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September 2014

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Date Content
19/09/2014Regulatory and procedural guideline: Member States' contact points for translation review (updated)
19/09/2014Referral: Article 31 referrals, Diacerein-containing medicines for oral administration,

diacerein

(updated)
19/09/2014Template letter of intent for request of parallel HTA scientific advice / protocol assistance (updated)
19/09/2014Letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party (updated)
19/09/2014Template letter of intent for request of scientific advice or protocol assistance (updated)
19/09/2014PDCO monthly report of opinions on paediatric investigation plans and other activities 10–12 September 2014
19/09/2014Minutes of the CVMP meeting of 8-10 July 2014
19/09/2014Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
19/09/2014Withdrawn application: Somavert,

pegvisomant

Post-authorisation
19/09/2014Veterinary medicine European public assessment report (EPAR): Equisolon,

Prednisolone

Revision: 2, Authorised
18/09/2014Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 1, Authorised
18/09/2014Referral: Article 20 procedures, Protelos and Osseor,

strontium ranelate

(updated)
18/09/2014Human medicines European public assessment report (EPAR): Rivastigmine 3M Health Care Ltd,

rivastigmine

Revision: 1, Withdrawn
18/09/2014HMPC: Overview of assessment work – priority list (updated)
18/09/2014Human medicines European public assessment report (EPAR): Mixtard,

insulin human (rDNA)

Revision: 12, Authorised
18/09/2014Human medicines European public assessment report (EPAR): Temozolomide Teva,

temozolomide

Revision: 11, Authorised
17/09/2014Veterinary medicine European public assessment report (EPAR): NexGard,

afoxolaner

Revision: 1, Authorised
17/09/2014Human medicines European public assessment report (EPAR): Baraclude,

entecavir

Revision: 19, Authorised
17/09/2014Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 0, Authorised
17/09/2014Human medicines European public assessment report (EPAR): Maci,

matrix-applied characterised autologous cultured chondrocytes

Revision: 1, Authorised
17/09/2014Human medicines European public assessment report (EPAR): Memantine ratiopharm,

memantine

Revision: 1, Authorised
16/09/2014Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors (updated)
16/09/2014Scientific guideline: Guideline on bioanalytical method validation, adopted (updated)
16/09/2014Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 22, Authorised
16/09/2014Veterinary medicine European public assessment report (EPAR): Ingelvac CircoFLEX,

inactivated porcine circovirus vaccine

Revision: 9, Authorised
16/09/2014Veterinary medicine European public assessment report (EPAR): Stronghold,

selamectin

Revision: 20, Authorised
16/09/2014Minutes - PDCO minutes of the 13–15 August 2014 meeting
16/09/2014Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
16/09/2014Withdrawn application: Faldaprevir Boehringer Ingelheim,

faldaprevir

Initial authorisation (updated)
16/09/2014Human medicines European public assessment report (EPAR): Relistor,

methylnaltrexone bromide

Revision: 10, Authorised
16/09/2014News and press releases: Policy on veterinary medicines for minor use, minor species / limited market revised
16/09/2014Scientific guideline: Draft guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market, draft: consultation open
16/09/2014Regulatory and procedural guideline: Draft revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS)/limited market
15/09/2014Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 28, Authorised
15/09/2014Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe,

olanzapine

Revision: 8, Authorised
15/09/2014Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 4, Authorised
15/09/2014Human medicines European public assessment report (EPAR): Olazax,

olanzapine

Revision: 7, Authorised
15/09/2014Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 0, Authorised
15/09/2014Human medicines European public assessment report (EPAR): Rasilamlo,

aliskiren / amlodipine

Revision: 3, Authorised
15/09/2014Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products with track changes (Rev 1)
15/09/2014Scientific guideline: Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections, adopted (updated)
15/09/2014Comments received from public consultation on good pharmacovigilance practices: GVP Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1)
15/09/2014Scientific guideline: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products, adopted (updated)
15/09/2014Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports
15/09/2014Olazax : EPAR - Summary for the public (updated)
15/09/2014Synagis : EPAR - All Authorised presentations (updated)
12/09/2014News and press releases: Is diclofenac a threat to European vultures?
12/09/2014Template for comments - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
12/09/2014Consultation procedure - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
12/09/2014Request for an opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
12/09/2014Publications (updated)
12/09/2014Pending EC decision: Porcilis PCV M Hyo,

porcine circovirus type 2 ORF2 subunit antigen /ATCC 25934 inactivated <i>Mycoplasma hyopneumoniae</i> J strain

Opinion date: 11-Sep-2014
12/09/2014Herbal Medicinal Products: Capsicum, Capsici fructus, Capsicum annuum L. var. minimum (Miller) Heiser (updated)
12/09/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014
12/09/2014Human medicines European public assessment report (EPAR): Renagel,

sevelamer

Revision: 22, Authorised
12/09/2014Training and best practice (updated)
12/09/2014eXtended EudraVigilance medicinal product dictionary data-entry tool user manual (updated)
12/09/2014XEVMPD e-learning course presentations (updated)
12/09/2014eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide: Update of an Authorised Medicinal Product (AMP)
12/09/2014eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide: Insert of a Pharmacovigilance System Master File Location (MFL)
12/09/2014eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide: Insert of an organisation
12/09/2014eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide: Insert of an Authorised Medicinal Product (AMP)
12/09/2014eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide: Insert of a Development Medicinal Product (DMP)
12/09/2014Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 13, Authorised
12/09/2014Agenda: Draft agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting Workshop on benefit-risk communication
12/09/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 September 2014
12/09/2014Buccolam (midazolam) supply shortage (updated)
12/09/2014Report: Applications for new human medicines under evaluation by the CHMP: September 2014
12/09/2014Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
12/09/2014Inventory of paediatric therapeutic needs - Ophthalmology
12/09/2014Inventory of paediatric therapeutic needs - Nephro-urology
11/09/2014Questions and answers following the initial experience of the Adaptive Licensing Pilot project
11/09/2014News and press releases: Regulatory information - Further guidance on adaptive licensing pilot project available
11/09/2014Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 13, Authorised
11/09/2014Referral: Article 31 referrals, Linoladiol N and Linoladiol HN,

estradiol

(updated)
11/09/2014Regulatory 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)
11/09/2014Referral: Article 31 referrals, Domperidone-containing medicines,

domperidone

(updated)
11/09/2014Human medicines European public assessment report (EPAR): Oprymea,

pramipexole

Revision: 12, Authorised
11/09/2014Human medicines European public assessment report (EPAR): Desloratadine Actavis,

desloratadine

Revision: 2, Authorised
11/09/2014Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 7, Authorised
11/09/2014Human medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion,

levodopa / carbidopa / entacapone

Revision: 4, Authorised
11/09/2014Human medicines European public assessment report (EPAR): Kolbam (previously Cholic Acid FGK),

Revision: 1, Authorised
10/09/2014Human medicines European public assessment report (EPAR): Entacapone Teva,

entacapone

Revision: 4, Authorised
10/09/2014Human medicines European public assessment report (EPAR): Comtess,

entacapone

Revision: 21, Authorised
10/09/2014Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation, European Medicines Agency, London, UK, From: 15-Sep-2014, To: 15-Sep-2014
10/09/2014Agenda: Agenda - Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation
10/09/2014Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 3, Authorised
10/09/2014News and press releases: New legislation for veterinary medicines
10/09/2014Regulatory and procedural guideline: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product, adopted (updated)
10/09/2014Template for sections A to E for the scientific part of the application for orphan designation (updated)
10/09/2014Human medicines European public assessment report (EPAR): ChondroCelect,

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

Revision: 5, Authorised
10/09/2014Herbal Medicinal Products: Rosa, Rosae flos, Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill. (updated)
10/09/2014Referral: Article 31 referrals, Hydroxyzine,

hydroxyzine/atarax

(updated)
09/09/2014Regulatory and procedural guideline: Initial notices for parallel distribution – July 2014 (updated)
09/09/2014Regulatory and procedural guideline: Initial notices for parallel distribution – August 2014
09/09/2014Paediatric osteoporosis expert meeting, European Medicines Agency, London, UK, From: 02-Jun-2014, To: 02-Jun-2014 (updated)
09/09/2014Referral: Article 30 referrals, Seroquel / Seroquel XR and associated names,

quetiapine

(updated)
09/09/2014COMP meeting report on the review of applications for orphan designation: September 2014
09/09/2014COMP meeting report on the review of applications for orphan designation: July 2014 (updated)
09/09/2014Innovation Task Force (updated)
09/09/2014Agenda: Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
09/09/2014Agenda: Agenda - PDCO agenda of the 10-12 September 2014 meeting
08/09/2014Opinion of the CVMP on the establishment of maximum residue limits: Cabergoline
08/09/2014Opinion of the CVMP on the establishment of maximum residue limits: Triclabendazole
08/09/2014Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide
08/09/2014Opinion of the CVMP on the establishment of maximum residue limits: Clorsulon
08/09/2014Opinion of the CVMP on the establishment of maximum residue limits: Closantel
08/09/2014Agenda: Agenda - PRAC draft agenda of meeting 8-11 September 2014
08/09/2014Agenda: Agenda - CVMP agenda of the 9-11 September 2014 meeting
08/09/2014Human medicines European public assessment report (EPAR): Clopidogrel Qualimed,

clopidogrel

Revision: 4, Withdrawn
08/09/2014Notices of calls for tender - 2014 (updated)
08/09/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure on how to conduct a procurement procedure (updated)
08/09/2014Referral: Article 31 referrals, Codeine containing medicinal products for the treatment of cough or cold in paediatric patients,

codeine

(updated)
05/09/2014News and press releases: European Medicines Agency website unavailable Saturday 6 September 2014
05/09/2014Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 2, Authorised
05/09/2014Newsletter: Human medicines highlights - August 2014
05/09/2014Referral: Article 35, Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs,

tylosin

05/09/2014Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (updated)
05/09/2014Monthly deadlines for submission of requests for CHMP scientific recommendation on eligibility to the Agency’s scientific services (updated)
05/09/2014List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
05/09/2014Template for a request for amendments of or addition of active substances or combinations of active substances to the European Union reference-date list (updated)
05/09/2014Mandate of the European Medcines Agency Innovation Task Force (ITF) (updated)
05/09/2014Request form for CHMP scientific recommendation on eligibility to the Agency’s scientific services (updated)
05/09/2014Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 9, Authorised
05/09/2014Human medicines European public assessment report (EPAR): Aubagio,

teriflunomide

Revision: 2, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 1, Authorised
04/09/2014Referral: Article 34, Linco-Spectin 100 and associated names,

lincomycin and spectinomycin

04/09/2014Human medicines European public assessment report (EPAR): Pravafenix,

fenofibrate / pravastatin

Revision: 2, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Prandin,

repaglinide

Revision: 12, Authorised
04/09/2014News and press releases: Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks
04/09/2014Human medicines European public assessment report (EPAR): Pergoveris,

follitropin alfa / lutropin alfa

Revision: 10, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 1, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Naglazyme,

galsulfase

Revision: 10, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Orfadin,

nitisinone

Revision: 8, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 8, Authorised
04/09/2014Joint European Forum for Good Clinical Practice / Drug Information Association / European Medicines Agency: Better medicines for children conference, European Medicines Agency, London, UK, From: 30-Sep-2014, To: 01-Oct-2014
04/09/2014Agenda: Programme of the joint European Forum for Good Clinical Practice / Drug Information Association / European Medicines Agency conference: Better medicines for children
04/09/2014Human medicines European public assessment report (EPAR): Vpriv,

velaglucerase alfa

Revision: 5, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 5, Authorised
04/09/2014Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 0, Authorised
04/09/2014National experts on secondment application form (updated)
04/09/2014Orphan designation:

3-[5-(2-Fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid

for the: Treatment of Duchenne muscular dystrophy (updated)
04/09/2014National experts on secondment (updated)
03/09/2014Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 1, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Enyglid,

repaglinide

Revision: 4, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK),

orlistat

Revision: 11, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 19, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 40, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Ranexa (previously Latixa),

ranolazine

Revision: 12, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Cholib,

fenofibrate / simvastatin

Revision: 2, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly),

tadalafil

Revision: 7, Authorised
03/09/2014Human medicines European public assessment report (EPAR): Rapilysin,

reteplase

Revision: 16, Authorised
03/09/2014Agenda: Agenda - COMP agenda of the 2-4 September 2014 meeting (updated)
02/09/2014European Medicines Agency meeting and holiday dates 2015
02/09/2014EU clinical trials portal and Union database: meeting with stakeholders, European Medicines Agency, London, UK, From: 09-Dec-2014, To: 09-Dec-2014
02/09/2014EU clinical trials portal and Union database: meeting with stakeholders, European Medicines Agency, London, UK, From: 30-Sep-2014, To: 30-Sep-2014
02/09/2014EU clinical trials portal and Union database: meeting with stakeholders, European Medicines Agency, London, UK, From: 28-Oct-2014, To: 28-Oct-2014
02/09/2014Referral: Article 29(4) referrals, Dexamed and associated names,

Dexamfetamine

(updated)
02/09/2014Human medicines European public assessment report (EPAR): Temozolomide Sun,

temozolomide

Revision: 6, Authorised
02/09/2014Human medicines European public assessment report (EPAR): Temozolomide Hospira,

temozolomide

Revision: 9, Authorised
02/09/2014Referral: Article 31 referrals, Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum,

bromocriptine

(updated)
02/09/2014Human medicines European public assessment report (EPAR): Trisenox,

arsenic trioxide

Revision: 20, Authorised
02/09/2014Human medicines European public assessment report (EPAR): Temozolomide Hexal,

temozolomide

Revision: 10, Authorised
01/09/2014News and press releases: European Medicines Agency welcomes new Head of Communication Department and new Head of Human Resources
01/09/2014Deputy Executive Director (updated)
01/09/2014Stakeholders and Communication (updated)
01/09/2014Advisory functions, Corporate Governance and Programme Management Office (updated)
01/09/2014Human Medicines Evaluation (updated)
01/09/2014Administration (updated)
01/09/2014Procedure Management and Business Support (updated)
01/09/2014Human medicines European public assessment report (EPAR): Reasanz,

serelaxin

Revision: 0, Refused
01/09/2014Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues

for the: Treatment of haemophilia B
01/09/2014Orphan designation:

Riociguat

for the: Treatment of systemic sclerosis
01/09/2014Human medicines European public assessment report (EPAR): Raloxifene Teva,

raloxifene

Revision: 3, Authorised
01/09/2014Orphan designation:

Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain

for the: Treatment of beta thalassaemia intermedia and major
01/09/2014Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues

for the: Treatment of haemophilia A
01/09/2014Orphan designation:

Oxytocin

for the: Treatment of Prader-Willi syndrome
01/09/2014Orphan designation:

Marizomib

for the: Treatment of plasma cell myeloma
01/09/2014Orphan designation:

Cysteamine bitartrate

for the: Treatment of Huntington’s disease
01/09/2014Orphan designation:

Rilotumumab

for the: Treatment of gastric cancer
01/09/2014Orphan designation:

Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F

for the: Treatment of glioma
01/09/2014Orphan designation:

Sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH

for the: Treatment of necrotising soft tissue infections
01/09/2014Orphan designation:

Recombinant monoclonal antibody to human serum amyloid P component

for the: Treatment of AL amyloidosis
01/09/2014Orphan designation:

Cediranib

for the: Treatment of ovarian cancer
01/09/2014Human medicines European public assessment report (EPAR): Nerventra,

laquinimod

Revision: 0, Refused
01/09/2014Pending EC decision: Nerventra,

laquinimod

Opinion date: 22-May-2014 (updated)
01/09/2014Orphan designation:

Humanised anti-alpha ν beta 6 monoclonal antibody

for the: Treatment of idiopathic pulmonary fibrosis
01/09/2014Orphan designation:

Adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene

for the: Treatment of catecholaminergic polymorphic ventricular tachycardia
01/09/2014Orphan designation:

Carboxy pyrrolidine hexanoyl pyrrolidine carboxylate

for the: Treatment of AL amyloidosis
01/09/2014Orphan designation:

Eculizumab

for the: Treatment myasthenia gravis
01/09/2014Annual renewal of conditional marketing authorisations: questions and answers (updated)
01/09/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
01/09/2014Periodic safety update reports (updated)
01/09/2014Periodic safety update reports: questions and answers (updated)
01/09/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
01/09/2014Worksharing: questions and answers (updated)
01/09/2014Formatted table template to be inserted in each procedural submission cover letter (updated)
01/09/2014Type-II-variation and extension applications: questions and answers (updated)
01/09/2014Renewals: questions and answers (updated)
01/09/2014Annual re-assessment: questions and answers (updated)
01/09/2014News and press releases: Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines
01/09/2014Type-IA variations: questions and answers (updated)
01/09/2014Post-authorisation safety studies: questions and answers (updated)
01/09/2014Post-authorisation measures: questions and answers (updated)
01/09/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for preparation and approval of Executive Decisions
01/09/2014Human medicines European public assessment report (EPAR): Capecitabine Medac,

capecitabine

Revision: 3, Authorised
01/09/2014Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 23, Authorised