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January 2017

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17/01/2017Human medicines European public assessment report (EPAR): Abseamed,

epoetin alfa

Revision: 17, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Pantoloc Control,

pantoprazole

Revision: 12, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Ibrance,

palbociclib

Revision: 1, Authorised
17/01/2017Nominations to the European Union Telematics governance bodies - 2017 (updated)
17/01/2017Human medicines European public assessment report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 14, Authorised
17/01/2017Human medicines highlights 2016
17/01/2017Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 14, Authorised
17/01/2017Agenda: Agenda - COMP agenda of the 17-19 January 2017
17/01/2017Multinational assessment team concept - The next phase – Broadening the concept to the post-authorisation phase
17/01/2017European medicines regulatory network (updated)
17/01/2017Fusidic acid (systemic use): List of nationally authorised medicinal products - PSUSA/00010226/201605
17/01/2017Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 12, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Twinrix Paediatric,

hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)

Revision: 18, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 10, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Twinrix Adult,

hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

Revision: 18, Authorised
16/01/2017Pharmaceutical industry (updated)
16/01/2017List of eligible industry stakeholder organisations
16/01/2017Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 31, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Ambirix,

hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)

Revision: 13, Authorised
16/01/2017Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201605
16/01/2017Lactulose: List of nationally authorised medicinal products - PSUSA/00001821/201605
16/01/2017F(ab’)2 fragments of equine antirabies immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001348/201605
16/01/2017Mxifloxacin (topical ophthalmic use): List of nationally authorised medicinal products - PSUSA/00002094/201605
16/01/2017Human medicines European public assessment report (EPAR): Tamiflu,

oseltamivir

Revision: 29, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 13, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Bronchitol,

mannitol

Revision: 10, Authorised
16/01/2017Human medicines European public assessment report (EPAR): NovoSeven,

eptacog alfa (activated)

Revision: 31, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 2, Authorised
13/01/2017Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 14, Authorised
13/01/2017MRL report: Purified semi-solid extract from Humulus lupuls L. containing approximately 48% of beta acids (as potassium salts): European public maximum-residue-limit assessment report (EPMAR) - CVMP (updated)
13/01/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 5, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 16, Authorised
13/01/2017European Medicines Agency and Medicines for Europe annual bilateral meeting, European Medicines Agency, London, UK, From: 24-Jan-2017, To: 24-Jan-2017
13/01/2017Human medicines European public assessment report (EPAR): Capecitabine Accord,

capecitabine

Revision: 7, Authorised
13/01/2017Newsletter: Human medicines highlights - January 2017
13/01/2017Classifications as minor-use-minor-species and limited-market classifications (updated)
13/01/2017Human medicines European public assessment report (EPAR): Capecitabine Teva,

capecitabine

Revision: 8, Authorised
13/01/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017
13/01/2017Human medicines European public assessment report (EPAR): Intuniv,

guanfacine

Revision: 2, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 17, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Orfadin,

nitisinone

Revision: 12, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 9, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Entyvio,

vedolizumab

Revision: 7, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 6, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Eucreas,

vildagliptin / metformin

Revision: 14, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 6, Authorised
12/01/2017Human medicines European public assessment report (EPAR): ChondroCelect,

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

Revision: 6, Withdrawn
12/01/2017Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 8, Authorised
12/01/2017Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Gamithromycin, adopted
12/01/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 7, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 9, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 17, Authorised
12/01/2017Agenda: Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 02-Mar-2017, To: 03-Mar-2017
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 27-Apr-2017, To: 28-Apr-2017
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 18-May-2017, To: 19-May-2017
12/01/2017Letter of support for drug-induced renal tubular injury biomarker(s)
12/01/2017Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 22, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Bortezomib Sun,

bortezomib

Revision: 1, Authorised
12/01/2017Human medicines European public assessment report (EPAR): NovoThirteen,

catridecacog

Revision: 4, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 22, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Telzir,

fosamprenavir

Revision: 37, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Lusduna,

insulin glargine

Revision: 0, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 3, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Crixivan,

indinavir

Revision: 37, Authorised
12/01/2017Q&A: Extension applications (updated)
12/01/2017Q&A: Renewals (updated)
12/01/2017Q&A: Post-authorisation measures (Recommendations, Conditions and Specific Obligations) (updated)
12/01/2017Q&A: 1-20 (updated)
12/01/2017Q&A: Type II variations (updated)
12/01/2017Q&A: Transfer (updated)
12/01/2017Q&A: Worksharing of variations (updated)
12/01/2017Type-IA variations: questions and answers (updated)
12/01/2017Q&A: Periodic Safety Update Report (PSUR) (updated)
12/01/2017Type-IB variations: questions and answers (updated)
12/01/2017Q&A: 21-37 (updated)
12/01/2017Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 9, Authorised
12/01/2017Involvement of patient representatives in scientific advice procedures at the European Medicines Agency (updated)
12/01/2017Involvement of patient representatives in scientific advisory groups at the European Medicines Agency (updated)
12/01/2017Herbal medicinal products: Peumus, Boldi folium, Peumus boldus Molina (updated)
11/01/2017Policy 44: European Medicines Agency policy on the handling of declarations of interests of scientific committees’ members and experts (updated)
11/01/2017List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
11/01/2017Minutes of the CHMP meeting 7-10 November 2016
11/01/2017Minutes - PDCO minutes of the 12-14 October 2016 meeting
10/01/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 8, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 9, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 16, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 25, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Sebivo,

telbivudine

Revision: 18, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Lucentis,

ranibizumab

Revision: 26, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 15, Authorised
10/01/2017Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 12, Authorised
10/01/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (updated)
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Candesartan / amlodipine

Therapeutic area: Cardiovascular diseases
10/01/2017MRL report: Gamithromycin (all ruminants except bovine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
10/01/2017Minutes of the COMP meeting 3-4 November 2016
10/01/2017Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 5, Authorised
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / atorvastatin

Therapeutic area: Cardiovascular diseases
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / Valsartan / Hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
10/01/2017Orphan designation:

Udenafil

for the: Treatment of functional single ventricle congenital heart disease
10/01/2017Orphan designation:

Arsenic trioxide

for the: Treatment of graft-versus-host disease
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Influenza virus surface antigens (haemagglutinin and neuraminidase)

Therapeutic area: Vaccines
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Perindopril / amlodipine

Therapeutic area: Cardiovascular diseases
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Naldemedine (tosylate)

Therapeutic area: Gastroentology-Hepatology
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ciclosporin

Therapeutic area: Ophthalmology
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Birch pollen extract (Betula verrucosa)

Therapeutic area: Pneumology-allergology
10/01/2017Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 5, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Sandoz,

aripiprazole

Revision: 3, Authorised
10/01/2017New vacancy: Contract Agent, long term (FG IV), Scientific Officer
10/01/2017Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 9, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Capecitabine Medac,

capecitabine

Revision: 6, Authorised
09/01/2017Human medicines European public assessment report (EPAR): Nonafact,

human coagulation factor IX

Revision: 9, Authorised
09/01/2017Orphan designation:

68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2

for the: Diagnosis of gastrointestinal stromal tumours
09/01/2017Orphan designation:

Dantrolene sodium

for the: Treatment of Wolfram syndrome
09/01/2017Orphan designation:

Ivosidenib

for the: Treatment of acute myeloid leukaemia
09/01/2017Orphan designation:

Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene

for the: Treatment of neuronal ceroid lipofuscinosis
09/01/2017Multi-stakeholder paediatric oncology strategy workshop (cancers with ALK aberrations), European Medicines Agency, London, UK, From: 30-Jan-2017, To: 31-Jan-2017
09/01/2017Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (updated)
09/01/2017Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)
09/01/2017Agenda: Agenda - PRAC draft agenda of meeting 9-12 January 2017
09/01/2017Orphan designation:

Pegylated recombinant human interleukin-10

for the: Treatment of pancreatic cancer
09/01/2017ICMRA - Mapping of the bilateral arrangements between the ICMRA members
09/01/2017ICMRA - Mapping of supply chain/anticounterfeiting initiatives
09/01/2017ICMRA - Mapping of pharmacovigilance initiatives
09/01/2017ICMRA - Mapping of multinational project initiatives
09/01/2017ICMRA - Mapping of IT initiatives as a support to global medicines regulation
09/01/2017ICMRA - Mapping of GMP inspection initiatives
09/01/2017ICMRA - Mapping of generic initiatives
09/01/2017Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives (updated)
09/01/2017ICMRA - Mapping of crisis management initiatives
09/01/2017Orphan designation:

Ibudilast

for the: Treatment of amyotrophic lateral sclerosis
09/01/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 7, Authorised
09/01/2017Orphan designation:

Propranolol

for the: Treatment of soft tissue sarcoma
09/01/2017Orphan designation:

Metformin

for the: Treatment of progressive myoclonic epilepsy type 2 (Lafora disease)
09/01/2017Orphan designation:

Avelumab

for the: Treatment of gastric cancer
09/01/2017Orphan designation:

Cabiralizumab

for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type
09/01/2017Orphan designation:

Adeno-associated viral vector serotype 8 encoding engineered rhodopsin DNA-binding repressor and human rhodopsin expression cassettes

for the: Treatment of retinitis pigmentosa
09/01/2017Dorzolamide: CMDh scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00003168/201602 (updated)
09/01/2017Orphan designation:

3-(3-Methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride

for the: Treatment of narcolepsy
09/01/2017Veterinary medicine European public assessment report (EPAR): Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Revision: 4, Authorised
06/01/2017Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 7, Authorised
06/01/2017Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 39, Authorised
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sirukumab

Therapeutic area: Immunology-Rheumatology-Transplantation
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Monoclonal IgG1 anti-influenza A antibody

Therapeutic area: Infectious diseases
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Peramivir

Therapeutic area: Infectious diseases
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Immunoglobulin G2, anti-(human α-calcitonin gene-related peptide/β-calcitonin gene-related peptide) (human-Mus musculus monoclonal TEV-48125 heavy chain), disulphide with human-Mus musculus monoclonal TEV-48125 light chain, dimer (TEV-48125)

Therapeutic area: Neurology
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)
L chain against epidermal growth factor receptor conjugated to maleimidocaproyl
monomethylauristatin F (ABT-414)

Therapeutic area:
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L)

Therapeutic area: Other
06/01/2017EudraVigilance training (updated)
06/01/2017Presentation - ISO ICSR standard implementation for IT system developers - Training module IT-M1
06/01/2017Presentation - EudraVigilance Data Analysis System (EVDAS) training for National Competent Authorities - Training module EV-M5a
06/01/2017Presentation - ADRreports.eu portal - Training module EV-M6
06/01/2017Presentation - EV Reporting process for users: EV Gateway, WEB-Trader, EV-Post functions - Training Module EV-M3a
06/01/2017Presentation - EV Reporting process for users: Export functions in EVWEB - Training Module EV-M3c
06/01/2017Presentation - EV Reporting process for users: Create and send ICSRs using EVWEB - Training Module EV-M3d
06/01/2017Presentation - EVDAS training for Marketing Authorisation Holders - Training module EV-M5b
06/01/2017Presentation - EV Reporting process for users: Introduction to EVWEB - Training Module EV-M3b
06/01/2017EudraVigilance change management (updated)
06/01/2017European Union BFC conversion (v.2.1) (updated)
06/01/2017Regulatory and procedural guideline: EudraVigilance auditable requirement project - EudraVigilance training plan, adopted (updated)
06/01/2017Herbal medicinal products: questions and answers (updated)
06/01/2017Regulatory questions and answers on herbal medicinal products (updated)
06/01/2017Antimicrobial resistance (updated)
06/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Description of the Journal/Reference databases used (updated)
05/01/2017Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 23, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Truberzi,

eluxadoline

Revision: 1, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Mepact,

mifamurtide

Revision: 13, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 4, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Cystadane,

betaine anhydrous

Revision: 9, Authorised
05/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency: Questions and answers (updated)
05/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Inclusion and exclusion criteria for processing of Individual Case Safety Reports (updated)
05/01/2017Work instructions for organisation of CVMP Working Party meetings, adopted
05/01/2017Human medicines European public assessment report (EPAR): Kolbam ,

cholic acid

Revision: 12, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 44, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Accord,

aripiprazole

Revision: 3, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 6, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Somac Control,

pantoprazole

Revision: 9, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 4, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 8, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 14, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Controloc Control,

pantoprazole

Revision: 8, Authorised
05/01/2017Orphan designation:

Recombinant human dyskerin

for the: Treatment of dyskeratosis congenita (updated)
05/01/2017Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 14, Authorised
05/01/2017Report: Summary report of the European Medicines Agency-EuropaBio information day - 22 November 2016
05/01/2017Minutes of the CAT meeting 3-4 November 2016
05/01/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2016
05/01/2017Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 2, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Zentiva,

aripiprazole

Revision: 3, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 23, Authorised
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 27-Feb-2017, To: 01-Mar-2017
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 15-May-2017, To: 17-May-2017
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 24-Apr-2017, To: 26-Apr-2017
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 23-Jan-2017, To: 25-Jan-2017
04/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA
04/01/2017Evofosfamide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
04/01/2017Enpr-EMA awareness webinar, European Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016 (updated)
04/01/2017Newsletter: European network of paediatric research at the European Medicines Agency newsletter: December 2016
04/01/2017Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science, CCT Venue Plus, London, UK, From: 14-Nov-2016, To: 15-Nov-2016 (updated)
04/01/2017Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 27, Authorised
04/01/2017Human medicines European public assessment report (EPAR): Libertek,

roflumilast

Revision: 10, Authorised
03/01/2017Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (updated)
03/01/2017Scientific guideline: Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Overview of comments received on 'Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'
03/01/2017Quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (updated)
03/01/2017Scientific guideline: Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Overview of comments received on ‘Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’
03/01/2017Agenda: Agenda - European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting
03/01/2017European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting, European Medicines Agency, London, UK, From: 11-Jan-2017, To: 11-Jan-2017
03/01/2017Efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (updated)
03/01/2017Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'
03/01/2017Scientific guideline: Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Levodopa/carbidopa/entacapone product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-specific bioequivalence guidance, adopted
03/01/2017Overview of comments received on Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-specific bioequivalence guidance’
03/01/2017Pazopanib product-specific bioequivalence guidance (updated)
03/01/2017Overview of comments received on Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance
03/01/2017Scientific guideline: Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance, adopted
03/01/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 28 November-1 December 2016 PRAC
03/01/2017PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016, adopted
03/01/2017List of signals discussed at the PRAC since September 2012 (updated)
03/01/2017Paliperidone product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance, adopted
03/01/2017Fingolimod product-specific bioequivalence guidance (updated)
03/01/2017Overview of comments received on 'Fingolimod capsules 0.5 mg product-specific bioequivalence guidance'
03/01/2017Scientific guideline: Fingolimod capsules 0.5 mg product-specific bioequivalence guidance, adopted
03/01/2017Everolimus product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance, adopted
03/01/2017Overview of comments received on ‘Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance’
03/01/2017European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 20-Sep-2016, To: 20-Sep-2016 (updated)
03/01/2017Current tenders for €135,000 or more (updated)
03/01/2017Organisation chart: Deputy Executive Director support services (updated)
03/01/2017Organisation chart: Human Medicines Research and Development Support (updated)
03/01/2017Organisation chart of the European Medicines Agency (updated)
03/01/2017Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
03/01/2017Organisation chart: Stakeholders and Communication (updated)
03/01/2017Inventory of herbal substances for assessment (updated)
03/01/2017Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines authorised to European Union (EU) standards, European Medicines Agency, London, UK, From: 31-Jan-2017, To: 31-Jan-2017
03/01/2017Human medicines European public assessment report (EPAR): Zomarist,

vildagliptin / metformin

Revision: 14, Authorised
03/01/2017Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 14, Authorised