What's New?

  • Email
  • Help

December 2016

Filter by:
Date Content
22/12/2016Veterinary medicine European public assessment report (EPAR): Sedadex,

dexmedetomidine

Revision: 1, Authorised
22/12/2016CHMP ORGAM minutes for the meeting on 5 December 2016
22/12/2016Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 11, Authorised
22/12/2016Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 23, Authorised
22/12/2016Veterinary medicine European public assessment report (EPAR): Halagon,

halofuginone

Revision: 0, Authorised
22/12/2016Scientific guideline: Guideline on the clinical development of medicinal products intended for the treatment of pain - First version, adopted
22/12/2016Clinical development of medicinal products intended for the treatment of pain (updated)
22/12/2016Veterinary medicine European public assessment report (EPAR): Cepedex,

dexmedetomidine

Revision: 0, Authorised
22/12/2016Human medicines European public assessment report (EPAR): Biograstim,

filgrastim

Revision: 8, Withdrawn
22/12/2016Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil film-coated tablets 150 mg / 150 mg / 200 mg / 245 mg product-specific bioequivalence guidance
22/12/2016Emtricitabine / rilpivirine / tenofovir disoproxil, film-coated tablets, 200 mg / 25 mg / 245 mg product-specific bioequivalence guidance
22/12/2016Vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg / ml product-specific bioequivalence guidance
22/12/2016Scientific guideline: Draft Crizotinib hard capsules 200 mg and 250 mg product-specific bioequivalence guidance, draft: consultation open
22/12/2016Elvitegravir 85 mg & 150 mg film-coated tablets product-specific bioequivalence guidance
22/12/2016Scientific guideline: Draft elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil film-coated tablets 150 mg/150 mg/200 mg/ 245 mg product-specific bioequivalence guidance, draft: consultation open
22/12/2016Scientific guideline: Draft elvitegravir 85 mg & 150 mg film-coated tablets product-specific bioequivalence guidance, draft: consultation open
22/12/2016Scientific guideline: Draft emtricitabine/rilpivirine/tenofovir disoproxil, film-coated tablets, 200 mg/25 mg/245 mg product-specific bioequivalence guidance, draft: consultation open
22/12/2016Scientific guideline: Draft vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg/ml product-specific bioequivalence guidance, draft: consultation open
22/12/2016Crizotinib hard capsules 200 mg and 250 mg product-specific bioequivalence guidance
22/12/2016Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 4 150 mg product-specific bioequivalence guidance
22/12/2016Human medicines European public assessment report (EPAR): Capecitabine SUN,

capecitabine

Revision: 3, Withdrawn
22/12/2016Scientific guideline: Draft dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance, draft: consultation open
22/12/2016Newsletter: What's new in pharmacovigilance - QPPV Update - Issue 3
22/12/2016Scientific guideline: Scientific guidance on post-authorisation efficacy studies - First version, adopted
22/12/2016Scientific guidance on post-authorisation efficacy studies (updated)
22/12/2016Granisetron: List of nationally authorised medicinal products -PSUSA/00001568/201602
22/12/2016Granisetron: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001568/201602
22/12/2016Scientific guideline: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), draft: consultation open
22/12/2016Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (updated)
22/12/2016Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) (updated)
22/12/2016Scientific guideline: Draft guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg), draft: consultation open
22/12/2016Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 20, Authorised
22/12/2016Dorzolamide: List of nationally authorised medicinal products - PSUSA/00003168/201602
22/12/2016Scientific guideline: Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches, adopted (updated)
22/12/2016Human medicines European public assessment report (EPAR): BeneFIX,

nonacog alfa

Revision: 34, Authorised
22/12/2016Triamcinolone (intraocular formulations): CMDh scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00010292/201603
22/12/2016Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201603
22/12/2016Dorzolamide: CMDh scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00003168/201602
22/12/2016Emtriva : EPAR - Summary for the public (updated)
21/12/2016Work plan for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (J3RsWG) (updated)
21/12/2016Mandate, objectives and rules of procedure for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (J3RsWG) (updated)
21/12/2016Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 5, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Vipdomet,

alogliptin / metformin

Revision: 4, Authorised
21/12/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
21/12/2016Agenda: Agenda - CHMP agenda of the 12-15 December 2016 (updated)
21/12/2016Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 18, Authorised
21/12/2016Orphan 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 

for the: Treatment of chronic lymphocytic leukaemia (updated)
21/12/2016Human medicines European public assessment report (EPAR): Venclyxto,

venetoclax

Revision: 0, Authorised
21/12/2016Withdrawn application: Zemfirza,

cediranib

Initial authorisation (updated)
21/12/2016External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use
21/12/2016News and press releases: Clinical data for two more medicines now available online
21/12/2016Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 8, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 3, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 14, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 12, Authorised
21/12/2016Withdrawn application: Pemetrexed ditromethamine Hospira,

pemetrexed

Initial authorisation (updated)
21/12/2016Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 7, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 4, Authorised
21/12/2016Veterinary medicine European public assessment report (EPAR): Bovalto Ibraxion,

Infectious bovine rhinotracheitis vaccine (inactivated)

Revision: 10, Authorised
21/12/2016Work plan for the Rheumatology-Immunology Working Party 2017 (updated)
21/12/2016Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand),

oxybutynin

Revision: 14, Authorised
21/12/2016Referral: Article 31 referrals, Metformin and metformin-containing medicines,

metformin

(updated)
21/12/2016Human medicines European public assessment report (EPAR): Sustiva,

efavirenz

Revision: 41, Authorised
21/12/2016Human medicines European public assessment report (EPAR): Celvapan,

influenza vaccine (H1N1)v (whole virion, inactivated, prepared in cell culture)

Revision: 11, Withdrawn
21/12/2016Work plan for the CHMP Oncology Working Party for 2017 (updated)
21/12/2016List of Union reference dates and frequency of submission of periodic safety update Reports (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Humira,

Adalimumab

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation/Ophthalmology/Gastroentology-Hepatology (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Exjade,

Deferasirox

Therapeutic area: Haematology-Hemostaseology (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Levamisole (hydrochloride)

Therapeutic area: Uro-nephrology (updated)
21/12/2016Signal management (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Firazyr,

icatibant acetate

Therapeutic area: Other (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Hydrocortisone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Livazo and associated names,

Pitavastatin (calcium)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Tasigna,

nilotinib

Therapeutic area: Oncology (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Alipza and associated names,

Pitavastatin (calcium)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
21/12/2016Opinion/decision on a Paediatric investigation plan (PIP): Inovelon,

Rufinamide

Therapeutic area: Neurology (updated)
21/12/2016Report: List of products granted eligibility to PRIME (updated)
21/12/2016Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 December 2016, adopted
21/12/2016Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 16, Authorised
21/12/2016Ibraxion : EPAR - Summary for the public (updated)
20/12/2016News and press releases: Simpler website navigation for regulatory information on veterinary medicines
20/12/2016Work plan of the CHMP Blood Products Working Party for 2017 (updated)
20/12/2016Training session for patients and consumers interested in EMA activities, European Medicines Agency, London, UK, From: 29-Nov-2016, To: 29-Nov-2016 (updated)
20/12/2016Work plan for the CHMP Respiratory Drafting Group for 2017 (updated)
20/12/2016Work plan for the Central Nervous System Working Party 2017 (updated)
20/12/2016Work plan for the Cardiovascular Working Party 2017 (updated)
20/12/2016Work plan for the Vaccine Working Party 2017 (updated)
20/12/2016Agenda: Agenda - Training session for patients and consumers interested in EMA activities (updated)
20/12/2016Work plan for the Pharmacogenomics Working Party 2017 (updated)
20/12/2016Work plan for the Biosimilar Medicinal Products Working Party 2017 (updated)
20/12/2016News and press releases: European Medicines Agency closed 23 December 2016 to 2 January 2017
20/12/2016Work plan for the CHMP Biologics Working Party 2017 (updated)
20/12/2016Workshop on measuring the impact of pharmacovigilance activities, European Medicines Agency, London, UK, From: 05-Dec-2016, To: 06-Dec-2016 (updated)
20/12/2016Work plan for the Gastroenterology Drafting Group 2017 (updated)
20/12/2016Human medicines European public assessment report (EPAR): Forsteo,

teriparatide

Revision: 18, Authorised
20/12/2016Work plan for the CHMP Excipients Drafting Group for 2017 (updated)
20/12/2016Questions and answers on the outcome of an extension of indication application for Inovelon (rufinamide) (updated)
20/12/2016Human medicines European public assessment report (EPAR): Vantobra,

tobramycin

Revision: 2, Authorised
20/12/2016EMA / International Federation for Animal Health Europe (IFAH-Europe) veterinary medicines information day , European Medicines Agency, London, UK, From: 16-Mar-2017, To: 17-Mar-2017
20/12/2016Registration form - 2017 EMA/IFAH-Europe veterinary medicines info day
20/12/2016Agenda: Programme - 2017 EMA/IFAH-Europe veterinary medicines info day
20/12/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi,

canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)

Revision: 3, Authorised
20/12/2016Minutes of the HMPC 19-20 September 2016 meeting
19/12/2016EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs, CCT venues, 40 Bank Street, Canary Wharf, London E14 5NR, From: 16-Dec-2016, To: 16-Dec-2016 (updated)
19/12/2016Orphan designation:

6alpha-ethyl-chenodeoxycholic acid

for the: Treatment of primary biliary cirrhosis (updated)
19/12/2016Human medicines European public assessment report (EPAR): Ocaliva,

obeticholic acid

Revision: 0, Authorised
19/12/2016Committee for Advanced Therapies (CAT) (updated)
19/12/2016Committee for Medicinal Products for Human Use (CHMP) (updated)
19/12/2016Paediatric Committee (PDCO) (updated)
19/12/2016How the committees work: overview
19/12/2016Committee for Medicinal Products for Veterinary Use (CVMP) (updated)
19/12/2016Committee for Orphan Medicinal Products (COMP) (updated)
19/12/2016Committee on Herbal Medicinal Products (HMPC) (updated)
19/12/2016Funding (updated)
19/12/2016Healthcare professionals (updated)
19/12/2016PRAC periodic-safety-update-report assessment report template NAP only (updated)
19/12/2016PRAC periodic-safety-update-report assessment report template CAP only (updated)
19/12/2016PRAC periodic-safety-update-report assessment report template CAP and NAP (updated)
19/12/2016Work plan for the Pharmacokinetics Working Party 2017 (updated)
19/12/2016Mandate, objectives and rules of procedure for the CVMP Ad Hoc Group on Veterinary Novel Therapies (updated)
19/12/2016Agenda: Agenda for the 94th meeting of the Management Board (updated)
19/12/2016Report: European Medicines Agency budget for 2017
19/12/2016News and press releases: EMA Management Board: highlights of December 2016 meeting
19/12/2016Type-II variations: questions and answers (updated)
19/12/2016Grouping of variations: questions and answers (updated)
19/12/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
19/12/2016Type-IA variations: questions and answers (updated)
19/12/2016Management Board meeting: 14-15 December 2016, European Medicines Agency, London, UK, From: 14-Dec-2016, To: 15-Dec-2016
19/12/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
19/12/2016Classification of changes: questions and answers (updated)
19/12/2016Worksharing: questions and answers (updated)
19/12/2016Human medicines European public assessment report (EPAR): Foclivia,

pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Revision: 5, Authorised
19/12/2016European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3
19/12/2016Revised framework for interaction between the European Medicines Agency and healthcare professionals and their organisations
19/12/2016Report: Summary of transfers of appropriations in budget 2016
19/12/2016Multinational assessment team concept - The next phase – Broadening the concept to the post-authorisation phase
19/12/2016Outcome of written procedures finalised during the period from 7 September 2016 to 16 November 2016
19/12/2016Work plan for the CVMP Ad Hoc Group on Veterinary Novel Therapies 2017
19/12/2016Work plan for the CVMP Immunologicals Working Party 2017
19/12/2016Work plan for the CVMP Scientific Advice Working Party 2017
19/12/2016Work plan for the CVMP Antimicrobials Working Party 2017
19/12/2016Work plan for the CVMP Efficacy Working Party 2017
19/12/2016Work plan for the CVMP Environmental Risk Assessment Working Party 2017
19/12/2016Work plan for the CVMP Safety Working Party 2017
19/12/2016Agenda: Programme of the EMA / EBE fifth annual regulatory conference on optimising the development of ATMPs to meet patient needs (updated)
19/12/2016Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 14, Authorised
19/12/2016Human medicines European public assessment report (EPAR): Holoclar,

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Revision: 2, Authorised
19/12/2016COMP meeting report on the review of applications for orphan designation: December 2016
19/12/2016Enpr-EMA awareness webinar, European Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016 (updated)
19/12/2016Timetable type II variation and worksharing application - Other variations assessed only by the CHMP
19/12/2016Timetable type II variation and worksharing application - Extensions of indication and other variations followed by immediate EC decision
19/12/2016Timetable type II variation and worksharing application - Other variations involving the PRAC
19/12/2016Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 26, Authorised
19/12/2016Human medicines European public assessment report (EPAR): Velmetia,

sitagliptin / metformin

Revision: 21, Authorised
19/12/2016VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD) (updated)
19/12/2016Scientific guideline: VICH GL54 studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD), adopted
19/12/2016Overview of comments received on 'CVMP reflection paper on methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products' (EMA/CVMP/IWP/251741/2015)
19/12/2016Scientific guideline: CVMP reflection paper on methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products, adopted
19/12/2016Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunulogical veterinary medicinal products (updated)
19/12/2016Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan,

tenofovir disoproxil

Revision: 0, Authorised
19/12/2016Overview of comments received on ‘Guideline on requirements for the production and control of IVMPs’ (EMA/CVMP/IWP/206555/2010-Rev.1) including Annex 2 on the approach to demonstrate freedom from extraneous agents
19/12/2016Scientific guideline: Guideline on requirements for the production and control of immunological veterinary medicinal products, adopted
19/12/2016Requirements for the production and control of immunological veterinary medicinal products (updated)
19/12/2016Agenda: Agenda - PDCO agenda of the 13-16 December 2016 meeting
19/12/2016Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) (updated)
19/12/2016Timetable initial (full) marketing authorisation application - Accelerated assessment (updated)
19/12/2016Timetable: Post-authorisation measure (PAM) assessed by Pharmacovigilance Risk Assessment Committee (PRAC) (updated)
19/12/2016News and press releases: EMA website briefly unavailable on 20 December
19/12/2016List of medicinal products under additional monitoring (updated)
19/12/2016List of medicinal products under additional monitoring (updated)
19/12/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4R,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 3, Authorised
19/12/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

Revision: 3, Authorised
19/12/2016Pharmacovigilance Risk Assessment Committee (PRAC) (updated)
16/12/2016Veterinary medicinal products for zootechnical purposes (updated)
16/12/2016Scientific guideline: Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea, draft: consultation open
16/12/2016Scientific guideline: Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes, draft: consultation open
16/12/2016Veterinary medicinal products for fluid therapy in case of diarrhoea (updated)
16/12/2016Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
16/12/2016Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 29, Authorised
16/12/2016Human medicines European public assessment report (EPAR): Stayveer,

bosentan monohydrate

Revision: 5, Authorised
16/12/2016Work plan for the CVMP Pharmacovigilance Working Party 2017
16/12/2016Human medicines European public assessment report (EPAR): Aldara,

imiquimod

Revision: 22, Authorised
16/12/2016Referral: Article 31 referrals, Gadolinium-containing contrast agents,

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

(updated)
16/12/2016Biosimilar medicines (updated)
16/12/2016News and press releases: Tailored scientific advice to support step-by-step development of new biosimilars
16/12/2016Scientific advice and protocol assistance (updated)
16/12/2016Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 30, Authorised
16/12/2016Agenda: CHMP ORGAM agenda for the meeting on 5 December 2016
16/12/2016News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
16/12/2016News and press releases: New oral treatment for rheumatoid arthritis
16/12/2016Pending EC decision: Pregabalin Zentiva k.s.,

pregabalin

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Cinryze,

C1 inhibitor (human)

Opinion date: 15-Dec-2016
16/12/2016Withdrawn application: Cavoley,

pegfilgrastim

Initial authorisation
16/12/2016Withdrawn application: Efgratin,

pegfilgrastim

Initial authorisation
16/12/2016Withdrawn application: Graspa,

eryaspase

Initial authorisation
16/12/2016Pending EC decision: Olumiant,

baricitinib

Opinion date: 15-Dec-2016
16/12/2016News and press releases: Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
16/12/2016Pending EC decision: Ilaris,

canakinumab

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Alecensa,

alectinib

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Votubia,

everolimus

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Truxima,

rituximab

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Ledaga,

chlormethine

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Tivicay,

dolutegravir

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Keytruda,

pembrolizumab

Opinion date: 15-Dec-2016
16/12/2016Overview of (invented) names reviewed in November 2016 by the Name Review Group (NRG) adopted at the CHMP meeting of 12-15 December 2016
16/12/2016Pending EC decision: Jardiance,

empagliflozin

Opinion date: 15-Dec-2016
16/12/2016Withdrawn application: Kepnetic,

aceneuramic acid

Initial authorisation
16/12/2016Pending EC decision: Lifmior,

etanercept

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Repatha,

evolocumab

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Jentadueto,

linagliptin / metformin hydrochloride

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Trajenta,

linagliptin

Opinion date: 15-Dec-2016
16/12/2016Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

(updated)
16/12/2016Withdrawn application: Arzerra,

ofatumumab

Post-authorisation
16/12/2016Referral: Article 31 referrals, Micro Therapeutic Research
16/12/2016Referral: Article 30 referrals, Lovenox and associated names,

enoxaparin

16/12/2016Pending EC decision: Ameluz,

5-aminolevulinic acid hydrochloride

Opinion date: 15-Dec-2016
16/12/2016Pending EC decision: Vihuma,

simoctocog alfa

Opinion date: 15-Dec-2016
15/12/2016Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 1, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 8, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Ebixa,

memantine

Revision: 24, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Empliciti,

elotuzumab

Revision: 1, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 9, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 7, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 9, Authorised
15/12/2016ICH Q3C (R6) Residual solvents (updated)
15/12/2016Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R5) on impurities: guideline for residual solvents - Step 5, adopted (updated)
15/12/2016Policy 81: Document classification policy
15/12/2016Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin),

insulin glargine

Revision: 23, Authorised
15/12/2016Minutes - PDCO minutes of the 14 - 16 September 2016 meeting
15/12/2016Human medicines European public assessment report (EPAR): Trulicity,

dulaglutide

Revision: 5, Authorised
15/12/2016Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 25, Authorised
15/12/2016Herbal medicinal products: Echinacea, Echinaceae purpureae radix, Echinacea purpurea (L.) Moench. (updated)
15/12/2016Herbal medicinal products: Vitis , Vitis viniferae folium, Vitis vinifera L. (updated)
15/12/2016Human medicines European public assessment report (EPAR): Bemfola,

follitropin alfa

Revision: 3, Authorised
15/12/2016Herbal medicinal products: Piper, Piperis methystici rhizoma, Piper methysticum G. Forst., rhizoma (updated)
15/12/2016National experts on secondment (updated)
15/12/2016HMPC meeting report on European Union herbal monographs, guidelines and other activities - 21-22 November 2016
15/12/2016HMPC: overview of assessment work – priority list (updated)
15/12/2016ICH E6 (R2) Good clinical practice (updated)
14/12/2016Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201604
14/12/2016Referral: Article 31 referrals, Pharmaceutics International Inc. (updated)
14/12/2016Human medicines European public assessment report (EPAR): Ammonaps,

sodium phenylbutyrate

Revision: 14, Authorised
14/12/2016Human medicines European public assessment report (EPAR): Numient,

levodopa / carbidopa

Revision: 1, Authorised
14/12/2016Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 6, Authorised
14/12/2016Human medicines European public assessment report (EPAR): Grepid,

clopidogrel

Revision: 13, Authorised
14/12/2016Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 3, Authorised
14/12/2016Clinical pharmacology and pharmacokinetics: questions and answers (updated)
14/12/2016Orphan designation:

2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde

for the: treatment of sickle cell disease
14/12/2016Orphan designation:

human monoclonal antibody against activin A

for the: treatment of fibrodysplasia ossificans progressive
14/12/2016Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 2, Authorised
14/12/2016Orphan designation:

sodium benzoate

for the: treatment of N-acetylglutamate synthase deficiency
14/12/2016Orphan designation:

sodium benzoate

for the: treatment of argininosuccinic aciduria
14/12/2016Orphan designation:

recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein

for the: treatment of aromatic L-amino acid decarboxylase deficiency
14/12/2016Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 8, Authorised
14/12/2016Human medicines European public assessment report (EPAR): Mimpara,

cinacalcet

Revision: 17, Authorised
14/12/2016Orphan designation:

brincidofovir

for the: treatment of smallpox
14/12/2016Orphan designation:

zinc gluconate

for the: treatment of facioscapulohumeral muscular dystrophy
14/12/2016Orphan designation:

alpha-tocopherol

for the: treatment of facioscapulohumeral muscular dystrophy
14/12/2016Orphan designation:

ascorbic acid

for the: treatment of facioscapulohumeral muscular dystrophy
14/12/2016Report: EU-USA strategic meeting on the future of paediatric medicines
14/12/2016EU-USA strategic meeting on the future of paediatric medicines, European Medicines Agency, London, UK, From: 28-Sep-2016, To: 28-Sep-2016
14/12/2016Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00002959/201502
14/12/2016Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus (...): List of nationally authorised medicinal products - PSUSA/00002786/201603
14/12/2016Orphan designation:

L-selenomethionine

for the: treatment of facioscapulohumeral muscular dystrophy
14/12/2016Orphan designation:

Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Gly-Gly-Asp-Leu-Leu-Pro-Arg-Gly-Ser

for the: treatment of Huntington’s disease
14/12/2016Human medicines European public assessment report (EPAR): Votrient,

pazopanib

Revision: 18, Authorised
14/12/2016Orphan designation:

adeno-associated viral vector serotype 8 containing the human glucose-6-phosphatase gene

for the: treatment of glycogen storage disease type Ia
14/12/2016Orphan designation:

valproic acid

for the: treatment of diffuse large B-cell lymphoma
14/12/2016Orphan designation:

live-attenuated non-replicative Pseudomonas aeruginosa strain expressing large T antigen of Merkel cell polyomavirus

for the: treatment of Merkel cell carcinoma
14/12/2016Orphan designation:

vaccine consisting of 5 survivin peptides with different human leukocyte antigen restrictions

for the: treatment of ovarian cancer
14/12/2016Orphan designation:

ibrutinib

for the: treatment of graft-versus-host disease
13/12/2016Orphan designation:

allogenic cytomegalovirus-specific cytotoxic T lymphocytes

for the: treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity
13/12/2016Orphan designation:

allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone

for the: treatment in haematopoietic stem cell transplantation
13/12/2016Orphan designation:

synthetic human hepcidin

for the: treatment of sickle cell disease
13/12/2016Formatted table template to be inserted in application submission cover letters for veterinary procedures (updated)
13/12/2016Orphan designation:

budesonide

for the: treatment of primary IgA nephropathy
13/12/2016Orphan designation:

N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide

for the: treatment of acute pancreatitis
13/12/2016Orphan designation:

adeno-associated viral vector serotype 8 containing the human UGT1A1 gene

for the: treatment of Crigler-Najjar syndrome
13/12/2016Orphan designation:

5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride

for the: treatment of adrenoleukodystrophy
13/12/2016Orphan designation:

R-azasetron besylate

for the: treatment of sudden sensorineural hearing loss
13/12/2016Orphan designation:

particles comprised of methacrylic acid based co-polymer, cross-linked with a bi-functional cross-linker, purified to bind L-phenylalanine and L-phenylalanine containing peptides

for the: treatment of hyperphenylalaninaemia
13/12/2016QRD annex IV conditional positive template (updated)
13/12/2016QRD annex IV standard positive template (updated)
13/12/2016QRD annex IV exceptional circumstances positive template (updated)
13/12/2016Orphan designation:

Naltrexone

for the: Treatment of fibromyalgia
13/12/2016News and press releases: EMA hosts workshop on adaptive pathways
13/12/2016Template 1 - Orphan designation transfer form (updated)
13/12/2016Human medicines European public assessment report (EPAR): Nordimet,

methotrexate

Revision: 2, Authorised
12/12/2016Template - Orphan designation sponsor’s name and/or address change notification letter (updated)
12/12/2016Human medicines European public assessment report (EPAR): Nucala,

mepolizumab

Revision: 2, Authorised
12/12/2016Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Aluminium salicylate, basic, adopted
12/12/2016Human medicines European public assessment report (EPAR): Lucentis,

ranibizumab

Revision: 25, Authorised
12/12/2016Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka),

capecitabine

Revision: 8, Authorised
12/12/2016Human medicines European public assessment report (EPAR): Fycompa,

perampanel

Revision: 10, Authorised
12/12/2016MRL report: Aluminium salicylate, basic (bovine, caprine, Equidae and rabbit) – after provisional maximum residue limits (MRLs): European public maximum-residue-limit assessment report (EPMAR) - CVMP
12/12/2016Quinapril: List of nationally authorised medicinal products - PSUSA/00002591/201604
12/12/2016Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605
09/12/2016Regulatory and procedural guideline: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure (updated)
09/12/2016Newsletter: Human medicines highlights - November 2016
09/12/2016List of details of national competent authority to contact for requests of translation exemption falling under Article 63(3) of Directive 2001/83/EC and cases of shortages (updated)
09/12/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 2016
09/12/2016Pending EC decision: Equioxx,

firocoxib

Opinion date: 08-Dec-2016
09/12/2016Pending EC decision: Respiporc FLUpan H1N1,

influenza A virus/Jena/VI5258/2009 (PanH1N1), inactivated

Opinion date: 08-Dec-2016
09/12/2016Pending EC decision: Stronghold Plus,

selamectin / sarolaner

Opinion date: 08-Dec-2016
09/12/2016Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 10, Authorised
09/12/2016Referral: Article 31 referrals, Factor VIII (updated)
09/12/2016N(2)-L-alanyl-L-glutamine: List of nationally authorised medicinal products - PSUSA/00003158/201603
09/12/2016Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation, European Medicines Agency, London, UK, From: 21-Nov-2016, To: 21-Nov-2016 (updated)
09/12/2016Agenda: Agenda – Update on the implementation of EMA policy on publication of clinical data (Policy 0070) and revisions to the guidance to industry – Industry associations webinar
09/12/2016Update on the implementation of EMA policy on publication of clinical data (Policy 0070) and revisions to the guidance to industry – Industry associations webinar, European Medicines Agency, London, UK, From: 09-Dec-2016, To: 09-Dec-2016
08/12/2016Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 6, Authorised
08/12/2016News and press releases: EMA website briefly unavailable on 9 December
08/12/2016Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 8, Authorised
08/12/2016Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 6, Authorised
08/12/2016Human medicines European public assessment report (EPAR): Helixate NexGen,

octocog alfa

Revision: 28, Authorised
08/12/2016Veterinary medicine European public assessment report (EPAR): Cardalis,

benazepril hydrochloride / spironolactone

Revision: 2, Authorised
08/12/2016Human medicines European public assessment report (EPAR): Mysildecard,

sildenafil

Revision: 0, Authorised
08/12/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Lebrikizumab

Therapeutic area: Pneumology-allergology (updated)
08/12/2016Lebrikizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
08/12/2016Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
08/12/2016Report: European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2015
07/12/2016Report: Applications for new human medicines under evaluation by the CHMP: December 2016
07/12/2016Human medicines European public assessment report (EPAR): Multaq,

dronedarone

Revision: 9, Authorised
07/12/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)

Therapeutic area: Cardiovascular diseases/Endocrinology, -gynacology-fertility-metabolism (updated)
07/12/2016Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201605
07/12/2016Agenda: Agenda - Adaptive pathways workshop (updated)
07/12/2016Human medicines European public assessment report (EPAR): Ninlaro,

ixazomib

Revision: 0, Authorised
07/12/2016Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 7, Authorised
07/12/2016Regulatory and procedural guideline: Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products , adopted (updated)
06/12/2016Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
06/12/2016Withdrawn application: Ertapenem Hospira,

ertapenem

Initial authorisation (updated)
06/12/2016Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 5, Authorised
05/12/2016Patient registries workshop, European Medicines Agency, London, UK, From: 28-Oct-2016, To: 28-Oct-2016 (updated)
05/12/2016Human medicines European public assessment report (EPAR): Portrazza,

necitumumab

Revision: 2, Authorised
05/12/2016Spinal muscular atrophy workshop, European Medicines Agency, London, From: 11-Nov-2016, To: 11-Nov-2016 (updated)
05/12/2016Human medicines European public assessment report (EPAR): Invirase,

saquinavir

Revision: 43, Authorised
05/12/2016Twelfth joint EMA/EUnetHTA dialogue meeting, European Medicines Agency, London, UK, From: 07-Dec-2016, To: 07-Dec-2016
05/12/2016Orphan designation:

Exon-55-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-52-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-53-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-45-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3'

for the: Treatment of Huntington's disease (updated)
02/12/2016Orphan designation:

Exon 44 specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
02/12/2016Human medicines European public assessment report (EPAR): Invanz,

ertapenem

Revision: 19, Authorised
02/12/2016Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
02/12/2016Herbal medicinal products: Harpagophytum , Harpagophyti radix, Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (updated)
02/12/2016Herbal medicinal products: Origanum, Origani majoranae herba, Origanum majorana L. (updated)
02/12/2016Herbal medicinal products: Arnica, Arnicae flos, Arnica montana L. (updated)
02/12/2016Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 8, Authorised
02/12/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016
02/12/2016News and press releases: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
02/12/2016Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 15, Authorised
02/12/2016Referral: Article 31 referrals, Retinoid-containing medicinal products,

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

(updated)
02/12/2016List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
01/12/2016Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures (updated)
01/12/2016News and press releases: Simpler website navigation for regulatory information on human medicines
01/12/2016Request for a joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food producing animals
01/12/2016Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 1, Authorised
01/12/2016Antimicrobial resistance (updated)
01/12/2016News and press releases: Workshop on adaptive pathways – discussion on development approach for medicines addressing unmet medical needs
01/12/2016Advanced therapy classification (updated)
01/12/2016Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 4, Authorised
01/12/2016Implementation of ISO IDMP standards (updated)
01/12/2016SPOR data management services high level changes
01/12/2016Introduction to ISO Identification of Medicinal Products, SPOR programme
01/12/2016Organisation Management Services OMS operating model
01/12/2016Transition plan from Article 57 and XEVMPD data submission to SPOR
01/12/2016Referentials Management Services RMS operating model
01/12/2016News and press releases: Kaisa Immonen elected as new co-chair of Patients’ and Consumers’ Working Party
01/12/2016Patients' and Consumers' Working Party (updated)