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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 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 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