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29/10/2021 Other: Release notes - production release version 01.04.04 November 2021 - Veterinary Medicinal Products Regulation: Union Product Database
29/10/2021 Other: Example files - production release version 01.04.04 November 2021 - Veterinary Medicinal Products Regulation: Union Product Database
29/10/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 11, Authorised
29/10/2021 Agenda: Agenda - COMP agenda of the 3 - 5 November 2021 meeting
29/10/2021 Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 13/02/2020, Additional monitoring, Biosimilar, 4, Authorised
29/10/2021 Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 21, Authorised
29/10/2021 Periodic safety update single assessment: Olodaterol : List of nationally authorised medicinal products - PSUSA/00010245/202103
29/10/2021 Periodic safety update single assessment: Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide : List of nationally authorised medicinal products - PSUSA/0009162202103
29/10/2021 Periodic safety update single assessment: Gliclazide : List of nationally authorised medicinal products - PSUSA/00001532/202102
29/10/2021 Periodic safety update single assessment: Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101
29/10/2021 Periodic safety update single assessment: Betamethasone : List of nationally authorised medicinal products - PSUSA/00000391/202101
29/10/2021 Periodic safety update single assessment: Allopurinol : CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000095/202012
29/10/2021 Periodic safety update single assessment: Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/202012
29/10/2021 Periodic safety update single assessment: Fluorodopa (18F) : List of nationally authorised medicinal products - PSUSA/00010002/202103
29/10/2021 Periodic safety update single assessment: Citrulline malate : List of the nationally authorised medicinal products - PSUSA/00010579/202103
29/10/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
29/10/2021 Periodic safety update single assessment: Nitrofurantoin, nifurtoinol : List of nationally authorised medicinal products - PSUSA/00002174/202102
29/10/2021 Periodic safety update single assessment: Butoconazole : List of nationally authorised medicinal products - PSUSA/00000471/202102
29/10/2021 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021
29/10/2021 Periodic safety update single assessment: Rabies vaccine : List of nationally authorised medicinal products - PSUSA/00009277/202103
29/10/2021 EMA regular press briefing on COVID-19 , Online, from 04/11/2021 to 04/11/2021
29/10/2021 Periodic safety update single assessment: Ampicillin / sulbactam : List of nationally authorised medicinal products - PSUSA/00000197/202102
29/10/2021 Human medicines European public assessment report (EPAR): Waylivra, Volanesorsen sodium, Hyperlipoproteinemia Type I, 03/05/2019, Orphan, Additional monitoring, Conditional approval, 4, Authorised
29/10/2021 Other: Principles for Sponsor organisation modelling for CTIS
29/10/2021 Human medicines European public assessment report (EPAR): Tracleer, bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary, 14/05/2002, 41, Authorised
28/10/2021 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 21, Authorised
28/10/2021 How to submit information
28/10/2021 News and press releases: Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia
28/10/2021 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/1998, 42, Authorised
28/10/2021 Human medicines European public assessment report (EPAR): Exforge, valsartan, amlodipine (as amlodipine besilate), Hypertension, 16/01/2007, 30, Authorised
28/10/2021 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia; Bipolar Disorder, 12/12/2007, Generic, 29, Authorised
28/10/2021 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease, 22/08/2014, 13, Authorised
28/10/2021 Herbal medicinal product: Species sedativae, Combination: Species sedativae, F: Assessment finalised
28/10/2021 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 48, Authorised
27/10/2021 News and press releases: Call for expressions of interest for civil society representatives to participate in work of EMA
27/10/2021 Handling competing interests
27/10/2021 Other: Mr Noel Wathion - Assessment outcome of occupational activities after leaving the service (Oct 2021)
27/10/2021 Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (Sept 2021)
27/10/2021 Minutes: Minutes of the COMP meeting 7-9 September 2021
27/10/2021 Periodic safety update single assessment: Cefoperazone - List of nationally authorised medicinal products - PSUSA-00000597-202101
27/10/2021 Periodic safety update single assessment: Cefoperazone - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000597-202101
27/10/2021 Periodic safety update single assessment: Carbamazepine - List of nationally authorised medicinal products - PSUSA-00000539-202012
27/10/2021 Periodic safety update single assessment: Carbamazepine - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000539-202012
27/10/2021 Human medicines European public assessment report (EPAR): Opatanol, olopatadine hydrochloride, Conjunctivitis, Allergic, 16/05/2002, 22, Authorised
27/10/2021 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
27/10/2021 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union
27/10/2021 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
27/10/2021 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, Additional monitoring, 8, Authorised
27/10/2021 Other: Mr Hans Georg Eichler - Assessment outcome of occupational activities after leaving the service (Sept 2021)
27/10/2021 News and press releases: EMA working on COVID-19 during closure on 1 and 2 November 2021
27/10/2021 Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection; Kidney Transplantation, 09/10/1998, 26, Authorised
27/10/2021 Periodic safety update single assessment: 5 fluorouracil (i.v. application) - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000007-202012
27/10/2021 Periodic safety update single assessment: 5 fluorouracil (i.v. application) - List of nationally authorised medicinal products - PSUSA-00000007-202012
27/10/2021 Orphan designation: besilesomab for the: Treatment in haematopoietic stem cell transplantation, 17/10/2019, Positive
27/10/2021 Veterinary medicines European public assessment report (EPAR): Strangvac, Recombinant Streptococcus equi protein CCE, Recombinant Streptococcus equi protein Eq85, Recombinant Streptococcus equi protein IdeE, 16/08/2021, Authorised
27/10/2021 Orphan designation: (E)-2,4,6-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl-sulfone sodium salt (rigosertib sodium) for the: Treatment of myelodysplastic syndromes, 26/04/2012, Withdrawn
27/10/2021 EPAR - Product Information: Hefiya : EPAR - Product Information
27/10/2021 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease; Parkinson Disease; Dementia, 03/12/1998, 41, Authorised
27/10/2021 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202103
27/10/2021 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 7, Authorised
27/10/2021 Veterinary medicines European public assessment report (EPAR): Chanhold, selamectin, 17/04/2019, 2, Authorised
27/10/2021 EPAR - All authorised presentations: Simulect : EPAR - All Authorised presentations
26/10/2021 Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma, telmisartan, Hypertension, 03/10/2011, Generic, 10, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Toviaz, fesoterodine fumarate, Urinary Bladder, Overactive, 20/04/2007, 25, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Prevenar 13, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization, 09/12/2009, 42, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Xadago, safinamide methanesulfonate, Parkinson Disease, 23/02/2015, 12, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), Thalidomide, Multiple Myeloma, 16/04/2008, 29, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, 22/09/1998, 26, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial, 19/02/2015, 13, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Copalia, valsartan, amlodipine (as amlodipine besilate), Hypertension, 15/01/2007, 28, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 24, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections, 24/04/2006, 33, Authorised
26/10/2021 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products) - List of nationally authorised medicinal products - PSUSA-00010298-202103
26/10/2021 Periodic safety update single assessment: Hydroxyethyl starch - List of nationally authorised medicinal products - PSUSA-00001694-202103
26/10/2021 Human medicines European public assessment report (EPAR): Sildenafil Teva, sildenafil, Erectile Dysfunction, 30/11/2009, Generic, 16, Authorised
26/10/2021 Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan, acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction, 09/01/2020, Generic, 3, Authorised
26/10/2021 Periodic safety update single assessment: Intravenous iron: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/J/0026
26/10/2021 Periodic safety update single assessment: Intravenous iron: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0026
26/10/2021 Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 31, Authorised
26/10/2021 Herbal medicinal product: Species amarae, Combination: Species amarae, F: Assessment finalised
26/10/2021 Regulatory and procedural guideline: PRIME eligibility requests: 2022 deadlines for submission and timetable for assessment
26/10/2021 Periodic safety update single assessment: Amiodarone - List of nationally authorised medicinal products - PSUSA-00000166-202012
26/10/2021 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
26/10/2021 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the 27-30 September 2021 PRAC
26/10/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 27-30 September 2021 PRAC meeting
26/10/2021 Patient registries
26/10/2021 Guideline on registry-based studies
26/10/2021 Scientific guideline: Guideline on registry-based studies
26/10/2021 Opinion/decision on a Paediatric investigation plan (PIP): etranacogene dezaparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0517/2020
25/10/2021 News and press releases: Spikevax: EMA recommendation on booster
25/10/2021 Agenda: Agenda - PRAC draft agenda of meeting 25-28 October 2021
25/10/2021 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 28 January 2022
25/10/2021 News and press releases: COVID-19: EMA starts rolling review of molnupiravir
25/10/2021 Veterinary medicines European public assessment report (EPAR): Arti-Cell Forte, chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, 29/03/2019, 5, Authorised
25/10/2021 Veterinary medicines European public assessment report (EPAR): Clomicalm, clomipramine hydrochloride, 01/04/1998, 18, Authorised
25/10/2021 Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19 November 2021 , Online, from 19/11/2021 to 19/11/2021
25/10/2021 Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 25 October 2021 , Online, from 25/10/2021 to 25/10/2021
22/10/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2021
22/10/2021 Orphan designation: Ibrutinib for the: Treatment of lymphoplasmacytic lymphoma, 29/04/2014, Withdrawn
22/10/2021 Orphan designation: 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one (ibrutinib) for the: Treatment of mantle cell lymphoma, 12/03/2013, Withdrawn
21/10/2021 Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, 20/11/2018, 6, Authorised
21/10/2021 Data submission on investigational medicines: guidance for clinical trial sponsors
21/10/2021 Orphan designation: 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one (ibrutinib) for the: Treatment of chronic lymphocytic leukaemia, 26/04/2012, Withdrawn
21/10/2021 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 11-14 October 2021
21/10/2021 SPOR webinar: How to access and use the SPOR API , Online, 14:00-16:00 (CEST), from 10/11/2021 to 10/11/2021
21/10/2021 Procurement: Ex ante publicity of a negotiated procedure : EMA/2021/24/SG - Collective leadership development
20/10/2021 Veterinary medicines European public assessment report (EPAR): Locatim (previously Serinucoli), Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, 29/03/1999, 15, Authorised
20/10/2021 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 14, Authorised
20/10/2021 Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, 08/02/2019, Generic, 2, Authorised
20/10/2021 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin (as acetate), Candidiasis; Aspergillosis, 23/10/2001, 28, Authorised
20/10/2021 Human medicines European public assessment report (EPAR): Trepulmix, Treprostinil sodium, Hypertension, Pulmonary, 03/04/2020, Orphan, 2, Authorised
20/10/2021 Other: Electronic submission of investigational medicinal product (IMP) data to the Extended EudraVigilance medicinal product dictionary (XEVMPD) - Frequently asked questions and answers (FAQs)
20/10/2021 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when
20/10/2021 What we publish on medicines and when
20/10/2021 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 18, Authorised
20/10/2021 Withdrawn application: Oportuzumab monatox DLRC Pharma Services, oportuzumab monatox, Date of withdrawal: 20/08/2021, Initial authorisation
19/10/2021 Other: Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA
19/10/2021 Other: Involvement of patients in scientific advice procedures at the European Medicines Agency
19/10/2021 Orphan designation: Palovarotene for the: Treatment of multiple osteochondromas, 27/06/2018, Withdrawn
19/10/2021 Orphan designation: Seletalisib for the: Treatment of activated phosphoinositide 3-kinase delta syndrome, 22/02/2018, Withdrawn
19/10/2021 Orphan designation: Rozanolixizumab for the: Treatment of immune thrombocytopenia, 11/01/2019, Positive
19/10/2021 Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary, 12/04/2006, Biosimilar, 19, Authorised
18/10/2021 Regulatory and procedural guideline: CHMP & EUnetHTA parallel Scientific Advice: Qualification of a Framework & Points to consider for method selection with methods for performing patient preference studies to inform regulatory & HTAbody medical product decision-making: Briefing document
18/10/2021 Newsletter: Clinical Trials Information System (CTIS) highlights - October 2021
18/10/2021 Veterinary medicines European public assessment report (EPAR): Halagon, halofuginone lactate, 13/12/2016, Generic, 4, Authorised
18/10/2021 News and press releases: EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18/10/2021 Human medicines European public assessment report (EPAR): Somavert, Pegvisomant, Acromegaly, 12/11/2002, 26, Authorised
18/10/2021 Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, 25/09/2006, 37, Authorised
18/10/2021 Other: Release notes - production release version 01.04.03 October 2021 - Veterinary Medicinal Products Regulation: Union Product Database
18/10/2021 News and press releases: New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer
18/10/2021 Human medicines European public assessment report (EPAR): Inductos, dibotermin alfa, Tibial Fractures; Fracture Fixation, Internal; Spinal Fusion, 09/09/2002, 23, Authorised
18/10/2021 Veterinary medicines European public assessment report (EPAR): Ingelvac CircoFLEX, porcine circovirus type 2 ORF2 protein, 13/02/2008, 16, Authorised
18/10/2021 Referrals document: Etifoxine-containing medicinal products Article-31 referral - Timetable for the procedure
18/10/2021 CHMP opinions on consultation procedures
18/10/2021 Veterinary medicines European public assessment report (EPAR): Evicto, selamectin, 19/07/2019, Generic, 1, Authorised
18/10/2021 EMA regular press briefing on COVID-19 , Online, from 21/10/2021 to 21/10/2021
18/10/2021 Veterinary medicines European public assessment report (EPAR): Easotic, gentamicin sulfate, hydrocortisone aceponate, miconazole nitrate, 19/11/2008, 10, Authorised
18/10/2021 Orphan designation: idursulfase for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 06/01/2021, Positive
18/10/2021 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 12, Authorised
18/10/2021 Veterinary product information templates
18/10/2021 Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, Generic, 13, Authorised
15/10/2021 Human medicines European public assessment report (EPAR): Ilaris, Canakinumab, Cryopyrin-Associated Periodic Syndromes; Arthritis, Juvenile Rheumatoid; Arthritis, Gouty, 23/10/2009, 26, Authorised
15/10/2021 Human medicines European public assessment report (EPAR): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell, 14/12/2020, Orphan, Additional monitoring, Conditional approval, 1, Authorised
15/10/2021 Other: PRAC rules of procedure
15/10/2021 Scientific guideline: Draft guideline on injection site residue - Revision 1
15/10/2021 Regulatory and procedural guideline: PDCO rules of procedure
15/10/2021 Scientific guideline: Draft guideline on determination of withdrawal periods for milk - Revision 1
15/10/2021 Scientific guideline: Draft guideline on determination of withdrawal periods for edible tissues - Revision 2
15/10/2021 Use of macrolides, lincosamides and streptogramins in food-producing animals in the European Union: development of resistance and impact on human and animal health
15/10/2021 Scientific guideline: Concept paper on an update to the CVMP’s reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health
15/10/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
15/10/2021 News and press releases: First-in-class medicine to treat aggressive form of breast cancer
15/10/2021 Annex to CHMP highlights: Start of Union reviews adopted during the CHMP meeting of 11-14 October 2021
15/10/2021 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 11-14 October 2021
15/10/2021 Annex to CHMP highlights: Overview of (invented) names reviewed in September 2021 by the Name Review Group (NRG) adopted at the CHMP meeting of 11-14 October 2021
15/10/2021 Scientific guideline: Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6
15/10/2021 Scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6
15/10/2021 Regulatory and procedural guideline: Draft qualification opinion on IMI PREFER
15/10/2021 Regulatory and procedural guideline: HMPC rules of procedure
15/10/2021 Minutes: Minutes of the CVMP meeting of 7-9 September 2021
15/10/2021 Report: Medicinal products for human use: monthly figures - September 2021
15/10/2021 Scientific guideline: Draft reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products
14/10/2021 Regulatory and procedural guideline: ICH guideline E8 (R1) on general considerations for clinical studies
14/10/2021 COVID-19 treatments
14/10/2021 Other: Records of data processing activity for Clinical data publication website
14/10/2021 News and press releases: EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14/10/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: October 2021
14/10/2021 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 29, Authorised
14/10/2021 Periodic safety update single assessment: Human coagulation factor VIII (inhibitor bypassing fraction) : List of nationally authorised medicinal products - PSUSA /00009174/202102
14/10/2021 Agenda: Agenda - Info day for micro, small and medium-sized enterprises (SMEs): EMA support for SMEs under the new Veterinary Medicinal Products Regulation
14/10/2021 Other: Tailored Scientific advice to support step-by-step development of new biosimilars
14/10/2021 Report: Tailored Scientific Advice for biosimilar development: report on the experience from the pilot (2017-2020)
14/10/2021 Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer, 27/08/2007, 18/06/2009, Biosimilar, 22, Authorised
13/10/2021 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 24, Authorised
13/10/2021 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, 25, Authorised
13/10/2021 Human medicines European public assessment report (EPAR): Shingrix, Recombinant varicella zoster virus glycoprotein E, Herpes Zoster, 21/03/2018, Additional monitoring, 7, Authorised
13/10/2021 Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein, anti-CD7 mAb (WT1)-ricin A chain fusion protein for the: Treatment of graft-versus-host disease, 26/08/2005, Positive
13/10/2021 Veterinary medicines European public assessment report (EPAR): HorStem, equine umbilical cord mesenchymal stem cells, 19/06/2019, 3, Authorised
13/10/2021 Orphan designation: Recombinant human alpha 1 chain homotrimer of type VII collagen for the: Treatment of epidermolysis bullosa, 04/06/2014, Positive
13/10/2021 Orphan designation: Recombinant human arylsulfatase A for the: treatment of metachromatic leukodystrophy, 26/11/2010, Positive
13/10/2021 Periodic safety update single assessment: Propafenone : List of nationally authorised medicinal products : PSUSA/00002550/202101
13/10/2021 Periodic safety update single assessment: Cilazapril, cilazapril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000749/202102
13/10/2021 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 10, Authorised
13/10/2021 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 21, Authorised
13/10/2021 Orphan designation: Zanidatamab for the: Treatment of gastric cancer, 13/11/2020, Positive
13/10/2021 Orphan designation: Tranilast for the: Prevention of scarring post glaucoma filtration surgery, 27/07/2010, Positive
13/10/2021 Orphan designation: Recombinant human hepatocarcinoma-intestine-pancreas, pancreatic associated protein for the: Treatment of acute liver failure, 11/02/2009, Positive
13/10/2021 Orphan designation: Carbetocin for the: Treatment of Prader-Willi syndrome, 21/03/2012, Positive
13/10/2021 Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding, Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/10/2021
13/10/2021 Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells for the: Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive
13/10/2021 Orphan designation: Myriocin for the: Treatment of retinitis pigmentosa, 12/02/2015, Positive
13/10/2021 Orphan designation: (E)-(6-((N-methyl-((3-methylbenzofuran-2-yl)methyl)amino)-3-oxoprop-1-en-1-yl)-2-oxo-3,4-dihydro-1,8-naphthyridin-1(2H)-yl)methyl phosphate, bis ethanolamine salt (afabicin) for the: Treatment of osteomyelitis, 14/10/2016, Positive
13/10/2021 Orphan designation: Itraconazole for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive
13/10/2021 Orphan designation: 225Ac-lintuzumab for the: Treatment of acute myeloid leukaemia, 22/05/2017, Positive
13/10/2021 Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for the: Treatment in haematopoietic stem cell transplantation, 14/10/2016, Positive
13/10/2021 Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells for the: Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive
13/10/2021 Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE), Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 13/10/2021
13/10/2021 Orphan designation: Mavorixafor for the: Treatment of WHIM syndrome, 25/07/2019, Positive
13/10/2021 Orphan designation: N-((R)-2,3-dihydroxypropoxyl)-3,4-difluro-2-(2-fluoro-4-iodo-phenylamino)-benzamide for the: Treatment of neurofibromatosis type 1, 25/07/2019, Positive
13/10/2021 Orphan designation: Tazemetostat for the: Treatment of malignant mesothelioma, 21/03/2018, Positive
13/10/2021 Orphan designation: Nirogacestat for the: Treatment of soft tissue sarcoma, 17/10/2019, Positive
13/10/2021 Orphan designation: Tazemetostat for the: Treatment of follicular lymphoma, 21/03/2018, Positive
13/10/2021 Orphan designation: Tazemetostat for the: Treatment of diffuse large B-cell lymphoma, 21/03/2018, Positive
13/10/2021 Orphan designation: Pamrevlumab for the: Treatment of Duchenne muscular dystrophy, 16/12/2019, Positive
12/10/2021 Regulatory and procedural guideline: COMP rules of procedure
12/10/2021 Other: CHMP rules of procedure
12/10/2021 Regulatory and procedural guideline: CAT rules of procedure
12/10/2021 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0345/2019
12/10/2021 Orphan designation: Setmelanotide for the: Treatment of Prader-Willi syndrome, 27/06/2016, Positive
12/10/2021 Orphan designation: Setmelanotide for the: Treatment of Alström syndrome, 09/01/2020, Positive
12/10/2021 Orphan designation: Setmelanotide for the: Treatment of Bardet-Biedl syndrome, 21/08/2019, Positive
12/10/2021 Orphan designation: Setmelanotide for the: Treatment of leptin receptor deficiency, 19/11/2018, Positive
12/10/2021 Orphan designation: Setmelanotide for the: Treatment of pro-opiomelanocortin deficiency, 14/07/2016, Positive
12/10/2021 Orphan designation: Venglustat for the: Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Withdrawn
12/10/2021 Withdrawal letter: Withdrawal letter: CureVac’s COVID-19 vaccine (CVnCoV)
12/10/2021 Medicine QA: Questions and answers on end of rolling review for CureVac’s COVID-19 vaccine (CVnCoV)
12/10/2021 News and press releases: EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
12/10/2021 Agenda: Agenda - PDCO agenda of the 12-15 October 2021 meeting
12/10/2021 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, 24, Authorised
12/10/2021 Veterinary medicines European public assessment report (EPAR): Fatrovax RHD, Rabbit hemorrhagic disease virus 2 VP1AB, Rabbit hemorrhagic disease virus VP1A, 16/08/2021, Authorised
12/10/2021 Orphan designation: Sulindac for the: Treatment of fragile X syndrome, 09/12/2020, Positive
12/10/2021 Other: Letter of support for International Niemann-Pick Disease Registry (INPDR)
12/10/2021 News and press releases: A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19
11/10/2021 Agenda: Agenda - CHMP agenda of the 11-14 October 2021 meeting
11/10/2021 Extended EudraVigilance medicinal product dictionary (XEVMPD) training
11/10/2021 Other: Decision of the Management Board on amending budget No. 01, amending appropriations in budget 2021
11/10/2021 Report: Outcome of written procedures finalised during the period from 26 May 2021 to 13 September 2021
11/10/2021 Other: Summary of transfers of appropriations in budget 2021 - Management Board meeting of 7 October 2021
11/10/2021 Report: European Medicines Agency mid-year report 2021 (January-June 2021)
11/10/2021 Other: Step-by-step guide : Assess an annual safety report - CTIS Training Programme - Module 20
11/10/2021 Other: Instructor's guide: Assess an annual safety report - CTIS Training Programme - Module 20
11/10/2021 Other: FAQs: Assess an annual safety report - CTIS Training Programme - Module 20
11/10/2021 Other: Crossword puzzle: How to assess an annual safety report - CTIS Training Programme - Module 20
11/10/2021 Other: Revised rules of procedure of the Management Board
11/10/2021 Human medicines European public assessment report (EPAR): Besremi, ropeginterferon alfa-2b, Polycythemia Vera, 15/02/2019, Additional monitoring, 2, Authorised
11/10/2021 Human medicines European public assessment report (EPAR): Qutenza, capsaicin, Neuralgia, 15/05/2009, 16, Authorised
11/10/2021 Human medicines European public assessment report (EPAR): Cialis, tadalafil, Erectile Dysfunction, 12/11/2002, 30, Authorised
11/10/2021 News and press releases: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
11/10/2021 Human medicines European public assessment report (EPAR): Zoledronic acid Teva, zoledronic acid, Fractures, Bone; Cancer, 16/08/2012, Generic, 14, Authorised
11/10/2021 Other: Clinical Trial Information System (CTIS) - Sponsor user personas
11/10/2021 Referral: Zynteglo , betibeglogene autotemcel, Article 20 procedures, European Commission final decision, 22/07/2021, 16/09/2021, 11/10/2021
11/10/2021 Template or form: Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified
11/10/2021 Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal, 15/04/2005, 29, Authorised
11/10/2021 Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, Additional monitoring, 5, Authorised
11/10/2021 Paediatric investigation plans: questions and answers
08/10/2021 Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan anhydrous free-base, Pancreatic Neoplasms, 14/10/2016, Orphan, 10, Authorised
08/10/2021 Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial, 19/01/2006, 36, Authorised
08/10/2021 Human medicines European public assessment report (EPAR): DuoTrav, travoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension, 23/04/2006, 18, Authorised
08/10/2021 Human medicines European public assessment report (EPAR): Dectova, Zanamivir, Influenza, Human, 26/04/2019, Additional monitoring, 4, Authorised
08/10/2021 Agenda: Agenda - PDCO agenda of the 22-25 June 2021 meeting