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November 2014

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21/11/2014Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 0, Authorised
21/11/2014Ebola (updated)
21/11/2014Publications (updated)
21/11/2014Veterinary medicine European public assessment report (EPAR): NexGard,

afoxolaner

Revision: 2, Authorised
21/11/2014Human medicines European public assessment report (EPAR): Xelevia,

sitagliptin

Revision: 17, Authorised
21/11/2014Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 9, Authorised
21/11/2014Minutes of the COMP meeting 7-9 October 2014
21/11/2014COMP meeting report on the review of applications for orphan designation: November 2014
21/11/2014Notices of calls for tender - 2014 (updated)
21/11/2014Adaptive licensing (updated)
21/11/2014National experts on secondment application form (updated)
21/11/2014Scientific advice and protocol assistance adopted during the CHMP meeting 17-20 November 2014
21/11/2014News and press releases: Regulatory update - EMA encourages companies to submit type-I variations for 2014 by end of November
21/11/2014News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 2014
21/11/2014News and press releases: Cerdelga recommended for approval in type 1 Gaucher disease
21/11/2014News and press releases: Two new medicines recommended for the treatment of chronic hepatitis C
21/11/2014News and press releases: EMA recommends availability of ellaOne emergency contraceptive without prescription
21/11/2014News and press releases: European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
21/11/2014Pending EC decision: Cosentyx,

secukinumab

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Exviera,

dasabuvir

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Ofev,

nibtedanib

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Senshio,

ospemifene

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Otezla,

apremilast

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Rasagiline Ratiopharm,

rasagiline

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: ellaOne,

ulipristal acetate

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Zontivity,

vorapaxar

Opinion date: 20-Nov-2014
21/11/2014Referral: Article 30 referrals, Nasonex,

mometasone furoate

21/11/2014Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproic acid, valproate semisodium, valpromide

(updated)
21/11/2014Pending EC decision: Sevelamer carbonate Zentiva,

sevelamer

Opinion date: 20-Nov-2014
21/11/2014Referral: Article 20 procedures, Corlentor and Procoralan,

ivabradine

(updated)
21/11/2014Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

(updated)
21/11/2014Pending EC decision: Travatan,

travoprost

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Cerdelga,

eliglustat

Opinion date: 20-Nov-2014
21/11/2014Pending EC decision: Viekirax,

ombitasvir / paritaprevir / ritonavir

Opinion date: 20-Nov-2014
21/11/2014News and press releases: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
21/11/2014News and press releases: No consistent evidence of an increased risk of heart problems with testosterone medicines
21/11/2014Pending EC decision: Inductos,

dibotermin alfa

Opinion date: 20-Nov-2014
21/11/2014Withdrawn application: Egranli,

balugrastim

Initial authorisation
20/11/2014Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 13, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Volibris,

ambrisentan

Revision: 14, Authorised
20/11/2014International Coalition of Medicines Regulatory Authorities
20/11/2014Scientific guideline: Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer's disease and other dementias (updated)
20/11/2014International Coalition of Medicines Regulatory Authorities (ICMRA) fact sheet
20/11/2014Human medicines European public assessment report (EPAR): Leflunomide Winthrop,

leflunomide

Revision: 8, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Metalyse,

tenecteplase

Revision: 14, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 23, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Leflunomide medac,

leflunomide

Revision: 9, Authorised
20/11/2014Regulatory and procedural guideline: Procedural guidance on inclusion of declared interests in the European Medicines Agency’s electronic declaration of interests form (for scientific committees’ members and experts)
20/11/2014European Medicines Agency policy on the handling of declarations of interests of scientific committees’ members and experts
20/11/2014News and press releases: Conflicts of interests: revised EMA policy reflects more balanced approach
20/11/2014Handling conflicts of interests (updated)
20/11/2014Human medicines European public assessment report (EPAR): Xeplion,

paliperidone

Revision: 5, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 5, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 2, Authorised
20/11/2014Human medicines European public assessment report (EPAR): Silapo,

epoetin zeta

Revision: 10, Authorised
20/11/2014Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live, oral

Revision: 18, Authorised
20/11/2014Questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance (updated)
20/11/2014Withdrawn application: Neofordex,

dexamethasone

Initial authorisation (updated)
19/11/2014Reporting requirements for marketing-authorisation holders (updated)
19/11/2014Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004
19/11/2014European Commission - European Medicines Agency - China Food and Drugs Administration bilateral and International Summit of Heads of Medicines Regulatory Agencies, Beijing, China, From: 17-Nov-2014, To: 21-Nov-2014
19/11/2014Agenda: Programme of European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease
19/11/2014Human medicines European public assessment report (EPAR): Januvia,

sitagliptin

Revision: 16, Authorised
19/11/2014Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 34, Authorised
19/11/2014Human medicines European public assessment report (EPAR): Jetrea,

ocriplasmin

Revision: 3, Authorised
19/11/2014Human medicines European public assessment report (EPAR): INOmax,

nitric oxide

Revision: 15, Authorised
19/11/2014Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 15, Authorised
19/11/2014Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 14, Authorised
19/11/2014Overview of comments received during the first public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine'
19/11/2014Scientific guideline: VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision at step 9, for implementation at step 7, adopted
19/11/2014Scientific guideline: Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with World Organisation for Animal Health (OIE) recommendations, adopted
19/11/2014Overview of comments received on 'Guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health (OIE) requirements'
19/11/2014Guide to RSS (updated)
19/11/2014Bitopertin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
19/11/2014Workshop on the 'guideline on pharmaceutical development of medicines for paediatric use', European Medicines Agency, London, UK, From: 01-Dec-2014, To: 01-Dec-2014
19/11/2014Human medicines European public assessment report (EPAR): Hemangiol,

propranolol

Revision: 2, Authorised
19/11/2014Human medicines European public assessment report (EPAR): Grastofil,

filgrastim

Revision: 4, Authorised
18/11/2014Scientific guideline: Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases, draft: consultation open
18/11/2014Scientific guideline: Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species, draft: consultation open
18/11/2014Work plan for the CVMP Efficacy Working Party 2015
18/11/2014Work plan for the CVMP Immunologicals Working Party 2015
18/11/2014Work plan for the CVMP Environmental Risk Assessment Working Party 2015
18/11/2014Work plan for the CVMP Scientific Advice Working Party 2015
18/11/2014Work plan for the CVMP Safety Working Party 2015
18/11/2014Work plan for the CVMP Pharmacovigilance Working Party 2015
18/11/2014Work plan for the CVMP Antimicrobials Working Party 2015
18/11/2014COMP meeting report on the review of applications for orphan designation: October 2014 (updated)
18/11/2014COMP meeting report on the review of applications for orphan designation: September 2014 (updated)
18/11/2014Human medicines European public assessment report (EPAR): Dynastat,

parecoxib

Revision: 22, Authorised
18/11/2014Human medicines European public assessment report (EPAR): Pumarix,

pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Revision: 4, Authorised
18/11/2014Dossier submitted for qualification opinion - In vitro hollow-fibre-system model of tuberculosis (HFS-TB)
18/11/2014Presentation for Drug Regimens Consortium (CPTR) scientific-advice meeting with the European Medicines Agency: Hollow-fiber system for tuberculosis (HFS-TB)
18/11/2014Response to the European Medicines Agency list of issues - In vitro hollow-fibre-system model of tuberculosis (HFS-TB)
18/11/2014Regulatory and procedural guideline: Draft qualification opinion on in vitro hollow-fibre-system model of tuberculosis (HFS-TB), draft: consultation open
18/11/2014Veterinary medicine European public assessment report (EPAR): Zolvix,

monepantel

Revision: 7, Authorised
18/11/2014Regulatory and procedural guideline: Member States' contact points for translation review (updated)
18/11/2014Agenda: Agenda - CHMP agenda of the 17-20 November 2014 meeting
18/11/2014Quality Review of Documents Working Group plenary and sub-group meeting dates - 2015 (updated)
18/11/2014Minutes - PDCO minutes of the 8-10 October 2014 meeting
18/11/2014Agenda: Agenda - PDCO agenda of the 12-14 November 2014 meeting
18/11/2014New vacancy: Temporary Agent, Business Analyst
18/11/2014New vacancy: Temporary Agent, Project Manager
17/11/2014Template for a European Union herbal monograph, adopted (updated)
17/11/2014Template for a public statement when no Community herbal monograph is established (updated)
17/11/2014Template for assessment report for the development of European Union herbal monographs and European Union list entries, adopted (updated)
17/11/2014Template for assessment report for the development of European Union herbal monographs and European Union list entries, adopted (updated)
17/11/2014Template for a European Union herbal monograph, adopted (updated)
17/11/2014Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries (updated)
17/11/2014Template for a public statement when no European Union herbal monograph is established (updated)
17/11/2014Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 27, Authorised
17/11/2014Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work, adopted (updated)
17/11/2014National experts on secondment (updated)
17/11/2014Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (updated)
17/11/2014Template for submission of a request for scientific support and advice on a traditional herbal medicinal product, adopted (updated)
17/11/2014Template for a European Union list entry, adopted (updated)
17/11/2014Regulatory and procedural guideline: Template and recommended format for list of references, adopted (updated)
17/11/2014Template and recommended format for list of references, adopted (updated)
17/11/2014Template for overview of comments received on on draft European Union herbal monograph or European Union list entry, adopted (updated)
17/11/2014Template for a European Union list entry, adopted (updated)
17/11/2014Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (updated)
17/11/2014Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (updated)
17/11/2014Administration (updated)
17/11/2014News and press releases: European Medicines Agency welcomes new Head of Administration
17/11/2014Deputy Executive Director (updated)
17/11/2014Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 5, Authorised
17/11/2014Human medicines European public assessment report (EPAR): Vepacel,

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)

Revision: 4, Authorised
14/11/2014Statement of expenses for candidates (updated)
14/11/2014Questions and answers relating to open procurement procedure EMA/2014/30/BD - Eudravigilance data management (updated)
14/11/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2014
14/11/2014Referral: Article 31 referrals, Hydroxyzine,

hydroxyzine/atarax

(updated)
14/11/2014Human medicines European public assessment report (EPAR): Topotecan Eagle,

topotecan

Revision: 2, Withdrawn
14/11/2014Current tenders for €60,000 or more (updated)
14/11/2014News and press releases: European Antibiotic Awareness Day 2014
14/11/2014Training overview for patients and consumers involved in European Medicines Agency activities (updated)
14/11/2014Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 2, Authorised
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Brodalumab

Therapeutic area: Dermatology (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Rosuvastatin / valsartan

Therapeutic area: Cardiovascular diseases/Endocrinology, -gynacology-fertility-metabolism (updated)
14/11/2014Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz),

levodopa / carbidopa / entacapone

Revision: 1, Authorised
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Perindopril / bisoprolol

Therapeutic area: Cardiovascular diseases (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ertugliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Antisense oligonucleotide (30-mer) with nucleotide sequence 5′-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3′(CODA001)

Therapeutic area: Dermatology (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Apremilast

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Bromfenac (sodium sesquihydrate)

Therapeutic area: Ophthalmology (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]-oxy}methyl)(phenoxy) phosphoryl]-l-alaninate, (2E)-but-2-enedioate (2:1) (GS-7340)

Therapeutic area: Infectious diseases (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl)phenoxy]butanoic acid

Therapeutic area: Cardiovascular diseases (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Captopril

Therapeutic area: Cardiovascular diseases (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Silicic acid, sodium zirconium (4+) salt (3:2:1) hydrate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
14/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Trifarotene

Therapeutic area: Dermatology (updated)
14/11/2014Veterinary medicine European public assessment report (EPAR): Porcilis PCV M Hyo,

porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Revision: 0, Authorised
14/11/2014Human medicines European public assessment report (EPAR): Ebilfumin,

oseltamivir

Revision: 1, Authorised
14/11/2014Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 10, Authorised
14/11/2014Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 4, Authorised
14/11/2014Mutual reliance between the United States Food and Drug Administration and the European Union on good-manufacturing-practice inspections, European Medicines Agency, London, UK, From: 14-Nov-2014, To: 17-Nov-2014
13/11/2014News and press releases: Judgement by European Union Civil Service Tribunal on appointment procedure of EMA Executive Director
13/11/2014Report: Applications for new human medicines under evaluation by the CHMP: November 2014
13/11/2014Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 6, Authorised
13/11/2014European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 26-Nov-2014, To: 26-Nov-2014
13/11/2014Training session for patients and consumers involved in European Medicines Agency activities, European Medicines Agency, London, UK, From: 25-Nov-2014, To: 25-Nov-2014
13/11/2014Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 30, Authorised
13/11/2014Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 33, Authorised
13/11/2014Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 33, Authorised
13/11/2014News and press releases: Herbal medicines 2004 – 2014
12/11/2014Orphan designation:

Osilodrostat

for the: Treatment of Cushing's syndrome
12/11/2014Orphan designation:

Cultured allogeneic corneal limbal stem cells

for the: Treatment of limbal stem cell deficiency
12/11/2014Orphan designation:

Cysteamine hydrochloride

for the: Treatment of cystinosis
12/11/2014Orphan designation:

Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor

for the: Treatment of tenosynovial giant cell tumour, localised and diffused type
12/11/2014Orphan designation:

Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23

for the: Treatment of X-linked hypophosphataemia
12/11/2014Orphan designation:

Acamprosate calcium

for the: Treatment of fragile X syndrome
12/11/2014Orphan designation:

Recombinant human bone morphogenetic protein 4

for the: Treatment of glioma
12/11/2014Orphan designation:

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

for the: Treatment of Crigler-Najjar syndrome
12/11/2014Orphan designation:

Glucagon

for the: Treatment of congenital hyperinsulinism
12/11/2014Orphan designation:

Raxibacumab

for the: Raxibacumab
12/11/2014Orphan designation:

Recombinant human insulin receptor monoclonal antibody-fused-α-L-iduronidase

for the: Treatment of mucopolysaccharidosis type I
12/11/2014Orphan designation:

(3S)-(+)-(5-Chloro-2-methoxyphenyl)-1,3-dihydro-3-fluoro-6-(trifluoromethyl)-2H-indol-2-one

for the: Treatment of fragile X syndrome
12/11/2014Scientific guideline: Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party, adopted (updated)
12/11/2014Human medicines European public assessment report (EPAR): Orencia,

abatacept

Revision: 17, Authorised
12/11/2014Report: Medicinal products for human use: Monthly figures - October 2014
12/11/2014Regulatory and procedural guideline: Qualification of novel methodologies for drug development: guidance to applicants (updated)
12/11/2014Orphan designation:

Oxalobacter formigenes strain HC-1

for the: Treatment of short bowel syndrome
12/11/2014Orphan designation:

Cannabidiol

for the: Treatment of Dravet syndrome
12/11/2014Orphan designation:

Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis (thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione

for the: The treatment of pancreatic cancer
12/11/2014Orphan designation:

(S)-6-Hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride

for the: Treatment of Leigh syndrome
12/11/2014Orphan designation:

Nitric oxide

for the: Treatment of cystic fibrosis
12/11/2014Orphan designation:

(S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile

for the: Treatment of pemphigus
12/11/2014Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 16, Authorised
12/11/2014Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 15, Authorised
12/11/2014Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 25, Authorised
12/11/2014Human medicines European public assessment report (EPAR): Lumigan,

bimatoprost

Revision: 25, Authorised
12/11/2014News and press releases: EMA responds to European Ombudsman
12/11/2014Orphan designation:

Pyridoxal 5'-phosphate

for the: Treatment of pyridoxamine 5'-phosphate oxidase deficiency
11/11/2014Referral: Article 31 referrals, Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients,

codeine

(updated)
11/11/2014Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
11/11/2014Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 9, Authorised
11/11/2014Referral: Article 31 referrals, GVK Biosciences (updated)
11/11/2014Notices of calls for tender - 2013 (updated)
11/11/2014Human medicines European public assessment report (EPAR): Iressa,

gefitinib

Revision: 8, Authorised
11/11/2014Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 2, Authorised
11/11/2014Minutes of the CVMP meeting of 7-9 October 2014
11/11/2014Overview of comments received on 'Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation'
10/11/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
10/11/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
10/11/2014Human medicines European public assessment report (EPAR): Clopidogrel DURA,

clopidogrel

Revision: 6, Authorised
10/11/2014News and press releases: Regulatory information – New tool for companies to facilitate maintenance of information on authorised medicines
10/11/2014Regulatory and procedural guideline: Initial notices for parallel distribution – October 2014
10/11/2014Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders, European Medicines Agency, London, UK, From: 10-Oct-2014, To: 10-Oct-2014 (updated)
10/11/2014Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 5, Authorised
10/11/2014Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 3, Authorised
10/11/2014Referral: Article 20 procedures, Iclusig,

ponatinib

(updated)
10/11/2014Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 7, Authorised
10/11/2014Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 1, Authorised
07/11/2014Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 10, Authorised
07/11/2014Letter of support for Predictive Safety Testing Consortium translational drug-induced kidney injury biomarkers
07/11/2014Qualification of novel methodologies for medicine development (updated)
07/11/2014Regulatory and procedural guideline: Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry, adopted (updated)
07/11/2014Pending EC decision: Nexgard Spectra,

afoxolaner / milbemycin oxime

Opinion date: 06-Nov-2014
07/11/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2014
07/11/2014Scientific guideline: Combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
07/11/2014Pilot project on adaptive licensing - Annex I: Framework for individual pilot studies submission form (updated)
07/11/2014Xofigo (radium-223 dichloride) supply shortage (updated)
07/11/2014Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 1, Authorised
07/11/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014
07/11/2014News and press releases: PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
07/11/2014Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 5, Authorised
07/11/2014Human medicines European public assessment report (EPAR): ChondroCelect,

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

Revision: 6, Authorised
07/11/2014European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials, European Medicines Agency, London, From: 07-Nov-2014, To: 07-Nov-2014 (updated)
07/11/2014Regulatory and procedural guideline: Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004, adopted (updated)
07/11/2014MRL pending EC decision: Virginiamycin - Summary opinion of the CVMP on the estabilishment of maximum residue limits
07/11/2014MRL pending EC decision: Propyl 4-hydroxybenzoate and its sodium salt - Summary opinion of the CVMP on the estabilishment of maximum residue limits
06/11/2014Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 1, Authorised
06/11/2014Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 41, Authorised
06/11/2014Human medicines European public assessment report (EPAR): Dukoral,

cholera vaccine (inactivated, oral)

Revision: 9, Authorised
06/11/2014Withdrawn application: Enthryv,

thiamazole

Initial authorisation
06/11/2014Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 23, Authorised
06/11/2014Human medicines European public assessment report (EPAR): Arava,

leflunomide

Revision: 28, Authorised
06/11/2014Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 4, Authorised
06/11/2014Newsletter: Human medicines highlights - October 2014
06/11/2014Technical specifications - Annex I costing sheet: Procurement procedure EMA/2014/30/BD (updated)
05/11/2014Human medicines European public assessment report (EPAR): Aerinaze,

desloratadine / pseudoephedrine

Revision: 12, Authorised
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (Cx601)

Therapeutic area: Gastroentology-Hepatology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases
05/11/2014Faldaprevir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ibuprofen (sodium dihydrate)

Therapeutic area: Other
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Potassium citrate monohydrated / potassium hydrogen carbonate (ADV7103)

Therapeutic area: Uro-nephrology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

D-Argininamide, N-acetyl-D-cysteinyl-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-, disulfide with L-cysteine (AMG 416)

Therapeutic area: Uro-nephrology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Potassium citrate monohydrated / Potassium hydrogen carbonate

Therapeutic area: Uro-nephrology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Revolade,

Eltrombopag (olamine)

Therapeutic area: Gastroentology-Hepatology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Allantoin

Therapeutic area: Dermatology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)

Therapeutic area: Neonatology-Paediactric Intensive care
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant soluble fusion protein with a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (ACE-536)

Therapeutic area: Haematology-Hemostaseology
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Volibris,

Ambrisentan

Therapeutic area: Cardiovascular diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): ,

Dihydroartemisinin / piperaquine phosphate anhydride

Therapeutic area: Infectious diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Adcetris,

Brentuximab vedotin

Therapeutic area: Oncology (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Vesicare and associated names,

Solifenacin (succinate)

Therapeutic area: Uro-nephrology (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): ,

Solifenacin (succinate)

Therapeutic area: Uro-nephrology (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Tedizolid (phosphate)

Therapeutic area: Infectious diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Edoxaban (tosylate)

Therapeutic area: Cardiovascular diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Metformin (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Amikacin (sulfate)

Therapeutic area: Infectious diseases/Pneumology-allergology (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Pradaxa,

Dabigatran etexilate

Therapeutic area: Haematology-Hemostaseology/Cardiovascular diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

7-[4-(4-Benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]quinolin-2(1H)-one (OPC-34712)

Therapeutic area: Psychiatry (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Viread,

Tenofovir (disoproxil fumarate)

Therapeutic area: Infectious diseases (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Vipidia,

Alogliptin benzoate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Migalastat (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Secukinumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
05/11/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Sirukumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
05/11/2014Human medicines European public assessment report (EPAR): Zoledronic acid Teva Pharma,

zoledronic acid

Revision: 4, Authorised
04/11/2014Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX,

avian infectious bronchitis vaccine (live)

Revision: 0, Authorised
04/11/2014Notification on arrangements for requesting European Medicines Agency certificates through urgent and standard procedure for December 2014
04/11/2014Agenda: Agenda - CVMP agenda of the 4-6 November 2014 meeting
04/11/2014Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 3, Authorised
04/11/2014Veterinary medicine European public assessment report (EPAR): Nobivac Bb,

live vaccine against Bordetella bronchiseptica in cats

Revision: 9, Authorised
04/11/2014Human 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: 20, Authorised
04/11/2014Human medicines European public assessment report (EPAR): Bexsero,

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

Revision: 4, Authorised
04/11/2014Periodic safety update reports (updated)
04/11/2014List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
04/11/2014Technical specifications - Annex IV draft service contract: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex IX template for completing the test: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex V tenderer information form: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex VI service level agreement: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex VIIA substances and related substance groups: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex VIIB herbal substance: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex VIII test: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex VIIIa test: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex X estimation of ICSRs per annum: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Letter of invitation to tender: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications -Technical specifications for open invitation to tender: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications -Annex III summary checklist of documents, which tenderers must submit: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex I costing sheet: Procurement procedure EMA/2014/48/PH
04/11/2014Technical specifications - Annex II exclusion criteria declaration: Procurement procedure EMA/2014/48/PH
03/11/2014Agenda: Agenda - PRAC draft agenda of meeting 3-6 November 2014
03/11/2014Marketing-authorisation-application pre-submission-meeting request form (updated)
03/11/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
03/11/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
03/11/2014Presubmission guidance: questions 31 to 40 (updated)
03/11/2014Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 5, Authorised
03/11/2014Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 23, Authorised
03/11/2014Human medicines European public assessment report (EPAR): Tesavel,

sitagliptin

Revision: 14, Authorised
03/11/2014Minutes of the COMP meeting 2-4 September 2014 (updated)