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April 2015

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17/04/2015HMPC: overview of assessment work – priority list (updated)
17/04/2015Human medicines European public assessment report (EPAR): Advate,

octocog alfa

Revision: 20, Authorised
17/04/2015News and press releases: Scientific advice leads to stronger applications from industry
17/04/2015Veterinary medicine European public assessment report (EPAR): Suvaxyn CSF Marker,

classical swine fever vaccine (live recombinant)

Revision: 0, Authorised
17/04/2015Report: 2014 activity report of the modelling and simulation working group
17/04/2015Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2015
17/04/2015European Medicines Agency modelling and simulation working group plan 2015
17/04/2015Regulatory and procedural guideline: Initial notices for parallel distribution - March 2015
17/04/2015Report: Report from the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products
16/04/2015Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 5, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Sylvant,

siltuximab

Revision: 2, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 2, Authorised
16/04/2015Agenda: Agenda - PDCO agenda of the 15-17 April 2015 meeting
16/04/2015Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 4, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Saxenda,

liraglutide

Revision: 0, Authorised
16/04/2015Human medicines European public assessment report (EPAR): NovoEight,

turoctocog alfa

Revision: 1, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Bridion,

sugammadex

Revision: 8, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 16, Authorised
16/04/2015European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 04-Mar-2015, To: 04-Mar-2015 (updated)
16/04/2015Orphan medicines figures 2000-2014
16/04/2015Regulatory and procedural guideline: Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency
16/04/2015Organisation chart: Information Management (updated)
16/04/2015Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 3, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop),

clopidogrel

Revision: 15, Authorised
16/04/2015Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 9, Authorised
16/04/2015Information Management (updated)
16/04/201520th anniversary scientific conference highlights
16/04/2015Human medicines European public assessment report (EPAR): Ristempa,

pegfilgrastim

Revision: 0, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva,

mycophenolate mofetil

Revision: 13, Authorised
16/04/2015Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria),

insulin glargine

Revision: 2, Authorised
16/04/2015Veterinary medicine European public assessment report (EPAR): Trifexis,

spinosad / milbemycin oxime

Revision: 2, Authorised
16/04/2015Clinical Trial Regulation (updated)
16/04/2015Revision of section 6 of the 'Functional specifications for the European Union (EU) portal and EU database to be audited - EMA/42176/2014' setting out features to support making information public
16/04/2015Functional specifications for the European Union (EU) portal and EU database to be audited (updated)
15/04/2015Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 18, Authorised
15/04/2015Minutes of the CVMP meeting of 10-12 March 2015
15/04/2015Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 0, Authorised
15/04/2015Human medicines European public assessment report (EPAR): Jakavi,

ruxolitinib

Revision: 7, Authorised
15/04/2015Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 18, Authorised
15/04/2015Veterinary medicine European public assessment report (EPAR): Meloxidolor,

meloxicam

Revision: 2, Authorised
15/04/2015Newsletter: News bulletin for small and medium-sized enterprises - Issue 31
15/04/2015Agenda: Agenda - Annual workshop of the European network of paediatric research at the European Medicines Agency (updated)
15/04/2015Human medicines European public assessment report (EPAR): Plavix,

clopidogrel

Revision: 29, Authorised
15/04/2015Human medicines European public assessment report (EPAR): Aprovel,

irbesartan

Revision: 33, Authorised
15/04/2015Human medicines European public assessment report (EPAR): Hexyon,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 5, Authorised
15/04/2015Public statement: Draft public statement on <i>Uncaria tomentosa</i> (Willd. ex Schult.) DC., cortex
15/04/2015Herbal Medicinal Products: Uncaria, Uncariae tomentosae cortex, Uncariae tomentosae (Willd.) DC. (updated)
15/04/2015Careers (updated)
14/04/2015Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 17, Authorised
14/04/2015Human medicines European public assessment report (EPAR): Karvea,

irbesartan

Revision: 32, Authorised
14/04/2015Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 17, Authorised
14/04/2015Medication errors (updated)
14/04/2015News and press releases: Preventing medication errors in the European Union
14/04/2015Regulatory and procedural guideline: Good practice guide on risk minimisation and prevention of medication errors, draft: consultation open
14/04/2015Regulatory and procedural guideline: Good practice guide on recording, coding, reporting and assessment of medication errors, draft: consultation open
14/04/2015Regulatory and procedural guideline: Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors, draft: consultation open
14/04/2015Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 26, Authorised
14/04/2015Veterinary medicine European public assessment report (EPAR): Ecoporc Shiga,

genetically modified Shiga-toxin-2e antigen

Revision: 2, Authorised
14/04/2015Regulatory and procedural guideline: Submission deadlines for 2014-2015 for submitting request for compliance check (updated)
14/04/2015Questions and answers relating to service concession pharmacovigilance training – EMA/2014/35/RE (updated)
14/04/2015Human medicines European public assessment report (EPAR): DuoCover,

clopidogrel / acetylsalicylic acid

Revision: 11, Authorised
14/04/2015Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 10, Authorised
14/04/2015Human medicines European public assessment report (EPAR): Leflunomide medac,

leflunomide

Revision: 10, Authorised
13/04/2015Human medicines European public assessment report (EPAR): Efavirenz Teva,

efavirenz

Revision: 5, Authorised
13/04/2015Human medicines European public assessment report (EPAR): Cayston,

aztreonam

Revision: 10, Authorised
13/04/2015Pending EC decision: Cerenia,

maropitant citrate

Opinion date: 10-Apr-2015
13/04/2015Pending EC decision: Sileo,

dexmedetomidine hydrochloride

Opinion date: 10-Apr-2015
13/04/2015News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 April 2015
13/04/2015Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, adopted (updated)
13/04/2015Regulatory and procedural guideline: Deadlines for submission of applications for orphan-medicinal-product designation to the European Medicines Agency 2015/2016 (updated)
13/04/2015Referral: Article 35, Colistin oral,

colistin

13/04/2015Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi,

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

Revision: 1, Authorised
13/04/2015Regulatory and procedural guideline: Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmonary disease, draft: consultation open
13/04/2015Qualification of novel methodologies for medicine development (updated)
13/04/2015Herbal Medicinal Products: Echinacea, Echinaceae purpureae herba, Echinacea purpurea (L.) Moench (updated)
13/04/2015Veterinary 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: 1, Authorised
13/04/2015Veterinary 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: 1, Authorised
13/04/2015News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015
13/04/2015Referral: Article 31 referrals, Ibuprofen- and dexibuprofen-containing medicines,

ibuprofen and dexibuprofen

(updated)
13/04/2015News and press releases: PRAC recommends updating advice on use of high-dose ibuprofen
13/04/2015Final CHMP work programme for 2015
10/04/2015Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
10/04/2015Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 14, Authorised
10/04/2015Human medicines European public assessment report (EPAR): Telmisartan Teva,

telmisartan

Revision: 7, Authorised
10/04/2015Report: Medicinal products for human use: Monthly figures - March 2015
10/04/2015Report: Applications for new human medicines under evaluation by the CHMP: April 2015
10/04/2015Scientific guideline: Compilation of individual product-specific guidance on demonstration of bioequivalence (Rev.1), adopted
10/04/2015Overview of comments received on 'Draft carglumic acid product-specific bioequivalence guidance'
10/04/2015Overview of comments received on 'Draft posaconazole product-specific bioequivalence guidance'
10/04/2015Overview of comments received on 'Draft oseltamivir product-specific bioequivalence guidance'
10/04/2015Overview of comments received on 'Draft memantine product-specific bioequivalence guidance'
10/04/2015Overview of comments received on 'Draft imatinib product-specific bioequivalence guidance'
10/04/2015Scientific guideline: Compilation of individual product-specific guidance on demonstration of bioequivalence, adopted (updated)
10/04/2015European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) workshop on testing of system for data collection by species, European Medicines Agency, London, UK, From: 09-Feb-2015, To: 09-Feb-2015
10/04/2015Referral: Article 35, Gentamicin,

gentamicin

10/04/2015Report: Medicinal products for human use: Monthly figures - February 2015
10/04/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
10/04/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
10/04/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
10/04/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
10/04/2015Veterinary medicine European public assessment report (EPAR): Onsior,

robenacoxib

Revision: 7, Authorised
10/04/2015Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 15, Authorised
10/04/2015Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group),

pioglitazone

Revision: 4, Authorised
10/04/2015Human medicines European public assessment report (EPAR): Bexsero,

meningococcal group-B vaccine (rDNA, component, adsorbed)

Revision: 6, Authorised
10/04/2015Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 15, Authorised
10/04/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
10/04/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
10/04/2015Type-II variations: questions and answers (updated)
10/04/2015Type-IB variations: questions and answers (updated)
10/04/2015Type-IA variations: questions and answers (updated)
10/04/2015Human medicines European public assessment report (EPAR): Comtess,

entacapone

Revision: 22, Authorised
09/04/2015Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 8, Authorised
09/04/2015Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 17, Authorised
09/04/2015CAT work plan 2015-2016
09/04/2015Human medicines European public assessment report (EPAR): Exforge HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 9, Authorised
09/04/2015Minutes of the CHMP meeting 23-26 February 2015
09/04/2015Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 18, Authorised
09/04/2015Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 18, Authorised
09/04/2015Regulatory and procedural guideline: Draft second revision of the guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products, draft: consultation open
09/04/2015Human medicines European public assessment report (EPAR): Abilify Maintena,

aripiprazole

Revision: 4, Authorised
09/04/2015Guidelines and concept papers adopted during the CHMP meeting 23-26 March 2015, adopted
09/04/2015Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 23-26 March 2015, adopted
09/04/2015Organisational matters - CHMP meeting 23-26 March 2015, adopted
09/04/2015Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 23-26 March 2015, adopted
09/04/2015Human medicines European public assessment report (EPAR): Imprida,

amlodipine / valsartan

Revision: 18, Authorised
09/04/2015Human medicines European public assessment report (EPAR): Aloxi,

palonosetron

Revision: 20, Authorised
09/04/2015Orphan designation:

Olaratumab

for the: Treatment of soft tissue sarcoma
09/04/2015Orphan designation:

N-(3-(4-(3-(diisobutylamino)propyl)piperazin-1-yl)propyl)-1H-benzo[d]imidazol-2-amine disulphate salt

for the: Treatment of progressive supranuclear palsy
09/04/2015Orphan designation:

Myriocin

for the: Treatment of retinitis pigmentosa
09/04/2015Orphan designation:

505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase

for the: Treatment of facioscapulohumeral muscular dystrophy
09/04/2015Human medicines European public assessment report (EPAR): Tasermity,

sevelamer hydrochloride

Revision: 0, Authorised
09/04/2015Orphan designation:

Fibrinogen-coated albumin spheres

for the: Treatment of Ebola virus disease
09/04/2015Orphan designation:

Alvocidib

for the: Treatment of acute myeloid leukaemia
09/04/2015Orphan designation:

Recombinant human glutamate oxaloacetate transaminase 1

for the: Treatment of glioma
09/04/2015Orphan designation:

Ulocuplumab

for the: Treatment of acute myeloid leukaemia
09/04/2015Orphan designation:

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

for the: Treatment of cytomegalovirus infection following haematopoietic stem cell transplantation
09/04/2015Orphan designation:

Lactobacillus reuteri

for the: Prevention of necrotising enterocolitis
09/04/2015Orphan designation:

Mazindol

for the: Treatment of narcolepsy
09/04/2015Orphan designation:

5-hydroxymethyl-2-furfural

for the: Treatment of sickle cell disease
09/04/2015Regulatory and procedural guideline: Appointment and responsibilities of rapporteur and co-rapporteur for procedures regarding veterinary medicinal products, adopted (updated)
09/04/2015Herbal Medicinal Products: Agrimonia, Agrimoniae herba, Agrimonia eupatoria L. (updated)
09/04/2015Herbal Medicinal Products: Melaleuca, Melaleucae alternifoliae aetheroleum, Melaleuca alternifolia (Maiden and Betche) Cheel (updated)
09/04/2015Agenda: Agenda - COMP agenda of the 14-16 April 2015 meeting (updated)
09/04/2015Shortages catalogue (updated)
09/04/2015Herbal Medicinal Products: Epilobium, Epilobii herba, Epilobium angustifolium L. and/or Epilobium parviflorum Schreb. (updated)
09/04/2015European Union herbal monograph on <i>Epilobium angustifolium</i> L. and/or <i>Epilobium parviflorum</i> Schreb., herba, draft: consultation open
09/04/2015Buccolam (midazolam) supply shortage (updated)
08/04/2015News and press releases: Promoting high quality scientific research in paediatric medicines
08/04/2015Orphan designation:

Sevuparin sodium

for the: Treatment of sickle cell disease
08/04/2015Agenda: Agenda - PRAC draft agenda of meeting 7-10 April 2015
08/04/2015Orphan designation:

3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid

for the: Treatment of hereditary angioedema
08/04/2015Orphan designation:

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

for the: Treatment of Huntington's disease
08/04/2015Orphan designation:

Nitroglycerin

for the: Treatment of systemic sclerosis
08/04/2015Orphan designation:

Chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions

for the: Treatment of ovarian cancer
08/04/2015Joint Drug Information Association (DIA)/European Medicines Agency (EMA) Information Day on Post-Authorisation Studies (PAS), European Medicines Agency, London, UK, From: 05-Jun-2015, To: 05-Jun-2015
08/04/2015Agenda: Agenda - CVMP agenda of the 8-10 April 2015 meeting
08/04/2015Annual workshop of the European network of paediatric research at the European Medicines Agency, European Medicines Agency, London, UK, From: 28-May-2015, To: 29-May-2015
08/04/2015Registration form - Annual workshop of the European network of paediatric research at the European Medicines Agency
08/04/2015Human medicines European public assessment report (EPAR): Copalia HCT,

amlodipine / valsartan / hydrochlorothiazide

Revision: 8, Authorised
08/04/2015Herbal Medicinal Products: Ginkgo, Ginkgo folium, <i>Ginkgo biloba</i> L., folium (updated)
08/04/2015Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)
08/04/2015Regulatory and procedural guideline: Names of the European Union / European Economic Area countries (updated)
08/04/2015Appendix V - Adverse-drug-reaction reporting details (updated)
07/04/2015Overview of comments received on 'Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues'
07/04/2015Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 2, Authorised
07/04/2015Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 33, Authorised
07/04/2015Veterinary medicine European public assessment report (EPAR): Stronghold,

selamectin

Revision: 21, Authorised
07/04/2015Trainee programme (updated)
07/04/2015Human medicines European public assessment report (EPAR): Rasilamlo,

aliskiren / amlodipine

Revision: 5, Authorised
07/04/2015Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 31, Authorised
07/04/2015Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 2, Authorised
07/04/2015Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 2, Authorised
07/04/2015Questions and answers on quality of herbal medicinal products / traditional herbal medicinal products (updated)
07/04/2015Procedure Management and Committees Support (updated)
07/04/2015Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 10, Authorised
07/04/2015Organisation chart: Procedure Management and Committees Support (updated)
07/04/2015Organisation chart of the European Medicines Agency (updated)
07/04/2015Human medicines European public assessment report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 17, Authorised
07/04/2015MRL report: Potassium selenate (all food producing species) Sodium selenate (all food producing species) Sodium selenite (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
07/04/2015MRL report: Tulathromycin (modification of the microbiological ADI and MRLs in bovine and porcine species) – after provisional maximum residue limits (MRLs): European public maximum-residue-limit assessment report (EPMAR) - CVMP
07/04/2015MRL report: Barium selenate (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
07/04/2015News and press releases: World Health Day 2015
01/04/2015Agenda: Programme - Joint European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA) workshop on requirements for the authorisation of veterinary vaccines in the European Union (updated)
01/04/2015Human medicines European public assessment report (EPAR): BindRen,

colestilan

Revision: 2, Withdrawn
01/04/2015Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 19, Authorised
01/04/2015Plasma-master-file certifications (updated)
01/04/2015Newsletter: Human medicines highlights - March 2015
01/04/2015List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
01/04/2015HMPC meeting report on Community herbal monographs, guidelines and other activities - 9-10 March 2015
01/04/2015Joint European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA) workshop on requirements for the authorisation of veterinary vaccines in the European Union (EU), European Medicines Agency, London, UK, From: 25-Mar-2015, To: 25-Mar-2015 (updated)
01/04/2015Scientific guideline: Concept paper on clinical investigation of medicinal products for the treatment of axial spondyloarthritis, draft: consultation open
01/04/2015Human medicines European public assessment report (EPAR): Controloc Control,

pantoprazole

Revision: 6, Authorised
01/04/2015Agenda: Agenda - CAT agenda of the 19–20 March 2015 meeting
01/04/2015Minutes of the CAT meeting 19-20 February 2015
01/04/2015CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2015 meeting
01/04/2015Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (updated)
01/04/2015Submission deadlines for 2015-2016 for submitting a request for modification to an agreed paediatric investigation plan (updated)
01/04/2015Submission deadlines for 2015 and 2016 for paediatric investigation plan applications, applications for waivers and answers to request for modification plan of the application (updated)
01/04/2015Submission deadlines for 2015-2016 for submitting a request for compliance check (updated)
01/04/2015PRAC assessment report of an non-interventional imposed post-authorisation-safety-study final study report (updated)
01/04/2015Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease, draft: consultation open