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February 2018

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Date Content
16/02/2018Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.6 release notes (updated)
16/02/2018Human medicines European public assessment report (EPAR): Xadago,

safinamide

Revision: 7, Authorised
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Erenumab

Therapeutic area: Neurology (updated)
16/02/2018Human medicines European public assessment report (EPAR): Adynovi,

rurioctocog alfa pegol

Revision: 0, Authorised
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy,

Tenofovir alafenamide (as fumarate)

Therapeutic area: Infectious diseases (updated)
16/02/2018Human medicines European public assessment report (EPAR): Reagila,

cariprazine

Revision: 1, Authorised
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Roxadustat

Therapeutic area: Haematology-Hemostaseology (updated)
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661) / ivacaftor

Therapeutic area: Pneumology-allergology (updated)
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Natpar,

Recombinant parathyroid hormone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
16/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Guselkumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
16/02/2018Pending EC decision: Eravac,

Rabbit haemorrhagic disease vaccine (inactivated)

Opinion date: 15-Feb-2018
16/02/2018Pending EC decision: Clevor,

ropinirole

Opinion date: 15-Feb-2018
16/02/2018MRL pending EC decision: Paromomycin - Summary opinion of the CVMP on the establishment of maximum residue limits
16/02/2018News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018
16/02/2018Pending EC decision: Porcilis PCV ID,

Porcine circovirus vaccine (inactivated)

Opinion date: 15-Feb-2018
16/02/2018Pending EC decision: Metacam,

meloxicam

Opinion date: 15-Feb-2018
16/02/2018Human medicines European public assessment report (EPAR): Bexsero,

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

Revision: 16, Authorised
16/02/2018Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 8, Authorised
16/02/2018EMA EudraVigilance and signal management information day, European Medicines Agency, London, UK, From: 16-Mar-2018, To: 16-Mar-2018
16/02/2018Human medicines European public assessment report (EPAR): Brinavess,

vernakalant hydrochloride

Revision: 11, Authorised
16/02/2018Withdrawn application: Infinia,

alpha-1-antitrypsin

Initial authorisation (updated)
16/02/2018Scientific guideline: Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote replacement, reduction, and refinement (3Rs) measures described in the European Pharmacopoeia - Applicable to human vaccines from 01/01/2018, adopted (updated)
16/02/2018Scientific guideline: Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote reduction, refinement and replacement (3Rs) measures described in the European Pharmacopoeia - Applicable to veterinary vaccines from 01/01/2017, adopted (updated)
16/02/2018Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 15, Authorised
15/02/2018Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 21, Authorised
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Sotagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Cabotegravir

Therapeutic area: Infectious diseases (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Adenuric,

Febuxostat

Therapeutic area: Oncology (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Human fibrinogen / human thrombin

Therapeutic area: Haematology-Hemostaseology (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,

Ceftazidime / avibactam

Therapeutic area: Infectious diseases (updated)
15/02/2018Human medicines European public assessment report (EPAR): Trisenox,

arsenic trioxide

Revision: 24, Authorised
15/02/2018Extension of reserve lists for Contract Agent selection procedures: Contract Agent reserve lists expiring in 2018 (updated)
15/02/2018Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
15/02/2018PRAC recommendations on signals adopted at the PRAC meeting of 8-11 January 2018 meeting, adopted (updated)
15/02/2018Update on Brexit regulatory preparedness activities for veterinary companies , European Medicines Agency, London, UK, From: 20-Apr-2018, To: 20-Apr-2018
15/02/2018Recruitment at the European Medicines Agency (updated)
15/02/2018Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 14, Authorised
15/02/2018Careers (updated)
15/02/2018Human medicines European public assessment report (EPAR): Ristaben,

sitagliptin

Revision: 17, Authorised
15/02/2018Orphan designation:

2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione

for the: Treatment of systemic sclerosis (updated)
15/02/2018Orphan designation:

2-(2-Chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione

for the: treatment of idiopathic pulmonary fibrosis (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Xydalba,

Dalbavancin

Therapeutic area: Infectious diseases (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Bumetanide

Therapeutic area: Neurology (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13

Therapeutic area: Haematology-Hemostaseology (updated)
15/02/2018Table of the amounts in euro of basic monthly salaries for contract agents for each grade and step
15/02/2018Table of the amounts in euro of basic monthly salaries for temporary agents for each grade and step
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Naloxegol

Therapeutic area: Gastroentology-Hepatology (updated)
15/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,

Edoxaban (tosylate)

Therapeutic area: Cardiovascular diseases (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Tralokinumab

Therapeutic area: Pneumology-allergology (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Tofacitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Ixiaro,

Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)

Therapeutic area: Vaccines (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Foster and associated names, Kantos and associated names, Kantos Master and associated names, Inuvair and associated names,

Beclometasone dipropionate / formoterol fumarate dihydrate

Therapeutic area: Pneumology-allergology (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology (updated)
14/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,

Dapagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
14/02/2018Veterinary medicine European public assessment report (EPAR): Trocoxil,

mavacoxib

Revision: 8, Authorised
14/02/2018Work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2018
14/02/2018Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 18, Authorised
14/02/2018Regulatory and procedural guideline: EudraVigilance - National competent authorities - Adobe connect invitation (updated)
14/02/2018EudraVigilance training and support (updated)
14/02/2018Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.2 (updated)
14/02/2018Regulatory and procedural guideline: EudraVigilance - Marketing authorisation holders - Adobe connect invitation (updated)
14/02/2018Human medicines European public assessment report (EPAR): Intrarosa,

prasterone

Revision: 0, Authorised
13/02/2018Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures (updated)
13/02/2018Agenda: Agenda - Second international awareness session for international regulators, academia and non-governmental organisations (updated)
13/02/2018Second international awareness session for international regulators, academia and non-governmental organisations, European Medicines Agency, London, UK, From: 08-Mar-2018, To: 09-Mar-2018 (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Humira,

Adalimumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Gastroentology-Hepatology (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Palexia, Yantil, Tapentadol and associated names,

Tapentadol

Therapeutic area: Pain (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Mircera,

Methoxy polyethylene glycol-epoetin beta

Therapeutic area: Haematology-Hemostaseology (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Revolade,

Eltrombopag

Therapeutic area: Haematology-Hemostaseology (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,

Dabigatran etexilate mesilate

Therapeutic area: Haematology-Hemostaseology/Cardiovascular diseases (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Votubia,

Everolimus

Therapeutic area: Neurology (updated)
13/02/2018Regulatory and procedural guideline: Dates of 2018 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (updated)
13/02/2018Cilastatin / Imipenem: List of nationally authorised medicinal products - PSUSA/00000748/201706
13/02/2018Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201707
13/02/2018Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 16, Authorised
13/02/2018Pentamidine: List of nationally authorised medicinal products - PSUSA/00002338/201706
13/02/2018Info day for micro, small and medium-sized enterprises: supporting innovative medicines' development and early access, European Medicines Agency, London, UK, From: 17-Nov-2017, To: 17-Nov-2017 (updated)
13/02/2018Committee for Orphan Medicinal Products (COMP) work plan 2018 (updated)
13/02/2018Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 14, Authorised
13/02/2018Orphan designation:

Marizomib

for the: Treatment of plasma cell myeloma (updated)
13/02/2018News and press releases: Veterinary medicines: highlights of 2017
13/02/2018Medicine evaluation figures (updated)
13/02/2018Report: Veterinary medicines highlights 2017
13/02/2018QRD annex IV exceptional circumstances positive template (updated)
13/02/2018QRD annex IV standard positive template (updated)
13/02/2018QRD annex IV conditional positive template (updated)
13/02/2018Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201707
13/02/2018Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2018, European Medicines Agency, London, UK, From: 13-Feb-2018, To: 15-Feb-2018 (updated)
13/02/2018Agenda: Agenda - CVMP agenda of the 13-15 February 2018 meeting
13/02/2018Minutes of the CAT meeting 6-8 December 2017
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Lactobacillus reuteri (IBP-9414)

Therapeutic area: Neonatology-Paediactric Intensive care/Other/Gastroentology-Hepatology
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human monoclonal antibody to GM-CSF (GSK3196165)

Therapeutic area: Immunology-Rheumatology-Transplantation
13/02/2018Committee for Advanced Therapies (CAT) - Work Plan 2018
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Ligelizumab

Therapeutic area: Dermatology
13/02/2018Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
13/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Enasidenib

Therapeutic area: Oncology
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (suspension)
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (sheet)
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular dermal matrix)
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular amniotic matrix)
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Haematopoietic stem cells genetically modified to express a zinc finger nuclease which disrupts the enhancer of BCL11A expression
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured human retinal pigment epithelial cells genetically modified to express human factor IX protein
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: CD1c (BDCA-1)+ myeloid dendritic cells
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone-marrow derived CD34+ cells
13/02/2018Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose-derived stem cells seeded on a collagen matrix scaffold
13/02/2018Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 12, Authorised
13/02/2018Latanoprost/timolol: List of nationally authorised medicinal products - PSUSA/00001833/201706
13/02/2018Report: Human autologous stromal vascular fraction (SVF) cells and human autologous adipose-derived mesenchymal stem cells (ADSC) cells (updated)
13/02/2018Minutes of the COMP meeting of 5-7 December 2017
13/02/2018Opdivo-H-C-3985-II-0030 : EPAR - Assessment Report - Variation, adopted
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Risankizumab

Therapeutic area: Immunology-Rheumatology-Transplantation
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate / pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate / ...

Therapeutic area: Vaccines
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)

Therapeutic area: Psychiatry
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Acalabrutinib

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin / ezetimibe

Therapeutic area: Cardiovascular diseases/Endocrinology, -gynacology-fertility-metabolism
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Filgotinib

Therapeutic area: Immunology-Rheumatology-Transplantation
12/02/2018Mosquirix H-W-2300 (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,

Ibrutinib

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Capmatinib

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Meldonium dihydrate

Therapeutic area: Cardiovascular diseases
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pilocarpine (hydrochloride) / Oxymetazoline (hydrochloride)

Therapeutic area: Ophthalmology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Bempedoic acid / ezetimibe

Therapeutic area: Cardiovascular diseases
12/02/2018Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 17, Authorised
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Netarsudil / Latanoprost

Therapeutic area: Ophthalmology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,

Ibrutinib

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Benralizumab

Therapeutic area: Oto-rhino-laryngology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Cyramza,

Ramucirumab

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Bisoprolol (fumarate) / perindopril arginine / amlodipine

Therapeutic area: Cardiovascular diseases
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa,

Ceftolozane / tazobactam

Therapeutic area: Infectious diseases
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / irbesartan / hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Veliparib

Therapeutic area:
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): Revlimid,

Lenalidomide

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Maribavir

Therapeutic area: Infectious diseases
12/02/2018Agenda: Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid (updated)
12/02/2018The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, MSL Formacion, Madrid, Spain, From: 04-Jun-2018, To: 06-Jun-2018 (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

(Z)-N-(3-bromo-4-fluorophenyl)-N'-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine (besylate) / candesartan (cilexetil) / hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
12/02/2018International Generic Drug Regulators Programme (IGDRP) (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Phenyl- and piperidin-containing derivative of amiloride (BI 443651)

Therapeutic area: Pneumology-allergology
12/02/2018International Pharmaceutical Regulators Forum (IPRF) (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Pyridopyrimidione SMN2 splicing modifier

Therapeutic area: Neurology
12/02/2018Pre-authorisation guidance (updated)
12/02/2018Orphan designation:

2-{4-[(5,6-Diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)acetamide

for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (updated)
12/02/2018Orphan designation:

Dexamethasone (40 mg tablet)

for the: Treatment of multiple myeloma (updated)
12/02/2018Agenda: Agenda - COMP agenda of the 13-15 February 2018
12/02/2018Orphan designation:

L-Asparaginase

for the: Treatment of acute lymphoblastic leukaemia (updated)
12/02/2018Minutes of the CHMP meeting 11-14 December 2017
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Entospletinib

Therapeutic area: Oncology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)

Therapeutic area: Neurology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Crisaborole

Therapeutic area: Dermatology
12/02/2018Orphan designation:

Lumacaftor / ivacaftor

for the: Treatment of cystic fibrosis (updated)
12/02/2018Orphan designation:

Recombinant fusion protein consisting of human coagulation factor VIII attached to the Fc domain of human IgG1 (efmoroctocog alfa)

for the: Treatment of haemophilia A (updated)
12/02/2018Orphan designation:

Chimeric monoclonal antibody against GD2 (dinutuximab)

for the: Treatment of neuroblastoma (updated)
12/02/2018Explanatory note on pharmacovigilance fees payable to the European Medicines Agency (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (JCAR017)

Therapeutic area: Oncology
12/02/2018Orphan designation:

Tolvaptan

for the: Treatment of autosomal dominant polycystic kidney disease (updated)
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Angiotensin II (LJPC-501)

Therapeutic area: Other
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-l]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid (A4250)

Therapeutic area: Gastroentology-Hepatology
12/02/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Influenza virus surface antigens (haemagglutinin) of strain A (H1N1) / influenza virus surface antigens (haemagglutinin) of strain A (H3N2) / influenza virus surface antigens (haemagglutinin) of strain B  (Victoria lineage) / influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)

Therapeutic area: Infectious diseases
12/02/2018News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018
12/02/2018Human medicines European public assessment report (EPAR): Pregabalin Mylan Pharma,

pregabalin

Revision: 2, Authorised
09/02/2018Orphan designation:

Tobramycin (inhalation use)

for the: Treatment of Pseudomonas Aeruginosa lung infection in cystic fibrosis (updated)
09/02/2018Orphan designation:

Levofloxacin hemihydrate

for the: Treatment of cystic fibrosis (updated)
09/02/2018Orphan designation:

(1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L-tartaric acid salt (eliglustat)

for the: Treatment of Gaucher Disease (updated)
09/02/2018Orphan designation:

Ex-vivo-expanded autologous human corneal epithelium-containing stem cells

for the: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns (updated)
09/02/2018Human medicines European public assessment report (EPAR): Firazyr,

icatibant

Revision: 14, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 11, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 54, Authorised
09/02/2018Solifenacin: List of nationally authorised medicinal products - PSUSA/00002769/201706
09/02/2018Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706
09/02/2018Sulfamethizole: List of nationally authorised medicinal products - PSUSA/00010561/201706
09/02/2018Technetium 99mtc sestamibi: List of nationally authorised medicinal products - PSUSA/00002868/201706
09/02/2018Human medicines European public assessment report (EPAR): Idelvion,

albutrepenonacog alfa

Revision: 3, Authorised
09/02/2018Human medicines European public assessment report (EPAR): LeukoScan,

sulesomab

Revision: 7, Withdrawn
09/02/2018Human medicines European public assessment report (EPAR): Emselex,

darifenacin hydrobromide

Revision: 20, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Hexyon,

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: 17, Authorised
09/02/2018Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000788/201704
09/02/2018Clarithromycin: List of nationally authorised medicinal products - PSUSA/00000788/201704
09/02/2018Human medicines European public assessment report (EPAR): Renagel,

sevelamer

Revision: 29, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Benepali,

etanercept

Revision: 6, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Hexacima,

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

Revision: 17, Authorised
09/02/2018Human medicines European public assessment report (EPAR): Briviact (in Italy: Nubriveo),

brivaracetam

Revision: 5, Authorised
09/02/2018News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018
09/02/2018News and press releases: PRAC recommends new measures to avoid valproate exposure in pregnancy
09/02/2018News and press releases: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
09/02/2018Referral: Article 31 referrals, Retinoid-containing medicinal products,

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene

(updated)
09/02/2018Referral: Article 20 procedures, Esmya,

ulipristal acetate

(updated)
09/02/2018Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

(updated)
09/02/2018Referral: Article 31 referrals, Flupirtine-containing medicinal products,

flupirtine

(updated)
09/02/2018Regulatory and procedural guideline: Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
09/02/2018Regulatory and procedural guideline: Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
09/02/2018Request form for the provision of information via Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
09/02/2018PDCO work plan 2018
09/02/2018Template for scientific document (part B-F) (updated)
09/02/2018Report: Medicinal products for human use: monthly figures - January 2018
09/02/2018Regulatory and procedural guideline: Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR), draft: consultation open
08/02/2018Work plan for Biostatistics Working Party (BSWP) 2018 (updated)
08/02/2018Paediatric Committee (PDCO): 23-26 January 2018, European Medicines Agency, London, UK, From: 23-Jan-2018, To: 26-Jan-2018 (updated)
08/02/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 January 2018
08/02/2018Human medicines European public assessment report (EPAR): Pregabalin Mylan,

pregabalin

Revision: 3, Authorised
08/02/2018Human medicines European public assessment report (EPAR): Lemtrada,

alemtuzumab

Revision: 4, Authorised
08/02/2018Newsletter: Human medicines highlights - February 2018
08/02/2018Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 11, Authorised
08/02/2018Withdrawn application: Zafiride,

ngr-human tumour necrosis factor alpha

Initial authorisation (updated)
08/02/2018Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 11, Authorised
08/02/2018Public statement: Public statement on Libertek: Withdrawal of the marketing authorisation in the European Union
08/02/2018Human medicines European public assessment report (EPAR): Libertek,

roflumilast

Revision: 11, Withdrawn
08/02/2018Human medicines European public assessment report (EPAR): Zejula,

niraparib

Revision: 3, Authorised
08/02/2018Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 9, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Vivanza,

vardenafil

Revision: 23, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Rasagiline ratiopharm,

rasagiline

Revision: 4, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Lifmior,

etanercept

Revision: 2, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 5, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 29, Authorised
07/02/2018Agenda: Agenda - Industry associations webinar: update on the implementation of the European Medicines Agency policy on publication of clinical data - Policy 0070
07/02/2018Industry associations webinar: update on the implementation of European Medicines Agency policy on publication of clinical data - Policy 0070, European Medicines Agency, London, UK, From: 29-Jan-2018, To: 29-Jan-2018
07/02/2018Human medicines European public assessment report (EPAR): Victoza,

liraglutide

Revision: 18, Authorised
07/02/2018Human medicines European public assessment report (EPAR): Vizarsin,

sildenafil

Revision: 14, Authorised
07/02/2018EudraVigilance Expert Working Group (EV-EWG) work programme 2018 (updated)
07/02/2018Workshop on site and histology - Independent indications in oncology, European Medicines Agency, London, UK, From: 14-Dec-2017, To: 15-Dec-2017 (updated)
07/02/2018Scientific guideline: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, draft: consultation closed (updated)
07/02/2018Human medicines European public assessment report (EPAR): Vemlidy,

tenofovir alafenamide

Revision: 2, Authorised
07/02/2018Report: Applications for new human medicines under evaluation by the CHMP: February 2018
07/02/2018Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2, draft: consultation open
07/02/2018CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2018
07/02/2018Relocation to Amsterdam (updated)
07/02/2018News and press releases: Management Board started building approval process of EMA premises in Amsterdam
07/02/2018Human medicines European public assessment report (EPAR): Ceplene,

histamine dihydrochloride

Revision: 11, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Daliresp,

roflumilast

Revision: 9, Withdrawn
06/02/2018Human medicines European public assessment report (EPAR): Desloratadine Teva,

desloratadine

Revision: 11, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Zalasta,

olanzapine

Revision: 15, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 20, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Maviret,

glecaprevir / pibrentasvir

Revision: 1, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 21, Authorised
06/02/2018Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
06/02/2018Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
06/02/2018Withdrawn application: Qizenday,

d-biotin

Initial authorisation (updated)
06/02/2018Human medicines European public assessment report (EPAR): Azilect,

rasagiline

Revision: 19, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Eporatio,

epoetin theta

Revision: 10, Authorised
06/02/2018Regulatory and procedural guideline: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure (updated)
06/02/2018Newsletter: News bulletin for small and medium-sized enterprises - Issue 42
06/02/2018Human medicines European public assessment report (EPAR): Abraxane,

paclitaxel

Revision: 20, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 5, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 14, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Rebif,

interferon beta-1a

Revision: 32, Authorised
06/02/2018Minutes - Meeting with Alliance for Regenerative Medicine
06/02/2018Human medicines European public assessment report (EPAR): Biopoin,

epoetin theta

Revision: 12, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Lonquex,

lipegfilgrastim

Revision: 11, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 1, Authorised
06/02/2018Agenda: Agenda for the extraordinary Management Board meeting for the building approval process of European Medicines Agency (EMA) premises in Amsterdam
06/02/2018Extraordinary Management Board meeting: 6 February 2018, European Medicines Agency, London, UK, From: 06-Feb-2018, To: 06-Feb-2018
06/02/2018Human medicines European public assessment report (EPAR): Pemetrexed Hospira UK Limited,

pemetrexed

Revision: 1, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 8, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 36, Authorised
06/02/2018Human medicines European public assessment report (EPAR): Darunavir Krka,

darunavir

Revision: 0, Authorised
06/02/2018Veterinary medicine European public assessment report (EPAR): Galliprant,

grapiprant

Revision: 0, Authorised
06/02/2018News and press releases: General Court confirms EMA approach to transparency
06/02/2018Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 9, Authorised
05/02/2018Orphan designation:

Trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride

for the: Treatment of acute myeloid leukaemia (updated)
05/02/2018Agenda: Agenda - PRAC draft agenda of meeting 5-8 February 2018
05/02/2018Human medicines European public assessment report (EPAR): Cinqaero,

reslizumab

Revision: 2, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva,

pregabalin

Revision: 2, Authorised
05/02/2018Monthly report on application procedures guidelines and related documents for veterinary medicines: December 2017
05/02/2018List of signals discussed at the PRAC since September 2012 (updated)
05/02/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 January 2018 PRAC
05/02/2018COMP meeting report on the review of applications for orphan designation: January 2018
05/02/2018Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 15, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 16, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 3, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Nyxoid,

naloxone

Revision: 1, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Mavenclad,

cladribine

Revision: 1, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Dupixent,

dupilumab

Revision: 1, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s.,

pregabalin

Revision: 1, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi,

busulfan

Revision: 3, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Docetaxel Accord,

docetaxel

Revision: 9, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ),

docetaxel

Revision: 7, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Twinrix Adult,

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

Revision: 19, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 35, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Tasermity,

sevelamer hydrochloride

Revision: 4, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Imraldi,

adalimumab

Revision: 1, Authorised
05/02/2018Human medicines European public assessment report (EPAR): Inhixa,

enoxaparin sodium

Revision: 5, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Fulvestrant Mylan,

fulvestrant

Revision: 0, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Natpar,

parathyroid hormone

Revision: 2, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Onzeald,

etirinotecan pegol

Revision: 0, Refused
02/02/2018Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 11, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Vectibix,

panitumumab

Revision: 28, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 22, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Halaven,

eribulin

Revision: 16, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Memantine LEK,

memantine

Revision: 4, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Multaq,

dronedarone

Revision: 12, Authorised
02/02/2018Human medicines European public assessment report (EPAR): Rydapt,

midostaurin

Revision: 1, Authorised
02/02/2018Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Alarelin, adopted
02/02/2018Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Bromelain, adopted
01/02/2018European medicines agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
01/02/2018Human medicines European public assessment report (EPAR): Zykadia,

ceritinib

Revision: 8, Authorised
01/02/2018Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018
01/02/2018Veterinary medicine European public assessment report (EPAR): Contacera,

meloxicam

Revision: 6, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Desloratadine Actavis,

desloratadine

Revision: 9, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 14, Authorised
01/02/2018Hexaxim H-W-2495 (updated)
01/02/2018Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin),

insulin glargine

Revision: 24, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 21, Authorised
01/02/2018Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91,

live attenuated vaccine against avian infectious bronchitis

Revision: 12, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Ultibro Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 6, Authorised
01/02/2018Veterinary medicine European public assessment report (EPAR): Semintra,

telmisartan

Revision: 4, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 32, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Ninlaro,

ixazomib

Revision: 3, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Evotaz,

atazanavir / cobicistat

Revision: 5, Authorised
01/02/2018Human medicines European public assessment report (EPAR): Besponsa,

inotuzumab ozogamicin

Revision: 2, Authorised
01/02/2018News and press releases: Strengthened guidance on follow-up and risk management for ATMP developers
01/02/2018Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products
01/02/2018Advanced therapy medicinal products (updated)
01/02/2018Pharmacovigilance for advanced therapies (updated)
01/02/2018Scientific guideline: Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Revision 1, draft: consultation open
01/02/2018Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations
01/02/2018Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance (updated)
01/02/2018Scientific guideline: Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014/Rev.1) - First version
01/02/2018Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance (updated)
01/02/2018Tadalafil product-specific bioequivalence guidance (updated)
01/02/2018Dolutegravir, film-coated tablet, 10mg, 25mg, 50mg, product-specific bioequivalence guidance (updated)
01/02/2018Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance (updated)
01/02/2018Scientific guideline: Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1, adopted
01/02/2018Scientific guideline: Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version, adopted
01/02/2018Scientific guideline: Overview of comments received on ‘Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance’ (EMA/CHMP/356878/2017) - First version
01/02/2018Scientific guideline: Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - First version, adopted
01/02/2018Scientific guideline: Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2017) - First version
01/02/2018Scientific guideline: Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, adopted
01/02/2018Scientific guideline: Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, adopted
01/02/2018Scientific guideline: Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population, draft: consultation open
01/02/2018Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population
01/02/2018Orphan designation:

Brentuximab vedotin

for the: Treatment of cutaneous T-cell lymphoma (updated)
01/02/2018Chimeric antigen receptor (CAR) T-cell therapy registries workshop, European Medicines Agency, London, UK, From: 09-Feb-2018, To: 09-Feb-2018 (updated)
01/02/2018News and press releases: Evaluation of advanced therapy medicines
01/02/2018Regulatory and procedural guideline: Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007, adopted
01/02/2018Marketing-authorisation procedures for advanced-therapy medicinal products (updated)
01/02/2018Presentation - Adoption of the procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007
01/02/2018Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis (updated)
01/02/2018Influenza vaccines - quality module (updated)
01/02/2018Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (updated)
01/02/2018Quality aspects included in the product information for vaccines for human use (updated)
01/02/2018Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 January 2018
01/02/2018Report: List of products granted eligibility to PRIME (updated)
01/02/2018Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines (updated)
01/02/2018Human Medicines Research and Development Support (updated)