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30/10/2020 Human medicines European public assessment report (EPAR): DuoTrav, travoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 23/04/2006, 17, Authorised (updated)
30/10/2020 Human medicines European public assessment report (EPAR): Palynziq, Pegvaliase, Phenylketonurias, 03/05/2019, Orphan, Additional monitoring, 1, Authorised (updated)
30/10/2020 Veterinary medicines European public assessment report (EPAR): Prevomax, maropitant, 19/06/2017, 2, Authorised (updated)
30/10/2020 Newsletter: Veterinary Medicines Regulation highlights - Issue 2 (new)
30/10/2020 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 11, Authorised (updated)
30/10/2020 Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 09/06/2010, 15, Authorised (updated)
30/10/2020 Open letters (updated)
30/10/2020 Clinical data publication (updated)
30/10/2020 News and press releases: Extra transparency measures for COVID-19 vaccines and therapeutics
30/10/2020 Veterinary medicines European public assessment report (EPAR): Suvaxyn Circo, porcine circovirus vaccine (inactivated, recombinant), 07/02/2018, 2, Authorised (updated)
30/10/2020 Regulatory and procedural guideline: Detailed guidance on ICSRs in the context of COVID-19 - Validity and coding of ICSRs (updated)
30/10/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020
30/10/2020 Human Medicines (updated)
30/10/2020 Other: Organisation chart: Human Medicines (updated)
30/10/2020 Information Management (updated)
30/10/2020 Other: Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
30/10/2020 Other: Nominations to the European Union Telematics governance bodies (updated)
30/10/2020 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 40, Authorised (updated)
30/10/2020 Referral: Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof , azaperone , Article 35, European Commission final decision, 16/07/2020, 12/10/2020
29/10/2020 Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, Additional monitoring, 1, Authorised (updated)
29/10/2020 Minutes: Minutes of the CHMP meeting 20-23 July 2020 (new)
29/10/2020 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2020 by end of November
29/10/2020 Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human, 20/05/2016, Additional monitoring, Conditional approval, 6, Authorised (updated)
29/10/2020 News and press releases: EMA closed 2 November 2020
29/10/2020 Minutes: Minutes of the HMPC 6-8 July 2020 meeting (new)
29/10/2020 Human medicines European public assessment report (EPAR): Movymia, teriparatide, Osteoporosis, 11/01/2017, Additional monitoring, Biosimilar, 7, Authorised (updated)
29/10/2020 Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI), Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020
29/10/2020 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet (as hydrochloride), Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 8, Authorised (updated)
29/10/2020 Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence, Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020
29/10/2020 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 13, Authorised (updated)
29/10/2020 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 15, Authorised (updated)
29/10/2020 Human medicines European public assessment report (EPAR): Hetlioz, tasimelteon, Sleep Disorders, Circadian Rhythm, 03/07/2015, Orphan, 6, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Vepacel, Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 17/02/2012, 9, Withdrawn (updated)
28/10/2020 Public Statement: Public statement on Vepacel: Withdrawal of the marketing authorisation in the European Union (new)
28/10/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
28/10/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
28/10/2020 List of medicines under additional monitoring (updated)
28/10/2020 Agenda: Agenda - EMA 25th anniversary symposium: New approaches in patient-focused cancer drug development (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 14, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Terrosa, teriparatide, Osteoporosis, 04/01/2017, Additional monitoring, Biosimilar, 4, Authorised (updated)
28/10/2020 Withdrawn application: Upkanz, deferiprone, Date of withdrawal: 10/08/2020, Initial authorisation (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Cabazitaxel Accord, cabazitaxel, Prostatic Neoplasms, Castration-Resistant, 28/08/2020, Additional monitoring, Generic, Authorised
28/10/2020 Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion, Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020
28/10/2020 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, 26/07/2018, Additional monitoring, Biosimilar, 6, Authorised (updated)
28/10/2020 Other: Lessons learnt from presence of N-nitrosamine impurities in sartan medicines - Implementation plan (new)
28/10/2020 Nitrosamine impurities (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Lymphoseek, tilmanocept, Radionuclide Imaging, 19/11/2014, 7, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 15, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 14, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 28, Authorised (updated)
28/10/2020 Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 13, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, Additional monitoring, 2, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Protaphane, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised (updated)
27/10/2020 Orphan designation: 5,7-dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)-one mesilate for the: Treatment of multiple system atrophy, 16/12/2019, Positive (updated)
27/10/2020 Minutes: Minutes of the CAT meeting 9-11 September 2020 (new)
27/10/2020 Agenda: Agenda and registration form - EMA EudraVigilance information day (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Esperoct, Turoctocog alfa pegol, Hemophilia A, 20/06/2019, Additional monitoring, 2, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8), bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated], 14/04/2011, Accelerated assessment, 7, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Additional monitoring, Biosimilar, 4, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 15, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, 1, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Alimta, pemetrexed, Mesothelioma, Carcinoma, Non-Small-Cell Lung, 20/09/2004, 25, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, Additional monitoring, 7, Authorised (updated)
27/10/2020 Orphan designation: arimoclomol citrate for the: Treatment of Niemann-Pick's disease, type C, 19/11/2014, Positive (updated)
27/10/2020 Orphan designation: Arimoclomol for the: Treatment of amyotrophic lateral sclerosis, 26/10/2006, Positive (updated)
27/10/2020 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, 8, Authorised (updated)
27/10/2020 Orphan designation: arimoclomol citrate for the: Treatment of inclusion body myositis, 30/05/2016, Positive (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Rozlytrek, Entrectinib, Cancer, Carcinoma, Non-Small-Cell Lung, 31/07/2020, Additional monitoring, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Onpattro, patisiran sodium, Amyloidosis, Familial, 27/08/2018, Orphan, Accelerated assessment, Additional monitoring, 7, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Mozobil, Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma, 30/07/2009, Orphan, 19, Authorised (updated)
27/10/2020 Human medicines European public assessment report (EPAR): Episalvan, betulae cortex dry extract  (5-10 : 1); extraction solvent: n-heptane 95% (w/w), Wounds and Injuries, Wound Healing, 14/01/2016, 5, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): Arti-Cell Forte, chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, 29/03/2019, 3, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): Equioxx, firocoxib, 25/06/2008, 8, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): BTVPUR, bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen , 17/12/2010, 12, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): Sedadex, dexmedetomidine hydrochloride, 12/08/2016, 3, Authorised (updated)
27/10/2020 Veterinary medicines European public assessment report (EPAR): Tulissin, tulathromycin, 24/04/2020, Generic, 1, Authorised (updated)
26/10/2020 Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names , ibuprofen , Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie,Ibuprofen Fresenius Kabi 400 mg solution pour perfusion,Ibuprofen Kabi,Ibuprofen Kabi 400 mg oldatos infúzió,Ibuprofen Kabi 400 mg soluţie perfuzabilă,Ibuprofen Kabi 400 mg,Ibuprofen Kabi 400 mg raztopina za infundiranje,Ibuprofeno Kabi 400 mg solución para perfusion,Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals, European Commission final decision, 23/07/2020, 15/10/2020, 26/10/2020 (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Zoledronic Acid Accord, zoledronic acid monohydrate, Hypercalcemia, Fractures, Bone, Cancer, 16/01/2014, Generic, 7, Authorised (updated)
26/10/2020 Agenda: Agenda - PRAC draft agenda of meeting 26-29 October 2020 (new)
26/10/2020 Other: Decision on Amending Budget No 1-2020 (new)
26/10/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC meeting (new)
26/10/2020 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC (new)
26/10/2020 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 9, Authorised (updated)
26/10/2020 Other: Summary on compassionate use for Sofosbuvir Gilead (updated)
26/10/2020 Other: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Sofosbuvir Gilead available for compassionate use (updated)
26/10/2020 Other: Summary on compassionate use for Daclatasvir (updated)
26/10/2020 Other: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Daclatasvir available for compassionate use (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Parkinson Disease, 27/08/1997, 24, Authorised (updated)
26/10/2020 Compassionate use (updated)
26/10/2020 Other: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Ledipasvir/Sofosbuvir available for compassionate use (updated)
26/10/2020 Other: Summary on compassionate use for Ledipasvir/Sofosbuvir (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Zeposia, ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting, 20/05/2020, Additional monitoring, Authorised (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, Orphan, Accelerated assessment, 25, Authorised (updated)
26/10/2020 Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for the: Treatment of cystic fibrosis, 08/07/2008, Positive (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, 22/05/2014, Generic, 13, Authorised (updated)
26/10/2020 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 5, Authorised (updated)
23/10/2020 Report: COMP meeting report on the review of applications for orphan designation: October 2020
23/10/2020 Other: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)
23/10/2020 Other: Mandate of the Coordinating Group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
23/10/2020 Presentation: European Network of Paediatric Research at the European Medicines Agency - Introduction
23/10/2020 European networkof paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , Virtual meeting, from 22/06/2020 to 22/06/2020
23/10/2020 Veterinary pre-submission Q&A: 21-40
23/10/2020 Agenda: CHMP ORGAM agenda for the meeting on 5 October 2020
23/10/2020 Report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2020
23/10/2020 Template or form: European Medicines Agency active-substance-master-file-number request form
23/10/2020 Human medicines European public assessment report (EPAR): Sixmo, Buprenorphine hydrochloride, Opioid-Related Disorders, 19/06/2019, Additional monitoring, 1, Authorised
23/10/2020 News and press releases: Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23/10/2020 Orphan designation: Humanised monoclonal antibody against myostatin (domagrozumab) for the: Treatment of Duchenne muscular dystrophy, 08/02/2013, Withdrawn
23/10/2020 Orphan designation: Mepolizumab for the: Treatment of Churg-Strauss syndrome, 12/03/2013, Withdrawn
23/10/2020 Orphan designation: Mepolizumab for the: Treatment of hypereosinophilic syndrome, 29/07/2004, Withdrawn
23/10/2020 Big data
23/10/2020 EU big data stakeholder virtual forum , Virtual meeting, from 15/12/2020 to 15/12/2020
23/10/2020 Patient registries
23/10/2020 Workshop on the draft guideline on registry-based studies , Virtual meeting, from 19/10/2020 to 19/10/2020
22/10/2020 Human medicines European public assessment report (EPAR): Adrovance, colecalciferol, alendronic acid (as sodium trihydrate), Osteoporosis, Postmenopausal, 04/01/2007, 21, Authorised
22/10/2020 Other: Membership list - HMA / EMA joint Big Data Steering Group
22/10/2020 Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Parkinson Disease, 12/01/2015, 7, Authorised
22/10/2020 Human medicines European public assessment report (EPAR): Beovu, brolucizumab, Wet Macular Degeneration, 13/02/2020, Additional monitoring, 1, Authorised
22/10/2020 Human medicines European public assessment report (EPAR): Azilect, rasagiline, Parkinson Disease, 21/02/2005, 21, Authorised
22/10/2020 Regulatory and procedural guideline: PRIME eligibility requests: 2021 deadlines for submission and timetable for assessment
22/10/2020 Human medicines European public assessment report (EPAR): Briviact (in Italy: Nubriveo), Brivaracetam, Epilepsy, 13/01/2016, 9, Authorised
22/10/2020 Pharmaceutical development of medicines for use in the older population
22/10/2020 Scientific guideline: Reflection paper on the pharmaceutical development of medicines for use in the older population - First version
22/10/2020 PRIME: priority medicines
22/10/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 15 October 2020
22/10/2020 Orphan designation: Adeno-associated virus serotype rh74 containing the human micro-dystrophin gene for the: Treatment of Duchenne muscular dystrophy, 28/02/2020, Positive
22/10/2020 Human medicines European public assessment report (EPAR): Sunosi, solriamfetol hydrochloride, Narcolepsy, Sleep Apnea, Obstructive, 16/01/2020, Additional monitoring, 1, Authorised
22/10/2020 Human medicines European public assessment report (EPAR): Zoledronic acid Actavis, zoledronic acid monohydrate, Fractures, Bone, 20/04/2012, Generic, 13, Authorised
22/10/2020 Withdrawn application: Abilify MyCite, aripiprazole, Date of withdrawal: 17/07/2020, Initial authorisation
22/10/2020 Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 18/11/2008, 20, Authorised
22/10/2020 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 11, Authorised
22/10/2020 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 14, Authorised
22/10/2020 Referral: Panexcell , Article 31 referrals, European Commission final decision, 27/02/2020, 24/09/2020, 22/10/2020
21/10/2020 Other: Records of data processing activity Regulatory Science Strategy interviews (public)
21/10/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), 22/02/2005, 14, Authorised
21/10/2020 Other: Records of data processing activity regarding EU Innovation Network (public)
21/10/2020 Report: Sales of veterinary antimicrobial agents in 31 European countries in 2018 - Trends from 2010 to 2018 Tenth ESVAC report
21/10/2020 News and press releases: 10th ESVAC report shows continued decrease in sales of veterinary antibiotics
21/10/2020 Other: European Medicines Agency’s Privacy Statement for the EU Innovation Network
21/10/2020 Other: European Medicines Agency’s Privacy Statement For the Regulatory Science Strategy interviews
21/10/2020 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 17, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 19, Authorised
21/10/2020 Veterinary medicines European public assessment report (EPAR): Vaxxitek HVT+IBD, Recombinant turkey herpesvirus, strain vhvt013-69, live, 09/08/2002, 12, Authorised
21/10/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 12, Authorised
21/10/2020 Periodic safety update reports (PSURs)
21/10/2020 Leaflet: Responsible use of antibiotics protects animals and people - 2011-2018 Sales of antibiotics for veterinary use are down - Infographic
21/10/2020 Other: Policy 80: European Medicines Agency policy on the use of expertise for specific tasks to be undertaken by the Agency
21/10/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 14, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Postmenopause, 16/12/2014, 11, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 13, Authorised
21/10/2020 Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate for the: Treatment of cystic fibrosis, 26/10/2018, Positive
21/10/2020 Periodic safety update single assessment: Levosalbutamol, salbutamol: List of nationally authorised medicinal products - PSUSA/00010330/202001
21/10/2020 Withdrawn application: Rayoqta, Date of withdrawal: 17/07/2020, Initial authorisation
21/10/2020 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 16, Authorised
21/10/2020 25 Years of EMA: building, learning and adapting to new challenges , Virtual meeting, from 22/10/2020 to 22/10/2020
21/10/2020 Agenda: Agenda - 25 Years of EMA: building, learning and adapting to new challenges
21/10/2020 Human medicines European public assessment report (EPAR): Carmustine Obvius, carmustine, Hodgkin Disease, Lymphoma, Non-Hodgkin, 18/07/2018, Generic, 5, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Ristfor, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/03/2010, 20, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, Generic, 11, Authorised
21/10/2020 Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Myocardial Infarction, 11/01/2016, Generic, 3, Authorised
21/10/2020 Periodic safety update single assessment: Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/202001
21/10/2020 Human medicines European public assessment report (EPAR): Hemangiol, propranolol hydrochloride, Hemangioma, 23/04/2014, 5, Authorised
21/10/2020 Union Product Database: release notes
21/10/2020 Other: SPOR API v2 specification
21/10/2020 Other: Examples of bundles for create product functionality
21/10/2020 Other: UPD Production Release Notes
21/10/2020 Presentation: Presentation PMS / ISO / IDMP / FHIR
21/10/2020 Human medicines European public assessment report (EPAR): Actrapid, human insulin, Diabetes Mellitus, 07/10/2002, 17, Authorised
20/10/2020 Orphan designation: hydrocortisone for the: Treatment of adrenal insufficiency, 20/03/2007, Positive
20/10/2020 Standard Operating Procedure - SOP: Standard operating procedure for audit programmes and internal audits conducted by the Audit Advisory Function
20/10/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 12, Authorised
20/10/2020 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, 13, Authorised
20/10/2020 Referrals document: Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Timetable for the procedure - CHMP Opinion on the impact of the Article 5(3) referral on nitrosamines in human medicinal products on the referral
20/10/2020 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 20, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors, Radionuclide Imaging, 08/12/2016, Orphan, Additional monitoring, 6, Authorised
20/10/2020 Herbal medicinal product: Tanaceti parthenii herba, Tanaceti parthenii herba, F: Assessment finalised
20/10/2020 Veterinary medicines European public assessment report (EPAR): Oxyglobin, haemoglobin glutamer-200 (bovine), 29/11/1999, 16, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, Accelerated assessment, Additional monitoring, 21, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Additional monitoring, Exceptional circumstances, 17, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Hyperammonemia, Amino Acid Metabolism, Inborn Errors, 23/06/2017, Generic, 6, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 5, Authorised
20/10/2020 Report: Medicinal products for human use: monthly figures - September 2020
20/10/2020 Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams
20/10/2020 Other: Contact details of national competent authorities for requests of translation exemption falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
20/10/2020 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 20, Authorised
20/10/2020 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 47, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 13, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 5, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Ratiograstim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 12, Authorised
19/10/2020 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/202003
19/10/2020 Human medicines European public assessment report (EPAR): Jivi, Damoctocog alfa pegol, Hemophilia A, 22/11/2018, Additional monitoring, 2, Authorised
19/10/2020 Other: Mandate, objectives and rules of procedure for the CVMP Efficacy Working Party (EWP-V)
19/10/2020 News and press releases: EMA virtual conference: 25 years of advancing public and animal health
19/10/2020 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, Additional monitoring, 3, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Juluca, dolutegravir sodium, rilpivirine hydrochloride, HIV Infections, 16/05/2018, Additional monitoring, 5, Authorised
19/10/2020 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202003
19/10/2020 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/202003
19/10/2020 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/202003
19/10/2020 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 6, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, 4, Authorised
19/10/2020 Periodic safety update single assessment: Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/202002
19/10/2020 Human medicines European public assessment report (EPAR): Pemetrexed Hospira, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 19/11/2015, Generic, 10, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020, Additional monitoring, 3, Authorised
19/10/2020 Academia
19/10/2020 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 9, Authorised
19/10/2020 Periodic safety update single assessment: Mefloquine: List of nationally authorised medicinal products - PSUSA/00001955/202002
19/10/2020 Human medicines European public assessment report (EPAR): Zoledronic acid Teva, zoledronic acid, Fractures, Bone, Cancer, 16/08/2012, Generic, 13, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, 20/09/2017, Additional monitoring, 11, Authorised
19/10/2020 Human medicines European public assessment report (EPAR): Levemir, Insulin detemir, Diabetes Mellitus, 01/06/2004, 28, Authorised
19/10/2020 Requesting scientific advice or protocol assistance from EMA
19/10/2020 Scientific advice and protocol assistance
19/10/2020 Human medicines European public assessment report (EPAR): Pheburane, Sodium phenylbutyrate, Carbamoyl-Phosphate Synthase I Deficiency Disease, 30/07/2013, 8, Authorised
19/10/2020 Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
19/10/2020 Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting scientific advice (veterinary)
19/10/2020 Template or form: Scientific advice request template
19/10/2020 Regulatory and procedural guideline: Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
19/10/2020 Regulatory and procedural guideline: Qualification of novel methodologies for drug development: guidance to applicants
19/10/2020 Qualification of novel methodologies for medicine development
19/10/2020 Regulatory and procedural guideline: Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
19/10/2020 Human medicines European public assessment report (EPAR): Bortezomib Hospira, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 9, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesylate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, Additional monitoring, 12, Authorised
16/10/2020 News and press releases: First long-acting injectable antiretroviral therapy for HIV recommended for approval
16/10/2020 Summary of opinion: Vocabria, 15/10/2020, Positive
16/10/2020 Summary of opinion: Rekambys, rilpivirine, 15/10/2020, Positive
16/10/2020 Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 51, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), Thalidomide, Multiple Myeloma, 16/04/2008, 26, Authorised
16/10/2020 Orphan designation: Magrolimab for the: Treatment of myelodysplastic syndromes, 26/06/2020, Positive
16/10/2020 Orphan designation: Enzastaurin hydrochloride for the: Treatment of diffuse large B-cell lymphoma, 20/03/2007, Positive
16/10/2020 Orphan designation: Enzastaurin hydrochloride for the: Treatment of glioma, 23/12/2005, Positive
16/10/2020 Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 17, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 9, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility, Hypogonadism, 02/05/1996, 29, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine hydrochloride, Cystinosis, 18/01/2017, Orphan, 7, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Praxbind, idarucizumab, Hemorrhage, 20/11/2015, Accelerated assessment, 8, Authorised
16/10/2020 Human medicines European public assessment report (EPAR): Tracleer, bosentan (as monohydrate), Scleroderma, Systemic, Hypertension, Pulmonary, 14/05/2002, 39, Authorised
16/10/2020 Summary of opinion: Recarbrio, imipenem, cilastatin, relebactam, 15/10/2020, Positive
16/10/2020 Summary of opinion: Lenalidomide Mylan, lenalidomide, 15/10/2020, Positive
16/10/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
16/10/2020 Summary of opinion: Dupixent, dupilumab, 15/10/2020, Positive
16/10/2020 Summary of opinion: Tremfya, guselkumab, 15/10/2020, Positive
16/10/2020 Summary of opinion: Plegridy, peginterferon beta-1a, 15/10/2020, Positive
16/10/2020 Summary of opinion: Oxlumo, 15/10/2020, Positive
16/10/2020 Summary of opinion: Fintepla, 15/10/2020, Positive
16/10/2020 Summary of opinion: Libmeldy, 15/10/2020, Positive
16/10/2020 Summary of opinion: Forxiga, dapagliflozin, 15/10/2020, Positive
16/10/2020 Summary of opinion: Edistride, dapagliflozin, 15/10/2020, Positive
16/10/2020 Summary of opinion: Blincyto, blinatumomab, 15/10/2020, Positive
16/10/2020 Summary of opinion: Leqvio, 15/10/2020, Positive
16/10/2020 Summary of opinion: Opdivo, nivolumab, 15/10/2020, Positive
16/10/2020 News and press releases: First treatment for rare condition primary hyperoxaluria type 1