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February 2016

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12/02/2016Human medicines European public assessment report (EPAR): Nimenrix,

meningococcal group A, C, W 135 and Y conjugate vaccine

Revision: 12, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Azilect,

rasagiline

Revision: 15, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 9, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Cotellic,

cobimetinib

Revision: 1, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Trobalt,

retigabine

Revision: 10, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 6, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Actraphane,

insulin human (rDNA)

Revision: 14, Authorised
12/02/2016Public statement: Public statement on Salvia officinalis L., aetheroleum (updated)
12/02/2016Final CHMP work plan 2016
12/02/2016Minute of the European Medicines Agency / European Network for Health Technology Assessment meeting - November 2015
12/02/2016Newsletter: Human medicines highlights - January 2016
12/02/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2016
12/02/2016News and press releases: Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
12/02/2016News and press releases: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed
12/02/2016Referral: Article 20 procedures, SGLT2 inhibitors,

canagliflozin, dapagliflozin, empagliflozin

(updated)
12/02/2016News and press releases: SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
12/02/2016Referral: Article 31 referrals, Fusafungine containing medicinal products for oromucosal and nasal use,

fusafungine

(updated)
12/02/2016Human medicines European public assessment report (EPAR): Viramune,

nevirapine

Revision: 34, Authorised
12/02/2016Referral: Article 20 procedures, Tysabri,

natalizumab

(updated)
12/02/2016Human medicines European public assessment report (EPAR): Orencia,

abatacept

Revision: 20, Authorised
12/02/2016Human medicines European public assessment report (EPAR): Lumigan,

bimatoprost

Revision: 26, Authorised
12/02/2016Veterinary medicine European public assessment report (EPAR): Novaquin,

meloxicam

Revision: 1, Authorised
11/02/2016Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 15, Authorised
11/02/2016Human medicines European public assessment report (EPAR): Sildenafil Actavis,

sildenafil

Revision: 9, Authorised
11/02/2016Veterinary medicine European public assessment report (EPAR): Velactis,

cabergoline

Revision: 0, Authorised
11/02/2016Human medicines European public assessment report (EPAR): Focetria,

influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)

Revision: 9, Withdrawn
11/02/2016Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC (updated)
11/02/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for procedures in accordance with Article 78 of Directive 2001/82/EC, related to pharmacovigilance measures for veterinary medicinal products authorised in the European Union (updated)
11/02/2016Minutes of the HMPC 23-24 November 2015 meeting
11/02/2016Practical information for patients visiting the European Medicines Agency (updated)
11/02/2016Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (updated)
11/02/2016Zika (updated)
11/02/2016International Coalition of Medicines Regulatory Authorities (updated)
11/02/2016Electronic submission of Article 57(2) data: questions and answers (updated)
11/02/2016Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
11/02/2016Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
11/02/2016Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 (updated)
11/02/2016Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004 (updated)
11/02/2016Extended EudraVigilance Medicinal Product Dictionary e-learning course presentations (updated)
11/02/2016International Coalition of Medicines Regulatory Authorities (ICMRA) Zika virus disease press release: global medicines regulators pledge support to tackle Zika virus disease
11/02/2016Electronic submission of medicinal product information by marketing-authorisation holders (updated)
11/02/2016International Coalition of Medicines Regulatory Authorities (ICMRA) Ebola press release: medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks
11/02/2016Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 10, Authorised
11/02/2016Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 23, Authorised
11/02/2016Scientific guideline: Draft guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use, draft: consultation open
11/02/2016Scientific guideline: Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use, draft: consultation open
11/02/2016Human medicines European public assessment report (EPAR): DaTSCAN,

ioflupane (123l)

Revision: 17, Authorised
11/02/2016Human medicines European public assessment report (EPAR): Zerit,

stavudine

Revision: 27, Authorised
11/02/2016Scientific guideline: Final guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, adopted
11/02/2016Scientific guideline: Final guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products, adopted
11/02/2016Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure, draft: consultation open
11/02/2016Human medicines European public assessment report (EPAR): Aldurazyme,

laronidase

Revision: 13, Authorised
11/02/2016European medicines agency Standard operating procedure (SOP): Standard Operating Procedure for Scientific Advice to be given by the CVMP for Veterinary Medicinal Products (updated)
10/02/2016Report: Applications for new human medicines under evaluation by the CHMP: Februay 2016
10/02/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use
10/02/2016Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs), adopted (updated)
10/02/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (updated)
10/02/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for orphan-medicinal-product designation and amendment of an existing orphan-medicinal-product designation (updated)
10/02/2016Work instructions for saving of documentation regarding the submission of an application for orphan medicinal product designation or amendment of an existing designation, and any other product related correspondence, adopted
10/02/2016Herbal medicinal products: Epilobium, Epilobii herba, Epilobium angustifolium L. and/or Epilobium parviflorum Schreb. (updated)
10/02/2016Herbal medicinal products: Centaurium, Centaurii herba, Centaurium erythraea Rafn (updated)
10/02/2016Herbal medicinal products: Eleutherococcus , Eleutherococci radix, Eleutherococcus senticosus (Rupr. et Maxim.) Maxim. (updated)
10/02/2016Orphan designation:

L-Asparaginase

for the: Treatment of acute lymphoblastic leukaemia (updated)
10/02/2016Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 1, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Velcade,

bortezomib

Revision: 37, Authorised
10/02/2016Orphan designation:

Verucerfont

for the: Treatment of congenital adrenal hyperplasia (updated)
10/02/2016Orphan designation:

Iodine (131I) anti-tenascin monoclonal antibody 81C6

for the: Treatment of glioma (updated)
10/02/2016Orphan designation:

5-[8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6-yl]-2-pyrimidinamine

for the: Treatment of malignant mesothelioma (updated)
10/02/2016Orphan designation:

5-hydroxymethyl-2-furfural

for the: Treatment of sickle cell disease (updated)
10/02/2016Orphan designation:

N-acetylgalactosamine 4-sulfatase

for the: Treatment of mucopolysaccharidosis VI (MPS VI) or Maroteaux-Lamy syndrome (updated)
10/02/2016Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 3, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Pramipexole Teva,

pramipexole

Revision: 14, Authorised
10/02/2016Orphan designation:

N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N'-(2-fluoro-5-methylphenyl) urea

for the: Treatment of hepatocellular carcinoma (updated)
10/02/2016Human medicines European public assessment report (EPAR): Grastofil,

filgrastim

Revision: 6, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 13, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Kolbam ,

cholic acid

Revision: 9, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Angiox,

bivalirudin

Revision: 21, Authorised
10/02/2016Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 17, Authorised
09/02/2016List of nationally authorised medicinal products: tamoxifen PSUSA/00002846/201504
09/02/2016List of nationally authorised medicinal products: diphtheria tetanus vaccines (adsorbed) PSUSA/00001128/201505
09/02/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: carmustine (powder and solvent for solution for infusion) PSUSA/00010349/201504
09/02/2016List of nationally authorised medicinal products: acarbose PSUSA/00000017/201503
09/02/2016Quality Review of Documents human product-information annotated template (English) version 10 (updated)
09/02/2016Quality Review of Documents human product-information annotated template (English) version 10 - highlighted (updated)
09/02/2016News and press releases: Measures to help protect patients from falsified medicines
09/02/2016Falsified medicines (updated)
09/02/2016Human medicines European public assessment report (EPAR): Insulatard,

insulin human (rDNA)

Revision: 14, Authorised
09/02/2016Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use
09/02/2016Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan,

lopinavir/ritonavir

Revision: 0, Authorised
09/02/2016Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page) (updated)
09/02/2016Orphan designation:

milciclib maleate

for the: Treatment of malignant thymoma (updated)
09/02/2016Orphan designation:

L-threo-3,4-dihydroxyphenylserine

for the: Treatment of orthostatic hypotension in patients with multiple system atrophy (updated)
09/02/2016Orphan designation:

L-threo-3,4-dihydroxyphenylserine

for the: Treatment of orthostatic hypotension in patients with pure autonomic failure (updated)
09/02/2016Orphan designation:

Miltefosine

for the: Treatment of Acanthamoeba keratitis (updated)
09/02/2016Orphan designation:

Tetrahydrobiopterin

for the: Treatment of hyperphenylalaninaemia (updated)
09/02/2016Orphan designation:

cholest-4-en-3-one, oxime

for the: Treatment of 5q spinal muscular atrophy (updated)
09/02/2016Orphan designation:

Ciprofloxacin (liposomal)

for the: Treatment of cystic fibrosis (updated)
09/02/2016Orphan designation:

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

for the: Treatment of follicular lymphoma (updated)
09/02/2016Orphan designation:

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma (updated)
09/02/2016Orphan designation:

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

for the: Treatment of catecholaminergic polymorphic ventricular tachycardia (updated)
09/02/2016Orphan designation:

Recombinant human glutamate oxaloacetate transaminase 1

for the: Treatment of glioma (updated)
09/02/2016Orphan designation:

Enoxacin

for the: Treatment of amyotrophic lateral sclerosis (updated)
09/02/2016Ex ante publicity of a negotiated procedure: managed services consultancy
09/02/2016Orphan designation:

Mexiletine hydrochloride

for the: Treatment of myotonic disorders (updated)
09/02/2016Orphan designation:

Recombinant human tripeptidyl-peptidase 1

for the: Treatment of neuronal ceroid lipofuscinosis type 2 (updated)
09/02/2016Orphan designation:

Pentosan polysulfate sodium

for the: Treatment of interstitial cystitis (updated)
09/02/2016Orphan designation:

Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt

for the: Treatment of acromegaly (updated)
09/02/2016Orphan designation:

recombinant human alpha-N-acetylglucosaminidase

for the: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome) (updated)
09/02/2016Orphan designation:

Selinexor

for the: Treatment of plasma cell myeloma (updated)
09/02/2016Orphan designation:

Selinexor

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma (updated)
09/02/2016Orphan designation:

Triheptanoin

for the: Treatment of glucose transporter type-1 deficiency syndrome (updated)
09/02/2016Orphan designation:

(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide

for the: Treatment of diffuse large B-cell lymphoma (updated)
09/02/2016Orphan designation:

(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide

for the: Treatment of acute myeloid leukaemia (updated)
09/02/2016Orphan designation:

Mifepristone

for the: Treatment of hypercortisolism (Cushing’s syndrome) of endogenous origin (updated)
09/02/2016Orphan designation:

Melatonin

for the: Treatment of perinatal asphyxia (updated)
09/02/2016Orphan designation:

N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide

for the: Treatment of cystic fibrosis (updated)
09/02/2016Orphan designation:

unoprostone isopropyl

for the: Treatment of retinitis pigmentosa (updated)
09/02/2016Orphan designation:

N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt

for the: Treatment of acute myeloid leukaemia (updated)
09/02/2016Orphan designation:

Reduced oxidised N-acetyl heparin

for the: Treatment of plasma cell myeloma (updated)
09/02/2016Minutes - PDCO minutes of the 9-11 December 2015 meeting
09/02/2016List of nationally authorised medicinal products: carmustine (powder and solvent for solution for infusion) PSUSA/00010349/201504
08/02/2016Agenda: Agenda - PRAC draft agenda of meeting 8-11 February 2016
08/02/2016Orphan designation:

Tipifarnib

for the: Treatment of acute myeloid leukaemia (updated)
08/02/2016Human medicines European public assessment report (EPAR): Rapilysin,

reteplase

Revision: 19, Authorised
08/02/2016Orphan 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 myelodysplastic syndromes (updated)
08/02/2016Orphan designation:

(S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine

for the: Treatment of tuberculosis (updated)
08/02/2016Orphan designation:

Belinostat

for the: Treatment of malignant thymoma (updated)
08/02/2016Orphan designation:

Belinostat

for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic / disseminated) (updated)
08/02/2016Orphan designation:

Iodine (131I) anti-nucleohistone H1 chimeric biotinylated monoclonal antibody

for the: Treatment of glioma (updated)
08/02/2016Orphan designation:

Lentiviral vector containing the human ABCA4 gene

for the: Treatment of Stargardt’s disease (updated)
08/02/2016Orphan designation:

Lentiviral vector containing the human MYO7A gene

for the: Treatment of retinitis pigmentosa in Usher syndrome 1B (updated)
08/02/2016Orphan designation:

Ataluren

for the: Treatment of Becker muscular dystrophy (updated)
08/02/2016Orphan designation:

Ataluren

for the: Treatment of mucopolysaccharidosis type I (updated)
08/02/2016Orphan designation:

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

for the: Treatment of cystic fibrosis (updated)
08/02/2016Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 1, Authorised
08/02/2016Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 8, Authorised
08/02/2016Human medicines European public assessment report (EPAR): Visudyne,

verteporfin

Revision: 28, Authorised
08/02/2016European 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)
08/02/2016PRAC recommendations on signals adopted at the PRAC meeting of 11-14 January 2016, adopted
08/02/2016List of signals discussed at the PRAC since September 2012 (updated)
08/02/2016New product information wording - Extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC
08/02/2016Minutes of the CHMP meeting 14-17 December 2015
08/02/2016Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 3, Authorised
08/02/2016Public health threats and pandemics
08/02/2016News and press releases: EMA sets up task force on Zika virus
05/02/2016Orphan designation:

Entolimod

for the: Treatment of acute radiation syndrome
05/02/2016Orphan designation:

Synthetic double-stranded oligomer specific to the SERPINA1 gene and containing a cholesterol-conjugated, acyclic nucleobase analogue

for the: Treatment of congenital alpha-1 antitrypsin deficiency
05/02/2016Orphan designation:

(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate

for the: Treatment of soft tissue sarcoma
05/02/2016Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
05/02/2016Orphan designation:

Two allogeneic irradiated pancreatic tumour cell lines

for the: Treatment of pancreatic cancer
05/02/2016Human medicines European public assessment report (EPAR): Xiliarx,

vildagliptin

Revision: 11, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Crixivan,

indinavir

Revision: 36, Authorised
05/02/2016Ex ante publicity of a negotiated procedure: project IT delivery lifecycle training
05/02/2016Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 7, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Protaphane,

insulin human (rDNA)

Revision: 12, Authorised
05/02/2016Pyramax H-W-2319 (updated)
05/02/2016Working for the European Medicines Agency (updated)
05/02/2016News and press releases: EMA concludes defective device in ROCKET study does not impact Xarelto’s safety
05/02/2016Referral: Article 33, Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys,

Amoxicillin (as trihydrate)

05/02/2016Minutes of the CAT meeting 10-11 December 2015
05/02/2016Ex ante publicity of a negotiated procedure: exhibition logistics
05/02/2016Orphan designation:

Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin

for the: Treatment of pancreatic cancer
05/02/2016Human medicines European public assessment report (EPAR): Kiovig,

human normal immunoglobulin

Revision: 16, Authorised
05/02/2016Orphan designation:

Live attenuated Listeria monocytogenes transfected with plasmids encoding the HPV-16E7 protein fused to a truncated fragment of the Lm protein listeriolysin O

for the: Treatment of anal cancer
05/02/2016Orphan designation:

Sodium benzoate

for the: Treatment of hyperargininaemia
05/02/2016Orphan designation:

Sodium benzoate

for the: Treatment of argininosuccinic aciduria
05/02/2016Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 4, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Adenuric,

febuxostat

Revision: 13, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Episalvan,

birch bark extract

Revision: 0, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Zeffix,

lamivudine

Revision: 17, Authorised
05/02/2016Human medicines European public assessment report (EPAR): Imlygic,

talimogene laherparepvec

Revision: 0, Authorised
04/02/2016Human medicines European public assessment report (EPAR): NovoMix,

insulin aspart

Revision: 24, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Pregabalin Mylan,

pregabalin

Revision: 1, Authorised
04/02/2016Minutes of the COMP meeting 8-10 December 2015
04/02/2016Human medicines European public assessment report (EPAR): Tractocile,

atosiban

Revision: 20, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 7, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 7, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Votrient,

pazopanib

Revision: 15, Authorised
04/02/2016Human medicines European public assessment report (EPAR): INOmax,

nitric oxide

Revision: 16, Authorised
04/02/2016List of nationally authorised medicinal products: ofloxacin (systemic use) PSUSA/00002203/201504
04/02/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: ofloxacin (systemic use) PSUSA/00002203/201504
04/02/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: amlodipine besilate / ramipril PSUSA/00000181/201503
04/02/2016List of nationally authorised medicinal products: amlodipine besilate / ramipril PSUSA/00000181/201503
04/02/2016List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
04/02/2016Human medicines European public assessment report (EPAR): Mycamine,

micafungin

Revision: 10, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Comtess,

entacapone

Revision: 24, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Actrapid,

human insulin (rDNA)

Revision: 13, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 7, Authorised
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Grazoprevir / Elbasvir

Therapeutic area: Infectious diseases (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Elbasvir

Therapeutic area: Infectious diseases (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Grazoprevir

Therapeutic area: Infectious diseases (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Obeticholic acid (6 alpha-ethylchenodeoxycholic acid)

Therapeutic area: Gastroentology-Hepatology (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Lymphoseek,

Tilmanocept

Therapeutic area: Oncology/Other/Diagnostic (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,

Dolutegravir / abacavir / lamivudine

Therapeutic area: Infectious diseases (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Odanacatib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Deltyba,

Delamanid

Therapeutic area: Infectious diseases (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Lorcaserin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli) / Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli)

Therapeutic area: Vaccines (updated)
04/02/2016Human medicines European public assessment report (EPAR): Evoltra,

clofarabine

Revision: 23, Authorised
04/02/2016Human medicines European public assessment report (EPAR): Sirturo,

bedaquiline

Revision: 7, Authorised
04/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Otezla,

Apremilast

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation (updated)
03/02/2016Efficacy: Availability (minor uses/minor species) (updated)
03/02/2016Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 4, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Oncaspar,

pegaspargase

Revision: 1, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 32, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 3, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Stalevo,

levodopa / carbidopa / entacapone

Revision: 22, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 20, Authorised
03/02/2016Orphan designation:

Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B-

for the: Treatment of haemophilia B
03/02/2016Orphan designation:

2-(2-Chlorobenzylidene)hydrazinecarboximidamide acetate-

for the: Treatment of Charcot-Marie-Tooth disease
03/02/2016Human medicines European public assessment report (EPAR): Biopoin,

epoetin theta

Revision: 9, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 5, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 7, Authorised
03/02/2016Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif),

human normal immunoglobulin

Revision: 12, Authorised
03/02/2016Orphan designation:

Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate for the treatment of acute myeloid leukaemia-

for the: Treatment of acute myeloid leukaemia
03/02/2016Orphan designation:

Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin

for the: Treatment of malignant mesothelioma
03/02/2016Orphan designation:

Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for the treatment of partial deep dermal and full thickness burns

for the: Treatment of haemophilia B
03/02/2016Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 23, Authorised
03/02/2016Orphan designation:

-[4-Aminobutanoic acid-glycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-L-threonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glutamyl-L-alanyl-L-lysyl-L-prolyl-L-tryptophyl-L-tyrosyl-L-aspartyl](cyclo 1-Dgamma17)

for the: Treatment of pseudohypoaldosteronism 1B
03/02/2016Orphan designation:

live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O

for the: Treatment of osteosarcoma
03/02/2016Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 3, Authorised
03/02/2016Orphan designation:

Imetelstat sodium

for the: Treatment of myelofibrosis
03/02/2016Orphan designation:

Synthetic peptide L-cysteine, L-cysteinylglycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-L-threonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glutamyl-L-alanyl-L-lysyl-L-prolyl-L-tryptophyl-L-tyrosyl-, cyclic (1.fwdarw.17)-disulfide-

for the: Treatment of pseudohypoaldosteronism type 1B
03/02/2016Agenda: Programme - Challenges for the approval of anti-cancer immunotherapeutic drugs (updated)
03/02/2016Herbal medicinal products: Linum, Lini semen, Linum usitatissimum L. (updated)
03/02/2016Plasma-master-file certifications (updated)
03/02/2016Orphan designation:

Recombinant human monoclonal IgG1 antibody against programmed death ligand-1-

for the: Treatment of Merkel cell carcinoma
03/02/2016Scientific guideline: Final guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances, adopted
03/02/2016Scientific guideline: Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species, draft: consultation open
03/02/2016Scientific guideline: Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open
03/02/2016Scientific guideline: Draft guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open
03/02/2016Overview of comments received on the draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
03/02/2016Scientific guideline: Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open
03/02/2016Scientific guideline: Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open
03/02/2016Ex ante publicity of a negotiated procedure: governance and portfolio, project and programme management training
03/02/2016Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 11, Authorised
03/02/2016Guidelines and concept papers adopted during the CHMP meeting 25-28 January 2016, adopted
03/02/2016Minutes of the PRAC meeting 30 November - 3 December 2015
03/02/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2016 meeting
03/02/2016Organisational matters - CHMP meeting 25-28 January 2016, adopted
03/02/2016Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 25-28 January 2016, adopted
03/02/2016Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 25-28 January 2016, adopted
03/02/2016Biopoin : EPAR - All Authorised presentations (updated)
02/02/2016Orphan designation:

Glibenclamide for the treatment of neonatal diabetes

for the: Treatment of neonatal diabetes
02/02/2016Orphan designation:

Combretastatin A1 diphosphate-

for the: Treatment of acute myeloid leukaemia
02/02/2016Orphan designation:

(R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea-

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours
02/02/2016Report of the expert meeting on paediatric development of fixed-dose combinations (FDCs) for the treatment of human immunodeficiency virus (HIV) infection
02/02/2016Orphan designation:

Recombinant human nerve growth factor

for the: Treatment of neurotrophic keratitis
02/02/2016Work plan for the Pharmacogenomics Working Party 2016 (updated)
02/02/2016Orphan designation:

Sirolimus

for the: Treatment of beta-thalassaemia intermedia and major
02/02/2016Orphan designation:

Variant of recombinant human fibroblast growth factor 19

for the: Treatment of primary sclerosing cholangitis
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Lipegfilgrastim

Therapeutic area: Oncology (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,

Edoxaban (tosylate)

Therapeutic area: Cardiovascular diseases (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,

Ceftaroline fosamil

Therapeutic area: Infectious diseases (updated)
02/02/2016Human medicines European public assessment report (EPAR): Galvus,

vildagliptin

Revision: 13, Authorised
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Cinryze,

C1 inhibitor (human)

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/02/2016Orphan designation:

2-amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy)phenyl]thio]phenyl]ethyl]-1,3-propanediol hydrochloride

for the: Prevention of graft-versus-host disease
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Brilique,

Ticagrelor

Therapeutic area: Cardiovascular diseases (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Tasigna,

nilotinib

Therapeutic area: Oncology (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Vosaroxin

Therapeutic area: Oncology (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Gammaplex,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/02/2016Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum-residue-limit applications to the European Medcines Agency and to members of CVMP (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Synflorix,

Pneumococcal polysaccharide serotype 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein / pneumococcal polysaccharide serotype 4 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein / pneumococcal polysaccharide serotype 5 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein...

Therapeutic area: Vaccines (updated)
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Oto-rhino-laryngology
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Inactivated poliovirus type 1 (Brunhilde)
Inactivated poliovirus type 2 (MEF-1)
Inactivated poliovirus type 3 (Saukett)

Therapeutic area: Vaccines
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human monoclonal IgG1 antibody directed against Programmed Death Ligand-1 (anti-PD-L1) (MSB0010718C)

Therapeutic area: Oncology
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Telotristat etiprate

Therapeutic area: Gastroentology-Hepatology
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Ketoprofen

Therapeutic area: Pain
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Emtricitabine / tenofovir alafenamide / Sodium (2R,5S, 13aR)-7,9-dioxo-10-[(2,4,6-trifluorobenzyl carbamoyl]-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate (GS-9883)

Therapeutic area: Infectious diseases
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Ethosuximide

Therapeutic area: Neurology
02/02/2016Opinion/decision on a Paediatric investigation plan (PIP): Truvada,

Emtricitabine / tenofovir disoproxil fumarate

Therapeutic area: Infectious diseases
02/02/2016News and press releases: How to facilitate development of cancer immunotherapies
02/02/2016Human medicines European public assessment report (EPAR): Docetaxel Hospira UK Limited,

docetaxel

Revision: 1, Authorised
02/02/2016Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 21, Authorised
02/02/2016Challenges for the approval of anti-cancer immunotherapeutic drugs, European Medicines Agency, London, UK, From: 04-Feb-2016, To: 05-Feb-2016 (updated)
02/02/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: influenza vaccine (surface antigen, inactivated) PSUSA/00001744/201504
02/02/2016List of nationally authorised medicinal products: influenza vaccine (surface antigen, inactivated) PSUSA/00001744/201504
02/02/2016List of nationally authorised medicinal products: pholcodine PSUSA/00002396/201505
02/02/2016List of nationally authorised medicinal products: ceftriaxone PSUSA/00000613/201505
02/02/2016Scientific guideline: Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function, adopted
02/02/2016Overview of comments received on Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function (EMA/CHMP/ 83874/2014)
01/02/2016European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 26-Nov-2015, To: 26-Nov-2015 (updated)
01/02/2016Training session for patients and consumers interested in European Medicines Agency activities, European Medicines Agency, London, UK, From: 25-Nov-2015, To: 25-Nov-2015 (updated)
01/02/2016Work plan for the Radiopharmaceuticals Drafting Group 2016
01/02/2016Scientific guideline: Draft guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin, draft: consultation open
01/02/2016Scientific guideline: Draft guideline on core SmPC and Package Leaflet for gadopentetate dimeglumine, draft: consultation open
01/02/2016Overview of comments received on ' Guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS)' (EMA/531686/2015)
01/02/2016Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): E18 on genomic sampling and management of genomic data - Step 3, draft: consultation open
01/02/2016Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): E14 questions and answers - Step 5 (updated)
01/02/2016Scientific guideline: Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias, draft: consultation open
01/02/2016News and press releases: Consultation on revised guideline on medicines to treat Alzheimer’s disease
01/02/2016EMA consultation on the proposal of a collaboration framework with Academia
01/02/2016Human medicines European public assessment report (EPAR): Emend,

aprepitant

Revision: 20, Authorised
01/02/2016Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 10, Authorised
01/02/2016Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 6, Authorised
01/02/2016List of nationally authorised medicinal products: ofloxacin (topical use) PSUSA/00002204/201504
01/02/2016Scientific conclusions and grounds for variation to the terms of the marketing authorisations: ofloxacin (topical use) PSUSA/00002204/201504
01/02/2016Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 5, Authorised
01/02/2016Deputy Executive Director (updated)
01/02/2016Organisation chart of the European Medicines Agency (updated)
01/02/2016Administration and Corporate Management (updated)
01/02/2016Stakeholders and Communication (updated)
01/02/2016Organisation chart: Advisory functions and Deputy Executive Director support services (updated)
01/02/2016Organisation chart: Stakeholders and Communication (updated)
01/02/2016Organisation chart: Information Management (updated)
01/02/2016Organisation chart: Administration and Corporate Management (updated)
01/02/2016Advisory functions and Deputy Executive Director support services (updated)
01/02/2016Information Management (updated)
01/02/2016Emend : EPAR - Summary for the public (updated)