News & events

What's new

RSS
Mar 2020 (227) Apr 2020 (239) May 2020 (207) Jun 2020 (318) Jul 2020 (263) Aug 2020 (228) Sep 2020 (196) Oct 2020 (306) Nov 2020 (349) Dec 2020 (368) Jan 2021 (379) Feb 2021 (554) Mar 2021 (237)
Date Content
31/07/2020 Mosquirix H-W-2300
31/07/2020 Task Forces
31/07/2020 Human medicines European public assessment report (EPAR): Olazax, olanzapine, Schizophrenia, Bipolar Disorder, 11/12/2009, Generic, 12, Authorised
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, PM: decision on the application for modification of an agreed PIP, P/0086/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate, PM: decision on the application for modification of an agreed PIP, P/0121/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin, PM: decision on the application for modification of an agreed PIP, P/0078/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, PM: decision on the application for modification of an agreed PIP, P/0101/2020
31/07/2020 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh final position, 24/06/2020, 31/07/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel, PM: decision on the application for modification of an agreed PIP, P/0072/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Xgeva, denosumab, PM: decision on the application for modification of an agreed PIP, P/0102/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Verdiperstat, W: decision granting a waiver in all age groups for all conditions or indications, P/0110/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Eftilagimod alpha, W: decision granting a waiver in all age groups for all conditions or indications, P/0118/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Parsaclisib, W: decision granting a waiver in all age groups for all conditions or indications, P/0067/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zolbetuximab, W: decision granting a waiver in all age groups for all conditions or indications, P/0090/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Brolucizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0112/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one, W: decision granting a waiver in all age groups for all conditions or indications, P/0091/2020
31/07/2020 EPAR - Procedural steps taken and scientific information after authorisation: Olazax : EPAR - Procedural steps taken and scientific information after authorisation
31/07/2020 Human medicines European public assessment report (EPAR): Zurampic, lesinurad, Hyperuricemia, 18/02/2016, Additional monitoring, 4, Withdrawn
31/07/2020 Umbipro H-W-3799
31/07/2020 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 10, Authorised
31/07/2020 Administration and Corporate Management
31/07/2020 Other: Summary on compassionate use for Remdesivir Gilead
31/07/2020 Other: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Remdesivir Gilead available for compassionate use
31/07/2020 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, Patient safety, Additional monitoring, 10, Withdrawn
31/07/2020 News and press releases: Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
31/07/2020 News and press releases: Global regulatory workshop on COVID-19 real-world evidence and observational studies
31/07/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols)
31/07/2020 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 22, Authorised
31/07/2020 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 12, Authorised
30/07/2020 Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, Patient safety, 18, Authorised
30/07/2020 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 4, Authorised
30/07/2020 Herbal medicinal product: Filipendulae ulmariae herba, Filipendulae ulmariae herba, F: Assessment finalised
30/07/2020 Herbal medicinal product: Filipendulae ulmariae flos, Filipendulae ulmariae flos, F: Assessment finalised
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa, W: decision granting a waiver in all age groups for all conditions or indications, P/0068/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): ( 2S )-2-[ [ 2-[ ( 4S)-4-( difluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo [ 1,2- d] [ 1,4 ]benzoxazepin-9-yl]amino ]propanamide, W: decision granting a waiver in all age groups for all conditions or indications, P/0113/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract, W: decision granting a waiver in all age groups for all conditions or indications, P/0077/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0094/2020
30/07/2020 Human medicines European public assessment report (EPAR): Xeloda, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 02/02/2001, Patient safety, 25, Authorised
30/07/2020 Standard Operating Procedure - SOP: Standard operating procedure for processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95
29/07/2020 Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 13, Authorised
29/07/2020 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 21, Authorised
29/07/2020 Human medicines European public assessment report (EPAR): Tybost, cobicistat, HIV Infections, 19/09/2013, 13, Authorised
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Levothyroxine (sodium), W: decision granting a waiver in all age groups for all conditions or indications, P/0096/2018
29/07/2020 Template or form: Template for a public statement when no Community herbal monograph is established
29/07/2020 Template or form: Template for a public statement when no European Union herbal monograph is established
29/07/2020 Template or form: Template for a European Union list entry
29/07/2020 Template or form: Template for a European Union list entry
29/07/2020 Template or form: Template for submission of comments on draft European Union herbal monograph or draft European Union list entry
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/073/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Efgartigimod alfa, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0097/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+enriched cells from patients with Fanconi anaemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene (PGK-FANCA-WPRE), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0114/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0115/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): cenobamate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0120/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding for the human Beta 2 Integrin/CD18 gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0106/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0098/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 1-[ 4-bromo-5-[ 1-ethyl-7-( methylamino )-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl ]-2-fluorophenyl]-3-, W: decision granting a waiver in all age groups for all conditions or indications, P/0122/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ladarixin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0124/2020
29/07/2020 Orphan designation: cholic acid for the: Treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid, 29/10/2009, Withdrawn
29/07/2020 Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 19, Authorised
29/07/2020 Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid for the: Treatment of dermatomyositis, Positive
28/07/2020 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201910
28/07/2020 Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
28/07/2020 Herbal medicinal product: Rhamni purshianae cortex, Rhamni purshianae cortex, F: Assessment finalised
28/07/2020 Agenda: Agenda - PDCO agenda of the 21-24 July 2020 meeting
28/07/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 July 2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Mosunetuzumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0108/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Timrepigene emparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0085/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): avapritinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0083/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Gefapixant (citrate salt), W: decision granting a waiver in all age groups for all conditions or indications, P/0100/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions or indications, P/0079/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0116/2020
28/07/2020 Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
28/07/2020 Minutes: Minutes of the PRAC meeting 10-13 February 2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+progenitor cells (CF),Allogeneic, non-expanded, umbilical cord blood-derived, haematopoietic mature myeloid and lymphoid cells (NF), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0099/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0119/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2020
28/07/2020 Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride) for the: Treatment of Huntington’s disease, 20/06/2005, Positive
28/07/2020 Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections, 23/04/2020, Additional monitoring, 1, Authorised
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0096/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0123/2020
27/07/2020 Periodic safety update single assessment: Opium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010670/201909
27/07/2020 Periodic safety update single assessment: Opium: List of nationally authorised medicinal products - PSUSA/00010670/201909
27/07/2020 Withdrawn application: Doxorubicin Hydrochloride Tillomed, doxorubicin, Date of withdrawal: 02/03/2020, Initial authorisation
27/07/2020 Annex to CHMP highlights: Overview of invented names reviewed in June 2020 by the Name Review Group (NRG) adopted at the CHMP meeting of 2-3 June 2020
27/07/2020 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 24, Authorised
27/07/2020 Human medicines European public assessment report (EPAR): Kyntheum, brodalumab, Psoriasis, 17/07/2017, Additional monitoring, 4, Authorised
27/07/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2020
27/07/2020 EPAR - Public assessment report: Rybelsus : EPAR - Public assessment report
27/07/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2020
27/07/2020 Agenda: Agenda - CHMP agenda of the 20-23 July 2020 meeting
27/07/2020 Human medicines European public assessment report (EPAR): Namuscla, Mexiletine hydrochloride, Myotonic Disorders, 18/12/2018, Orphan, 3, Authorised
24/07/2020 Herbal medicinal product: Hippocastani semen, Hippocastani semen, F: Assessment finalised
24/07/2020 Minutes: Minutes of the CAT meeting 17-19 June 2020
24/07/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
24/07/2020 News and press releases: Authorised uses of cancer medicine Yondelis unchanged following review of new data
24/07/2020 News and press releases: Panexcell Clinical Laboratories: suspension of medicines over flawed studies
24/07/2020 News and press releases: Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden
24/07/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 July 2020
24/07/2020 News and press releases: First antibody-drug conjugate for multiple myeloma patients with limited treatment options
24/07/2020 Leaflet: Infographic: Medicines for use outside the EU – EU-M4all
24/07/2020 Annex to CHMP highlights: Overview of invented names reviewed in June/July 2020 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 July 2020
24/07/2020 Stem cell-based products for veterinary use: Specific question on target animal safety addressed by CVMP/ADVENT
24/07/2020 Other: Questions and answers on adverse event reporting
23/07/2020 Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products , capecitabine, fluorouracil, tegafur, flucytosine , Article 31 referrals, European Commission final decision, 30/04/2020, 07/07/2020, 23/07/2020
23/07/2020 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections, Skin Diseases, Bacterial, Soft Tissue Infections, 24/04/2006, 31, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 34, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Sialanar, glycopyrronium bromide, Sialorrhea, 15/09/2016, 5, Authorised
23/07/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2020
23/07/2020 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, 10, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 30, Authorised
23/07/2020 Minutes: Minutes of the HMPC 4-6 May 2020 meeting
23/07/2020 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2020
23/07/2020 Regulatory and procedural guideline: EudraVigilance registration manual
23/07/2020 Human medicines European public assessment report (EPAR): Zabdeno, Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola, 01/07/2020, Additional monitoring, Exceptional circumstances, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 5, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Aspergillosis, Candidiasis, Mycoses, 16/05/2013, Generic, 12, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 16, Authorised
22/07/2020 Periodic safety update single assessment: Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201911
21/07/2020 Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, 27/07/2010, Generic, 15, Authorised
21/07/2020 News and press releases: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
21/07/2020 Human medicines European public assessment report (EPAR): Enerzair Breezhaler, indacaterol, glycopyrronium bromide, mometasone, Asthma, 03/07/2020, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 14, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Patient safety, Additional monitoring, 10, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 2, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 11, Authorised
21/07/2020 Other: Orientation guide for industry - EMA building
21/07/2020 Other: Orientation guide for delegates - EMA building
21/07/2020 Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A, von Willebrand Diseases, 12/08/2013, 14, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, 1, Authorised
21/07/2020 EPAR - Risk-management-plan summary: Pregabalin Accord : EPAR - Risk-management-plan summary
21/07/2020 Human medicines European public assessment report (EPAR): Trydonis, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 26/04/2018, 2, Authorised
21/07/2020 Referral: Carbamazepin Tillomed , carbamazepin , Carbamazepin Tillomed,Carbamazepina Tillomed,Karbamazepin Tillomed,Karbamazepina Tillomed, Article 29(4) referrals, European Commission final decision, 30/04/2020, 25/06/2020, 21/07/2020
21/07/2020 Direct healthcare professional communication (DHPC): Insuman Implantable 400 IU/ml insulin solution for infusion: no new patients should be started due to discontinuation of MiniMed Implantable Pump, Active substance: insulin human, DHPC type: Type II variation, Last updated: 21/07/2020
21/07/2020 Orphan designation: Marzeptacog alfa (activated) for the: Treatment of haemophilia B, 01/04/2019, Positive
21/07/2020 Veterinary medicines European public assessment report (EPAR): Coxevac, inactivated Coxiella burnetii vaccine, strain Nine Mile, 30/09/2010, 7, Authorised
20/07/2020 Other: Privacy statement for legal entity and bank account validation
20/07/2020 Scientific guideline: Guideline on the quality of water for pharmaceutical use
20/07/2020 Overview of comments: Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018)
20/07/2020 Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, 23/04/2017, 5, Authorised
20/07/2020 Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group), pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 15/03/2012, Generic, 7, Authorised
20/07/2020 Regulatory and procedural guideline: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6
20/07/2020 Orphan designation: Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa) for the: Treatment of haemophilia B, 20/06/2017, Positive
20/07/2020 Procurement: Ex ante publicity of a negotiated procedure : EMA/2020/23/DED – Catering consultancy services - Corrigendum
20/07/2020 Minutes: Minutes - PDCO minutes of the 25-28 February 2020 meeting
20/07/2020 Template or form: Change of applicant checklist - pre-submission guidance (human)
17/07/2020 Regulatory and procedural guideline: Draft Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082
17/07/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 14-16 July 2020
16/07/2020 Periodic safety update single assessment: Anthrax vaccine: List of nationally authorised medicinal products - PSUSA/00010771/201912
16/07/2020 Periodic safety update single assessment: Domperidone: List of nationally authorised medicinal products - PSUSA/00001158/201911
16/07/2020 Periodic safety update single assessment: Tibole: List of nationally authorised medicinal products - PSUSA/00002947/201912
16/07/2020 Periodic safety update single assessment: Sulbactam: List of nationally authorised medicinal products - PSUSA/00002800/201911
16/07/2020 Periodic safety update single assessment: Drospirenone / estradiol: List of nationally authorised medicinal products - PSUSA/00001184/201912
16/07/2020 Periodic safety update single assessment: Dienogest:List of nationally authorised medicinal products - PSUSA/00003167/201912
16/07/2020 Periodic safety update single assessment: Apomorphine: List of nationally authorised medicinal products - PSUSA/00000227/201911
15/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 19, Authorised
15/07/2020 Human medicines European public assessment report (EPAR): Kolbam , cholic acid, Metabolism, Inborn Errors, 20/11/2015, Exceptional circumstances, 14, Withdrawn
15/07/2020 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, 8, Authorised
15/07/2020 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 12, Authorised
15/07/2020 Periodic safety update single assessment: Sumatriptan : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002832/201909
15/07/2020 Periodic safety update single assessment: Sumatriptan : List of nationally authorised medicinal products - PSUSA/00002832/201909
15/07/2020 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 20, Authorised
14/07/2020 Other: Record of data processing for validation of proof of establishment when natural persons apply for orphan designation or a transfer of an orphan designation (public)
14/07/2020 Report: Medicinal products for human use: monthly figures - June 2020
14/07/2020 Regulatory and procedural guideline: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans
14/07/2020 Regulatory and procedural guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products
14/07/2020 Human medicines European public assessment report (EPAR): Delstrigo, Doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 5, Authorised
14/07/2020 Periodic safety update single assessment: Artemether-lumefantrin (apart from the dispersible tablet): List of nationally authorised medicinal products - PSUSA/00000236/201910
14/07/2020 Periodic safety update single assessment: Artemether-lumefantrin (apart from the dispersible tablet): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000236/201910
14/07/2020 Agenda: Agenda - CAT agenda of the 15-17 July 2020 meeting
14/07/2020 Agenda: Agenda - CVMP agenda of the 14-16 July 2020 meeting
13/07/2020 Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 30, Authorised
13/07/2020 Human medicines European public assessment report (EPAR): Mektovi, binimetinib, Melanoma, 20/09/2018, Additional monitoring, 3, Authorised
13/07/2020 Report: Applications for new human medicines under evaluation by the CHMP: July 2020
13/07/2020 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 36, Authorised
13/07/2020 Periodic safety update single assessment: Brotizolam: List of nationally authorised medicinal products - PSUSA/00000444/201912
13/07/2020 Periodic safety update single assessment: Human coagulation factor VIII (antihemophilic factor A): List of nationally authorised medicinal products - PSUSA/00001620/201911
13/07/2020 Periodic safety update single assessment: Cinolazepam: List of nationally authorised medicinal products - PSUSA/00000769/201912
13/07/2020 Agenda: Agenda - COMP agenda of the 14-16 July 2020 meeting
13/07/2020 Orphan designation: Humanised Fc engineered monoclonal antibody against CD19, active ingredient tafasitamab for the: Treatment of diffuse large B-cell lymphoma, 15/01/2015, Positive
13/07/2020 Periodic safety update single assessment: Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/201911
13/07/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / lactic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010414/201909
13/07/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / lactic acid : List of nationally authorised medicinal products - PSUSA/000010414/201909
13/07/2020 Human medicines European public assessment report (EPAR): Hopveus, sodium oxybate, Substance Withdrawal Syndrome, Alcohol Abstinence, 06/07/2020, Refused
10/07/2020 Other: European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs)
10/07/2020 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, Accelerated assessment, 4, Authorised
10/07/2020 Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Schizophrenia, Bipolar Disorder, 20/08/2015, Generic, 8, Authorised
10/07/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020
10/07/2020 Marketing authorisation
10/07/2020 Other: Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Art. 12(3) of Directive 2001/82)
10/07/2020 Other: Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82)
10/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma, Glioblastoma, 28/01/2010, Generic, 19, Authorised
10/07/2020 Human medicines European public assessment report (EPAR): MicardisPlus, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 29, Authorised
10/07/2020 Orphan designation: Oleylphosphocholine for the: Treatment of leishmaniasis, 23/04/2012, Positive
09/07/2020 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 13, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 6, Authorised
09/07/2020 News and press releases: International regulators align positions on phase 3 COVID-19 vaccine trials
09/07/2020 News and press releases: EMA finalises opinion on presence of nitrosamines in medicines
09/07/2020 Veterinary medicines European public assessment report (EPAR): Novaquin, meloxicam, 08/09/2015, 3, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Targretin, bexarotene, Lymphoma, T-Cell, Cutaneous, 29/03/2001, 20, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 16, Authorised
08/07/2020 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, Authorised
08/07/2020 News and press releases: Workshop: safe use of medicines during pregnancy and breastfeeding
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 95(8) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for active substances used as starting materials in veterinary medicinal products
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 99(6) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for veterinary medicinal products
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 57(4) of Regulation (EU) 2019/6 on veterinary medicinal products - Report on the format of the data to be collected on antimicrobial medicinal products used in animals
08/07/2020 Classifications as minor-use-minor-species and limited-market
08/07/2020 Agenda: Agenda - HMPC agenda of the 6-8 July 2020 meeting
07/07/2020 Human medicines European public assessment report (EPAR): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 03/11/2009, 19, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Cotellic, cobimetinib hemifumarate, Melanoma, 20/11/2015, 8, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Exforge HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 15/10/2009, 17, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Paliperidone Janssen-Cilag International, paliperidone palmitate, Schizophrenia, 18/06/2020, Authorised
07/07/2020 Orphan designation: Osilodrostat for the: Treatment of Cushing's syndrome, 15/10/2014, Positive
07/07/2020 Periodic safety update single assessment: Carbidopa / levodopa: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000548/201910
07/07/2020 Periodic safety update single assessment: Carbidopa / levodopa: List of nationally authorised medicinal products - PSUSA/00000548/201910
07/07/2020 Periodic safety update single assessment: Levosimendan: List of nationally authorised medicinal products - PSUSA/00001858/201909
07/07/2020 Periodic safety update single assessment: Levosimendan: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001858/201909
07/07/2020 Human medicines European public assessment report (EPAR): PritorPlus, telmisartan, hydrochlorothiazide, Hypertension, 22/04/2002, 35, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Nevanac, nepafenac, Pain, Postoperative, Ophthalmologic Surgical Procedures, 11/12/2007, 16, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Tavlesse, Fostamatinib disodium, Thrombocytopenia, 09/01/2020, Additional monitoring, 2, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Cayston, aztreonam lysine, Cystic Fibrosis, Respiratory Tract Infections, 21/09/2009, 18, Authorised
06/07/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen
06/07/2020 Regulatory and procedural guideline: Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities
06/07/2020 Other: European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change
06/07/2020 News and press releases: Launch of public consultation on joint network strategy to 2025
06/07/2020 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Afastural,Berny Adulti,Danifos Adulti,Fomicyt,Fosfocin,Fosfocina,Fosfocine,Fosfopharm,Fosfuro,Fosmol,Fostrofemge,Gynofostrome,Infectofos,Infeur Adulti,Interfos,Monural,Monuril,Monurol,Rapidnorm,Solufos,Symural,Uridoz,Urifos,Urinex,Urofast,Uromaste,Uroseptic, Article 31 referrals, European Commission final decision, 26/03/2020, 09/06/2020, 06/07/2020
06/07/2020 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 22, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Intuniv, guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity, 17/09/2015, Additional monitoring, 7, Authorised
06/07/2020 Agenda: Agenda - PRAC draft agenda of meeting 6-9 July 2020
06/07/2020 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 25, Authorised
06/07/2020 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC
06/07/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting
03/07/2020 Scientific guideline: Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b
03/07/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: June 2020
03/07/2020 Work programme: Work plan for the Pharmacovigilance Inspectors Working Group for 2020
03/07/2020 Newsletter: Clinical Trials Information System (CTIS) highlights - June 2020
03/07/2020 Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, Generic, Authorised
03/07/2020 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 19, Authorised
03/07/2020 Report: Annual accounts: Financial year 2019
02/07/2020 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting , Virtual meeting, from 24/06/2020 to 24/06/2020
02/07/2020 Paediatric Committee (PDCO): 9-11 December 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 09/12/2019 to 11/12/2019
02/07/2020 Agenda: Agenda - PCWP/HCPWP joint meeting on 24 June 2020
02/07/2020 Human medicines European public assessment report (EPAR): Evra, norelgestromin, ethinyl estradiol, Contraception, 21/08/2002, 21, Authorised
02/07/2020 Minutes: Minutes - PDCO minutes of the 09-11 December 2019 meeting
02/07/2020 Minutes: Minutes - PDCO minutes of the 28-31 January 2020 meeting
02/07/2020 Annual Report: Annual report of the Pharmacovigilance Inspectors Working Group for 2018
02/07/2020 Maximum Residue Limits - Report: Ketoprofen (Bovine, Porcine and Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/07/2020 Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), 21/11/2017, 3, Authorised
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (7-11 Sept 2020) , Virtual meeting, from 07/09/2020 to 11/09/2020
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (28 Sept - 2 Oct 2020) , Virtual meeting, from 28/09/2020 to 02/10/2020
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (12-16 Oct 2020) , Virtual meeting, from 12/10/2020 to 16/10/2020