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December 2017

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21/12/2017Work plan for the Vaccine Working Party 2018
21/12/2017Minutes - PDCO minutes of the 10-13 October 2017 meeting
21/12/2017Questions and answers: Classification of changes for veterinary medicines
21/12/2017Veterinary medicine European public assessment report (EPAR): Bovela,

bovine viral diarrhoea vaccine (modified, live)

Revision: 3, Authorised
21/12/2017Veterinary medicine European public assessment report (EPAR): Nexgard Spectra,

afoxolaner / milbemycin oxime

Revision: 2, Authorised
21/12/2017Leaflet - Orphan medicines in the EU
21/12/2017News and press releases: Orphan medicines in the EU – leaving no-one behind
21/12/2017Human medicines European public assessment report (EPAR): Samsca,

tolvaptan

Revision: 6, Authorised
21/12/2017Veterinary medicine European public assessment report (EPAR): Virbagen Omega,

interferon (omega)

Revision: 10, Authorised
21/12/2017Orphan designation:

Humanised monoclonal antibody targeting interleukin-15

for the: Treatment of eosinophilic oesophagitis (updated)
21/12/2017Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 16, Authorised
21/12/2017News and press releases: End of year message from EMA’s Executive Director
21/12/2017Orphan designation:

6-Chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide (selisistat)

for the: Huntington’s disease (updated)
21/12/2017Orphan designation:

P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide

for the: Treatment of acute myeloid leukaemia (updated)
21/12/2017Orphan designation:

2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide

for the: Treatment of cystic fibrosis (updated)
21/12/2017Work plan for the Safety Working Party 2018
21/12/2017Work plan for the CHMP Biologics Working Party 2018
21/12/2017Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (updated)
21/12/2017Minutes of the HMPC 18-19 September 2017 meeting
21/12/2017Newsletter: What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017
21/12/2017Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017 (updated)
21/12/2017Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 (updated)
21/12/2017Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 November 2017, European Medicines Agency, London, UK, From: 07-Nov-2017, To: 09-Nov-2017 (updated)
21/12/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: November2017
20/12/2017Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.3 - Release notes (updated)
20/12/2017Questions and answers: Article 13 veterinary referral procedures
20/12/2017Questions and answers: Article 35 veterinary referral procedures
20/12/2017Questions and answers: Article 33(4) veterinary referral procedures
20/12/2017Regulatory and procedural guideline: Questions and answers on Article 34 veterinary referral procedures
20/12/2017Regulatory and procedural guideline: Questions and answers on Article 13 veterinary referral procedures
20/12/2017Regulatory and procedural guideline: Questions and answers on Article 35 veterinary referral procedures
20/12/2017Regulatory and procedural guideline: Questions and answers on Article 33(4) veterinary referral procedures
20/12/2017Pending EC decision: Aplidin,

plitidepsin

Opinion date: 14-Dec-2017
20/12/2017Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 17, Authorised
20/12/2017Agenda: Agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting
20/12/2017European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting, European Medicines Agency, London, UK, From: 20-Oct-2017, To: 20-Oct-2017
20/12/2017Minutes of the European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting
20/12/2017Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 42, Authorised
20/12/2017Promestriene (cream and vaginal capsules): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009271/201703
20/12/2017Promestriene (cream and vaginal capsules): List of nationally authorised medicinal products - PSUSA/00009271/201703
20/12/2017Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 11-14 December 2017
20/12/2017Report: List of products granted eligibility to PRIME (updated)
20/12/2017Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 29, Authorised
20/12/2017Ipratropium/salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00001781-201701 (updated)
20/12/2017Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 7, Authorised
20/12/2017News and press releases: European Medicines Agency closed 22 December 2017 to 2 January 2018
20/12/2017Scientific guideline: Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD), draft: consultation open
20/12/2017Qualification of novel methodologies for medicine development (updated)
20/12/2017Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 6, Authorised
20/12/2017Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 26, Authorised
20/12/2017News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications to EMA from January 2018
20/12/2017Herbal medicinal products: Olea, Oleae folium, Olea europaea L. (updated)
19/12/2017Human medicines European public assessment report (EPAR): Vemlidy,

tenofovir alafenamide

Revision: 1, Authorised
19/12/2017European database of suspected adverse drug reaction reports’ website (www.adrreports.eu): release notes v.1.0
19/12/2017Overview of comments received on “Reflection paper on Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products” (EMA/HMPC/300551/2015)
19/12/2017Agenda: Agenda - Meeting with Alliance for Regenerative Medicine
19/12/2017Meeting with Alliance for Regenerative Medicine, European Medicines Agency, London, UK, From: 14-Dec-2017, To: 14-Dec-2017
19/12/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
19/12/2017Decision of the Executive Director on a 1-year initiative for fee reductions for notifications of parallel distribution (updated)
19/12/2017The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union (updated)
19/12/2017Statement of the Committee for Medicinal Products for Veterinary Use position on the ethical use of animals in the testing, development and manufacture of veterinary medicines
19/12/2017Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting scientific advice (veterinary) (updated)
19/12/2017Incident management plan for medicines for veterinary use (updated)
19/12/2017Work plan for the CVMP Ad Hoc Group on Veterinary Novel Therapies 2018
19/12/2017Work plan for the CVMP Scientific Advice Working Party 2018
19/12/2017Work plan 2018 for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (J3RsWG)
19/12/2017Work plan for the CVMP Safety Working Party 2018
19/12/2017Work plan for the CVMP Immunologicals Working Party 2018
19/12/2017Anti-fraud strategy (updated)
19/12/2017Human medicines European public assessment report (EPAR): DaTSCAN,

ioflupane (123l)

Revision: 19, Authorised
19/12/2017CVMP work plan 2018
19/12/2017Work plan for the CVMP Efficacy Working Party 2018
19/12/2017Work plan for the CVMP Environmental Risk Assessment Working Party 2018
19/12/2017Work plan for the CVMP Antimicrobials Working Party 2018
19/12/2017Herbal medicinal products: Ribes , Ribis nigri folium, Ribes nigrum L. (updated)
19/12/2017Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 46, Authorised
19/12/2017Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 19, Authorised
18/12/2017Human medicines European public assessment report (EPAR): Evotaz,

atazanavir / cobicistat

Revision: 4, Authorised
18/12/2017Second international awareness session for international regulators, academia and non-governmental organisations, European Medicines Agency, London, UK, From: 08-Mar-2018, To: 09-Mar-2018
18/12/2017Agenda: Agenda - Second international awareness session for international regulators, academia and non-governmental organisations
18/12/2017Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 4, Authorised
18/12/2017Minutes of the CAT meeting 4-6 October 2017
18/12/2017Herbal medicinal products: questions and answers (updated)
18/12/2017Regulatory questions and answers on herbal medicinal products (updated)
18/12/2017Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 28, Authorised
18/12/2017Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version, draft: consultation open
18/12/2017Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version, draft: consultation open
18/12/2017ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
18/12/2017Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, 25 October 2017
18/12/2017European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 25-Oct-2017, To: 25-Oct-2017
18/12/2017Minutes of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, 25 October 2017
18/12/2017ICH guideline E17 on general principles for planning and design of multi-regional clinical trials (updated)
18/12/2017Scientific guideline: ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version, adopted
18/12/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 20-21 November 2017
18/12/2017European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 22-Nov-2017, To: 22-Nov-2017
18/12/2017Minutes of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
18/12/2017Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
18/12/2017HMPC: overview of assessment work – priority list (updated)
18/12/2017Agenda: CHMP ORGAM agenda for the meeting on 4 December 2017
18/12/2017Veterinary medicine European public assessment report (EPAR): Rabitec,

Rabies vaccine (live, oral) for foxes and raccoon dogs

Revision: 0, Authorised
18/12/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
18/12/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Vonicog alfa

Therapeutic area: Haematology-Hemostaseology (updated)
18/12/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Lifitegrast

Therapeutic area: Ophthalmology (updated)
18/12/2017Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/10381/201704
18/12/2017Human medicines European public assessment report (EPAR): Betmiga,

mirabegron

Revision: 10, Authorised
18/12/2017Orphan designation:

Cannabidiol

for the: Treatment of Dravet syndrome (updated)
18/12/2017Orphan designation:

Alicaforsen

for the: Treatment of pouchitis (updated)
15/12/2017Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 25, Authorised
15/12/2017Anti-fraud strategy revised December 2017
15/12/2017Outcome of written procedures during the period 13 September 2017 to 20 November 2017
15/12/2017Financial compensation and workload estimation of the revised EMA organisation of translations of product related informationIII
15/12/2017Summary of transfers of appropriations in budget 2017: Management Board meeting: 13-14 December 2017
15/12/2017Management Board meeting: 13-14 December 2017, European Medicines Agency, London, UK, From: 13-Dec-2017, To: 14-Dec-2017 (updated)
15/12/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
15/12/2017News and press releases: Modified-release paracetamol-containing products to be suspended from EU market
15/12/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 62, Authorised
15/12/2017Scientific guideline: Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics, draft: consultation open
15/12/2017Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 48, Authorised
15/12/2017Human medicines European public assessment report (EPAR): Selincro,

nalmefene

Revision: 9, Authorised
15/12/2017News and press releases: European Commission closes infringement procedure against Roche
15/12/2017Plasma-master-file certifications (updated)
15/12/2017Pending EC decision: Herzuma,

trastuzumab

Opinion date: 14-Dec-2017
15/12/2017List of medicinal products under additional monitoring (updated)
15/12/2017List of medicines under additional monitoring (updated)
15/12/2017List of medicinal products under additional monitoring (updated)
15/12/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017
15/12/2017News and press releases: New medicine to treat perianal fistulas in patients with Crohn’s disease
15/12/2017News and press releases: First paediatric medicine to treat rare hormonal disorder
15/12/2017News and press releases: New medicine for rare bone disease
15/12/2017Scientific guideline: ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - Step 5 - First version, adopted
15/12/2017Pending EC decision: Anagrelide Mylan,

anagrelide

Opinion date: 14-Dec-2017
15/12/2017News and press releases: Mycophenolate: updated recommendations for contraception for men and women
15/12/2017Withdrawn application: Qizenday,

d-biotin

Initial authorisation
15/12/2017Pending EC decision: Truvada,

emtricitabine / tenofovir disoproxil

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Alofisel,

Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Ozempic,

semaglutide

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Yervoy,

ipilimumab

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Crysvita,

burosumab

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka,

efavirenz / emtricitabine / tenofovir disoproxil

Opinion date: 14-Dec-2017
15/12/2017Pending EC decision: Alkindi,

hydrocortisone

Opinion date: 14-Dec-2017
15/12/2017Scientific advice and protocol assistance adopted during the CHMP meeting 11 – 14 December 2017, adopted
15/12/2017Overview of (invented) names reviewed in November 2017 by the Name Review Group (NRG) adopted at the CHMP meeting of 11-14 December 2017, adopted
15/12/2017Pending EC decision: Taltz,

ixekizumab

Opinion date: 14-Dec-2017
15/12/2017Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 12, Authorised
15/12/2017Report: Medicinal products for human use: monthly figures - November 2017
15/12/2017News and press releases: EMA Management Board: highlights of December 2017 meeting
15/12/2017Brexit-related guidance for companies
15/12/2017Clinical Trial Regulation (updated)
15/12/2017Relocation to Amsterdam
15/12/2017United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
15/12/2017Substance, product, organisation and referential (SPOR) master data (updated)
15/12/2017Referentials and organisations management services (updated)
15/12/2017Using Referential and Organisation data in the electronic application form (eAF)
15/12/2017Human medicines European public assessment report (EPAR): Oncaspar,

pegaspargase

Revision: 4, Authorised
14/12/2017Human medicines European public assessment report (EPAR): Truberzi,

eluxadoline

Revision: 3, Authorised
14/12/2017Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 11, Authorised
14/12/2017Agenda: Agenda - Workshop on site and histology - Independent indications in oncology (updated)
14/12/2017Questions and answers: Article 34 veterinary referral procedures
14/12/2017Human medicines European public assessment report (EPAR): Ketoconazole HRA,

ketoconazole

Revision: 7, Authorised
14/12/2017Procurement (updated)
13/12/2017Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 11, Authorised
13/12/2017Day 80 assessment report - Quality template rev. 12.17 (updated)
13/12/2017Regulatory and procedural guideline: Day 80 assessment report - Quality guidance rev.12.17 (updated)
13/12/2017Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 32, Authorised
13/12/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 9, Authorised
13/12/2017Human medicines European public assessment report (EPAR): Bortezomib Hospira,

bortezomib

Revision: 3, Authorised
13/12/2017Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 13, Authorised
13/12/2017Agenda: Agenda for the 98th meeting of the Management Board
13/12/2017Advanced therapy classification (updated)
13/12/2017Interested parties to the HMPC (updated)
13/12/2017Human medicines European public assessment report (EPAR): Forsteo,

teriparatide

Revision: 19, Authorised
13/12/2017Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (updated)
13/12/2017Scientific guideline: Guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, adopted
13/12/2017Overview of comments received on 'Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products’
13/12/2017Human medicines European public assessment report (EPAR): Stelara,

ustekinumab

Revision: 22, Authorised
13/12/2017Agenda: Agenda - Training session for patients, consumers and healthcare professionals interested in European Medicines Agency activities (updated)
13/12/2017Training session for patients, consumers and healthcare professionals interested in European Medicines Agency activities, European Medicines Agency, London, UK, From: 21-Nov-2017, To: 21-Nov-2017 (updated)
13/12/2017Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 11, Authorised
13/12/2017Human medicines European public assessment report (EPAR): Aubagio,

teriflunomide

Revision: 8, Authorised
13/12/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
13/12/2017Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 6, Authorised
13/12/2017EudraVigilance change management (updated)
13/12/2017European Union BFC conversion (v.2.6) (updated)
12/12/2017COMP meeting report on the review of applications for orphan designation: 5-7 December 2017
12/12/2017Human medicines European public assessment report (EPAR): Prepandrix,

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Revision: 12, Authorised
12/12/2017Nominations to the European Union Telematics governance bodies (updated)
12/12/2017Diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents: List of nationally authorised medicinal products - PSUSA/00001125/201703
12/12/2017Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704
12/12/2017Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 18, Authorised
12/12/2017Human medicines European public assessment report (EPAR): Nyxoid,

naloxone

Revision: 0, Authorised
12/12/2017Human medicines European public assessment report (EPAR): Zevalin,

ibritumomab tiuxetan

Revision: 21, Authorised
12/12/2017Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 25, Authorised
12/12/2017Regulatory and procedural guideline: Quality review of documents (QRD) guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP), adopted (updated)
12/12/2017The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course, Zagreb, Croatia, From: 14-May-2018, To: 16-May-2018
12/12/2017The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course, Bucharest, Romania, From: 26-Feb-2018, To: 28-Feb-2018
12/12/2017Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE,

Foot-and-mouth disease vaccine (inactivated) (multistrain: 1-3 strains out of set of 8)

Revision: 3, Authorised
12/12/2017Veterinary medicine European public assessment report (EPAR): Veraflox,

pradofloxacin

Revision: 6, Authorised
12/12/2017Agenda: Agenda - CHMP agenda of the 11-14 December 2017 meeting
11/12/2017Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 23, Authorised
11/12/2017Pre-authorisation guidance (updated)
11/12/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
11/12/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
11/12/2017Marketing authorisation templates (updated)
11/12/2017Improving quality of submissions (updated)
11/12/2017Risk management plan (RMP): questions and answers (updated)
11/12/2017Marketing authorisation (updated)
11/12/2017Pre-submission queries service: questions and answers (updated)
11/12/2017Regulatory and procedural guideline: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
11/12/2017Subject disposition for clinical study
11/12/2017Checklist for requesting new EU sub-numbers (type IAIN and Type IB lead procedures only)
11/12/2017Type-IB variations: questions and answers (updated)
11/12/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
11/12/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
11/12/2017Type-IA variations: questions and answers (updated)
11/12/2017Validation issues frequently seen with initial marketing authorisation holders
11/12/2017Human medicines European public assessment report (EPAR): Zejula,

niraparib

Revision: 1, Authorised
11/12/2017European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 22-Nov-2017, To: 22-Nov-2017 (updated)
11/12/2017Regulatory and procedural guideline: Compilation of Quality Review of Documents decisions on stylistic matters in product information (updated)
11/12/2017Racecadotril: List of nationally authorised medicinal products - PSUSA/00002602/201703
11/12/2017Tioconazole, tioconazole / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00010382/201704
11/12/2017Fourteenth joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting , European Medicines Agency, London, UK, From: 15-Dec-2017, To: 15-Dec-2017
11/12/2017Meeting summary - Patients and Consumers Working Party (PCWP) meeting with all EMA eligible patient/consumer organisations
11/12/2017List of participants - Patients and Consumers Working Party (PCWP) meeting with all EMA eligible patient/consumer organisations
11/12/2017Agenda: Agenda - PDCO agenda of the 12-15 December 2017 meeting
11/12/2017Scientific guideline: Questions and answers on monoclonal antibodies for veterinary use, adopted
11/12/2017Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) (updated)
11/12/2017News and press releases: First guidance on monoclonal antibodies for use in animals
11/12/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 14, Authorised
11/12/2017Minutes of the CVMP meeting of 7-9 November 2017
11/12/2017Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 14, Withdrawn
11/12/2017Public statement: Public statement on Optimark: Expiry of the marketing authorisation in the European Union
11/12/2017Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 6, Authorised
08/12/2017Herbal medicinal products: Combination: Valeriana and Humulus, Combination: Valerianae radix and Lupuli flos, Combination: Valeriana officinalis L. and Humulus lupulus L. (updated)
08/12/2017Draft European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1, draft: consultation open
08/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for compliance check of an agreed paediatric investigation plan
08/12/2017Herbal medicinal products: Curcuma, Curcumae longae rhizoma, Curcuma longa L. (updated)
08/12/2017Info day for micro, small and medium-sized enterprises: supporting innovative medicines' development and early access, European Medicines Agency, London, UK, From: 17-Nov-2017, To: 17-Nov-2017 (updated)
08/12/2017Draft European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1, draft: consultation open
08/12/2017Appendix V - Adverse-drug-reaction reporting details (updated)
08/12/2017Agenda: Agenda - CAT agenda of the 6-8 December 2017 meeting
08/12/2017Presubmission request form (updated)
08/12/2017Pending EC decision: Suvaxyn Circo,

porcine circovirus vaccine (inactivated, recombinant)

Opinion date: 07-Dec-2017
08/12/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017
08/12/2017Pending EC decision: Zactran,

gamithromycin

Opinion date: 07-Dec-2017
08/12/2017Veterinary medicine European public assessment report (EPAR): Pexion,

imepitoin

Revision: 5, Authorised
08/12/2017Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704
08/12/2017Itraconazole: List of nationally authorised medicinal products - PSUSA/00001798/201703
08/12/2017Lidocaine / prilocaine (not centrally authorised product): List of nationally authorised medicinal products - PSUSA/00001867/201703
08/12/2017Etoricoxib: List of nationally authorised medicinal products - PSUSA/00001334/201703
08/12/2017Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 34, Authorised
08/12/2017Periodic safety update reports: questions and answers (updated)
08/12/2017Post-authorisation measures: questions and answers (updated)
08/12/2017Chlormadinone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000677/201611
08/12/2017Chlormadinone: List of nationally authorised medicinal products - PSUSA/00000677/201611
08/12/2017Veterinary medicine European public assessment report (EPAR): Simparica,

sarolaner

Revision: 4, Authorised
08/12/2017Veterinary medicine European public assessment report (EPAR): Bovilis Blue-8,

bluetongue virus vaccine, serotype 8 (inactivated)

Revision: 0, Authorised
08/12/2017Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 12, Authorised
08/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions
07/12/2017Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella),

rituximab

Revision: 2, Authorised
07/12/2017Estradiol / norethisterone: List of nationally authorised medicinal products - PSUSA/00001278/201703
07/12/2017Estradiol (17-beta) / trimegestone: List of nationally authorised medicinal products - PSUSA/00001275/201703
07/12/2017Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

(updated)
07/12/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
07/12/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
07/12/2017Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 4, Authorised
07/12/2017Linezolid : List of nationally authorised medicinal products - PSUSA/00001888/201704
07/12/2017Moclobemide : List of nationally authorised medicinal products - PSUSA/00002079/201704
07/12/2017Mupirocin : List of nationally authorised medicinal products - PSUSA/00002096/201703
07/12/2017Tretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00003015/201703
07/12/2017Agenda: Agenda - CVMP agenda of the 5-7 December 2017 meeting
07/12/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.9) (updated)
07/12/2017Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi,

busulfan

Revision: 2, Authorised
07/12/2017Human medicines European public assessment report (EPAR): Pramipexole Accord,

pramipexole

Revision: 6, Authorised
07/12/2017Human medicines European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG),

telmisartan

Revision: 27, Authorised
07/12/2017Doxylamine: List of nationally authorised medicinal products - PSUSA/00001174/201704
06/12/2017Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 35, Authorised
06/12/2017Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 12, Authorised
06/12/2017Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 18, Authorised
06/12/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 14, Authorised
06/12/2017Newsletter: Human medicines highlights - December 2017
06/12/2017Agenda: Agenda and registration form - EudraVigilance information day (updated)
06/12/2017Human medicines European public assessment report (EPAR): Firazyr,

icatibant

Revision: 13, Authorised
06/12/2017Human medicines European public assessment report (EPAR): Olumiant,

baricitinib

Revision: 2, Authorised
06/12/2017Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 13, Authorised
06/12/2017Minutes of the European Medicines Agency - Payer Community meeting
06/12/2017Withdrawn application: Opdivo,

nivolumab

Post-authorisation (updated)
06/12/2017Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 52, Authorised
06/12/2017Horizon 2020 research funding
06/12/2017Essential considerations for successful qualification of novel methodologies
06/12/2017Q&A: Type II variations (updated)
06/12/2017Type-IB variations: questions and answers (updated)
06/12/2017Human medicines European public assessment report (EPAR): Symtuza,

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 1, Authorised
06/12/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: October 2017
05/12/2017Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 20, Authorised
05/12/2017Pravastatin: List of nationally authorised medicinal products - PSUSA/00002500/201703
05/12/2017Piroxicam: List of nationally authorised medicinal products - PSUSA/00002438/201704
05/12/2017Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 4, Authorised
05/12/2017Piribedil: List of nationally authorised medicinal products - PSUSA/00002436/201703
05/12/2017Sertraline: List of nationally authorised medicinal products - PSUSA/00002696/201703
05/12/2017Referral: Article 31 referrals, Retinoid-containing medicinal products,

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene

(updated)
05/12/2017Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/201704
05/12/2017Triptorelin : List of nationally authorised medicinal products - PSUSA/00003048/201703
05/12/2017Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201705
05/12/2017Anacetrapib - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
05/12/2017Orphan designation:

(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate

for the: Treatment of soft tissue sarcoma (updated)
05/12/2017Agenda: Agenda - COMP agenda of the 5-7 December 2017 meeting
05/12/2017Referral: Article 31 referrals, Factor VIII (updated)
05/12/2017Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201705
04/12/2017Orphan designation:

(3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (niraparib)

for the: Treatment of ovarian cancer (updated)
04/12/2017Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 40, Authorised
04/12/2017Human medicines European public assessment report (EPAR): Abilify Maintena,

aripiprazole

Revision: 11, Authorised
04/12/2017Zidovudine : List of nationally authorised medicinal products - PSUSA/00003143/201703
04/12/2017Referral: Article 31 referrals, Gadolinium-containing contrast agents,

gadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid

(updated)
04/12/2017Human medicines European public assessment report (EPAR): Remicade,

infliximab

Revision: 48, Authorised
04/12/2017Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 10, Authorised
04/12/2017News and press releases: Call for patient organisation representatives to join the Committee for Orphan Medicines
04/12/2017Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2016
04/12/2017European Medicines Agency meeting and holiday dates 2017 (updated)
01/12/2017Human medicines European public assessment report (EPAR): Somatropin Biopartners,

somatropin

Revision: 3, Withdrawn
01/12/2017Report: Applications for new human medicines under evaluation by the CHMP: December 2017
01/12/2017Notification on arrangements for requesting European Medicines Agency certificates through urgent and standard procedure for December 2017
01/12/2017Day 120 list of questions template rev. 10.17 (updated)
01/12/2017Public statement: Public statement on Somatropin Biopartners: Cessation of validity of the marketing authorisation in the European Union
01/12/2017SPOR data management services high level changes (updated)
01/12/2017Organisation Management Services (OMS) operating model (updated)
01/12/2017SPOR webinar: Using OMS & RMS data in eAF
01/12/2017Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications, European Medicines Agency, London, UK, From: 23-Nov-2017, To: 23-Nov-2017 (updated)
01/12/2017Human medicines European public assessment report (EPAR): Besponsa,

inotuzumab ozogamicin

Revision: 1, Authorised
01/12/2017Referentials Management Service (RMS) and Organisations Management Services (OMS) industry on-boarding plan (updated)
01/12/2017Latanoprost (products with paediatric indication) : List of nationally authorised medicinal products - PSUSA/00001834/201704
01/12/2017Q&A: 21-38 (updated)
01/12/2017Human medicines European public assessment report (EPAR): Grastofil,

filgrastim

Revision: 8, Authorised
01/12/2017Saccharomyces boulardii : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00009284/201702 (updated)
01/12/2017Orphan designation:

Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin

for the: Treatment of pneumonia caused by Staphylococcus aureus (updated)
01/12/2017Urofollitropin : List of nationally authorised medicinal products - PSUSA/00003082/201703
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for rectifying errors in PDCO opinions and European Medicines Agency decisions (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion (updated)
01/12/2017Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/201704
01/12/2017COMP meeting report on the review of applications for orphan designation: 30-31 October 2017
01/12/2017Pharmacovigilance (updated)
01/12/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017
01/12/2017Minutes of the EMA/EUnetHTA meeting - 8 June 2017
01/12/2017Referral: Article 20 procedures, Esmya,

ulipristal acetate

01/12/2017PRAC strategy on measuring the impact of pharmacovigilance activities (updated)
01/12/2017Referral: Article 20 procedures, Xofigo,

radium Ra223 dichloride

01/12/2017Regulatory and procedural guideline: Checklist for sponsors applying for the transfer of orphan medicinal product designation (updated)
01/12/2017Cefuroxime axetil : List of nationally authorised medicinal products - PSUSA/00009099/201704
01/12/2017Cefodizime : List of nationally authorised medicinal products - PSUSA/00000595/201703
01/12/2017Porfimer: List of nationally authorised medicinal products - PSUSA/00010332/201704
01/12/2017Carvedilol : List of nationally authorised medicinal products - PSUSA/00000575/201704
01/12/2017Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703
01/12/2017News and press releases: Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
01/12/2017Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure (updated)
01/12/2017Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 29, Authorised
01/12/2017Referral: Article 107i procedures, Hydroxyethyl starch (HES) containing medicinal products,

hydroxyethyl starch (HES)

(updated)
01/12/2017Emerging safety issues (ESI) contact points at the national competent authority (NCA) level (updated)
01/12/2017Inspections, Human Medicines Pharmacovigilance and Committees (updated)
01/12/2017Information Management (updated)
01/12/2017Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
01/12/2017Organisation chart: Information Management (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for modification of an agreed paediatric investigation plan (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for re-examination of Paediatric Committee opinions (updated)
01/12/2017Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 11, Authorised