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30/11/2018 Agenda: Agenda - COMP agenda of the 4-6 December 2018 meeting
30/11/2018 Other: Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004
30/11/2018 Other: CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004
30/11/2018 Other: EudraVigilance registration documents
30/11/2018 Regulatory and procedural guideline: Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
30/11/2018 Regulatory and procedural guideline: Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
30/11/2018 Human medicines European public assessment report (EPAR): Synflorix, pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18c / pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f / pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 5 / pneumococcal polysaccharide serotype 6b / pneumococcal polysaccharide serotype 7f / pneumococcal polysaccharide serotype 9v, Pneumococcal Infections, Immunization, 29/03/2009, 31, Authorised
30/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, PM: decision on the application for modification of an agreed PIP, P/0230/2018
30/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, PM: decision on the application for modification of an agreed PIP, P/0231/2018
30/11/2018 News and press releases: Revised guideline to assess risk of human medicines for the environment
30/11/2018 News and press releases: Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30/11/2018 News and press releases: Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018
30/11/2018 Environmental risk assessment of medicinal products for human use
30/11/2018 Scientific guideline: Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1
30/11/2018 Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3
30/11/2018 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesylate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, Additional monitoring, 8, Authorised
30/11/2018 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 17, Authorised
30/11/2018 Human medicines European public assessment report (EPAR): Evicel, human fibrinogen, human thrombin, Hemostasis, Surgical, 05/10/2008, 14, Authorised
29/11/2018 Committee meeting report: COMP meeting report on the review of applications for orphan designation: November 2018
29/11/2018 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 15, Authorised
29/11/2018 Minutes: Minutes of the PRAC meeting 1-4 October 2018
29/11/2018 News and press releases: Workshop: advancing regulatory science to 2025 for veterinary medicines
29/11/2018 Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel, Stroke, Peripheral Vascular Diseases, Myocardial Infarction, Acute Coronary Syndrome, 15/07/2008, 23, Authorised
29/11/2018 Human medicines European public assessment report (EPAR): Arixtra, fondaparinux sodium, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Angina, Unstable, 20/03/2002, 29, Authorised
29/11/2018 Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B, Hepatitis A, Immunization, 19/09/1996, 20, Authorised
29/11/2018 News and press releases: Five additional countries to benefit from EU-US mutual recognition agreement for inspections
29/11/2018 Human medicines European public assessment report (EPAR): Kivexa, abacavir, lamivudine, HIV Infections, 16/12/2004, 29, Authorised
29/11/2018 Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the: Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive
29/11/2018 Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018 , European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018
29/11/2018 Minutes: Minutes of the CHMP meeting 15-18 October 2018
29/11/2018 Scientific guideline: Guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - Revision 1
29/11/2018 Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
29/11/2018 Periodic safety update single assessment: Nomegestrol: List of nationally authorised medicinal products - PSUSA/00002181/201801
29/11/2018 Periodic safety update single assessment: Nomegestrol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002181/201801
28/11/2018 Standard Operating Procedure - SOP: Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status
28/11/2018 Standard Operating Procedure - SOP: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0151/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, PM: decision on the application for modification of an agreed PIP, P/0198/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0210/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, PM: decision on the application for modification of an agreed PIP, P/0182/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, PM: decision on the application for modification of an agreed PIP, P/0186/2018
28/11/2018 Other: UCUM units for E2B (R3) version 1.2
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi, Sofosbuvir, PM: decision on the application for modification of an agreed PIP, P/0172/2018
28/11/2018 European Medicines Agency EudraVigilance and signal management information day , Hilton Canary Wharf, London, UK, from 07/12/2018 to 07/12/2018
28/11/2018 Agenda: Agenda and registration form - European Medicines Agency EudraVigilance and signal management information day
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Spherox, spheroids of human autologous matrix-associated chondrocytes, PM: decision on the application for modification of an agreed PIP, P/0161/2018
28/11/2018 Other: EudraVigilance support guide
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Zinforo, Ceftaroline fosamil, PM: decision on the application for modification of an agreed PIP, P/0176/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri, pixantrone (dimaleate), W: decision granting a waiver in all age groups for all conditions/indications, P/0227/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast, PM: decision on the application for modification of an agreed PIP, P/0163/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, PM: decision on the application for modification of an agreed PIP, P/0159/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): trandolapril, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0192/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): moxonidine, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0228/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Verapamil / trandolapril, W: decision granting a waiver in all age groups for all conditions/indications, P/0162/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, W: decision granting a waiver in all age groups for all conditions/indications, P/0134/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Andecaliximab, W: decision granting a waiver in all age groups for all conditions/indications, P/0169/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): eszopiclone, W: decision granting a waiver in all age groups for all conditions/indications, P/0133/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Patidegib, W: decision granting a waiver in all age groups for all conditions/indications, P/0218/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), PM: decision on the application for modification of an agreed PIP, P/0212/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Arimoclomol (citrate), PM: decision on the application for modification of an agreed PIP, P/0213/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Epclusa, Sofosbuvir,velpatasvir, PM: decision on the application for modification of an agreed PIP, P/0150/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0171/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0146/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): vonicog alfa, PM: decision on the application for modification of an agreed PIP, P/0225/2018
28/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): nitrous oxide, W: decision granting a waiver in all age groups for all conditions/indications, P/0217/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0219/2018
27/11/2018 Report: Annual report of the Good Clinical Practice Inspectors Working Group 2017
27/11/2018 Periodic safety update single assessment: Enoxaparin (except for biosimilars): List of nationally authorised products - PSUSA/00010560/201804
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Isatuximab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0156/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA), RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0184/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ravicti, Glycerol phenylbutyrate, PM: decision on the application for modification of an agreed PIP, P/0191/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Hetlioz, tasimelteon, PM: decision on the application for modification of an agreed PIP, P/0215/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), PM: decision on the application for modification of an agreed PIP, P/0214/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, PM: decision on the application for modification of an agreed PIP, P/0199/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): brodalumab, PM: decision on the application for modification of an agreed PIP, P/0189/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Parsabiv, Etelcalcetide, PM: decision on the application for modification of an agreed PIP, P/0173/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split influenza virus, inactivated containing antigens equivalent to the B-like strain, W: decision granting a waiver in all age groups for all conditions/indications, P/0155/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Dasiglucagon, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0220/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Setmelanotide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0164/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor, PM: decision on the application for modification of an agreed PIP, P/0205/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, W: decision granting a waiver in all age groups for all conditions/indications, P/0145/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Bimekizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0193/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0207/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant IgG degrading enzyme of Streptococcus pyogenes, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0229/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Trajenta, linagliptin, PM: decision on the application for modification of an agreed PIP, P/0204/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Itacitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0208/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Lubiprostone, PM: decision on the application for modification of an agreed PIP, P/0175/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil, PM: decision on the application for modification of an agreed PIP, P/0144/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant, PM: decision on the application for modification of an agreed PIP, P/0188/2018
27/11/2018 Minutes: Minutes - 15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban, PM: decision on the application for modification of an agreed PIP, P/0154/2018
27/11/2018 15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting , Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban, PM: decision on the application for modification of an agreed PIP, P/0153/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0157/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, PM: decision on the application for modification of an agreed PIP, P/0211/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0180/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen,Paracetamol, W: decision granting a waiver in all age groups for all conditions/indications, P/0135/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0209/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Somapacitan, W: decision granting a waiver in all age groups for all conditions/indications, P/0178/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine,tenofovir alafenamide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0139/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0187/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, W: decision granting a waiver in all age groups for all conditions/indications, P/0202/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Delafloxacin, W: decision granting a waiver in all age groups for all conditions/indications, P/0148/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Fostamatinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0195/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Sutent, sunitinib, PM: decision on the application for modification of an agreed PIP, P/0147/2018
27/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Ligelizumab, PM: decision on the application for modification of an agreed PIP, P/0221/2018
26/11/2018 Agenda: Agenda - PRAC draft agenda of meeting 26-29 November 2018
26/11/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: October 2018
26/11/2018 Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation
26/11/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC
26/11/2018 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC meeting
26/11/2018 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised
26/11/2018 Template or form: Template for notification of change of the paediatric-investigation-plan / waiver applicant / addressee
26/11/2018 Agenda: Agenda - Multi-stakeholder workshop with the HMA/EMA task force on availability of authorised medicines
23/11/2018 Scientific guideline: Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
23/11/2018 Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
23/11/2018 Scientific guideline: Reflection paper on the qualification of non-genotoxic impurities
23/11/2018 Qualification of non-genotoxic impurities
23/11/2018 Access to documents
23/11/2018 Other: Policy/0043: European Medicines Agency policy on access to documents
23/11/2018 Regulatory and procedural guideline: Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use
23/11/2018 Newsletter: News bulletin for small and medium-sized enterprises - Issue 45
23/11/2018 Human medicines European public assessment report (EPAR): Leflunomide ratiopharm, leflunomide, Arthritis, Rheumatoid, 28/11/2010, Generic, 13, Authorised
22/11/2018 Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax) for the: Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), PM: decision on the application for modification of an agreed PIP, P/0185/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, PM: decision on the application for modification of an agreed PIP, P/0158/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir / paritaprevir / ritonavir, PM: decision on the application for modification of an agreed PIP, P/0179/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Exviera, Dasabuvir (sodium monohydrate), PM: decision on the application for modification of an agreed PIP, P/0174/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant varicella zoster virus (VZV) glycoprotein E, PM: decision on the application for modification of an agreed PIP, P/0222/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Cotellic, Cobimetinib, PM: decision on the application for modification of an agreed PIP, P/0216/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Adenuric, febuxostat, W: decision granting a waiver in all age groups for all conditions/indications, P/0226/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Sirolimus, PM: decision on the application for modification of an agreed PIP, P/0197/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), PM: decision on the application for modification of an agreed PIP, P/0223/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Velphoro, Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), PM: decision on the application for modification of an agreed PIP, P/0196/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0200/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0201/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0165/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0142/2018
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, W: decision granting a waiver in all age groups for all conditions/indications, P/0206/2018
22/11/2018 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/0190/2018
22/11/2018 Scientific guideline: Draft guideline on the non-clinical requirements for radiopharmaceuticals - First version
22/11/2018 Opinion/decision on a Paediatric investigation plan (PIP): Orencia, Abatacept, W: decision granting a waiver in all age groups for all conditions/indications, P/0183/2018
22/11/2018 Non-clinical requirements for radiopharmaceuticals
22/11/2018 Newsletter: Human medicines highlights - November 2018
22/11/2018 Paediatric Committee (PDCO): 16-19 October 2018 , European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018
22/11/2018 Orphan designation: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor (tezacaftor and ivacaftor) for the: Treatment of cystic fibrosis, 27/02/2017, Positive
22/11/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 16-19 October 2018
21/11/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 November 2018
21/11/2018 Off-label use of antimicrobials in veterinary medicine in the European Union
21/11/2018 Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP...
21/11/2018 Scientific guideline: Overview of comments received on 'Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union' (EMA/CVMP/AWP/237294/2017) - First version
21/11/2018 Scientific guideline: Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version
21/11/2018 Agenda: Agenda - HMPC agenda of the 19-20 November 2018 meeting
21/11/2018 Scientific guideline: Draft reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
21/11/2018 Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
21/11/2018 Modelling and simulation: questions and answers
21/11/2018 News and press releases: Towards electronic product information for EU medicines
20/11/2018 News and press releases: Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications
19/11/2018 News and press releases: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
19/11/2018 Human medicines European public assessment report (EPAR): Trobalt, retigabine, Epilepsy, 27/03/2011, 12, Withdrawn
19/11/2018 Periodic safety update single assessment: Ioxaglic acid: List of nationally authorised medicinal products - PSUSA/00001777/201802
19/11/2018 Periodic safety update single assessment: BCG (bacillus calmette-guérin) for immunotherapy: List of nationally authorised medicinal products - PSUSA/00000303/201803
19/11/2018 Periodic safety update single assessment: Aprotinin: List of nationally authorised medicinal products - PSUSA-00000230-201802
19/11/2018 Draft reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
19/11/2018 Sodium laurilsulfate
19/11/2018 Scientific guideline: Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use
19/11/2018 Report: Sodium laurilsulfate used as an excipient - Report published in support of the ‘Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use’
19/11/2018 Aspartame and phenylalanine
19/11/2018 Scientific guideline: Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use
19/11/2018 Dextrans
19/11/2018 Excipients labelling
19/11/2018 Proline
19/11/2018 Polysorbates
19/11/2018 Scientific guideline: Draft information for the package leaflet regarding proline used as an excipient in medicinal products for human use
19/11/2018 Scientific guideline: Draft information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use
19/11/2018 Lactose
19/11/2018 Scientific guideline: Draft information for the package leaflet regarding lactose used as an excipient in medicinal products for human use
19/11/2018 Scientific guideline: Draft information for the package leaflet regarding dextrans used as excipients in medicinal products for human use
16/11/2018 News and press releases: Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
16/11/2018 Periodic safety update single assessment: Levonorgestrel: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001856/201712
16/11/2018 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
16/11/2018 Summary of opinion: Macimorelin Aeterna Zentaris, macimorelin, 15/11/2018, Positive
16/11/2018 Withdrawn application: Tecentriq, atezolizumab, Date of withdrawal: 22/10/2018, Post-authorisation
16/11/2018 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 12-15 November 2018
16/11/2018 News and press releases: CHMP recommends first oral-only treatment for sleeping sickness
16/11/2018 Scientific guideline: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 3
15/11/2018 Report: Medicinal products for human use: monthly figures - October 2018
15/11/2018 Report: Meeting summary - EMA Human Scientific’ Committees Working Party with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP) (25 September 2018)
15/11/2018 Scientific guideline: Draft guideline on the quality of water for pharmaceutical use
15/11/2018 Quality of water for pharmaceutical use
15/11/2018 Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease
15/11/2018 Scientific guideline: Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1)
15/11/2018 Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation , European Medicines Agency, London, UK, from 12/10/2018 to 12/10/2018
15/11/2018 Regulatory and procedural guideline: eSource Direct Data Capture (DDC) qualification opinion
15/11/2018 Human medicines European public assessment report (EPAR): Fertavid, follitropin beta, Infertility, Hypogonadism, 19/03/2009, 11, Authorised
14/11/2018 Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals), split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human, Immunization, Disease Outbreaks, 10/10/2009, Exceptional circumstances, 9, Authorised
14/11/2018 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 32, Authorised
14/11/2018 Agenda: Agenda - EU-Innovation network workshop with academia
14/11/2018 Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains for the: Treatment of multiple myeloma, 20/04/2017, Positive
14/11/2018 Periodic safety update single assessment: Levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001856/201712
14/11/2018 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/05/1998, 37, Authorised
13/11/2018 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility, Hypogonadism, 02/05/1996, 26, Authorised
13/11/2018 News and press releases: EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
13/11/2018 Risk assessment guideline focus group meeting , European Medicines Agency, London, UK, from 19/09/2018 to 19/09/2018
13/11/2018 Agenda: Agenda - PDCO agenda of the 13-16 November 2018 meeting
13/11/2018 Report: Report of Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products
13/11/2018 Other: Quality Review of Documents (QRD) working group plenary meeting dates
13/11/2018 Veterinary medicines European public assessment report (EPAR): Zolvix, monepantel, 04/11/2009, 13, Authorised
13/11/2018 Veterinary medicines European public assessment report (EPAR): BTVPUR AlSap 2-4, bluetongue-virus serotype-2 antigen, bluetongue-virus serotype-4 antigen, 04/11/2010, 4, Withdrawn
13/11/2018 News and press releases: EMA gives guidance on safety monitoring of medicines used in children
13/11/2018 Periodic safety update single assessment: Germanium (68Ge) chloride / gallium (68Ga) chloride: List of nationally authorised medicinal products - PSUSA/00010364/201803
13/11/2018 Agenda: Agenda - CAT agenda of the 7-8 November 2018 meeting
12/11/2018 Other: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure
12/11/2018 Minutes: CHMP ORGAM minutes for the meeting on 8 October 2018
12/11/2018 Agenda: CHMP ORGAM agenda for the meeting on 8 October 2018
12/11/2018 Human medicines European public assessment report (EPAR): Carmustine Obvius, carmustine, Hodgkin Disease, Lymphoma, Non-Hodgkin, 18/07/2018, Generic, 1, Authorised
12/11/2018 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) , European Medicines Agency, London, UK, from 25/09/2018 to 25/09/2018
12/11/2018 Human medicines European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover), clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 21, Authorised
12/11/2018 Minutes: Meeting summary - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP)
12/11/2018 Agenda: Agenda - CHMP agenda of the 12-15 November 2018 meeting
12/11/2018 Periodic safety update single assessment: Gemcitabine: List of nationally authorised medicinal products - PSUSA/00001519/201801
12/11/2018 Periodic safety update single assessment: Gemcitabine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001519/201801
12/11/2018 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201803
12/11/2018 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201803
12/11/2018 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201803
12/11/2018 Committee for Medicinal Products for Human Use (CHMP): 12-15 November 2018 , European Medicines Agency, London, UK, from 12/11/2018 to 15/11/2018
12/11/2018 Human medicines European public assessment report (EPAR): Xiliarx, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 16, Authorised
12/11/2018 Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 16, Authorised
12/11/2018 Human medicines European public assessment report (EPAR): Grastofil, filgrastim, Neutropenia, 17/10/2013, Biosimilar, 10, Authorised
09/11/2018 Human medicines European public assessment report (EPAR): Caelyx, doxorubicin hydrochloride, Sarcoma, Kaposi, Multiple Myeloma, Ovarian Neoplasms, Breast Neoplasms, 20/06/1996, 29, Authorised
09/11/2018 Veterinary medicines European public assessment report (EPAR): Cerenia, maropitant citrate, 28/09/2006, 19, Authorised
09/11/2018 Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 11, Authorised
09/11/2018 Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals' Organisations (HCPWP)
09/11/2018 Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and with Healthcare Professionals' Organisations (HCPWP)
09/11/2018 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals' Organisations (HCPWP) , European Medicines Agency, London, UK, from 26/09/2018 to 26/09/2018
09/11/2018 Other: List of participants of the European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting
09/11/2018 Other: List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
09/11/2018 Veterinary medicines European public assessment report (EPAR): Virbagen Omega, recombinant omega interferon of feline origin, 05/11/2001, 11, Authorised
09/11/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018
09/11/2018 Summary of opinion: CVMP post-authorisation summary of positive opinion for Aftovaxpur DOE
09/11/2018 Veterinary medicines European public assessment report (EPAR): Naxcel, ceftiofur, 19/05/2005, 14, Authorised
09/11/2018 Veterinary medicines European public assessment report (EPAR): Poulvac E. coli, Live aroA gene deleted Escherichia coli, type 078, strain EC34195, 15/06/2012, 8, Authorised
09/11/2018 Report: Report - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems
09/11/2018 CVMP: Agendas, minutes and reports
09/11/2018 Report: Applications for new human medicines under evaluation by the CHMP: November 2018
09/11/2018 Minutes: Minutes of the CVMP meeting of 9-11 October 2018
09/11/2018 Other: Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’
09/11/2018 Regulatory and procedural guideline: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use
09/11/2018 Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
09/11/2018 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated, adjuvanted): List of nationally authorised medicinal products - PSUSA/00010300/201803