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July 2015

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03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Misoprostol

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Peanut allergen extract

Therapeutic area: Pneumology-allergology
03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology
03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): RoActemra,

Tocilizumab

Therapeutic area: Immunology-Rheumatology-Transplantation
03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Norovirus GI.1 virus-like particle antigen / norovirus GII.4 virus-like particle antigen

Therapeutic area: Vaccines
03/07/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Vericiguat

Therapeutic area: Cardiovascular diseases
03/07/2015European medicines agency Standard operating procedure (SOP): Standard operating procedure for involvement of the CVMP Antimicrobials Working Party in the evaluation of applications for centralised marketing authorisations for veterinary medicinal products containing antimicrobial substances (updated)
03/07/2015Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 0, Authorised
03/07/2015Annual report of the Good Clinical Practice Inspections Working Group 2014
03/07/2015Report: Annual accounts: Financial year 2014
03/07/2015Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product (updated)
03/07/2015Agenda: Agenda - HMPC agenda of the 6-7 July 2015 meeting
03/07/2015Agenda: Agenda - Workshop on first-line acute promyelocytic leukaemia treatment: European Union cooperative groups and the pharmaceutical industry
03/07/2015Workshop on first-line acute promyelocytic leukaemia treatment: European Union cooperative groups and the pharmaceutical industry, European Medicines Agency, London, UK, From: 06-Jul-2015, To: 06-Jul-2015
03/07/2015CHMP opinions on consultation procedures (updated)
03/07/2015Consultation on an ancillary medicinal substance incorporated in a medical device: Hemoblast, haemostatic agent
03/07/2015Human medicines European public assessment report (EPAR): Lixiana,

edoxaban

Revision: 0, Authorised
03/07/2015Workshop on the therapeutic use of bacteriophages, European Medicines Agency, London, UK, From: 08-Jun-2015, To: 08-Jun-2015 (updated)
03/07/2015Newsletter: News bulletin for pharmacovigilance programme update - Issue 4
02/07/2015Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) (updated)
02/07/2015Timetable: Post-authorisation safety study protocols (central and national application procedures) (updated)
02/07/2015Timetable: Periodic safety update reports (PSURs) (updated)
02/07/2015Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)
02/07/2015Timetable: Post-authorisation safety study (PASS) protocols
02/07/2015Timetable: Post-authorisation measure (PAM) assessed by Pharmacovigilance Risk Assessment Committee (PRAC)
02/07/2015Timetable: Post-authorisation measure (PAM) assessed by Committee for Medicinal Products for Human Use (CHMP)
02/07/2015Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission (60-day timetable for initial assessment)
02/07/2015Timetable: Extension application - Initial 120-day assessment timetable
02/07/2015Timetable: Full application (updated)
02/07/2015Timetable: Extension (Annex I) applications (updated)
02/07/2015Timetable: Full application - Initial 120-day assessment timetable (updated)
02/07/2015Timetable: Post-authorisation measures (PAMs) and specific obligations (60-day assessment procedure) as stand-alone submissions (updated)
02/07/2015Timetable: Type II variations (90-day assessment procedure) (updated)
02/07/2015Timetable: Type II variations and worksharing variations (60-day assessment procedure) (updated)
02/07/2015Type II variation and worksharing application: 60-day weekly-start timetable (updated)
02/07/2015Type II variation and worksharing application: 90-day assessment timetable (updated)
02/07/2015Type II variation and worksharing application: 60-day monthly-start timetable (updated)
02/07/2015Type II variation and worksharing application: 30-day assessment timetable (updated)
02/07/2015Procedural timetables (updated)
02/07/2015Regulatory and procedural guideline: Guideline on influenza vaccines – submission and procedural requirements, adopted
02/07/2015Overview of comments on 'Guideline on influenza vaccines – submission and procedural requirements'
02/07/2015Timetable: Periodic safety update report (PSUR) and PSUR single sssessment (PSUSA) - Advanced therapy medicinal products (ATMPs) (updated)
02/07/2015Human medicines European public assessment report (EPAR): Zoledronic acid Teva Pharma,

zoledronic acid

Revision: 7, Authorised
02/07/2015Human medicines European public assessment report (EPAR): DepoCyte,

cytarabine

Revision: 14, Authorised
02/07/2015Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 5, Authorised
02/07/2015Presentation - Medical literature monitoring start-up phase (Sabine Brosch, Tom Paternoster-Howe)
02/07/2015Organisational matters - CHMP meeting 22-25 June 2015
02/07/2015Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 22-25 June 2015
02/07/2015Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 22-25 June 2015
02/07/2015Guidelines and concept papers adopted during the CHMP meeting 22-25 June 2015
02/07/2015PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template (updated)
02/07/2015Minutes of the COMP meeting 12-13 May 2015 (updated)
02/07/2015Minutes of the CAT meeting 12-13 May 2015
02/07/2015Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 22, Authorised
02/07/2015Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 8, Authorised
02/07/2015Timetable: Type II variations (30-day assessment procedure) (updated)
01/07/2015News and press releases: Regulatory information – Mandatory use of common repository for human centralised procedures as of today
01/07/2015Human medicines European public assessment report (EPAR): Temozolomide Accord,

temozolomide

Revision: 11, Authorised
01/07/2015Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 11, Authorised
01/07/2015News and press releases: Regulatory information - Electronic application becomes mandatory today
01/07/2015Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva,

irbesartan / hydrochlorothiazide

Revision: 10, Authorised
01/07/2015Meeting on redacting commercially confidential information (CCI) in clinical reports and anonymising clinical reports for the purpose of publication, European Medicines Agency, London, UK, From: 06-Jul-2015, To: 06-Jul-2015
01/07/2015Agenda: Agenda - Meeting on redacting commercially confidential information (CCI) in clinical reports and anonymising clinical reports for the purpose of publication
01/07/2015Buying medicines online
01/07/2015News and press releases: Staying safe when buying medicines online
01/07/2015Inventory of herbal substances for assessment (updated)
01/07/2015Human medicines European public assessment report (EPAR): Libertek,

roflumilast

Revision: 7, Authorised
01/07/2015List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
01/07/2015PDCO monthly report of opinions on paediatric investigation plans and other activities 17-19 June 2015
01/07/2015Minutes of the European Medicines Agency and European Network for Health Technology Assessment (EUnetHTA) May 2015 meeting
01/07/2015Human medicines European public assessment report (EPAR): Leflunomide ratiopharm,

leflunomide

Revision: 8, Authorised
01/07/2015Scientific guideline: Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus, draft: consultation open