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January 2015

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26/01/2015News and press releases: Central repository to facilitate assessment of medicines safety reports
26/01/2015Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 24, Authorised
26/01/2015Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 8, Authorised
26/01/2015Human medicines European public assessment report (EPAR): Sustiva,

efavirenz

Revision: 38, Authorised
26/01/2015Human medicines European public assessment report (EPAR): Nplate,

romiplostim

Revision: 10, Authorised
26/01/2015Veterinary medicine European public assessment report (EPAR): Bluevac BTV8,

bluetongue virus inactivated, serotype 8

Revision: 2, Authorised
26/01/2015Human medicines European public assessment report (EPAR): Irbesartan Teva,

irbesartan

Revision: 7, Authorised
26/01/2015Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 17, Authorised
26/01/2015Human medicines European public assessment report (EPAR): Duloxetine Lilly,

duloxetine

Revision: 0, Authorised
26/01/2015Minutes - PDCO minutes of the 10-12 December 2014 meeting
26/01/2015Current tenders for €60,000 or more (updated)
26/01/2015Questions and answers relating to procurement procedure: effectiveness and pharmacoepidemiology studies - EMA/2014/50/RE (updated)
23/01/2015Human medicines European public assessment report (EPAR): Tobi Podhaler,

tobramycin

Revision: 5, Authorised
23/01/2015Human medicines European public assessment report (EPAR): Gardasil,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 27, Authorised
23/01/2015Human medicines European public assessment report (EPAR): Topotecan Teva,

topotecan

Revision: 5, Authorised
23/01/2015Human medicines European public assessment report (EPAR): Stocrin,

efavirenz

Revision: 35, Authorised
23/01/2015Human medicines European public assessment report (EPAR): Rapamune,

sirolimus

Revision: 30, Authorised
23/01/2015Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 15, Authorised
23/01/2015Casopitant - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
23/01/2015News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015
23/01/2015News and press releases: GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
23/01/2015News and press releases: Saxenda recommended for approval in weight management in adults
23/01/2015Pending EC decision: Ikervis,

ciclosporin

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Dutrebis,

lamivudine / raltegravir

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Abraxane,

paclitaxel

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Vantobra,

tobramycin

Opinion date: 22-Jan-2015 (updated)
23/01/2015Pending EC decision: Orbactiv,

oritavancin

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Kengrexal,

cangrelor

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Jakavi,

ruxolitinib

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Raplixa,

human fibrinogen / human thrombin

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Opinion date: 22-Jan-2015
23/01/2015Pending EC decision: Aloxi,

palonosetron

Opinion date: 22-Jan-2015
23/01/2015Start of community reviews - CHMP meeting of 19-22 January 2015
23/01/2015Withdrawn application: Teysuno,

tegafur / gimeracil / oteracil

Post-authorisation
23/01/2015Pending EC decision: Sivextro,

tedizolid phosphate

Opinion date: 22-Jan-2015
23/01/2015Scientific advice and protocol assistance adopted during the CHMP meeting 19-22 January 2015
23/01/2015Pending EC decision: Saxenda,

liraglutide

Opinion date: 22-Jan-2015
23/01/2015Referral: Article 31 referrals, GVK Biosciences (updated)
22/01/2015Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 6, Authorised
22/01/2015Information Technology (updated)
22/01/2015Organisation chart: Information Technology (updated)
22/01/2015Organisation chart of the European Medicines Agency (updated)
22/01/2015Human medicines European public assessment report (EPAR): M-M-RVAXPRO,

measles, mumps and rubella vaccine (live)

Revision: 14, Authorised
22/01/2015Veterinary medicine European public assessment report (EPAR): Purevax RCCh,

Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila virus infections

Revision: 8, Withdrawn
22/01/2015Registration form - European Medicines Agency/International Federation for Animal Health-Europe info day 2015
22/01/2015Human medicines European public assessment report (EPAR): Firmagon,

degarelix

Revision: 11, Authorised
22/01/2015Agenda: Programme - European Medicines Agency/International Federation for Animal Health-Europe info day 2015
22/01/2015European Medicines Agency/International Federation for Animal Health-Europe info day 2015, European Medicines Agency, London, UK, From: 12-Mar-2015, To: 13-Mar-2015
22/01/2015Human medicines European public assessment report (EPAR): Ristaben,

sitagliptin

Revision: 10, Authorised
22/01/2015Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 2, Authorised
22/01/2015Questions and answers relating to procurement procedure EMA/2014/16/COM – Provision of support to communication activities (services including communication consulting, printing and exhibition material) – three lots (updated)
22/01/2015eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 19-Feb-2015, To: 20-Feb-2015
22/01/2015eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, Austrian Medicines and Medical Devices, Vienna, Austria, From: 19-Mar-2015, To: 20-Mar-2015
22/01/2015eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 23-Apr-2015, To: 24-Apr-2015
22/01/2015eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 11-Jun-2015, To: 12-Jun-2015
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human immunoglobulin G2Lambda monoclonal antibody directed against thymic stromal lymphopoietin (MEDI9929)

Therapeutic area: Pneumology-allergology
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Exforge,

Amlodipine (besylate) / valsartan

Therapeutic area: Cardiovascular diseases
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124)

Therapeutic area: Psychiatry/Neurology
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Bilaxten and associated names,

Bilastine

Therapeutic area: Dermatology/Oto-rhino-laryngology/Pneumology-allergology (updated)
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Drisapersen

Therapeutic area: Neurology (updated)
22/01/2015Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 0, Authorised
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, San Marino, From: 04-May-2015, To: 06-May-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, Austrian Medicines and Medical Devices, Vienna, Austria, From: 16-Mar-2015, To: 18-Mar-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain, From: 04-Mar-2015, To: 06-Mar-2015
22/01/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Entyvio,

vedolizumab

Therapeutic area: Gastroentology-Hepatology (updated)
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 20-Apr-2015, To: 22-Jan-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 11-Mar-2015, To: 13-Mar-2015
22/01/2015Introduction to pharmacovigilance and rules for expedited reporting of Individual Case Safety Reports in Europe, European Medicines Agency, London, UK, From: 10-Mar-2015, To: 10-Mar-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 16-Feb-2015, To: 18-Feb-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 28-Jan-2015, To: 30-Jan-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 20-May-2015, To: 22-May-2015
22/01/2015EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area, European Medicines Agency, London, UK, From: 08-Jun-2015, To: 10-Jun-2015
22/01/2015Introduction to pharmacovigilance and rules for expedited reporting of Individual Case Safety Reports in Europe, European Medicines Agency, London, UK, From: 19-May-2015, To: 19-May-2015
22/01/2015Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 4, Authorised
22/01/2015Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 9, Authorised
22/01/2015Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 29, Authorised
21/01/2015Annex 1 - Active substance master file (ASMF) assessment report template (updated)
21/01/2015Veterinary medicine European public assessment report (EPAR): Comfortis,

spinosad

Revision: 4, Authorised
21/01/2015Veterinary medicine European public assessment report (EPAR): Respiporc Flu3,

inactivated influenza-A virus / swine

Revision: 1, Authorised
21/01/2015Veterinary medicine European public assessment report (EPAR): Zolvix,

monepantel

Revision: 8, Authorised
21/01/2015Human medicines European public assessment report (EPAR): Paliperidone Janssen,

paliperidone

Revision: 0, Authorised
21/01/2015Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified (updated)
21/01/2015Template for scientific document (part B-E) for application for paediatric investigation plan including deferral and waiver (updated)
21/01/2015Template for letter of intent to submit an application (updated)
21/01/2015Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion (updated)
21/01/2015News and press releases: Regulatory information - Paediatric guidance revised to reflect changes to European Commission guideline
21/01/2015Regulatory and procedural guideline: Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards, adopted (updated)
21/01/2015Paediatric investigation plans: questions and answers (updated)
21/01/2015Regulatory and procedural guideline: Re-examination procedure of paediatric investigation plan and / or waiver opinions by the PDCO (updated)
21/01/2015Annual report on deferral granted in the paediatric investigation plan - (PED6) certified (updated)
21/01/2015Request for compliance check on an agreed paediatric-investigation-plan form - (PED3) certified (updated)
21/01/2015News and press releases: New international standard to improve safety of medicines
21/01/2015Regulatory and procedural guideline: European Union individual case safety report (ICSR) implementation guide, adopted (updated)
21/01/2015Training session for patients and consumers involved in European Medicines Agency activities, European Medicines Agency, London, UK, From: 25-Nov-2014, To: 25-Nov-2014 (updated)
21/01/2015Clinical Trial Regulation
21/01/2015Questions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation
21/01/2015Orphan designation:

Pasireotide

for the: Treatment of acromegaly (updated)
21/01/2015Letter of support for micro-aneurysm formation rate (MAFR) biomarker
21/01/2015Extension of reserve lists for Contract Agent selection procedures: Contract Agent reserve lists expiring in 2014/2015 (updated)
21/01/2015Extension of reserve lists for external selection procedures: Temporary Agent reserve lists expiring on 31 December 2014 (updated)
21/01/2015Draft appendices to draft proposal for an addendum, on transparency, to the 'Functional specifications for the European Union portal and EU database to be audited'
21/01/2015Respiporc Flu3 : EPAR - Product Information (updated)
21/01/2015Draft proposal for an addendum, on transparency, to the 'Functional specifications for the European Union portal and EU database to be audited'
20/01/2015Human medicines European public assessment report (EPAR): RoActemra,

tocilizumab

Revision: 15, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 3, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Incivo,

telaprevir

Revision: 16, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Imprida,

amlodipine / valsartan

Revision: 17, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria),

insulin glargine

Revision: 1, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 4, Authorised
20/01/2015Human medicines European public assessment report (EPAR): DuoCover,

clopidogrel / acetylsalicylic acid

Revision: 10, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 2, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Sycrest,

asenapine

Revision: 9, Authorised
20/01/2015Human medicines European public assessment report (EPAR): Nexavar,

sorafenib

Revision: 25, Authorised
20/01/2015Agenda: Agenda - CAT agenda of the 15–16 January 2015 meeting
20/01/2015Minutes of the CVMP meeting of 9-11 December 2015
20/01/2015Questions and answers relating to procurement procedure: provision of internal audit services - EMA/2014/49/AUD (updated)
19/01/2015Orphan designation:

Olaparib

for the: Treatment of ovarian cancer (updated)
19/01/2015News and press releases: Europe to boost international cooperation on generics
19/01/2015International Generic Drug Regulators Programme information sharing pilot
19/01/2015Request form - Expression of interest to participate in the information sharing pilot for the evaluation of generic drug applications involving the centralised procedure of the European Union
19/01/2015Summary of quality differences form
19/01/2015Veterinary medicine European public assessment report (EPAR): Draxxin,

tulathromycin

Revision: 13, Authorised
19/01/2015Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 3, Authorised
19/01/2015Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 17, Authorised
19/01/2015Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 13, Authorised
19/01/2015Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2014
19/01/2015Agenda: Agenda - CHMP agenda of the 19-22 January 2015 meeting
19/01/2015Human medicines European public assessment report (EPAR): Vistide,

cidofovir

Revision: 21, Withdrawn
16/01/2015Trainee programme (updated)
16/01/2015Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 17, Authorised
16/01/2015Orphan designation:

Humanised IgG1 monoclonal antibody against human eotaxin-2

for the: Treatment of systemic sclerosis
16/01/2015Orphan designation:

Siponimod

for the: Treatment of dermatomyositis
16/01/2015Orphan designation:

Siponimod

for the: Treatment of polymyositis
16/01/2015Orphan designation:

Arimoclomol citrate

for the: Treatment of Niemann-Pick disease, type C
16/01/2015Orphan designation:

Diaspirin cross-linked haemoglobin

for the: Treatment of hepatocellular carcinoma
16/01/2015Orphan designation:

Chloroquine

for the: Treatment of glioma
16/01/2015Human medicines European public assessment report (EPAR): Ibandronic Acid Teva,

ibandronic acid

Revision: 3, Authorised
16/01/2015Pending EC decision: Coliprotec F4,

Escherichia coli, type 08, strain K87 (live)

Opinion date: 15-Jan-2015
16/01/2015Pending EC decision: Lodipressine,

amlodipine

Opinion date: 15-Jan-2015
16/01/2015Stakeholders and Communication (updated)
16/01/2015Organisation chart: Stakeholders and Communication (updated)
16/01/2015Pending EC decision: Stronghold,

selamectin

Opinion date: 15-Jan-2015
16/01/2015Technical specifications - Annex VII - European Medicines Agency editorial guide
16/01/2015Provision of support to communication activities - Technical specifications (updated)
16/01/2015News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 January 2015
16/01/2015Orphan designation:

Dantrolene sodium

for the: Treatment of malignant hyperthermia
16/01/2015Orphan designation:

Adeno-associated viral vector serotype 8 containing the human MD1 gene

for the: Treatment of Duchenne muscular dystrophy
16/01/2015Orphan designation:

Ataluren

for the: Treatment of mucopolysaccharidosis type I
16/01/2015Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 24, Authorised
16/01/2015Human medicines European public assessment report (EPAR): Cerezyme,

imiglucerase

Revision: 19, Authorised
16/01/2015Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 8, Authorised
16/01/2015Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 24, Authorised
16/01/2015Orphan designation:

Pro-Pro-Thr-Val-Pro-Thr-Arg

for the: Treatment of xeroderma pigmentosum
15/01/2015Referral: Article 30 referrals, EMLA cream and associated names,

lidocaine / prilocaine

(updated)
15/01/2015Orphan designation:

Recombinant human pentraxin-2

for the: Treatment of primary myelofibrosis
15/01/2015Orphan designation:

Selinexor

for the: Treatment of plasma cell myeloma
15/01/2015Orphan designation:

Donor T lymphocytes depleted ex-vivo of host alloreactive T cells using photodynamic treatment

for the: Treatment of acute myeloid leukaemia
15/01/2015Orphan designation:

Recombinant human pentraxin-2

for the: Treatment of post-essential thrombocythaemia myelofibrosis
15/01/2015Orphan designation:

Pentosan polysulfate sodium

for the: Treatment of mucopolysaccharidosis type I
15/01/2015Orphan designation:

Imatinib

for the: Treatment of acute respiratory distress syndrome
15/01/2015Orphan designation:

Selinexor

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
15/01/2015Orphan designation:

Recombinant human pentraxin-2

for the: Treatment of post-polycythaemia vera myelofibrosis
15/01/2015Newsletter: Human medicines highlights - December 2014
15/01/2015COMP meeting report on the review of applications for orphan designation: January 2015
15/01/2015Orphan designation:

Palovarotene

for the: Treatment of fibrodysplasia ossificans progressiva
15/01/2015Orphan designation:

Olaptesed pegol

for the: Treatment of glioma
15/01/2015Orphan designation:

Bazedoxifene acetate

for the: Treatment of hereditary haemorrhagic telangiectasia
15/01/2015Orphan designation:

Mexiletine hydrochloride

for the: Treatment of myotonic disorders
15/01/2015Human medicines European public assessment report (EPAR): Sprycel,

dasatinib

Revision: 22, Authorised
15/01/2015Human medicines European public assessment report (EPAR): Memantine Accord,

memantine

Revision: 2, Authorised
15/01/2015Orphan designation:

(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide

for the: Treatment of microscopic polyangiitis
15/01/2015Orphan designation:

(3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbaNmate

for the: Treatment of Gaucher disease
15/01/2015Orphan designation:

A combination of H-Lys-Lys-Gly-Pro-Arg-Cys(SH)-Leu-Thr-Arg-Tyr-Tyr-Ser-Ser-Phe-Val-Asn-Met-Glu-Gly-Lys-Lys-OH and H-Lys-Lys-Gly-Asp-Asn-Ile-Met-Val-Thr-Phe-Arg-Asn-Gln-Ala-Ser-Arg-Pro-Tyr-Gly-Lys-Lys-OH

for the: Treatment of haemophilia A
15/01/2015Orphan designation:

1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid

for the: Treatment of systemic sclerosis
15/01/2015Orphan designation:

1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid

for the: Treatment of idiopathic pulmonary fibrosis
15/01/2015Orphan designation:

4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid

for the: Treatment of cystic fibrosis
15/01/2015Orphan designation:

(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide

for the: Treatment of granulomatosis with polyangiitis
14/01/2015Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif),

human normal immunoglobulin

Revision: 11, Authorised
14/01/2015Human medicines European public assessment report (EPAR): Ifirmacombi,

irbesartan / hydrochlorothiazide

Revision: 3, Authorised
14/01/2015Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 17, Authorised
14/01/2015Recruitment at the European Medicines Agency (updated)
14/01/2015MRL report: Lufenuron (fin fish): European public maximum-residue-limit assessment report (EPMAR) - CVMP
14/01/2015Minutes of the PRAC meeting 1-4 December 2014
14/01/2015Agenda: Agenda - PDCO agenda of the 14-16 January 2015 meeting
14/01/2015Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
14/01/2015Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 5, Authorised
14/01/2015Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 16, Authorised
14/01/2015Human medicines European public assessment report (EPAR): Victrelis,

boceprevir

Revision: 16, Authorised
14/01/2015Fee reductions for designated orphan medicinal products (updated)
14/01/2015Agenda: Agenda - CVMP agenda of the 13-15 January 2015 meeting
14/01/2015Report: Applications for new human medicines under evaluation by the CHMP: January 2015
13/01/2015Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 16, Authorised
13/01/2015Human medicines European public assessment report (EPAR): Sifrol,

pramipexole

Revision: 26, Authorised
12/01/2015World Health Organization international consultation on regulatory systems strengthening, Geneva, Switzerland, From: 13-Jan-2015, To: 15-Jan-2015
12/01/2015Human medicines European public assessment report (EPAR): Opsumit,

macitentan

Revision: 2, Authorised
12/01/2015Veterinary medicine European public assessment report (EPAR): Neocolipor,

Adjuvanted vaccine against enterotoxicosis of piglets due to E. coli

Revision: 10, Authorised
12/01/2015Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 on electronic common technical document (eCTD) - file format criteria - Step 5
12/01/2015Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 4
12/01/2015European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated)
12/01/2015Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R5): Questions and answers: Data elements for transmission of individual case safety reports - Step 5, adopted (updated)
12/01/2015TachoSil-H-C-505-P46-39 : EPAR - Assessment Report, adopted
12/01/2015Veterinary medicine European public assessment report (EPAR): Dexdomitor,

dexmedetomidine

Revision: 15, Authorised
12/01/2015Questions and answers on the withdrawal of the marketing authorisation application for Folcepri (etarfolatide) (updated)
12/01/2015Questions and answers on the withdrawal of the marketing authorisation application for Vynfinit (vintafolide) (updated)
12/01/2015Questions and answers on the withdrawal of the marketing authorisation application for Neocepri (folic acid) (updated)
12/01/2015Human medicines European public assessment report (EPAR): Infanrix Hexa,

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Revision: 22, Authorised
12/01/2015Regulatory and procedural guideline: Initial notices for parallel distribution – December 2014
12/01/2015Workshop on development pathways for advanced-therapy medicinal products, European Medicines Agency, London, UK, From: 15-Dec-2014, To: 15-Dec-2014
12/01/2015Report: Report on the development pathways for advanced-therapy medicinal products workshop
12/01/2015News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015
12/01/2015News and press releases: PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small
12/01/2015Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
09/01/2015Referral: Article 13, Resflor solution injectable and associated names,

florfenicol, flunixin

09/01/2015Agenda: Agenda - CAT agenda of the 11–12 December 2014 meeting
09/01/2015Scientific guideline: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, adopted
09/01/2015Telematics Enterprise Architecture Board - Terms of reference (updated)
09/01/2015The joint European Union Telematics governance model (updated)
09/01/2015Nominations to the European Union Telematics governance bodies (updated)
09/01/2015Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
09/01/2015Report: European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2013
09/01/2015Human medicines European public assessment report (EPAR): Lynparza,

olaparib

Revision: 0, Authorised
09/01/2015Human medicines European public assessment report (EPAR): Panretin,

alitretinoin

Revision: 12, Authorised
09/01/2015Human medicines European public assessment report (EPAR): Hizentra,

human normal immunoglobulin (SCIg)

Revision: 10, Authorised
09/01/2015News and press releases: Record number of medicines for rare diseases recommended for approval in 2014
09/01/2015Human medicines European public assessment report (EPAR): Rilutek,

riluzole

Revision: 20, Authorised
09/01/2015Executive Director decision laying down rules on the secondment of national experts to the Agency (updated)
08/01/2015Publication of clinical data (updated)
08/01/2015Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 24, Authorised
08/01/2015Publications (updated)
08/01/2015EudraVigilance eXtended medicinal product dictionary acknowledgment codes
08/01/2015Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 5: Extended EudraVigilance product report acknowledgement message (updated)
08/01/2015Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No 726/2004: Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (updated)
08/01/2015Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No 726/2004: Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (updated)
08/01/2015Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 5: Extended EudraVigilance product report acknowledgement message (updated)
08/01/2015Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 39, Authorised
08/01/2015HMPC: Overview of assessment work – priority list (updated)
08/01/2015Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 15-18 December 2014
08/01/2015Organisational matters - CHMP meeting 15-18 December 2014
08/01/2015Guidelines and concept papers adopted during the CHMP meeting 15-18 December 2014
08/01/2015Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 15-18 December 2014
08/01/2015Technical specifications - Annex V Tenderer information form: Procurement procedure EMA/2014/50/RE (updated)
08/01/2015National experts on secondment (updated)
08/01/2015Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 0, Authorised
08/01/2015Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

(updated)
07/01/2015European 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, European Medicines Agency, London, UK, From: 04-Dec-2014, To: 05-Dec-2014 (updated)
07/01/2015Agenda: Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products (updated)
06/01/2015Agenda: Agenda - PRAC draft agenda of meeting 6-9 January 2015
06/01/2015CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2014 meeting
06/01/2015Scientific guideline: Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products, draft: consultation open
06/01/2015Minutes of the CAT meeting 13-14 November 2014
06/01/2015CAT meeting dates 2015, 2016, 2017 and 2018
06/01/2015Human medicines European public assessment report (EPAR): Masiviera,

masitinib

Revision: 0, Refused
05/01/2015Referral: Article 31 referrals, Polymyxin-containing medicines,

colistimethate sodium

(updated)
05/01/2015Regulatory and procedural guideline: The dates of 2015 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel European Medicines Agency-health-technology-assessment requests (updated)
05/01/2015Qualification of novel methodologies for medicine development (updated)
05/01/2015Letter of intent for request of qualification of biomarkers/clinical outcome assessments (COAs) in a joint US FDA-EMA submission
05/01/2015Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 36, Authorised