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10/04/2019 Human medicines European public assessment report (EPAR): Pemetrexed Lilly, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 14/09/2015, Generic, 4, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 3, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Hemophilia B, 12/05/2016, Orphan, Additional monitoring, 4, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Betmiga, Mirabegron, Urinary Bladder, Overactive, 20/12/2012, 11, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 23, Authorised
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of CHARGE syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of DiGeorge syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine for the: Treatment of cystic fibrosis, 26/02/2019, Positive
09/04/2019 Orphan designation: losartan for the: Treatment of epidermolysis bullosa, 26/02/2019, Positive
09/04/2019 Orphan designation: Lentiviral vector encoding human coagulation factor IX for the: Treatment of haemophilia B, 26/02/2019, Positive
09/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, PM: decision on the application for modification of an agreed PIP, P/0010/2019
09/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax, PM: decision on the application for modification of an agreed PIP, P/0001/2019
09/04/2019 Template or form: Template letter of intent for request of scientific advice or protocol assistance
09/04/2019 Human medicines European public assessment report (EPAR): Ibandronic acid Accord, ibandronic acid, Wounds and Injuries, Breast Diseases, Neoplastic Processes, Calcium Metabolism Disorders, Neoplasms by Site, Water-Electrolyte Imbalance, 18/11/2012, Generic, 9, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Raloxifene Teva, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 29/04/2010, Generic, 8, Authorised
09/04/2019 European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe
09/04/2019 Other: Acceptance of working arrangement between EMA-EC and EDQM
09/04/2019 Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester for the: Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive
09/04/2019 Orphan designation: Risdiplam for the: Treatment of spinal muscular atrophy, 26/02/2019, Positive
09/04/2019 Template or form: Notification of discontinuation of an agreed PIP decision
09/04/2019 Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 26/02/2019, Positive
09/04/2019 Orphan designation: Autologous adult live cultured osteoblasts for the: Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive
09/04/2019 Other: Privacy Statement on the processing of personal data in the context of public procurement procedures
09/04/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 29 January - 1 February 2019
09/04/2019 Orphan designation: Lurbinectedin for the: Treatment of small cell lung cancer, 26/02/2019, Positive
09/04/2019 Submitting annual reports on medicine development
08/04/2019 Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the: Treatment of fragile X syndrome, 20/04/2017, Positive
08/04/2019 Orphan designation: Recombinant human club cell 10 KDa protein for the: Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive
08/04/2019 Orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the: Treatment of systemic sclerosis, 28/04/2016, Positive
08/04/2019 Orphan designation: Sirolimus for the: Treatment of tuberous sclerosis, 23/08/2017, Positive
08/04/2019 Agenda: Agenda - PRAC draft agenda of meeting 8-11 April 2019
08/04/2019 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 8, Authorised
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0004/2019
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, PM: decision on the application for modification of an agreed PIP, P/0003/2019
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, PM: decision on the application for modification of an agreed PIP, P/0055/2019
08/04/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC meeting
08/04/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC
05/04/2019 Periodic safety update single assessment: Paracetamol/pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00002307/201806
05/04/2019 Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb / permethrin, 09/01/2012, 7, Authorised
05/04/2019 Veterinary medicines European public assessment report (EPAR): Activyl, indoxacarb, 18/02/2011, 8, Authorised
05/04/2019 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 13, Authorised
05/04/2019 Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation
05/04/2019 Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation
05/04/2019 Periodic safety update single assessment: Metyrapone: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002046/201806
05/04/2019 Periodic safety update single assessment: Metyrapone: List of nationally authorised medicinal products - PSUSA/00002046/201806
04/04/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 March 2019
03/04/2019 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 25, Authorised
03/04/2019 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin, Candidiasis, Aspergillosis, 23/10/2001, 25, Authorised
03/04/2019 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 33, Authorised
03/04/2019 Minutes: Minutes - PDCO minutes of the 11-14 December 2018 meeting
03/04/2019 VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
03/04/2019 Scientific guideline: VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2
03/04/2019 VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
03/04/2019 Scientific guideline: VICH GL57 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
02/04/2019 Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS , European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019
02/04/2019 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 2, Authorised
02/04/2019 Minutes: Minutes of the CVMP meeting of 19-21 February 2019
02/04/2019 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 4, Authorised
02/04/2019 Human medicines European public assessment report (EPAR): Silgard, human papillomavirus type 11 L1 protein / human papillomavirus type 16 L1 protein / human papillomavirus type 18 L1 protein / human papillomavirus type 6 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 19/09/2006, 33, Withdrawn
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-18 : EPAR - Assessment Report - Variation
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-06 : EPAR - Assessment Report - Variation
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-12 : EPAR - Assessment Report - Variation
01/04/2019 Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation
01/04/2019 Minutes: Minutes of the CHMP meeting 28-31 January 2019
01/04/2019 Other: Decision of the Executive Director on rules governing the secondment of national experts to the European Medicines Agency
01/04/2019 Agenda: CHMP ORGAM agenda for the meeting on 18 February 2019
01/04/2019 News and press releases: EU recommendations for 2019/2020 seasonal flu vaccine composition
01/04/2019 Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Hyperphosphatemia, Renal Dialysis, 26/08/2014, 6, Authorised
01/04/2019 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2019
01/04/2019 Regulatory and procedural guideline: Commission Regulation (EU) 2019/480 of 22 March 2019 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2019
01/04/2019 News and press releases: Regulatory information – 1.7% increase of fees from 1 April 2019
01/04/2019 Other: Organisation chart: Veterinary Medicines
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