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30/08/2019 Periodic safety update single assessment: Iron dextran: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010696/201901
30/08/2019 Periodic safety update single assessment: Iron dextran: List of nationally authorised medicinal products - PSUSA/00010696/201901
30/08/2019 Orphan designation: Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the: Treatment of acute myeloid leukaemia, 13/05/2011, Withdrawn
30/08/2019 Orphan designation: 2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}oxy)propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate for the: Treatment of acute myeloid leukaemia, 05/12/2008, Withdrawn
30/08/2019 Periodic safety update single assessment: Azathioprine: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00000275/201812
30/08/2019 Orphan designation: Treosulfan for the: Conditioning treatment prior to haematopoietic-progenitor-cell transplantation, 22/02/2004, Withdrawn
30/08/2019 Periodic safety update single assessment: Azathioprine: List of nationally authorised medicinal products - PSUSA/00000275/201812
30/08/2019 Orphan designation: 5'-CTG CCA CGT TCT CCT GC-(2' methoxy)A-(2' methoxy)C-(2' methoxy)C-3' for the: Treatment of myasthenia gravis, 21/06/2004, Withdrawn
30/08/2019 News and press releases: Global public meeting on draft ICH guideline on clinical trials
30/08/2019 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, Additional monitoring, 7, Authorised
30/08/2019 Committee for Advanced Therapies (CAT): 22-24 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/05/2019 to 24/05/2019
30/08/2019 Minutes: Minutes of the CAT meeting 22-24 May 2019
30/08/2019 Human medicines European public assessment report (EPAR): Daklinza, daclatasvir dihydrochloride, Hepatitis C, Chronic, 22/08/2014, Accelerated assessment, 15, Withdrawn
30/08/2019 Public Statement: Public statement on Daklinza: Expiry of the marketing authorisation in the European Union
29/08/2019 Human medicines European public assessment report (EPAR): Brimica Genuair, aclidinium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 11, Authorised
29/08/2019 Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major, 17/12/2004, 28, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 11, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Xeloda, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 02/02/2001, Patient safety, 24, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Posaconazole AHCL, posaconazole, Mycoses, 25/07/2019, Generic, Authorised
28/08/2019 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 2, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Vihuma, simoctocog alfa, Hemophilia A, 13/02/2017, Additional monitoring, 2, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, 7, Authorised
27/08/2019 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 4, Authorised
26/08/2019 Template or form: CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46
26/08/2019 Template or form: CHMP rapporteurs' assessment report for post-authorisation measures (PAMs)
26/08/2019 Minutes: Minutes of the CAT meeting 16-17 April 2019
26/08/2019 Human medicines European public assessment report (EPAR): Doxolipad, doxorubicin hydrochloride, Breast Neoplasms, Ovarian Neoplasms, 08/08/2019, Refused
26/08/2019 Newsletter: News bulletin for small and medium-sized enterprises - Issue 47
26/08/2019 Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A, von Willebrand Diseases, 12/08/2013, 13, Authorised
23/08/2019 Human medicines European public assessment report (EPAR): Twynsta, telmisartan, amlodipine, Hypertension, 07/10/2010, 10, Authorised
23/08/2019 Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Hemophilia A, 08/01/2018, Additional monitoring, 3, Authorised
23/08/2019 Herbal medicinal product: Avenae fructus, Avenae fructus, F: Assessment finalised
23/08/2019 Herbal medicinal product: Avenae herba, Avenae herba, F: Assessment finalised
23/08/2019 Herbal medicinal product: Myrrha, gummi-resina, Myrrha, gummi-resina, F: Assessment finalised
23/08/2019 Herbal medicinal product: Bursae pastoris herba, Bursae pastoris herba, F: Assessment finalised
23/08/2019 Orphan designation: Imetelstat sodium for the: Treatment of myelofibrosis, 14/12/2015, Positive
23/08/2019 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 30, Authorised
23/08/2019 News and press releases: New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
23/08/2019 Other: European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 4
22/08/2019 Herbal medicinal product: Polypodii rhizoma, Polypodii rhizoma, F: Assessment finalised
22/08/2019 Herbal medicinal product: Phaseoli fructus (sine semine), Phaseoli fructus (sine semine), F: Assessment finalised
22/08/2019 Herbal medicinal product: Rusci aculeati rhizoma, Rusci aculeati rhizoma, D: Draft under discussion
22/08/2019 Herbal medicinal product: Millefolii flos, Millefolii flos, F: Assessment finalised
22/08/2019 Herbal medicinal product: Leonuri cardiacae herba, Leonuri cardiacae herba, F: Assessment finalised
22/08/2019 Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Kidney Failure, Chronic, Anemia, Cancer, Blood Transfusion, Autologous, 16/07/1997, 28, Authorised
22/08/2019 Herbal medicinal product: Gentianae radix, Gentianae radix, F: Assessment finalised
22/08/2019 Herbal medicinal product: Fragariae folium, Fragariae folium, F: Assessment finalised
22/08/2019 Human medicines European public assessment report (EPAR): Nevirapine Teva, nevirapine, HIV Infections, 30/11/2009, Generic, 9, Authorised
22/08/2019 Human medicines European public assessment report (EPAR): Zutectra, human hepatitis-B immunoglobulin, Immunization, Passive, Hepatitis B, Liver Transplantation, 30/11/2009, 13, Authorised
22/08/2019 Referral: Lartruvo , olaratumab , Article 20 procedures, European Commission final decision, 31/01/2019, 19/07/2019, 22/08/2019
22/08/2019 Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Cholestasis, Vitamin E Deficiency, 23/07/2009, Additional monitoring, Exceptional circumstances, 13, Authorised
22/08/2019 General privacy statement
21/08/2019 Agenda: Agenda - CHMP agenda of the 19-22 August 2019 written procedure
21/08/2019 Other: Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
20/08/2019 Agenda: Agenda - PDCO agenda of the 20-23 August 2019 written procedure
20/08/2019 Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, Orphan, 17, Authorised
20/08/2019 Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, European Commission final decision, 31/01/2019, 02/04/2019, 20/08/2019
20/08/2019 Other: Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
20/08/2019 Human medicines European public assessment report (EPAR): Copalia, amlodipine (as besylate), valsartan, Hypertension, 15/01/2007, 23, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited), pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 24/04/2017, Generic, 6, Authorised
20/08/2019 Human medicines European public assessment report (EPAR): Hetlioz, tasimelteon, Sleep Disorders, Circadian Rhythm, 03/07/2015, Orphan, Additional monitoring, 4, Authorised
20/08/2019 European Medicines Agency and European Union payer community meeting , Zorginstituut Nederland, Diemen, The Netherlands, from 18/06/2019 to 18/06/2019
20/08/2019 Periodic safety update single assessment: Phloroglucinol, phloroglucinol trimethylphloroglucinol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010355/201809
20/08/2019 Periodic safety update single assessment: Phloroglucinol, phloroglucinol trimethylphloroglucinol: List of nationally authorised medicinal products - PSUSA/00010355/201809
19/08/2019 Orphan designation: Lonafarnib for the: Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive
19/08/2019 Orphan designation: Exendin (9-39) for the: Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 14/10/2016, Positive
19/08/2019 Orphan designation: Ubenimex for the: Treatment of pulmonary arterial hypertension, 21/03/2016, Positive
19/08/2019 Orphan designation: Lonafarnib for the: Treatment of hepatitis delta virus infection, 16/01/2014, Positive
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2019
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: March 2019
19/08/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: February 2019
19/08/2019 Biosimilar medicines: marketing authorisation
19/08/2019 Generic and hybrid applications
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes)
19/08/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
19/08/2019 Orphan designation: Sodium benzoate for the: Treatment of hyperargininaemia, 11/01/2016, Positive
19/08/2019 Orphan designation: Sodium benzoate for the: Treatment of argininosuccinic aciduria, 11/01/2016, Positive
19/08/2019 Orphan designation: Sodium thiosulfate for the: Treatment for calciphylaxis, 15/01/2015, Positive
19/08/2019 Orphan designation: Sodium nitrite for the: Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive
19/08/2019 Orphan designation: Diacerein for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
19/08/2019 Orphan designation: Heat-killed Mycobacterium obuense (whole cell) for the: Treatment of pancreatic cancer, 16/12/2014, Positive
19/08/2019 Orphan designation: Recombinant fragment of human surfactant protein-D for the: Prevention of bronchopulmonary dysplasia, 23/08/2017, Positive
19/08/2019 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for the: Prevention of delayed graft function after renal transplantation, 06/06/2010, Positive
16/08/2019 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 25, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 27, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma, Urticaria, 25/10/2005, 38, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 15, Authorised
16/08/2019 News and press releases: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
16/08/2019 Report: Medicinal products for human use: monthly figures - July 2019
16/08/2019 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests, Helicobacter Infections, 14/08/1997, 16, Authorised
16/08/2019 Human medicines European public assessment report (EPAR): Dukoral, recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera, Immunization, 28/04/2004, 13, Authorised
14/08/2019 Withdrawn application: Radicava, edaravone, Date of withdrawal: 24/05/2019, Initial authorisation
14/08/2019 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 25, Authorised
14/08/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2019
14/08/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 18/06/2019 to 20/06/2019
14/08/2019 Human medicines European public assessment report (EPAR): Azacitidine Celgene, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 02/08/2019, Authorised
13/08/2019 Paediatric Committee (PDCO): 26 February-1 March 2019 , European Medicines Agency, from 26/02/2019 to 01/03/2019
13/08/2019 Minutes: Minutes - PDCO minutes of the 26 February-01 March 2019 meeting
13/08/2019 News and press releases: EMA closed 15 August 2019
13/08/2019 Newsletter: Human medicines highlights - August 2019
13/08/2019 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 25, Authorised
13/08/2019 Veterinary medicines European public assessment report (EPAR): Bovalto Ibraxion, inactivated IBR virus, 09/03/2000, 10, Withdrawn
12/08/2019 Orphan designation: Zanubrutinib for the: Treatment of lymphoplasmacytic lymphoma, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of carbamoyl-phosphate synthase-1 deficiency, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of citrullinaemia type 1, 29/05/2019, Positive
12/08/2019 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 16, Authorised
12/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 April 2019
09/08/2019 Fingolimod product-specific bioequivalence guidance
09/08/2019 Scientific guideline: Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
09/08/2019 Newsletter: What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019
09/08/2019 Orphan designation: Relacorilant for the: Treatment of Cushing's syndrome, 29/05/2019, Positive
09/08/2019 Orphan designation: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide for the: Treatment of cystic fibrosis, 29/05/2019, Positive
09/08/2019 Orphan designation: Emixustat hydrochloride for the: Treatment of Stargardt's disease, 29/05/2019, Positive
09/08/2019 Orphan designation: Allogeneic skin-derived ABCB5-positive mesenchymal stem cells for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
09/08/2019 Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium for the: Treatment of pulmonary arterial hypertension, 29/05/2019, Positive
08/08/2019 Periodic safety update single assessment: Dextromethorphan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001009/201811
08/08/2019 Periodic safety update single assessment: Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201811
08/08/2019 Committee for Medicinal Products for Human Use (CHMP): 27-29 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 27/05/2019 to 29/05/2019
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 15 July 2019
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 20 May 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 July 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 17 June 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 20 May 2019
08/08/2019 Minutes: Minutes - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2019 to 04/07/2019
08/08/2019 Human medicines European public assessment report (EPAR): Hepsera, adefovir dipivoxil, Hepatitis B, Chronic, 06/03/2003, 26, Authorised
07/08/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0298/2016
07/08/2019 Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version
06/08/2019 Periodic safety update single assessment: Danaparoid: List of nationally authorised medicinal products - PSUSA/00000923/201812
06/08/2019 Periodic safety update single assessment: Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810
06/08/2019 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201810
06/08/2019 Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 19, Authorised
06/08/2019 Minutes: Minutes of the COMP meeting 15-17 April 2019
06/08/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC meeting
05/08/2019 Human medicines European public assessment report (EPAR): Docetaxel Teva, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 26/01/2010, Generic, 17, Authorised
05/08/2019 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, Additional monitoring, 20, Authorised
02/08/2019 Periodic safety update single assessment: Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201810
02/08/2019 Periodic safety update single assessment: Acitretin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000051/201810
02/08/2019 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/12/2009, 10, Authorised
02/08/2019 Human medicines European public assessment report (EPAR): Striascan, ioflupane (123i), Radionuclide Imaging, Dementia, Movement Disorders, 25/06/2019, Generic, Authorised
01/08/2019 Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis, Keratosis, Actinic, 23/08/2012, 8, Authorised
01/08/2019 Tritanrix HB H-W-3838
01/08/2019 Medicine for use outside EU: Tritanrix HB: Public statement on the withdrawal of the scientific opinion under Article 58
01/08/2019 Veterinary medicines European public assessment report (EPAR): Evicto, selamectin, 19/07/2019, Generic, Authorised
01/08/2019 European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting (May 2019) , European Medicines Agency, Amsterdam, the Netherlands, from 24/05/2019 to 24/05/2019
01/08/2019 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 11, Authorised