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December 2017

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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)
11/12/2017Regulatory and procedural guideline: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
11/12/2017Marketing authorisation templates (updated)
11/12/2017Marketing authorisation (updated)
11/12/2017Pre-submission queries service: questions and answers (updated)
11/12/2017Marketing authorisation (updated)
11/12/2017Risk management plan (RMP): questions and answers (updated)
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)
11/12/2017Improving quality of submissions (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
11/12/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
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 - EMA - 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
06/12/2017Type-IB variations: questions and answers (updated)
06/12/2017Q&A: Type II variations (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
05/12/2017The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union (updated)
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 Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion (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 rectifying errors in PDCO opinions and European Medicines Agency decisions (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
01/12/2017PRAC strategy on measuring the impact of pharmacovigilance activities (updated)
01/12/2017Referral: Article 20 procedures, Xofigo,

radium Ra223 dichloride

01/12/2017Referral: Article 20 procedures, Esmya,

ulipristal acetate

01/12/2017Minutes of the EMA/EUnetHTA meeting - 8 June 2017
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
01/12/2017United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
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: Information Management (updated)
01/12/2017Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for re-examination of Paediatric Committee opinions (updated)
01/12/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for modification of an agreed paediatric investigation plan (updated)
01/12/2017Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 11, Authorised