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September 2017

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22/09/2017Minutes of the PRAC meeting 3-6 July 2017
22/09/2017Human medicines European public assessment report (EPAR): Vosevi,

sofosbuvir / velpatasvir / voxilaprevi

Revision: 0, Authorised
22/09/2017Regulatory and procedural guideline: EudraVigilance technical support plan for national competent authorities in the EEA (updated)
22/09/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 25, Authorised
22/09/2017Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP) (updated)
22/09/2017Summary 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’ (v.1.3)
22/09/2017External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (updated)
22/09/2017Regulatory 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 (version 1.3), adopted
22/09/2017Agenda: Agenda - Public hearing: Valproate
22/09/2017Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 34, Authorised
22/09/2017Human medicines European public assessment report (EPAR): Insulin lispro Sanofi,

insulin lispro

Revision: 0, Authorised
21/09/2017Agenda: Agenda – Industry and assessors’ joint training on the explanatory note to GVP Module VII and the Q&A for assessors (updated)
21/09/2017Carbidopa / levodopa (except for centrally authorised product): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000548/201610 (updated)
21/09/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn PRRS MLV,

Porcine respiratory and reproductive syndrome virus vaccine (live)

Revision: 0, Authorised
21/09/2017Human medicines European public assessment report (EPAR): Skilarence,

dimethyl fumarate

Revision: 0, Authorised
21/09/2017Human medicines European public assessment report (EPAR): Alprolix,

eftrenonacog alfa

Revision: 2, Authorised
21/09/2017Human medicines European public assessment report (EPAR): Zoledronic Acid Accord,

zoledronic acid

Revision: 4, Authorised
21/09/2017Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD,

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus

Revision: 0, Authorised
21/09/2017Human medicines European public assessment report (EPAR): Vedrop,

tocofersolan

Revision: 10, Authorised
20/09/2017Report: List of products granted eligibility to PRIME (updated)
20/09/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 11-14 September 2017, adopted
20/09/2017PRIME: priority medicines (updated)
20/09/2017Agenda: Agenda – Eleventh stakeholder forum on the pharmacovigilance legislation (updated)
20/09/2017Eleventh stakeholder forum on the pharmacovigilance legislation, European Medicines Agency, London, UK, From: 21-Sep-2017, To: 21-Sep-2017 (updated)
20/09/2017European Medicines Agency response to European Ombudsman regarding pre-submission activities
20/09/2017Human medicines European public assessment report (EPAR): Zontivity,

vorapaxar

Revision: 2, Withdrawn
20/09/2017Human medicines European public assessment report (EPAR): Hetlioz,

tasimelteon

Revision: 2, Authorised
20/09/2017Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 11, Authorised
20/09/2017Human medicines European public assessment report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 20, Authorised
20/09/2017Scientific guideline: Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version, adopted
20/09/2017Clinical investigation of medicinal products in the treatment of chronic heart failure (updated)
20/09/2017Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2, adopted
20/09/2017Clinical investigation of new medicinal products for the treatment of acute coronary syndrome (updated)
20/09/2017European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines, European Medicines Agency, London, United Kingdom, From: 01-Dec-2017, To: 01-Dec-2017
20/09/2017Agenda: Agenda and registration form - EMA/DIA statistics forum: The role of observational data in assessing the benefits and risks of drugs
19/09/2017Human medicines European public assessment report (EPAR): Invega,

paliperidone

Revision: 13, Authorised
19/09/2017Plasma-master-file certifications (updated)
19/09/2017Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 6, Authorised
19/09/2017Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm,

levetiracetam

Revision: 7, Authorised
19/09/2017Human medicines European public assessment report (EPAR): Ruconest,

conestat alfa

Revision: 7, Authorised
19/09/2017Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017 (updated)
19/09/2017Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development , European Medicines Agency, London, UK, From: 03-May-2018, To: 04-May-2018
19/09/2017Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 16, Authorised
19/09/2017Human medicines European public assessment report (EPAR): Ofev,

nintedanib

Revision: 5, Authorised
19/09/2017Minutes of the CVMP meeting of 11-13 July 2017
19/09/2017Agenda: Agenda - HMPC agenda of the 18-19 September 2017 meeting
19/09/2017Veterinary medicine European public assessment report (EPAR): Circovac,

adjuvanted inactivated vaccine against porcine circovirus type 2

Revision: 9, Authorised
19/09/2017European Medicines Agency information day on measuring the impact of pharmacovigilance activities, European Medicines Agency, London, UK, From: 14-Nov-2017, To: 14-Nov-2017 (updated)
19/09/2017Agenda: Programme and registration form - European Medicines Agency information day on measuring the impact of pharmacovigilance activities, 14 November 2017 (updated)
19/09/2017Veterinary medicine European public assessment report (EPAR): Cerenia,

maropitant

Revision: 18, Authorised
19/09/2017Veterinary medicine European public assessment report (EPAR): Letifend,

canine leishmaniasis vaccine (recombinant protein)

Revision: 3, Authorised
18/09/2017Human medicines European public assessment report (EPAR): Zarzio,

filgrastim

Revision: 13, Authorised
18/09/2017Veterinary medicine European public assessment report (EPAR): Vepured,

E. coli verotoxoid vaccine (inactivated recombinant)

Revision: 0, Authorised
18/09/2017Pre-authorisation guidance (updated)
18/09/2017Human medicines European public assessment report (EPAR): Reagila,

cariprazine

Revision: 0, Authorised
18/09/2017Felbamate: List of nationally authorised medicinal products - PSUSA/00010155/201609
18/09/2017Felbamate: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -PSUSA/00010155/201609
18/09/2017Second EMA-EFPIA annual bilateral meeting, European Medicines Agency, London, UK, From: 10-Jul-2017, To: 10-Jul-2017 (updated)
18/09/2017First European Medicines Agency-EuropaBio annual bilateral meeting, European Medicines Agency, London, UK, From: 09-Jun-2017, To: 09-Jun-2017 (updated)
18/09/2017Mandate, objectives and rules of procedure for the CVMP Scientific Advice Working Party (updated)
18/09/2017Data requirements for multi-strain dossiers for Inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD) (updated)
18/09/2017Scientific guideline: Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - Revision 1, draft: consultation open
18/09/2017Questions and answers on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD)
18/09/2017Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 10, Authorised
18/09/2017Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 35, Authorised
18/09/2017Presentation - Summary of product characteristics: What is it and what does it contain? (updated)
18/09/2017Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated)
18/09/2017Q&A: Transfer (updated)
18/09/2017Agenda: Agenda - PDCO agenda of the 12-15 September 2017 meeting
18/09/2017Human medicines European public assessment report (EPAR): Gardasil,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 37, Authorised
18/09/2017Human medicines European public assessment report (EPAR): Silgard,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 32, Authorised
15/09/2017Patients' and Consumers' Working Party (updated)
15/09/2017Pending EC decision: Benlysta,

belimumab

Opinion date: 14-Sep-2017
15/09/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017
15/09/2017Withdrawn application: Fulphila, Initial authorisation
15/09/2017Withdrawn application: Opdivo,

nivolumab

Post-authorisation
15/09/2017Pending EC decision: Zubsolv, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Nyxoid, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Tasigna,

nilotinib

Opinion date: 14-Sep-2017
15/09/2017Withdrawn application: Ogivri, Initial authorisation
15/09/2017Withdrawn application: Tigecycline Accord, Initial authorisation
15/09/2017Pending EC decision: Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: VeraSeal, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Tookad, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Firazyr,

icatibant

Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Miglustat Gen.Orph, Opinion date: 14-Sep-2017
15/09/2017Scientific advice and protocol assistance adopted during the CHMP meeting 11 – 14 September 2017, adopted
15/09/2017Pending EC decision: Cyltezo, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Ritonavir Mylan, Opinion date: 14-Sep-2017
15/09/2017Start of community reviews - CHMP meeting of 11-14 September 2017
15/09/2017Pending EC decision: Ontruzant, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech,

human IgG1 monoclonal antibody specific for human interleukin-1 alpha

Opinion date: 14-Sep-2017 (updated)
15/09/2017Pending EC decision: Masipro,

masitinib

Opinion date: 14-Sep-2017 (updated)
15/09/2017Pending EC decision: Tremfya, Opinion date: 14-Sep-2017
15/09/2017News and press releases: Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes
15/09/2017Referral: Article 30 referrals, Scandonest and associated names
15/09/2017Pending EC decision: Elebrato Ellipta, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Adlumiz,

anamorelin

Opinion date: 14-Sep-2017 (updated)
15/09/2017Pending EC decision: Imatinib Teva B.V., Opinion date: 14-Sep-2017
15/09/2017Referral: Article 31 referrals, Factor VIII (updated)
15/09/2017Pending EC decision: Trelegy Ellipta, Opinion date: 14-Sep-2017
15/09/2017Pending EC decision: Zejula, Opinion date: 14-Sep-2017
14/09/2017Human medicines European public assessment report (EPAR): Karvea,

irbesartan

Revision: 35, Authorised
14/09/2017Withdrawn application: Somnena, Initial authorisation
14/09/2017Human medicines European public assessment report (EPAR): Qutenza,

capsaicin

Revision: 11, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Victoza,

liraglutide

Revision: 17, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Luveris,

lutropin alfa

Revision: 18, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / human von willebrand factor

Revision: 8, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 6, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Thorinane,

enoxaparin sodium

Revision: 2, Authorised
14/09/2017Human medicines European public assessment report (EPAR): Intanza,

influenza vaccine (split virion, inactivated)

Revision: 18, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 21, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Docetaxel Kabi,

docetaxel

Revision: 8, Authorised
13/09/2017Questions and answers: Good manufacturing practice (updated)
13/09/2017Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 6, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Cerezyme,

imiglucerase

Revision: 22, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Clopidogrel Krka,

clopidogrel

Revision: 10, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Tepadina,

thiotepa

Revision: 10, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 10, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group),

pioglitazone

Revision: 6, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Clopidogrel TAD,

clopidogrel

Revision: 7, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Docetaxel Accord,

docetaxel

Revision: 8, Authorised
13/09/2017Human medicines European public assessment report (EPAR): Afinitor,

everolimus

Revision: 19, Authorised
13/09/2017Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus,

indoxacarb / permethrin

Revision: 5, Authorised
12/09/2017Agenda: Agenda - CHMP agenda of the 11-14 September 2017 meeting (updated)
12/09/2017Report: Medicinal products for human use: monthly figures - August 2017
12/09/2017Agenda: CHMP ORGAM agenda for the meeting on 4 September 2017
12/09/2017Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 25, Authorised
12/09/2017News and press releases: Raising awareness of the perils of antimicrobial resistance
11/09/2017Iron / parenteral preparations : List of nationally authorised medicinal products - PSUSA/00010236/201701
11/09/2017Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 37, Authorised
11/09/2017News and press releases: How the EU regulates medicines
08/09/2017Human medicines European public assessment report (EPAR): Mavenclad,

cladribine

Revision: 0, Authorised
08/09/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
08/09/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 2017
08/09/2017Pending EC decision: Oxybee, Opinion date: 07-Sep-2017
08/09/2017Pending EC decision: Nobivac LeuFel, Opinion date: 07-Sep-2017
08/09/2017Pending EC decision: Bovilis Blue-8, Opinion date: 07-Sep-2017
08/09/2017Pending EC decision: Simparica,

sarolaner

Opinion date: 07-Sep-2017
08/09/2017Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator (updated)
08/09/2017Beclometasone: List of nationally authorised medicinal products - PSUSA/00000306/201612
08/09/2017Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis: List of nationally authorised medicinal products - PSUSA/00010465/201612
08/09/2017Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/201611
08/09/2017Idarubicin : List of nationally authorised medicinal products - PSUSA/00001720/201611
08/09/2017Furosemide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001493/201612
08/09/2017Beclometasone / salbutamol : List of nationally authorised medicinal products - PSUSA/00000309/201701
08/09/2017Scientific guideline: Guideline on core SmPC and Package Leaflet for (68Ge/68Ga) generator - First version, adopted
07/09/2017Agenda: Agenda - CAT agenda of the 6-8 September 2017 meeting
07/09/2017Veterinary medicine European public assessment report (EPAR): Bovela,

bovine viral diarrhoea vaccine (modified, live)

Revision: 2, Authorised
07/09/2017Veterinary medicine European public assessment report (EPAR): Ingelvac CircoFLEX,

inactivated porcine circovirus vaccine

Revision: 13, Authorised
07/09/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 11, Authorised
07/09/2017Varicella zoster-immunoglobulin : List of nationally authorised medicinal products - PSUSA/00010266/201612
07/09/2017Human medicines European public assessment report (EPAR): Lonsurf,

trifluridine / tipiracil

Revision: 2, Authorised
07/09/2017Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 4, Authorised
07/09/2017Cefazolin: List of nationally authorised medicinal products - PSUSA/00000589/201611
07/09/2017Brotizolam: List of nationally authorised medicinal products - PSUSA/00000444/201612
07/09/2017Pergolide: List of nationally authorised medicinal products - PSUSA/00002351/201612
07/09/2017Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
07/09/2017Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 23, Authorised
07/09/2017Veterinary medicine European public assessment report (EPAR): Novem,

meloxicam

Revision: 11, Authorised
07/09/2017Veterinary medicine European public assessment report (EPAR): Ingelvac PCV FLEX,

Porcine circovirus vaccine (inactivated)

Revision: 1, Authorised
07/09/2017Veterinary medicine European public assessment report (EPAR): ProZinc,

insulin human

Revision: 6, Authorised
07/09/2017Human medicines European public assessment report (EPAR): Betaferon,

interferon beta-1b

Revision: 29, Authorised
07/09/2017Human medicines European public assessment report (EPAR): Rasilez HCT,

aliskiren / hydrochlorothiazide

Revision: 12, Authorised
06/09/2017Escitalopram : List of nationally authorised medicinal products - PSUSA/00001265/201612
06/09/2017Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/201611
06/09/2017Amlodipine lisinopril : List of nationally authorised medicinal products - PSUSA/00010192/201612
06/09/2017Antithrombin iii : List of nationally authorised medicinal products - PSUSA/00003159/201612
06/09/2017Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201701 (updated)
06/09/2017Testosterone undecanoate (injection): List of nationally authorised medicinal products - PSUSA/00010161/201612
06/09/2017Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201701
06/09/2017Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/201701
06/09/2017Aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin... : List of nationally authorised medicinal products - PSUSA/00010346/201611
06/09/2017Ciprofibrate: List of nationally authorised medicinal products - PSUSA/00000771/201612
06/09/2017Chlormadinone acetate / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00000679/201611
06/09/2017Indapamide / perindopril: List of nationally authorised medicinal products - PSUSA/00010230/201611
06/09/2017Citalopram: List of nationally authorised medicinal products - PSUSA/00000779/201612
06/09/2017Dienogest : List of nationally authorised medicinal products - PSUSA/00003167/201612
06/09/2017Report: Applications for new human medicines under evaluation by the CHMP: September 2017
06/09/2017Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 45, Authorised
06/09/2017Presentation - Introduction: summary of product characteristics (SmPC)
06/09/2017Resources for healthcare professionals (updated)
06/09/2017Presentation - Summary of product characteristics (SmPC)
06/09/2017Ursodeoxycholic acid : List of nationally authorised medicinal products - PSUSA/00003084/201611
06/09/2017Lubiprostone : List of nationally authorised medicinal products - PSUSA/00010290/201701
06/09/2017Human medicines European public assessment report (EPAR): Nimenrix,

meningococcal group A, C, W 135 and Y conjugate vaccine

Revision: 19, Authorised
05/09/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 13, Authorised
05/09/2017Human medicines European public assessment report (EPAR): Ledaga,

chlormethine

Revision: 1, Authorised
05/09/2017Orphan designation:

Sorafenib tosylate

for the: Treatment of hepatocellular carcinoma (updated)
05/09/2017Orphan designation:

Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate

for the: Treatment of pulmonary arterial hypertension (updated)
05/09/2017Orphan designation:

Lutetium (177Lu) edotreotide

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours (updated)
05/09/2017Agenda: Agenda - CVMP agenda of the 5-7 September 2017 meeting
05/09/2017Newsletter: Human medicines highlights - September 2017
05/09/2017Rupatadine: List of nationally authorised medicinal products - PSUSA/00002673/201612
05/09/2017Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201701
05/09/2017European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 20-Sep-2017, To: 20-Sep-2017
05/09/2017Agenda: Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
05/09/2017Agenda: Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial resistance
05/09/2017EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial resistance, European Medicines Agency, London, UK, From: 19-Sep-2017, To: 19-Sep-2017
05/09/2017Human medicines European public assessment report (EPAR): Rolufta,

umeclidinium

Revision: 1, Authorised
05/09/2017Yellow fever vaccine: List of nationally authorised medicinal products - PSUSA/00003135/201612
05/09/2017Magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001926/201610
05/09/2017Magnesium hydroxide: List of nationally authorised medicinal products - PSUSA/00001926/201610
05/09/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 15–18 August 2017
05/09/2017Domperidone: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001158/201611
05/09/2017Domperidone: List of nationally authorised medicinal products - PSUSA/00001158/201611
05/09/2017Minutes of the CAT meeting 15-16 June 2017
05/09/2017CVMP interested parties' meeting, European Medicines Agency, London, UK, From: 06-Sep-2017, To: 06-Sep-2017
05/09/2017Human medicines European public assessment report (EPAR): Izba,

travoprost

Revision: 2, Authorised
05/09/2017Agenda: Agenda - CVMP interested parties’ meeting
05/09/2017Agenda: Agenda - COMP agenda of the 5-7 September 2017 meeting
04/09/2017Application form for variation to Article 58 CHMP scientific opinion (updated)
04/09/2017Regulatory and procedural guideline: European Medicines Agency procedural advice on medicinal products intended exclusively for markets outside the Community under Article 58 of Regulation (EC) No 726/2004 in the context of cooperation with the World Health Organization (updated)
04/09/2017Sulbactam: List of nationally authorised medicinal products - PSUSA/00002800/201611
04/09/2017Terbutaline: List of nationally authorised medicinal products - PSUSA/00002897/201612
04/09/2017Tibolone: List of nationally authorised medicinal products - PSUSA/00002947/201612
04/09/2017Amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil) / with or without electrolytes / mineral compounds (i.v. application) - only for the drug Numeta: List of nationally authorised medicinal products - PSUSA/00010190/201612
04/09/2017Vecuronium bromide: List of nationally authorised medicinal products - PSUSA/00003102/201611
04/09/2017Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
04/09/2017Human medicines European public assessment report (EPAR): Avamys,

fluticasone furoate

Revision: 17, Authorised
04/09/2017Human medicines European public assessment report (EPAR): Mimpara,

cinacalcet

Revision: 18, Authorised
04/09/2017Human medicines European public assessment report (EPAR): SomaKit TOC,

edotreotide

Revision: 2, Authorised
04/09/2017News and press releases: Reporting side effects of medicines
04/09/2017Veterinary medicine European public assessment report (EPAR): Activyl,

indoxacarb

Revision: 7, Authorised
04/09/2017Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
04/09/2017Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 8, Authorised
04/09/2017Human medicines European public assessment report (EPAR): Rapilysin,

reteplase

Revision: 23, Authorised
04/09/2017New vacancy: Temporary Agent (AD8), Scientific Administrator, Paediatric oncology
04/09/2017Administrative information Application form for a Scientific Opinion according to Article 58 of Regulation (EC) 726/2004 , adopted (updated)
01/09/2017Emerging safety issues (ESI) contact points at the national competent authority (NCA) level
01/09/2017Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 11, Authorised
01/09/2017Herbal medicinal products: Prunus, Pruni africanae cortex, Prunus africana (Hook f.) Kalkm. (updated)
01/09/2017News and press releases: Facilitating submission of post-approval data
01/09/2017Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi,

pemetrexed

Revision: 2, Authorised
01/09/2017Follow up information session on the TransCelerate initiative, European Medicines Agency, London, UK, From: 22-Sep-2017, To: 22-Sep-2017
01/09/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017
01/09/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
01/09/2017Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 5, Authorised
01/09/2017Human medicines European public assessment report (EPAR): Lenvima,

lenvatinib

Revision: 3, Authorised
01/09/2017Human medicines European public assessment report (EPAR): Zavesca,

miglustat

Revision: 25, Authorised
01/09/2017Organisation chart: Veterinary Medicines (updated)