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31/03/2022 Periodic safety update single assessment: Rabbit anti-human T-lymphocyte immunoglobulin : List of nationally authorised medicinal products - PSUSA/00010252/202106
31/03/2022 Academia
31/03/2022 News and press releases: EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31/03/2022 Cancer Medicines Forum: kick-off meeting , Online, 08:30 - 12:30 Amsterdam time (CEST), from 31/03/2022 to 31/03/2022
31/03/2022 Periodic safety update single assessment: Goserelin : List of nationally authorised medicinal products - PSUSA/00001562/202105
31/03/2022 Periodic safety update single assessment: Nimesulide (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00009236/202106
31/03/2022 Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Multiple Myeloma, 20/09/2018, Generic, 9, Authorised
30/03/2022 News and press releases: Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
30/03/2022 Human medicines European public assessment report (EPAR): Tractocile, atosiban (as acetate), Premature Birth, 20/01/2000, 24, Authorised
30/03/2022 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 21-24 March 2022
30/03/2022 Regulatory and procedural guideline: Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2022/2023
30/03/2022 Orphan designation: Adeno-associated virus serotype 9 expressing the cDNA for human MECP2 for the: Treatment of Rett syndrome, 20/05/2021, Withdrawn
29/03/2022 Work programme: HMPC work plan 2022
29/03/2022 Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial, 11/01/2008, 22, Authorised
29/03/2022 News and press releases: EU recommendations for 2022-2023 seasonal flu vaccine composition
29/03/2022 Withdrawn application: Bravecto, fluralaner, Date of withdrawal: 03/08/2021, Post-authorisation
29/03/2022 Scientific guideline: ICH guideline E14/S7B: clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - questions and answers - Step 5
29/03/2022 News and press releases: EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
29/03/2022 Regulatory and procedural guideline: User guide on how to generate PDF versions of the product information - veterinary
29/03/2022 Veterinary medicines European public assessment report (EPAR): Purevax RC, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), 23/02/2005, 16, Authorised
29/03/2022 Agenda: Agenda of the HMPC meeting 28-30 March 2022
29/03/2022 Template or form: Veterinary signal assessment report for marketing authorisation holders
29/03/2022 Report: COMP meeting report on the review of applications for orphan designation: March 2022
28/03/2022 Human medicines European public assessment report (EPAR): Temomedac, temozolomide, Glioma; Glioblastoma, 25/01/2010, Generic, 15, Authorised
28/03/2022 Human medicines European public assessment report (EPAR): Rivaroxaban Accord, rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism, 16/11/2020, Generic, 2, Authorised
28/03/2022 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - May 2022 , Online, 09:00 - 13:00 Amsterdam time (CEST) , from 05/05/2022 to 06/05/2022
28/03/2022 Fifth Nitrosamine Implementation Oversight Group (NIOG) meeting , Online, from 07/03/2022 to 07/03/2022
28/03/2022 Newsletter: CTIS newsflash - 25 March 2022
28/03/2022 Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 02/09/1999, 39, Authorised
28/03/2022 Human medicines European public assessment report (EPAR): Rekovelle, follitropin delta, Anovulation, 12/12/2016, 5, Authorised
25/03/2022 Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Multiple Myeloma, 20/07/2015, Generic, 13, Authorised
25/03/2022 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms; Sarcoma, 17/09/2007, 27, Authorised
25/03/2022 News and press releases: New gene therapy to treat adult patients with multiple myeloma
25/03/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
25/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pevonedistat, PM: decision on the application for modification of an agreed PIP, P/0357/2021
25/03/2022 Herbal medicinal product: Urticae folium, Urticae folium, F: Assessment finalised
25/03/2022 Other: FAQs: How to respond to Requests for Information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11
25/03/2022 Other: FAQs: How to manage a CT - CTIS Training Programme - Module 05
25/03/2022 Template or form: Template - Innovation Task Force briefing meeting report
25/03/2022 Template or form: Template - Innovation Task Force briefing document
25/03/2022 Other: Applying for an Innovation Task Force Briefing Meeting (ITF BM) - Step-by-step guide and FAQ
25/03/2022 Report: Medicinal products for human use: monthly figures - February 2022
25/03/2022 Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva, lamivudine, zidovudine, HIV Infections, 28/02/2011, Generic, 16, Authorised
25/03/2022 Interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products - Scientific guideline
25/03/2022 Scientific guideline: Concept paper on the elaboration of guidance for the application of Article 34 of Regulation (EU) 2019/6
25/03/2022 Injection-site residues - Scientific guideline
25/03/2022 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Scientific guideline
25/03/2022 Determination of withdrawal periods for milk - Scientific guideline
25/03/2022 Approach towards harmonisation of withdrawal periods for edible tissues - Scientific guideline
25/03/2022 Minutes: Minutes of the CVMP meeting of 15-16 February 2022
24/03/2022 Minutes: CHMP PROM minutes for the meeting on 14 February 2022
24/03/2022 Agenda: CHMP PROM agenda for the meeting on 14 February 2022
24/03/2022 News and press releases: EMA recommends authorisation of COVID-19 medicine Evusheld
24/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, PM: decision on the application for modification of an agreed PIP, P/0003/2019
24/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Venglustat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0505/2020
24/03/2022 ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline
24/03/2022 ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers - Scientific guideline
24/03/2022 Minutes: Minutes - PDCO minutes of the 14-17 December 2021 meeting
24/03/2022 Minutes: Minutes of the CAT meeting 8-10 December 2021
24/03/2022 Minutes: Minutes of the PRAC meeting 3-6 May 2021
24/03/2022 Orphan designation: Dantrolene sodium, hemiheptahydrate for the: Treatment of malignant hyperthermia, 20/05/2021, Positive
24/03/2022 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 5, Authorised
23/03/2022 Human medicines European public assessment report (EPAR): Kerendia, Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2, 16/02/2022, Additional monitoring, Authorised
23/03/2022 Other: European Medicines Agency's data protection notice concerning the VMP-Reg stakeholders meetings
23/03/2022 Human medicines European public assessment report (EPAR): Ameluz, 5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell, 13/12/2011, 19, Authorised
23/03/2022 Report: Applications for new human medicines under evaluation by the CHMP: February 2022
23/03/2022 Report: Applications for new human medicines under evaluation by the CHMP: March 2022
22/03/2022 Other: Step-by-step guide: How to evaluate a substantial modification clinical trial application - CTIS Training Programme - Module 8
22/03/2022 Other: Draft qualification opinion for prognostic covariate adjustment (PROCOVA™)
22/03/2022 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 15, Authorised
22/03/2022 Agenda: Agenda of the PDCO meeting 22-25 March 2022
22/03/2022 Minutes: Minutes - PDCO minutes of the 9-12 November 2021 meeting
22/03/2022 Minutes: Minutes of the COMP meeting on 18-20 January 2022
22/03/2022 Union Product Database: follow up webinar for marketing authorisation holders , Online, 15:00 - 16:30 Amsterdam time (CET), from 25/01/2022 to 25/01/2022
22/03/2022 Other: Response to 2nd list of issues
22/03/2022 Other: Response to list of issues
22/03/2022 Other: PROCOVA™ handbook
22/03/2022 Other: Briefing book
22/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Brensocatib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0403/2021
22/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): crisantaspase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0453/2021
21/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Clazakizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0029/2014
21/03/2022 Newsletter: CTIS newsflash - 18 March 2022
21/03/2022 Orphan designation: Veledimex for the: Treatment of glioma, 21/08/2019, Withdrawn
21/03/2022 Orphan designation: Adenoviral vector serotype 5 encoding the human interleukin-12 p70 transgene under the control of activator ligand veledimex for the: Treatment of glioma, 21/08/2019, Withdrawn
21/03/2022 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 17, Authorised
21/03/2022 Other: Example files - production release version 1.6.1 March 2022 - Veterinary Medicinal Products Regulation: Union Product Database
21/03/2022 Other: Release notes - production release version 1.6.1 March 2022 - Veterinary Medicinal Products Regulation: Union Product Database
21/03/2022 Veterinary medicines European public assessment report (EPAR): Respiporc FLUpan H1N1, Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, 17/05/2017, 6, Authorised
21/03/2022 Human medicines European public assessment report (EPAR): NovoThirteen, catridecacog, Blood Coagulation Disorders, Inherited, 03/09/2012, 7, Authorised
21/03/2022 Fourth European Medicines Agency and European Federation of Pharmaceutical Industries and Associations annual bilateral meeting , Online, from 21/03/2022 to 21/03/2022
21/03/2022 Agenda: Agenda of the CHMP meeting 21-24 March 2022
21/03/2022 Minutes: Minutes of the PRAC meeting 6-9 April 2021
21/03/2022 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma; Glioblastoma, 15/03/2010, Generic, 22, Authorised
21/03/2022 Template or form: Template to be used to notify the European Medicines Agency and concerned Member States of 'withdrawn products'
18/03/2022 Report: European Medicines Agency annual report on independence - 2021
18/03/2022 Report: Minor uses and minor species (MUMS)/limited market scheme for veterinary medicinal products - 12th annual report
18/03/2022 Agenda: Agenda for the 115th meeting of the Management Board: 16-17 March 2022
18/03/2022 Orphan designation: Adeno-associated viral vector serotype 5 expressing the human Cone-Rod Homeobox gene for the: Treatment of Leber's congenital amaurosis, 20/05/2021, Positive
18/03/2022 Orphan designation: Autologous mobilised peripheral blood-derived CD34+ cells transduced ex vivo with a self-inactivating lentiviral vector containing a normal version of the coding region of the IL2RG gene for the: Treatment of X-linked severe combined immunodeficiency, 20/05/2021, Positive
18/03/2022 News and press releases: EMA Management Board: highlights of March 2022 meeting
18/03/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 2022
18/03/2022 Summary of opinion: Advocate, imidacloprid, moxidectin, 16/03/2022, Positive
18/03/2022 Orphan designation: melatonin for the: Treatment of retinitis pigmentosa, 20/05/2021, Positive
18/03/2022 Type-IA variations: questions and answers
18/03/2022 Worksharing: questions and answers
18/03/2022 Type-IB variations: questions and answers
18/03/2022 Template or form: GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)
18/03/2022 Orphan designation: Synthetic 2′-O-(2-methoxyethyl)-modified antisense oligonucleotide linked to a triantennary cluster of N-acetyl galactosamine sugars targeting transmembrane protease, serine 6 mRNA for the: Treatment of beta thalassaemia intermedia and major, 20/05/2021, Positive
18/03/2022 Orphan designation: Ribonucleotide reductase R2 specific phosphorothioate oligonucleotide for the: Treatment of acute myeloid leukaemia, 08/05/2008, Positive
18/03/2022 Orphan designation: Recombinant human surfactant protein D for the: Prevention of bronchopulmonary dysplasia, 11/04/2014, Positive
18/03/2022 Orphan designation: N-terminal hexaglutamine-tagged recombinant human N-acetylgalactosamine-6-sulfate sulfatase for the: Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 27/02/2009, Positive
18/03/2022 Orphan designation: Bovine bile extract for the: Treatment of pancreatic cancer, 20/06/2005, Positive
18/03/2022 Orphan designation: mifepristone for the: Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin, 27/10/2011, Positive
18/03/2022 Orphan designation: Trabedersen for the: Treatment of pancreatic cancer, 24/07/2009, Positive
18/03/2022 Orphan designation: TGF-ß2-specific phosphorothioate antisense oligodeoxynucleotide for the: Treatment of high-grade glioma, 22/03/2002, Positive
18/03/2022 Orphan designation: Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Gly-Gly-Asp-Leu-Leu-Pro-Arg-Gly-Ser for the: Treatment of Huntington’s disease, 18/11/2016, Positive
18/03/2022 Orphan designation: 2-(2-phenylvinyl)-4-[4- methylpiperazin-1-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt for the: Treatment of hepatocellular carcinoma, 10/08/2015, Positive
18/03/2022 Orphan designation: carboplatin, Sodium valproate for the: Treatment of glioma, 31/07/2018, Positive
18/03/2022 Orphan designation: Live attenuated Listeria monocytogenes transfected with plasmids encoding the HPV-16E7 protein fused to a truncated fragment of the Lm protein listeriolysin O for the: Treatment of anal cancer, 11/01/2016, Positive
18/03/2022 Orphan designation: Trehalose for the: Treatment of amyotrophic lateral sclerosis, 20/05/2021, Positive
18/03/2022 Orphan designation: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one for the: Treatment of hyperphenylalaninemia, 20/05/2021, Positive
18/03/2022 Orphan designation: 6-Amino-5-chloro-N-((1R)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide for the: Treatment of glioma, 20/05/2021, Positive
18/03/2022 Orphan designation: Adeno-associated viral vector serotype 2.5T encoding the human cystic fibrosis transmembrane conductance regulator with a partial deletion in the R domain for the: Treatment of cystic fibrosis, 20/05/2021, Positive
18/03/2022 Orphan designation: Ponatinib hydrochloride for the: Treatment of gastrointestinal stromal tumours, 15/01/2015, Withdrawn
17/03/2022 Human medicines European public assessment report (EPAR): Integrilin, eptifibatide, Angina, Unstable; Myocardial Infarction, 01/07/1999, 26, Authorised
17/03/2022 Orphan designation: C1 esterase inhibitor (human) for the: Treatment in solid organ transplantation, 14/12/2018, Positive
17/03/2022 Other: Letter of support for Sjögren’s Tool for Assessing Response (STAR)
17/03/2022 Other: Letter of support for Sjögren’s Tool for Assessing Response (STAR)
17/03/2022 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 21/03/2014, 25, Authorised
17/03/2022 COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 17 March 2022
17/03/2022 Veterinary medicines European public assessment report (EPAR): Purevax FeLV, feline leukaemia virus recombinant canarypox virus (vCP97), 13/04/2000, 12, Authorised
17/03/2022 Orphan designation: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (voxelotor) for the: Treatment of sickle cell disease, 18/11/2016, Positive
17/03/2022 Seventh industry stakeholder platform on research and development support , Online, from 23/11/2021 to 23/11/2021
17/03/2022 Supply shortage: Zerbaxa (ceftolozane / tazobactam) supply shortage
17/03/2022 Human medicines European public assessment report (EPAR): Temozolomide Sun, temozolomide, Glioma; Glioblastoma, 13/07/2011, Generic, 19, Authorised
17/03/2022 News and press releases: EMA Management Board elects Lorraine Nolan as chair
17/03/2022 Orphan designation: 2-[4-[3-(methylamino)-1-phenylpropoxy]phenyl]ethanol hydrochloride for the: Treatment of fragile X syndrome, 20/05/2021, Positive
17/03/2022 Orphan designation: Human IgG1 monoclonal antibody against alpha-synuclein for the: Treatment of multiple system atrophy, 20/05/2021, Positive
17/03/2022 Orphan designation: Elamipretide for the: Treatment of Barth syndrome, 20/05/2021, Positive
17/03/2022 Orphan designation: Eflornithine for the: Treatment of neuroblastoma, 20/05/2021, Positive
16/03/2022 Periodic safety update single assessment: Lovastatin : List of nationally authorised medicinal products - PSUSA/00010051/202107
16/03/2022 Agenda: Agenda of the COMP meeting 15-17 March 2022
16/03/2022 Agenda: Agenda of the CAT meeting 16-18 March 2022
16/03/2022 Periodic safety update single assessment: Calcifediol : List of nationally authorised medicinal products - PSUSA/00000491/202106
16/03/2022 Minutes: Minutes of the CHMP meeting 24-27 January 2022
16/03/2022 Work programme: PRAC work plan 2022
16/03/2022 Periodic safety update single assessment: Fluticasone propionate / formoterol fumarate dihydrate : List of nationally authorised medicinal products - PSUSA/00010339/202107
16/03/2022 Herbal medicinal product: Fucus, Fucus, F: Assessment finalised
16/03/2022 Herbal medicinal product: Cucurbitae semen, Cucurbitae semen, F: Assessment finalised
16/03/2022 Herbal medicinal product: Fraxini folium, Fraxini folium, F: Assessment finalised
16/03/2022 Herbal medicinal product: Eucalypti folium, Eucalypti folium, F: Assessment finalised
16/03/2022 Herbal medicinal product: Grindeliae herba, Grindeliae herba, F: Assessment finalised
16/03/2022 Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 28/06/2017, Orphan, 9, Authorised
16/03/2022 Periodic safety update single assessment: Budesonide / salmeterol : List of nationally authorised medicinal products - PSUSA/00010511/202107
16/03/2022 Orphan designation: Macitentan for the: Treatment of functional single ventricle congenital heart disease, 20/05/2021, Positive
16/03/2022 Orphan designation: begelomab for the: Treatment of dermatomyositis, 20/05/2021, Positive
16/03/2022 Periodic safety update single assessment: Glibenclamide / metformin hydrochloride : List of nationally authorised medicinal products - PSUSA/00002002/202106
16/03/2022 Periodic safety update single assessment: Alprostadil (patency of the ductus arteriosus) : List of nationally authorised medicinal products - PSUSA/00010021/202107
16/03/2022 Periodic safety update single assessment: Alprostadil (erectile dysfunction) : List of nationally authorised medicinal products - PSUSA/00000110/202101
16/03/2022 Periodic safety update single assessment: Misoprostol (gynaecological indication - labour induction) : List of nationally authorised medicinal products - PSUSA/00010353/202105
16/03/2022 Periodic safety update single assessment: Propranolol (except for centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00010251/202106
16/03/2022 Periodic safety update single assessment: Calcitonin salmon, synthetic analogue of eel calcitonin : List of nationally authorised medicinal products - PSUSA/00000494/202106
16/03/2022 Periodic safety update single assessment: Pamidronate : List of nationally authorised medicinal products - PSUSA/00002269/202105
16/03/2022 Periodic safety update single assessment: Nitrendipine : List of nationally authorised medicinal products - PSUSA/00002171/202103
15/03/2022 Periodic safety update single assessment: Tianeptine : List of nationally authorised medicinal products - PSUSA/00002943/202106
15/03/2022 Human medicines European public assessment report (EPAR): Mirvaso, brimonidine tartrate, Skin Diseases, 20/02/2014, 11, Authorised
15/03/2022 Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Breast Neoplasms, 06/05/2019, Generic, 7, Authorised
15/03/2022 Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.6 Corr
15/03/2022 Veterinary medicines European public assessment report (EPAR): Zenalpha, medetomidine hydrochloride, vatinoxan hydrochloride, 15/12/2021, Authorised
15/03/2022 Agenda: Agenda of the CVMP meeting 15-17 March 2022
15/03/2022 Herbal - HMPC assessment report: Addendum to Assessment report on Levisticum officinale W.D.J. Koch, radix
15/03/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Ononidis radix - Revision 1
15/03/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Myrtilli fructus siccus - Revision 1
15/03/2022 Herbal medicinal product: Ononidis radix, Ononidis radix, F: Assessment finalised
15/03/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Melaleucae aetheroleum - Revision 1
15/03/2022 Report: Big Data Steering Group (BDSG): 2021 report
15/03/2022 Other: Instructor's guide: Management roles and permissions - CTIS Training Programme - Module 07
15/03/2022 Herbal medicinal product: Pruni africanae cortex, Pruni africanae cortex, F: Assessment finalised
15/03/2022 Herbal medicinal product: Origani majoranae herba, Origani majoranae herba, F: Assessment finalised
15/03/2022 Herbal medicinal product: Pilosellae herba cum radice, Pilosellae herba cum radice, F: Assessment finalised
15/03/2022 Herbal medicinal product: Polygoni avicularis herba, Polygoni avicularis herba, F: Assessment finalised
15/03/2022 Periodic safety update single assessment: Ethinylestradiol / gestodene : List of nationally authorised medicinal products - PSUSA/00001308/202103
15/03/2022 Periodic safety update single assessment: Alendronate : List of nationally authorised medicinal products - PSUSA/00000078/202101
14/03/2022 Periodic safety update single assessment: Lactulose : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001821/202105
14/03/2022 Periodic safety update single assessment: Lactulose : List of nationally authorised medicinal products - PSUSA/00001821/202105
14/03/2022 Periodic safety update single assessment: Pholcodine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002396/202105
14/03/2022 Periodic safety update single assessment: Pholcodine : List of nationally authorised medicinal products - PSUSA/00002396/202105
14/03/2022 Newsletter: CTIS newsflash - 11 March 2022
14/03/2022 Periodic safety update single assessment: Montelukast : List of nationally authorised medicinal products - PSUSA/00002087/202107
14/03/2022 Periodic safety update single assessment: Timolol (eye preparations) : List of nationally authorised medicinal products - PSUSA/00010439/202107
14/03/2022 Periodic safety update single assessment: magnesium sulphate sodium sulphate potassium sulphate : List of nationally authorised medicinal products - PSUSA 00010239202108
14/03/2022 Periodic safety update single assessment: fluocinolone acetonide (intravitreal implant in applicator) : List of nationally authorised medicinal products - PSUSA/00010224/202108
14/03/2022 Periodic safety update single assessment: Tiapride : List of nationally authorised medicinal products - PSUSA/00002944/202107
14/03/2022 Periodic safety update single assessment: Pilocarpine / timolol : List of nationally authorised medicinal products - PSUSA/00002408/202107
14/03/2022 Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Epilepsy, 21/04/2009, 31, Authorised
14/03/2022 Periodic safety update single assessment: Loperamide, loperamide / simeticone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/202105
14/03/2022 Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures
14/03/2022 Periodic safety update single assessment: Loperamide, loperamide / simeticone : List of nationally authorised medicinal products - PSUSA/00010665/202105
11/03/2022 Periodic safety update single assessment: Minoxidil (non-topical formulations) : List of nationally authorised medicinal products - PSUSA/00002066/202010
11/03/2022 Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Urinary Incontinence, Urge, 15/06/2004, 20, Authorised
11/03/2022 Transparency: exceptional measures for COVID-19 medicines
11/03/2022 Periodic safety update single assessment: Lisinopril, lisinopril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00010532/202009
11/03/2022 Paediatric Committee (PDCO): 12-15 October 2021 , Virtual meeting, from 12/10/2021 to 15/10/2021
11/03/2022 Minutes: Minutes - PDCO minutes of the 12-15 October 2021 meeting
11/03/2022 EMA regular press briefing on COVID-19 , Online, from 17/03/2022 to 17/03/2022
11/03/2022 Periodic safety update single assessment: Indium (In-111) chloride, indium (In-111) oxine : List of nationally authorised medicinal products - PSUSA/00001734/202107
11/03/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
11/03/2022 Periodic safety update single assessment: Levonorgestrel (all indications except emergency contraception) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010828/202105
11/03/2022 Periodic safety update single assessment: Levonorgestrel (all indications except emergency contraception) : List of nationally authorised medicinal products - PSUSA/00010828/202105
10/03/2022 Submission dates (veterinary medicines)
10/03/2022 Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous, 26/07/2018, Additional monitoring, Biosimilar, 9, Authorised
10/03/2022 Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, Generic, 2, Authorised
10/03/2022 Periodic safety update single assessment: Everolimus (indicated for rejection of transplanted organs) : List of nationally authorised medicinal products - PSUSA/00010269/202107
10/03/2022 Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt for the: Treatment of graft-versus-host disease, 17/10/2019, Positive
10/03/2022 Human medicines European public assessment report (EPAR): Trisenox, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 05/03/2002, 30, Authorised
10/03/2022 Assessment templates and guidance (veterinary medicines)
10/03/2022 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 52, Authorised
10/03/2022 Other: FAQs: How to search, view and download a Clinical Trial and a Clinical Trial Application (sponsors) - CTIS Training Programme - Module 09
10/03/2022 Other: Step-by-step guide: How to search, view and download a Clinical Trial and a Clinical Trial Application (sponsors) - CTIS Training Programme - Module 09
10/03/2022 Other: Quick guide: How to search, view and download a Clinical Trial and a Clinical Trial Application (sponsors) - CTIS Training Programme - Module 09
10/03/2022 Other: European Medicines Agency’s data protection notice for the processing of the contact points of scientific committees (CXMP) members/alternates’ for internal use by the same committees
09/03/2022 Veterinary medicines European public assessment report (EPAR): Felpreva, emodepside, praziquantel, Tigolaner, 11/11/2021, Authorised
09/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one (SAR442168), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0310/2020
09/03/2022 Other: Letter of support for Minimal Disease Activity Score (MDA) as primary outcome instrument for clinical studies in psoriatic arthritis (PsA)
09/03/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: Hands-on training course on using the EudraVigilance system , Online, 14:00 - 16:30 Amsterdam time (CEST), from 25/04/2022 to 29/04/2022
09/03/2022 Other: MedDRA Important medical event terms list - version 25.0
09/03/2022 Periodic safety update single assessment: Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103
08/03/2022 Minutes: Minutes of the COMP meeting on 7-9 December 2021
08/03/2022 Minutes: Minutes of the COMP meeting on 7-9 December 2021
08/03/2022 Herbal - HMPC assessment report: Addendum to assessment report on Cetraria islandica (L.) Acharius s.l., thallus - First version
08/03/2022 Committee meeting report: COMP meeting report on the review of applications for orphan designation: February 2022
08/03/2022 Human medicines European public assessment report (EPAR): Trydonis, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 26/04/2018, 4, Authorised
08/03/2022 Periodic safety update single assessment: Remifentanil : List of nationally authorised medicinal products - PSUSA/00002617/202105
08/03/2022 Other: Infographic: The Clinical Trials Regulation
08/03/2022 Other: Instructor's guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014 - CTIS Training Programme - Module 01
08/03/2022 Newsletter: CTIS newsflash - 4 March 2022
08/03/2022 Orphan designation: Heat-killed Mycobacterium obuense (whole cell) for the: Treatment of pancreatic cancer, 16/12/2014, Positive
08/03/2022 Orphan designation: Heat-killed Mycobacterium vaccae (whole cell) for the: Treatment of tuberculosis, 20/09/2010, Positive
07/03/2022 Work programme: COMP work plan 2022
07/03/2022 Opinion/decision on a Paediatric investigation plan (PIP): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (KHK4083), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0320/2021
07/03/2022 Direct healthcare professional communication (DHPC): Infliximab (Remicade, Flixabi, Inflectra, Remsima and Zessly): Use of live vaccines in infants exposed in utero or during breastfeeding, Active substance: infliximab, DHPC type: New contraindication, Last updated: 07/03/2022
07/03/2022 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (1 January - 31 December 2021)
07/03/2022 Agenda: Agenda of the PRAC meeting 7-10 March 2022
07/03/2022 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC
07/03/2022 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC meeting
07/03/2022 Newsletter: Human medicines highlights - March 2022
07/03/2022 Orphan designation: losartan for the: Treatment of epidermolysis bullosa, 26/02/2019, Positive
07/03/2022 Other: CAT work plan 2022
07/03/2022 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 20, Authorised
07/03/2022 Orphan designation: Alvocidib for the: Treatment of acute myeloid leukaemia, 12/02/2015, Positive