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31/10/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet,Ledertrexate,Maxtrex,Metex,Metoject, Article 31 referrals, European Commission final decision, 22/08/2019, 21/10/2019, 31/10/2019
31/10/2019 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 18/08/2016, 9, Authorised
31/10/2019 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 5, Authorised
31/10/2019 Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia, Kidney Failure, Chronic, 28/08/2007, Biosimilar, 20, Authorised
31/10/2019 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,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,Enantone-Gyn 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,Leupro-Sandoz 3-Monats-Depot,Leuprostin,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, Under evaluation, 31/10/2019
31/10/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019
31/10/2019 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 31/10/2019
31/10/2019 Plasma master file certificates
31/10/2019 News and press releases: EMA closed 1 November 2019
31/10/2019 Other: Electronic registration process – EudraVigilance registration phases I, II and III
31/10/2019 Other: Required registration documents for EudraVigilance XCOMP
31/10/2019 Brexit-related guidance for companies
31/10/2019 Brexit: the United Kingdom's withdrawal from the European Union
31/10/2019 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 13, Authorised
31/10/2019 Regulatory Science to 2025
30/10/2019 Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Carcinoma, Non-Small-Cell Lung, 21/09/2018, Additional monitoring, 2, Authorised
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/201812
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000427/201812
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gilteritinib (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0194/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW), PM: decision on the application for modification of an agreed PIP, P/0164/2019
30/10/2019 Human medicines European public assessment report (EPAR): Fiasp, insulin aspart, Diabetes Mellitus, 09/01/2017, Patient safety, Additional monitoring, 5, Authorised
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imipenem (monohydrate),cilastatin (sodium),relebactam (MK-7655A), PM: decision on the application for modification of an agreed PIP, P/0173/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, PM: decision on the application for modification of an agreed PIP, P/0196/2019
30/10/2019 ICH guideline E19 on optimisation of safety data collection - Step 2b
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, PM: decision on the application for modification of an agreed PIP, P/0172/2019
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline E19 on optimisation of safety data collection - Step 2b'
30/10/2019 ICH M10 on bioanalytical method validation
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0165/2019
30/10/2019 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 21/03/2017, Additional monitoring, Biosimilar, 7, Authorised
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline M10 on bioanalytical method validation - Step 2b'
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Deferiprone, PM: decision on the application for modification of an agreed PIP, P/0189/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, PM: decision on the application for modification of an agreed PIP, P/0195/2019
30/10/2019 Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Graft Rejection, 23/04/2007, 19, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Xadago, safinamide methanesulfonate, Parkinson Disease, 23/02/2015, 10, Authorised
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa, PM: decision on the application for modification of an agreed PIP, P/0176/2019
30/10/2019 Human medicines European public assessment report (EPAR): Truberzi, eluxadoline, Irritable Bowel Syndrome, Diarrhea, 19/09/2016, Additional monitoring, 5, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, Additional monitoring, 6, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 37, Authorised
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0190/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab, PM: decision on the application for modification of an agreed PIP, P/0174/2019
30/10/2019 Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, 18/05/2018, Additional monitoring, Biosimilar, 4, Authorised
30/10/2019 Other: Informed consent for paediatric clinical trials in Europe 2015
30/10/2019 Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma, Glioblastoma, 26/01/1999, 32, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, 1, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 4, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 27, Authorised
30/10/2019 Template or form: Application for authorisation to engage in an occupation after leaving the European Medicines Agency - Article 16 of the Staff Regulations
30/10/2019 Template or form: Application for authorisation to engage in an occupation after leaving the European Medicines Agency - National expert on secondment
30/10/2019 Human medicines European public assessment report (EPAR): Sildenafil Teva, sildenafil, Erectile Dysfunction, 30/11/2009, Generic, 14, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Lysodren, Mitotane, Adrenal Cortex Neoplasms, 28/04/2004, Orphan, 14, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, 14, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Pixuvri, pixantrone dimaleate, Lymphoma, Non-Hodgkin, 10/05/2012, Additional monitoring, Conditional approval, 21, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 18, Authorised
30/10/2019 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, 19/09/2018, Additional monitoring, 3, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): colecalciferol, W: decision granting a waiver in all age groups for all conditions/indications, P/0182/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Amoxicillin (in combination with pantoprazole + clarithromycin), W: decision granting a waiver in all age groups for all conditions/indications, P/0184/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Clarithromycin (in combination with pantoprazole + amoxicillin), W: decision granting a waiver in all age groups for all conditions/indications, P/0183/2019
29/10/2019 Agenda: Agenda - CHMP agenda of the 14-17 October 2019 meeting
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Seladelpar, W: decision granting a waiver in all age groups for all conditions/indications, P/0192/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): salbutamol sulfate,budesonide, W: decision granting a waiver in all age groups for all conditions/indications, P/0185/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Candesartan,Atorvastatin,amlodipine, W: decision granting a waiver in all age groups for all conditions/indications, P/0187/2019
29/10/2019 Template or form: Day 80 assessment report - Non-clinical template with guidance rev. 10.19
29/10/2019 Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance rev. 10.19
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate),Olopatadine (hydrochloride) (GSP 301 NS), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0170/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pantoprazole (in combination with amoxicillin + clarithromycin), W: decision granting a waiver in all age groups for all conditions/indications, P/0188/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human lecithin cholesterol acyltransferase, W: decision granting a waiver in all age groups for all conditions/indications, P/0175/2019
29/10/2019 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 12, Authorised
29/10/2019 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 14, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanized antibody targeting B cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F, W: decision granting a waiver in all age groups for all conditions/indications, P/0168/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0191/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): ofatumumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0122/2019
29/10/2019 Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia, Gout, 28/03/2019, Generic, 1, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibandronic acid (in the form of ibandronate sodium monohydrate), W: decision granting a waiver in all age groups for all conditions/indications, P/0180/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dusquetide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0177/2019
29/10/2019 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2019 by end of November 2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib, W: decision granting a waiver in all age groups for all conditions/indications, P/0167/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Efpeglenatide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0181/2019
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00010631/201812
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010631/201812
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0178/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib, W: decision granting a waiver in all age groups for all conditions/indications, P/0171/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0186/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate,Glycopyrronium bromide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0179/2019
29/10/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 6, Authorised
29/10/2019 Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid, 01/07/2013, Orphan, Accelerated assessment, Additional monitoring, 20, Authorised
29/10/2019 Overview of comments: Overview of comments received on 'Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms'
29/10/2019 Report: Outcome of public consultation on 'Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms'
29/10/2019 Pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Leaflet: Biosimilars in the EU - Information guide for healthcare professionals
28/10/2019 Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia, Iron Overload, 25/08/1999, 25, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 3, Authorised
28/10/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 28/10/2019 to 31/10/2019
28/10/2019 Other: Organisation chart: Administration and Corporate Management
28/10/2019 Work programme: Committee for Medicinal Products for Human Use (CHMP): Work Plan 2019
28/10/2019 Agenda: Agenda - PRAC draft agenda of meeting 28-31 October 2019
28/10/2019 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 45, Authorised
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/201812
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002908/201812
28/10/2019 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, Additional monitoring, 28, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/05/1998, 38, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 36, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 11, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 3, Authorised
28/10/2019 Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 3, Authorised
28/10/2019 Other: The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees
28/10/2019 Other: PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 30 September-3 October 2019
28/10/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
28/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, Generic, 12, Authorised
28/10/2019 Periodic safety update single assessment: Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812
28/10/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
28/10/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
28/10/2019 Risk management plan (RMP): questions and answers
28/10/2019 Notifying a change of marketing status
28/10/2019 Grouping of variations: questions and answers
28/10/2019 Post-authorisation safety studies (PASS)
28/10/2019 Type-IA variations: questions and answers
28/10/2019 Type-II variations: questions and answers
28/10/2019 Periodic safety update reports (PSURs)
28/10/2019 Extensions of marketing authorisations: questions and answers
28/10/2019 Worksharing: questions and answers
28/10/2019 Nitrosamine impurities overview
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 2 - Nitrosamine detected response template
28/10/2019 Template or form: Step 2 Nitrosamine detected response template
25/10/2019 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, Additional monitoring, 4, Authorised
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812
25/10/2019 News and press releases: Dialogue with Chinese authorities on medicine regulation
25/10/2019 Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 2, Authorised
25/10/2019 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 19, Authorised
24/10/2019 Human medicines European public assessment report (EPAR): Thorinane, enoxaparin sodium, Venous Thromboembolism, 14/09/2016, Additional monitoring, Biosimilar, 2, Withdrawn
24/10/2019 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, Authorised
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of glioma, 19/11/2018, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of salivary gland cancer, 21/03/2018, Withdrawn
24/10/2019 Orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib) for the: Treatment of soft tissue sarcoma, 11/01/2016, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of papillary thyroid cancer, 19/11/2018, Withdrawn
23/10/2019 Aluvia H-W-764
23/10/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1+8 Bovis, inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, 08/03/2012, Accelerated assessment, 6, Authorised
23/10/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1+8 Ovis, inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 /inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02, 14/03/2011, 6, Authorised
23/10/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1 Bovis, inactivated bluetongue virus, serotype 1, 05/08/2011, Accelerated assessment, 7, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Shingrix, Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster, 21/03/2018, Additional monitoring, 2, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Dengvaxia, chimeric yellow fever dengue virus serotype 1 (live, attenuated) / chimeric yellow fever dengue virus serotype 2 (live, attenuated) / chimeric yellow fever dengue virus serotype 3 (live, attenuated) / chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue, 12/12/2018, Additional monitoring, 1, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesylate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, Additional monitoring, 9, Authorised
23/10/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 14-17 October 2019
23/10/2019 Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, 20/09/2017, Additional monitoring, 6, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 1, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid monohydrate, Fractures, Bone, Cancer, 03/08/2012, Generic, 11, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Temomedac, temozolomide, Glioma, Glioblastoma, 25/01/2010, Generic, 12, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 13, Authorised
23/10/2019 Human medicines European public assessment report (EPAR): Kromeya, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 3, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, Additional monitoring, 7, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 18, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, Orphan, Accelerated assessment, Additional monitoring, 4, Authorised
22/10/2019 Regulatory and procedural guideline: Notification on arrangements for requesting and receiving EMA certificates through urgent and standard procedure from November 2019 to January 2020
22/10/2019 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis, 25/10/2005, 26, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 7, Authorised
22/10/2019 Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, 31/08/2018, Additional monitoring, 3, Authorised
22/10/2019 Report: Medicinal products for human use: monthly figures - September 2019
22/10/2019 Regulatory and procedural guideline: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes
22/10/2019 Regulatory and procedural guideline: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
22/10/2019 Other: Mandate, objectives and rules of procedure for the Name Review Group (NRG)
21/10/2019 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 19/05/2006, 18, Authorised
21/10/2019 Human medicines European public assessment report (EPAR): Fluenz Tetra, reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human, 04/12/2013, 17, Authorised
21/10/2019 How to prepare and review a summary of product characteristics
21/10/2019 News and press releases: Enhancing consistency in wording of therapeutic indications to support healthcare decision-making
21/10/2019 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 13, Authorised
21/10/2019 Regulatory and procedural guideline: Wording of therapeutic indication - A guide for assessors of centralised applications
21/10/2019 Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 17, Authorised
21/10/2019 Other: Quality Review of Documents (QRD) working group plenary meeting dates
21/10/2019 Human medicines European public assessment report (EPAR): Zejula, niraparib tosylate monohydrate, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 6, Authorised
21/10/2019 Committee for Herbal Medicinal Products (HMPC): 14-16 January 2019 , European Medicines Agency, London, UK, from 14/01/2019 to 16/01/2019
21/10/2019 Minutes: Minutes of the HMPC 14-16 January 2019 meeting
21/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma), clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 16/10/2009, Generic, 17, Authorised
18/10/2019 Withdrawn application: Nuzyra, omadacycline, Date of withdrawal: 17/10/2019, Initial authorisation
18/10/2019 Scientific guideline: CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
18/10/2019 CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
18/10/2019 Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
18/10/2019 Summary of opinion: Translarna, ataluren, 27/06/2019, Negative
18/10/2019 Inspections procedure
18/10/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019
18/10/2019 Summary of opinion: Ervebo, Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), 17/10/2019, Positive
18/10/2019 Summary of opinion: Rinvoq, upadacitinib, 17/10/2019, Positive
18/10/2019 Summary of opinion: Baqsimi, glucagon, 17/10/2019, Positive
18/10/2019 Summary of opinion: Kalydeco, ivacaftor, 17/10/2019, Positive
18/10/2019 Summary of opinion: Darzalex, daratumumab, 17/10/2019, Positive
18/10/2019 Withdrawn application: Xyndari, glutamine, Date of withdrawal: 18/09/2019, Initial authorisation
18/10/2019 Summary of opinion: Spravato, esketamine, 17/10/2019, Positive
18/10/2019 Summary of opinion: Vanflyta, quizartinib, 17/10/2019, Negative
18/10/2019 Summary of opinion: Quofenix, delafloxacin, 17/10/2019, Positive
18/10/2019 Summary of opinion: Evotaz, atazanavir / cobicistat, 17/10/2019, Positive
18/10/2019 Summary of opinion: Pegfilgrastim Mundipharma, pegfilgrastim, 17/10/2019, Positive
18/10/2019 Referral: Flurbiprofen Geiser , flurbiprofen , Flurbiprofen Sejmet,Mentocaína Spray,Flurbiprofeno Geiser, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 17/10/2019
18/10/2019 Withdrawn application: Ekesivy, diclofenamide, Date of withdrawal: 02/10/2019, Initial authorisation
18/10/2019 Summary of opinion: Toujeo (previously Optisulin), insulin glargine, 17/10/2019, Positive
18/10/2019 Summary of opinion: Evenity, romosozumab, 17/10/2019, Positive
18/10/2019 Summary of opinion: Revolade, eltrombopag, 17/10/2019, Negative
18/10/2019 News and press releases: First non-injectable treatment for severe low blood sugar levels
17/10/2019 Procurement: Ex ante publicity of a negotiated procedure : EMA/2019/32/LD – Legal advice in relation to Dutch law on real estate and building maintenance
17/10/2019 Human medicines European public assessment report (EPAR): Tacforius, tacrolimus monohydrate, Liver Transplantation, Kidney Transplantation, 08/12/2017, Generic, 2, Authorised
17/10/2019 Minutes: Minutes of the PRAC meeting 13-16 May 2019
17/10/2019 Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 21, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Sialanar, Glycopyrronium bromide, Sialorrhea, 15/09/2016, 4, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Efavirenz Teva, efavirenz, HIV Infections, 09/01/2012, Generic, 9, Authorised
17/10/2019 Minutes: Minutes of the CVMP meeting of 10-12 September 2019
17/10/2019 Minutes: Minutes of the CVMP meeting of 16-18 July 2019
17/10/2019 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 37, Authorised
17/10/2019 Minutes: Minutes of the CVMP meeting of 18-20 June 2019
17/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel hydrochloride, 20/09/2009, Generic, 10, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Duloxetine Lilly, duloxetine, Neuralgia, Diabetic Neuropathies, Depressive Disorder, Major, 08/12/2014, 6, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 12, Authorised
17/10/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC
17/10/2019 Human medicines European public assessment report (EPAR): Zomarist, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 19, Authorised
17/10/2019 Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - July 2019
17/10/2019 Human medicines European public assessment report (EPAR): Anoro Ellipta (previously Anoro), umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 13, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 21, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Pemetrexed medac, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 26/11/2015, Generic, 5, Authorised
17/10/2019 Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 17/07/2014, 17, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 3, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Imatinib medac, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, 25/09/2013, Generic, 5, Withdrawn
16/10/2019 Human medicines European public assessment report (EPAR): Brilique, ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome, 03/12/2010, 14, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Prasugrel Mylan, prasugrel besilate, Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, 15/05/2018, Generic, 4, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, Generic, 4, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 15, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Rebif, interferon beta-1a, Multiple Sclerosis, 03/05/1998, 34, Authorised
16/10/2019 Orphan designation: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class (atinumab) for the: Treatment of spinal cord injury, 19/01/2009, Withdrawn
16/10/2019 Orphan designation: Aztreonam lysinate (inhalation use) for the: Treatment of Gram-negative bacterial lung infection in cystic fibrosis, 21/06/2004, Expired
16/10/2019 Human medicines European public assessment report (EPAR): Maviret, glecaprevir / pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 8, Authorised
16/10/2019 Orphan designation: Recombinant human soluble Fc-gamma receptor II b for the: Treatment of idiopathic thrombocytopenic purpura, 02/08/2007, Withdrawn
16/10/2019 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 64, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Dectova, Zanamivir, Influenza, Human, 26/04/2019, Additional monitoring, 1, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative, 13/08/1999, 55, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Zyllt, clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction, 28/09/2009, Generic, 12, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 52, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, Additional monitoring, 3, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 31, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 45, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis), vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 20, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 5, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Kisqali, ribociclib succinate, Breast Neoplasms, 22/08/2017, Additional monitoring, 2, Authorised
16/10/2019 Other: Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82)
16/10/2019 Other: Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Art. 12(3) of Directive 2001/82)
16/10/2019 Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 24, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Betaferon, interferon beta-1b, Multiple Sclerosis, 30/11/1995, 31, Authorised
16/10/2019 Orphan designation: pentetrazol for the: Treatment of idiopathic hypersomnia, 11/11/2015, Positive
16/10/2019 Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, Additional monitoring, 10, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 24, Authorised
16/10/2019 Human medicines European public assessment report (EPAR): Exforge, amlodipine (as besylate), valsartan, Hypertension, 16/01/2007, 25, Authorised
16/10/2019 Orphan designation: Recombinant human acid ceramidase for the: Treatment of Farber disease, 19/02/2014, Positive
16/10/2019 Orphan designation: Recombinant human acid ceramidase for the: Treatment of cystic fibrosis, 10/08/2015, Positive