitochondrial DNA depletion syndrome, myopathic form, 20/04/2017, Positive
05/09/2018 Human medicines European public assessment report (EPAR): Telmisartan Teva, telmisartan, Hypertension, 25/01/2010, Generic, 10, Authorised
05/09/2018 Human medicines European public assessment report (EPAR): Hepsera, adefovir dipivoxil, Hepatitis B, Chronic, 06/03/2003, 25, Authorised
05/09/2018 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin
05/09/2018 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin
05/09/2018 Periodic safety update single assessment: Mizolastine: List of nationally authorised medicinal products - PSUSA/00002078/201711
05/09/2018 Periodic safety update single assessment: Mizolastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002078/201711
05/09/2018 Human medicines European public assessment report (EPAR): Atosiban SUN, atosiban acetate, Premature Birth, 31/07/2013, Generic, 5, Authorised
05/09/2018 Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Parkinson Disease, 27/08/1997, 22, Authorised
05/09/2018 Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency, 26/05/2016, Orphan, Additional monitoring, 2, Authorised
04/09/2018 Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure
04/09/2018 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 10, Authorised
04/09/2018 Human medicines European public assessment report (EPAR): Votubia, everolimus, Tuberous Sclerosis, 02/09/2011, Orphan, 24, Authorised
04/09/2018 Veterinary medicines European public assessment report (EPAR): Gripovac 3, inactivated influenza-A virus, swine, 14/01/2010, 1, Withdrawn
04/09/2018 Human medicines European public assessment report (EPAR): Intanza, influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human, Immunization, 24/02/2009, 18, Withdrawn
04/09/2018 Human medicines European public assessment report (EPAR): Travatan, travoprost, Glaucoma, Open-Angle, Ocular Hypertension, 27/11/2001, 28, Authorised
04/09/2018 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 4, Authorised
04/09/2018 Veterinary medicines European public assessment report (EPAR): Porcilis PCV M Hyo, Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated, 06/11/2014, 4, Authorised
04/09/2018 Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis, Respiratory Tract Infections, 20/07/2011, Orphan, 14, Authorised
03/09/2018 Agenda: Agenda - PRAC draft agenda of meeting 3-6 September 2018
03/09/2018 Human medicines European public assessment report (EPAR): Ratiograstim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 9, Authorised
03/09/2018 Human medicines European public assessment report (EPAR): Protopic, tacrolimus, Dermatitis, Atopic, 27/02/2002, 23, Authorised
03/09/2018 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, 16, Authorised
03/09/2018 Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma, Glioblastoma, 26/01/1999, 31, Authorised
03/09/2018 Human medicines European public assessment report (EPAR): Nevanac, nepafenac, Pain, Postoperative, Ophthalmologic Surgical Procedures, 11/12/2007, 15, Authorised
03/09/2018 Human medicines European public assessment report (EPAR): Pergoveris, follitropin alfa / lutropin alfa, Infertility, Female, 25/06/2007, 12, Authorised