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February 2015

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Date Content
27/02/2015Scientific guideline: VICH GL49: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies, adopted (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Safety Working Party (SWP-V) (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Scientific Advice Working Party (updated)
27/02/2015Mandate, objectives and rules of procedure for the joint Committee on Medicinal Products for Veterinary Use/Committee for Medicinal Products for Human Use ad-hoc expert group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (JEG 3Rs) (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Antimicrobials Working Party (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Ad Hoc Group on Veterinary Novel Therapies (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Environmental Risk Assessment Working Party (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Efficacy Working Party (EWP) (updated)
27/02/2015Mandate, objectives and rules of procedure for the CVMP Immunologicals Working Party (IWP) (updated)
27/02/2015Scientific guideline: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods, adopted (updated)
27/02/2015Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, adopted (updated)
27/02/2015Work plan for the Pharmacokinetics Working Party 2015 (updated)
27/02/2015Orphan designation:

Allogeneic adipose-derived adult mesenchymal stem cells contained in a fibrin-based bioengineered dermis

for the: Treatment of epidermolysis bullosa
27/02/2015Orphan designation:

Chenodeoxycholic acid

for the: Treatment of inborn errors in primary bile acid synthesis
27/02/2015Orphan designation:

Autologous collagen type II-specific regulatory T cells

for the: Treatment of non-infectious uveitis
27/02/2015Orphan designation:

5,5’-(4-(trifluromethyl)benzylazanediyl)bis(methylene)diquinolin-8-ol

for the: Treatment of glioma
27/02/2015Minutes of the PRAC meeting 6-9 January 2015
27/02/2015Orphan designation:

1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one

for the: Treatment of multiple system atrophy
27/02/2015Scientific advice and protocol assistance adopted during the CHMP meeting 23–26 February 2015, adopted
27/02/2015Orphan designation:

Plerixafor

for the: Treatment of WHIM syndrome
27/02/2015Orphan designation:

Benserazide hydrochloride

for the: Treatment of beta thalassaemia intermedia and major
27/02/2015News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015
27/02/2015News and press releases: Jinarc recommended for approval in rare kidney disease
27/02/2015News and press releases: Zykadia recommended for approval in advanced non small cell lung cancer
27/02/2015Pending EC decision: Zykadia,

ceritinib

Opinion date: 26-Feb-2015
27/02/2015Pending EC decision: Jinarc,

tolvaptan

Opinion date: 26-Feb-2015
27/02/2015Pending EC decision: Ristempa,

pegfilgrastim

Opinion date: 26-Feb-2015
27/02/2015Pending EC decision: Avastin,

bevacizumab

Opinion date: 26-Feb-2015
27/02/2015Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
27/02/2015Overview of (invented) names reviewed in January 2015 by the Name Review Group (NRG) adopted at the CHMP meeting of 23-26 February 2015, adopted
27/02/2015Pending EC decision: Sustiva,

efavirenz

Opinion date: 26-Feb-2015
27/02/2015News and press releases: Ambroxol and bromhexine expectorants: safety information to be updated
27/02/2015Pending EC decision: Soliris,

eculizumab

Opinion date: 26-Feb-2015
27/02/2015Referral: Article 31 referrals, GVK Biosciences (updated)
27/02/2015Pending EC decision: Adenuric,

febuxostat

Opinion date: 26-Feb-2015
27/02/2015Pending EC decision: Toujeo (previously Optisulin),

insulin glargine

Opinion date: 26-Feb-2015
27/02/2015Withdrawn application: Rienso,

ferumoxytol

Post-authorisation
27/02/2015Pending EC decision: Humira,

adalimumab

Opinion date: 26-Feb-2015
27/02/2015Pending EC decision: Vectibix,

panitumumab

Opinion date: 26-Feb-2015
27/02/2015Orphan designation:

Riluzole

for the: Treatment of traumatic spinal cord injury
27/02/2015Minutes of the European Medicines Agency and EUnetHTA meeting - December 2014
26/02/2015Orphan designation:

(1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine

for the: Treatment of neurotrophic keratitis
26/02/2015Orphan designation:

Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor

for the: Treatment of malignant mesothelioma
26/02/2015Orphan designation:

Edaravone

for the: Treatment of amyotrophic lateral sclerosis
26/02/2015Orphan designation:

Amikacin sulfate

for the: Treatment of Pseudomonas aeuriginosa lung infection in cystic fibrosis
26/02/2015News and press releases: Regulatory information - Adjusted fees for applications to European Medicines Agency from 1 April 2015
26/02/2015News and press releases: Rare Disease Day 2015
26/02/2015Orphan designation:

Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain

for the: Treatment of glioma
26/02/2015Orphan designation:

Allogeneic ex vivo-generated natural killer cells from CD34+ umbilical cord blood progenitor cells

for the: Treatment of acute myeloid leukaemia
26/02/2015Orphan designation:

Pegylated recombinant human hyaluronidase PH20

for the: Treatment of pancreatic cancer
26/02/2015Orphan designation:

5-bromo-N-(prop-2-yn-1-yl)-2-(1H-1,2,4-triazol-1-yl)pyrimidine-4,6-diamine

for the: Treatment of Huntington’s disease
26/02/2015Orphan designation:

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor

for the: Treatment of diffuse large B cell lymphoma
26/02/2015Orphan designation:

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

for the: Treatment of malignant mesothelioma
26/02/2015Orphan designation:

Allogeneic bone marrow derived mesenchymal cells expanded ex vivo in synthetic media

for the: Prevention of graft-versus-host disease
26/02/2015Orphan designation:

Bevacizumab

for the: Treatment of hereditary haemorrhagic telangiectasia
26/02/2015Orphan designation:

Adeno-associated viral vector serotype rh.rh.10 carrying the human N-sulfoglucosamine sulfohydrolase cDNA

for the: Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)
26/02/2015Orphan designation:

2-hydroxymethyl-2-methoxymethyl-1-azabicyclo[2,2,2]octan-3-one

for the: Treatment of ovarian cancer
26/02/2015Orphan designation:

Exisulind

for the: Treatment of familial cerebral cavernous malformations
26/02/2015Orphan designation:

Heat-killed Mycobacterium obuense (whole cell)

for the: Treatment of pancreatic cancer
26/02/2015Orphan designation:

Single-chain urokinase plasminogen activator

for the: Treatment of pleural empyema
26/02/2015Orphan designation:

((E)-1-(4'-chlorophenyl)-3-(4-hydroxy-3-metoxyphenyl)prop-2-en-1-one)

for the: Treatment of WHIM syndrome
26/02/2015Orphan designation:

Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist

for the: Treatment of acute lymphoblastic leukaemia
26/02/2015List of medicinal products under additional monitoring (updated)
26/02/2015List of medicinal products under additional monitoring (updated)
25/02/2015News and press releases: Regulatory information - Transitioning to mandatory use of electronic application forms
25/02/2015Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 10, Authorised
24/02/2015Veterinary medicine European public assessment report (EPAR): Slentrol,

dirlotapide

Revision: 7, Withdrawn
24/02/2015Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 42, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Opsumit,

macitentan

Revision: 3, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Nulojix,

belatacept

Revision: 4, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Envarsus,

tacrolimus

Revision: 1, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Prometax,

rivastigmine

Revision: 28, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 7, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 25, Authorised
24/02/2015Veterinary medicine European public assessment report (EPAR): Emdocam,

meloxicam

Revision: 4, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Zoledronic acid Actavis,

zoledronic acid

Revision: 5, Authorised
24/02/2015MRL report: Methylprednisolone (Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP
24/02/2015MRL report: Gamithromycin (porcine): European public maximum-residue-limit assessment report (EPMAR) - CVMP
24/02/2015MRL report: Doxycycline (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
24/02/2015MRL report: Tulathromycin (ovine and caprine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
24/02/2015Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 3, Authorised
24/02/2015Human medicines European public assessment report (EPAR): Pantozol Control,

pantoprazole

Revision: 7, Authorised
24/02/2015Pharmacovigilance Inspectors Working Group (updated)
24/02/2015Withdrawn application: Oncept Melanoma,

canine melanoma vaccine

Initial authorisation
24/02/2015Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 19, Authorised
24/02/2015Coordination of Pharmacovigilance inspections (updated)
24/02/2015Agenda: Agenda - CHMP agenda of the 23-26 February 2015 meeting
23/02/2015Veterinary medicine European public assessment report (EPAR): Purevax RCP,

vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia

Revision: 10, Authorised
23/02/2015Veterinary medicine European public assessment report (EPAR): Purevax RC,

vaccine against feline viral rhinotracheitis and feline calicivirosis

Revision: 9, Authorised
23/02/2015Veterinary medicine European public assessment report (EPAR): Purevax RCPCh,

vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila virus infections

Revision: 10, Authorised
23/02/2015Veterinary medicine European public assessment report (EPAR): Purevax RCP FeLV,

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia

Revision: 8, Authorised
23/02/2015Veterinary medicine European public assessment report (EPAR): Purevax RCPCh FeLV,

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukaemia and feline Chlamydophila virus infections

Revision: 8, Authorised
23/02/2015Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol fumarate dihydrate

Revision: 1, Authorised
23/02/2015Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 6, Authorised
23/02/2015Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 3, Authorised
23/02/2015Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 3, Authorised
23/02/2015Human medicines European public assessment report (EPAR): Prevenar,

pneumococcal saccharide conjugated vaccine, adsorbed

Revision: 22, Authorised
23/02/2015European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Information session on biosimilars , European Medicines Agency, London, UK, From: 05-Mar-2015, To: 05-Mar-2015
23/02/2015European 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: 04-Mar-2015, To: 04-Mar-2015
23/02/2015Technical specifications - Annex I - Costing sheet - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications - Annex V - Applicant information sheet - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications - Annex VI - Agency Policy 0062 - Procurement procedure EMA/2014/35/RE
23/02/2015Letter of invitation for service concession - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications for service concession - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications - Annex II - Exclusion criteria declaration - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications - Annex III - Summary checklist - Procurement procedure EMA/2014/35/RE
23/02/2015Technical specifications - Annex IV - Draft concession agreement - Procurement procedure EMA/2014/35/RE
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Lumacaftor / ivacaftor

Therapeutic area: Pneumology-allergology (updated)
23/02/2015Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004 (updated)
23/02/2015Current tenders for €60,000 or more (updated)
23/02/2015Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 4, Authorised
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ibandronic acid (in combination with calcium (carbonate) / cholecalciferol)

Therapeutic area: Other
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Saxagliptin / dapagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Zoledronic acid (monohydrate) (in combination with calcium (carbonate) / cholecalciferol)

Therapeutic area: Oncology
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113)

Therapeutic area: Infectious diseases
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Glycopyrronium bromide

Therapeutic area: Neurology/Oto-rhino-laryngology
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Calcium (carbonate) / cholecalciferol (in combination with ibandronic acid)

Therapeutic area: Other
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Calcium (carbonate) / cholecalciferol (in combination with zoledronic acid (monohydrate))

Therapeutic area: Oncology
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Mepolizumab

Therapeutic area: Pneumology-allergology
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Amlodipine / Ramipril

Therapeutic area: Cardiovascular diseases
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Clostridium difficile toxin B human monoclonal antibody

Therapeutic area: Infectious diseases
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Urofollitropin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Samsca,

Tolvaptan

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant single-chain coagulation factor VIII

Therapeutic area: Haematology-Hemostaseology (updated)
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human fibrinogen

Therapeutic area: Haematology-Hemostaseology (updated)
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Serelaxin

Therapeutic area: Cardiovascular diseases (updated)
23/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Tafinlar,

Dabrafenib (mesilate)

Therapeutic area: Oncology (updated)
20/02/2015Minutes of the CVMP meeting of 13-15 January 2015
20/02/2015Report: Medicinal products for human use: Monthly figures - January 2015
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Deferiprone

Therapeutic area: Haematology-Hemostaseology (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Pollen from Phleum pratense

Therapeutic area: Other (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale cereale

Therapeutic area: Other (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Noxafil,

Posaconazole

Therapeutic area: Infectious diseases (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation/Haematology-Hemostaseology (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Edurant,

Rilpivirine (hydrochloride)

Therapeutic area: Infectious diseases (updated)
20/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Victoza,

liraglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/02/2015News and press releases: Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015
20/02/2015Worksharing: questions and answers (updated)
20/02/2015Type-II variations: questions and answers (updated)
20/02/2015Regulatory and procedural guideline: The linguistic review process of product information in the centralised procedure - Human (updated)
20/02/2015Grouping of variations: questions and answers (updated)
20/02/2015Procedural timetables (updated)
20/02/2015Timetable: Full application and extension application (updated)
20/02/2015Type II variation and worksharing application: 60-day monthly-start timetable
20/02/2015News and press releases: Regulatory information - Committee chairs’ handwritten signatures no longer included in opinion documents from March 2015
20/02/2015Type II variation and worksharing application: 90-day assessment timetable
20/02/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
20/02/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
20/02/2015Type II variation and worksharing application: 60-day weekly-start timetable
20/02/2015Type II variation and worksharing application: 30-day assessment timetable
20/02/2015Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 14, Authorised
20/02/2015News and press releases: Identification of medicines: EU task force to implement new international standards
20/02/2015Call for expressions of interest, from terminology maintenance organisations, software vendors, service providers and developers of medicinal product dictionaries/databases, for membership in a Task Force for the implementation of international standards on identification of medicinal products in the EU (i.e. EU ISO IDMP Task Force)
20/02/2015Day 180 list of outstanding issues generics template (updated)
20/02/2015Day 120 list of questions generics template (updated)
20/02/2015Day 150 joint report assessment report generics template (updated)
20/02/2015Day 80 assessment report generics overview template (updated)
20/02/2015Day 80 assessment report - Overview template (updated)
20/02/2015Day 180 list of outstanding issues template (updated)
20/02/2015Day 150 joint response assessment report - Overview template (updated)
20/02/2015Reporting requirements for marketing-authorisation holders (updated)
20/02/2015Regulatory and procedural guideline: Day 80 assessment report generics overview guidance (updated)
20/02/2015Regulatory and procedural guideline: Day 80 assessment report - Overview guidance (updated)
20/02/2015Day 120 list of questions template (updated)
19/02/2015Agenda: Programme - European Medicines Agency/International Federation for Animal Health-Europe info day 2015 (updated)
19/02/2015Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 6, Authorised
19/02/2015Publication of results-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’) (updated)
19/02/2015Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 38, Authorised
19/02/2015Human medicines European public assessment report (EPAR): Prepandrix,

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

Revision: 11, Authorised
19/02/2015Veterinary medicine European public assessment report (EPAR): Novem,

meloxicam

Revision: 8, Authorised
19/02/2015Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals),

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

Revision: 7, Authorised
19/02/2015Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 2, Authorised
19/02/2015Letter of invitation - Procurement procedure for access to drug pipeline database(s) - EMA/2014/68/COM
19/02/2015Questions and answers: Good manufacturing practice (updated)
19/02/2015Technical specifications - Annex I, II, III, IV to be completed by tenderers: procurement procedure for access to drug pipeline database(s) - EMA/2014/68/COM
19/02/2015Technical specifications - Procurement procedure for access to drug pipeline database(s) - EMA/2014/68/COM
18/02/2015Herbal Medicinal Products: Picrorhiza, Picrorhizae kurroae rhizoma et radix, Picrorhiza kurroa Royle ex. Benth. (updated)
18/02/2015Monthly report on application procedures, guidelines and related documents for veterinary medicines: January 2015
18/02/2015Training session for patients and consumers involved in European Medicines Agency activities, European Medicines Agency, London, UK, From: 25-Nov-2014, To: 25-Nov-2014 (updated)
18/02/2015Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 18, Authorised
18/02/2015Presubmission guidance: questions 11 to 20 (updated)
18/02/2015Periodic safety update reports: questions and answers (updated)
18/02/2015Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
18/02/2015Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
18/02/2015Presubmission guidance: questions 1 to 10 (updated)
18/02/2015Pharmacovigilance system: questions and answers (updated)
18/02/2015Presubmission guidance: questions 41 to 50 (updated)
18/02/2015Presubmission guidance: questions 31 to 40 (updated)
18/02/2015Minutes of the COMP meeting 7-9 January 2015
18/02/2015Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 18, Authorised
18/02/2015Human medicines European public assessment report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 13, Authorised
18/02/2015European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for the organisation of European Medicines Agency Scientific Committees’ Working Party with Patients' and Consumers' Organisations (PCWP) meetings (updated)
18/02/2015Agenda: Agenda - PDCO agenda of the 11-13 February 2015 meeting
18/02/2015PRAC recommendations on safety signals (updated)
18/02/2015News and press releases: Safety signals: recommendations now available in all EU languages
18/02/2015Committee for Orphan Medicinal Products (COMP) meetings 2013-2015 (updated)
18/02/2015Pending EC decision: Revlimid,

lenalidomide

Opinion date: 18-Dec-2014 (updated)
17/02/2015Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 4, Authorised
17/02/2015Human medicines European public assessment report (EPAR): Luveris,

lutropin alfa

Revision: 17, Authorised
17/02/2015Human medicines European public assessment report (EPAR): Starlix,

nateglinide

Revision: 11, Authorised
17/02/2015Human medicines European public assessment report (EPAR): Retacrit,

epoetin zeta

Revision: 13, Authorised
17/02/2015Veterinary medicine European public assessment report (EPAR): Bovela,

bovine viral diarrhoea vaccine (modified, live)

Revision: 0, Authorised
17/02/2015Orphan designation:

[Nle4, D-Phe7]-alfa-melanocyte stimulating hormone

for the: Treatment of erythropoietic protoporphyria (updated)
17/02/2015Orphan 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

for the: Treatment of Gaucher Disease (updated)
17/02/2015Human medicines European public assessment report (EPAR): Senshio,

ospemifene

Revision: 0, Authorised
17/02/2015European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for handling invoice payment within deadline of 30 days (standard payments) (updated)
17/02/2015Orphan designation:

Nintedanib

for the: Treatment of idiopathic pulmonary fibrosis (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Exforge,

Amlodipine (besylate) / valsartan

Therapeutic area: Cardiovascular diseases (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human immunoglobulin G2Lambda monoclonal antibody directed against thymic stromal lymphopoietin (MEDI9929)

Therapeutic area: Pneumology-allergology (updated)
17/02/2015Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted
17/02/2015Opinion of the CVMP on the establishment of maximum residue limits: Lasalocid, adopted
17/02/2015Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin, adopted
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Valaciclovir (Hydrochloride)

Therapeutic area: Infectious diseases (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Abaloparatide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Daclatasvir (dihydrochloride) / asunaprevir / (1aR,12bS)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325)

Therapeutic area: Infectious diseases (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Sofosbuvir / ledipasvir

Therapeutic area: Infectious diseases (updated)
17/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Trajenta,

Linagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
17/02/2015Human medicines European public assessment report (EPAR): Kalydeco,

ivacaftor

Revision: 6, Authorised
17/02/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
17/02/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
17/02/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of presentation (updated)
17/02/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
17/02/2015EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
16/02/2015(1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
16/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023)

Therapeutic area: Psychiatry (updated)
16/02/2015Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
16/02/2015Report: Applications for new human medicines under evaluation by the CHMP: February 2015
16/02/2015Work plan for the Oncology Working Party 2015 (updated)
16/02/2015Minutes of the European network of paediatric research at the European Medicines Agency coordinating group teleconference - 24 October 2014
16/02/2015Agenda: Agenda - European network of paediatric research at the European Medicines Agency coordinating group and working group meeting - 21 January 2015
16/02/2015European Network of Paediatric Research at the European Medicines Agency - Background information (updated)
16/02/2015PROTECT symposium, European Medicines Agency, London, UK, From: 19-Feb-2015, To: 20-Feb-2015
16/02/2015News and press releases: Major European research project on monitoring and evaluation of medicines concludes
16/02/2015Work plan for the CHMP Biologics Working Party 2015 (updated)
16/02/2015Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 2, Authorised
16/02/2015PDCO opinion template (annex I and II) (updated)
16/02/2015AllerSlit forte Birch - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
16/02/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Allergens of birch pollen (Betula alba / Pendula / Verrucosa)

Therapeutic area: Pneumology-allergology (updated)
16/02/2015Human medicines European public assessment report (EPAR): Sprycel,

dasatinib

Revision: 23, Authorised
16/02/2015Human medicines European public assessment report (EPAR): Dificlir,

fidaxomicin

Revision: 7, Authorised
16/02/2015Withdrawn application: Egranli,

balugrastim

Initial authorisation (updated)
16/02/2015Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 0, Authorised
16/02/2015Referral: Article 20 procedures, Corlentor and Procoralan,

ivabradine

(updated)
13/02/2015Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 1, Authorised
13/02/2015Human medicines European public assessment report (EPAR): Focetria,

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

Revision: 9, Authorised
13/02/2015Human medicines European public assessment report (EPAR): Ofev,

nintedanib

Revision: 0, Authorised
13/02/2015Veterinary medicine European public assessment report (EPAR): Easotic,

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

Revision: 4, Authorised
13/02/2015News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 February 2015
13/02/2015Pending EC decision: Zuprevo,

tildipirosin

Opinion date: 12-Feb-2015
13/02/2015Pending EC decision: Metacam,

meloxicam

Opinion date: 12-Feb-2015
13/02/2015Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 16, Authorised
13/02/2015Human medicines European public assessment report (EPAR): Exelon,

rivastigmine

Revision: 31, Authorised
13/02/2015Human medicines European public assessment report (EPAR): Cholestagel,

colesevelam

Revision: 16, Authorised
13/02/2015News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015
13/02/2015Human medicines European public assessment report (EPAR): Twinrix Adult,

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

Revision: 16, Authorised
13/02/2015News and press releases: PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
13/02/2015Referral: Article 31 referrals, Hydroxyzine,

hydroxyzine

(updated)
13/02/2015European Medicines Agency - Ebola timeline (updated)
13/02/2015Human medicines European public assessment report (EPAR): Circadin,

melatonin

Revision: 24, Authorised
13/02/2015Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 0, Authorised
12/02/2015Human medicines European public assessment report (EPAR): Telmisartan Teva,

telmisartan

Revision: 6, Authorised
12/02/2015Human medicines European public assessment report (EPAR): Scenesse,

afamelanotide

Revision: 0, Authorised
12/02/2015Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 0, Authorised
12/02/2015Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 8, Authorised
12/02/2015Draft European Union herbal monograph on <i>Hedera helix</i> L., folium, draft: consultation open (updated)
12/02/2015Herbal Medicinal Products: Hedera, Hederae helicis folium, Hedera helix L. (updated)
12/02/2015Human medicines European public assessment report (EPAR): Teysuno,

tegafur / gimeracil / oteracil

Revision: 8, Authorised
12/02/2015Orphan designation:

Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class

for the: Treatment of systemic-onset juvenile idiopathic arthritis (updated)
12/02/2015Orphan designation:

Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class

for the: Treatment of cryopirin-associated periodic syndromes (FCUS, MWS, and NOMID) (updated)
12/02/2015Orphan designation:

Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class

for the: Treatment of chronic non-infectious uveitis (updated)
12/02/2015Orphan designation:

Recombinant human monoclonal antibody to hsp90

for the: Treatment of invasive fungal infections (updated)
12/02/2015Orphan designation:

Recombinant human monoclonal antibody against activin receptor type IIB

for the: Treatment of inclusion-body myositis (updated)
11/02/2015Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 12, Authorised
11/02/2015Orphan designation:

Patupilone

for the: Treatment of primary peritoneal cancer (updated)
11/02/2015Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 26, Authorised
11/02/2015Orphan designation:

Pasireotide

for the: Treatment of Cushing’s disease (updated)
11/02/2015Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 37, Authorised
11/02/2015Orphan designation:

Pasireotide

for the: Treatment of acromegaly (updated)
11/02/2015Orphan designation:

Panobinostat lactate

for the: Treatment of cutaneous T-Cell Lymphoma (updated)
11/02/2015Orphan designation:

Panobinostat

for the: Treatment of Hodgkin’s lymphoma (updated)
11/02/2015Work plan for the Pharmacogenomics Working Party 2015 (updated)
11/02/2015Herbal Medicinal Products: Cetraria, Lichen islandicus, Cetraria islandica (L.) Acharius s.l. (updated)
11/02/2015HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-28 January 2015
11/02/2015Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 18, Authorised
11/02/2015Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 28, Authorised
11/02/2015Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 1, Authorised
10/02/2015MRL report: Eprinomectin (ovine and caprine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
10/02/2015MRL report: Lasalocid (modification of the ADI and MRLs in poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP
10/02/2015MRL report: Tulathromycin (modification of the microbiological ADI and MRLs in bovine and porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
10/02/2015Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 14, Authorised
10/02/2015Orphan designation:

Nilotinib hydrochloride monohydrate

for the: Treatment of gastrointestinal stromal tumours (updated)
10/02/2015Orphan designation:

Nilotinib

for the: Treatment of chronic myeloid leukaemia (updated)
10/02/2015Orphan designation:

N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide

for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome) (updated)
10/02/2015Orphan designation:

Midostaurin

for the: Treatment of acute myeloid leukaemia (updated)
10/02/2015Agenda: Agenda - CVMP agenda of the 10-12 February 2015 meeting
10/02/2015Work plan for the Radiopharmaceuticals Drafting Group 2015 (updated)
10/02/2015Orphan designation:

Midostaurin

for the: Treatment of mastocytosis (updated)
10/02/2015Orphan designation:

Mavoglurant 

for the: Treatment of fragile-X syndrome (updated)
10/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of chronic myeloid leukaemia (updated)
10/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of mastocytosis (updated)
10/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of acute lymphoblastic leukaemia (updated)
10/02/2015Letter to European Ombudsman
10/02/2015News and press releases: EMA explains its redaction rules
10/02/2015Human medicines European public assessment report (EPAR): Rixubis,

nonacog gamma

Revision: 0, Authorised
10/02/2015Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 25, Authorised
10/02/2015Draft Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix, draft: consultation closed (updated)
10/02/2015Herbal Medicinal Products: Thymus / Primula , Thymi herba / Primulae radix, Thymus vulgaris L.; Thymus zygis Loefl. ex L. / Primula veris L.; Primula elatior (L.) Hill (updated)
10/02/2015Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 15, Authorised
10/02/2015Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 4, Authorised
10/02/2015Agenda: Agenda - PRAC draft agenda of meeting 9-12 February 2015
10/02/2015Human medicines European public assessment report (EPAR): Selincro,

nalmefene

Revision: 3, Authorised
10/02/2015Veterinary medicine European public assessment report (EPAR): Nexgard Spectra,

afoxolaner / milbemycin oxime

Revision: 0, Authorised
10/02/2015Human medicines European public assessment report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 20, Authorised
09/02/2015Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 4, Authorised
09/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of malignant gastrointestinal stromal tumours (updated)
09/02/2015Orphan designation:

Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class

for the: Treatment of spinal cord injury (updated)
09/02/2015Orphan designation:

Ruxolitinib

for the: Treatment of polycythaemia vera (updated)
09/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of myelodysplastic / myeloproliferative diseases (updated)
09/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of chronic eosinophilic leukaemia and the hypereosinophilic syndrome (updated)
09/02/2015Orphan designation:

Tobramycin (inhalation powder)

for the: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis (updated)
09/02/2015Orphan designation:

Imatinib mesilate

for the: Treatment of dermatofibrosarcoma protuberans (updated)
09/02/2015Orphan designation:

Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt

for the: Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia) (updated)
09/02/2015Orphan designation:

Human monoclonal antibody against human interleukin 13

for the: Treatment of eosinophilic oesophagitis (updated)
09/02/2015Orphan designation:

Fingolimod

for the: Treatment of chronic inflammatory demyelinating polyneuropathy (updated)
09/02/2015Orphan designation:

Everolimus

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours (updated)
09/02/2015CHMP post-authorisation summary of positive opinion for Prezista, adopted (updated)
09/02/2015CHMP post-authorisation summary of positive opinion for Prezista, adopted (updated)
09/02/2015Orphan designation:

Everolimus

for the: Treatment of gastric cancer (updated)
09/02/2015Orphan designation:

Everolimus

for the: Treatment of tuberous sclerosis (updated)
09/02/2015Regulatory and procedural guideline: Qualification opinion on in-vitro hollow-fibre-system model of tuberculosis (HFS-TB), adopted (updated)
09/02/2015Orphan designation:

Epothilone B

for the: Treatment of ovarian cancer (updated)
09/02/2015Orphan designation:

Canakinumab

for the: Treatment of tumour-necrosis-factor-receptor-associated periodic syndrome (updated)
09/02/2015Orphan designation:

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 for the treatment of B-lymphoblastic leukaemia/lymphoma

for the: Treatment of B-lymphoblastic leukaemia/lymphoma (updated)
09/02/2015Orphan designation:

4-(3,5-Bis(hydroxy-phenyl)-1,2,4) triazol-1-yl) benzoic acid

for the: Treatment of chronic iron overload requiring chelation therapy (updated)
09/02/2015Orphan designation:

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate

for the: Treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia (updated)
09/02/2015Orphan designation:

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate

for the: Treatment of chronic idiopathic myelofibrosis (updated)
09/02/2015Orphan designation:

(2-aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxy benzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosu

for the: Treatment of functional gastro-entero-pancreatic endocrine tumours (updated)
09/02/2015Human medicines European public assessment report (EPAR): Votrient,

pazopanib

Revision: 12, Authorised
09/02/2015Human medicines European public assessment report (EPAR): DuoTrav,

travoprost / timolol

Revision: 13, Authorised
09/02/2015Regulatory and procedural guideline: Guidance on meetings with applicants on the responses to questions received from European Medicines Agency scientific Committees during the evaluation within the centralised procedure, adopted
09/02/2015Work plan for the Biosimilar Medicinal Products Working Party 2015 (updated)
09/02/2015Herbal Medicinal Products: Harpagophytum, Harpagophyti radix, Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (updated)
09/02/2015Herbal Medicinal Products: Hypericum, Hyperici herba, Hypericum perforatum L. (updated)
09/02/2015Herbal Medicinal Products: Crataegus, Crataegi folium cum flore, Crataegus spp, folium cum flore (updated)
09/02/2015Call for scientific data for the systematic review of the monograph on <i>Hypericum perforatum</i> L., herba, draft: consultation open
09/02/2015Call for scientific data for the systematic review of the monograph on <i>Harpagophytum procumbens</i> DC.; <i>Harpagophytum zeyheri</i> Decne, radix, draft: consultation open
09/02/2015Herbal Medicinal Products: Vaccinium, Myrtilli fructus siccus, Vaccinium myrtillus L. (updated)
09/02/2015Herbal Medicinal Products: Vaccinium, Myrtilli fructus recens, Vaccinium myrtillus L. (updated)
09/02/2015Draft European Union herbal monograph on <i>Vaccinium myrtillus</i> L., fructus siccus, draft: consultation open
09/02/2015Draft European Union herbal monograph on <i>Vaccinium myrtillus</i> L., fructus recens, draft: consultation open
09/02/2015Work plan for the Infectious Diseases Working Party 2015 (updated)
09/02/2015Submission of scientific data (updated)
09/02/2015Human medicines European public assessment report (EPAR): Efavirenz Teva,

efavirenz

Revision: 4, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / von Willebrand factor

Revision: 3, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 6, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Aclasta,

zoledronic acid

Revision: 18, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 7, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Potactasol,

topotecan

Revision: 1, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Insulin Human Winthrop,

insulin human

Revision: 13, Authorised
06/02/2015Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 11, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 8, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Victoza,

liraglutide

Revision: 11, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Optaflu,

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Revision: 10, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Savene,

dexrazoxane

Revision: 9, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 6, Authorised
06/02/2015Newsletter: Human medicines highlights - January 2015
06/02/2015Human medicines European public assessment report (EPAR): Inductos,

dibotermin alfa

Revision: 17, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Zoledronic acid Teva,

zoledronic acid

Revision: 4, Authorised
06/02/2015Human medicines European public assessment report (EPAR): Tasigna,

nilotinib

Revision: 25, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 21, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva,

irbesartan / hydrochlorothiazide

Revision: 9, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 7, Authorised
05/02/2015Scientific guideline: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products, draft: consultation open
05/02/2015Minutes of the HMPC 24 November 2014 meeting
05/02/2015Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 4, Authorised
05/02/2015Questions and answers relating to procurement procedure EMA/2014/16/COM – Provision of support to communication activities (services including communication consulting, printing and exhibition material) – three lots (updated)
05/02/2015Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 19, Authorised
05/02/2015PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2015 (updated)
05/02/2015Human medicines European public assessment report (EPAR): Incresync,

alogliptin / pioglitazone

Revision: 4, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Aloxi,

palonosetron

Revision: 19, Authorised
05/02/2015List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
05/02/2015Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 49, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 11, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 20, Authorised
05/02/2015Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 20, Authorised
05/02/2015Human medicines European public assessment report (EPAR): Dynastat,

parecoxib

Revision: 23, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 2, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 4, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Zoledronic acid Teva Pharma,

zoledronic acid

Revision: 5, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 15, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 1, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 4, Authorised
04/02/2015How to apply for micro-, small- and medium-sized-enterprise (SME) status (updated)
04/02/2015News and press releases: Regulatory information – Changes in SME registration procedures to reduce administrative burden
04/02/2015News and press releases: Better use of EMA support tools and increased success rate for SME applications
04/02/2015Report: Annual report from the SME office 2014
04/02/2015Summary of European Union (EU) support to micro, small and medium-sized enterprises in health research: Horizon 2020 – The EU research and innovation programme for 2014-2020 (updated)
04/02/2015Overview of current initiatives at European Union level to assist micro, small and medium-sized enterprises with financing (updated)
04/02/2015Scientific guideline: Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A), adopted (updated)
04/02/2015Human medicines European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka),

irbesartan

Revision: 6, Authorised
04/02/2015Notification of annual update to the parallel distribution of a centrally authorised medicinal product (updated)
04/02/2015Minutes of the CHMP meeting 15-18 December 2014
04/02/2015Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 1, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Xiliarx,

vildagliptin

Revision: 9, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Xyrem,

sodium oxybate

Revision: 21, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 1, Authorised
04/02/2015Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 1, Authorised
04/02/2015Work plan for the Gastroenterology Drafting Group 2015 (updated)
04/02/2015Opinion of the CVMP on the establishment of maximum residue limits: Lufenuron, adopted
04/02/2015Withdrawn application: Imagify,

perflubutane

Initial authorisation (updated)
04/02/2015Tazarotene - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
03/02/2015Human medicines European public assessment report (EPAR): Capecitabine Teva,

capecitabine

Revision: 4, Authorised
03/02/2015Human medicines European public assessment report (EPAR): Vipidia,

alogliptin benzoate

Revision: 3, Authorised
03/02/2015Human medicines European public assessment report (EPAR): Sildenafil Teva,

sildenafil

Revision: 10, Authorised
03/02/2015Provision of support to communication activities - Technical specifications - Annex I - Financial form for lot 1 (updated)
03/02/2015Provision of support to communication activities - Technical specifications - Annex I - Financial form for lot 2 (updated)
03/02/2015Referral: Article 35, Suanovil 20 / Captalin associated names and generic products thereof,

spiramycin

03/02/2015Work plan for the joint CHMP / CVMP Quality Working Party 2015 (updated)
03/02/2015Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 2, Authorised
03/02/2015Veterinary medicine European public assessment report (EPAR): TruScient,

dibotermin alfa

Revision: 4, Withdrawn
03/02/2015Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product
03/02/2015Human medicines European public assessment report (EPAR): Sebivo,

telbivudine

Revision: 17, Authorised
03/02/2015Human medicines European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.,

clopidogrel

Revision: 4, Withdrawn
03/02/2015Human medicines European public assessment report (EPAR): Erbitux,

cetuximab

Revision: 24, Authorised
03/02/2015European Union list of planned and conducted pharmacovigilance inspections
03/02/2015Referral: Article 30 referrals, Nasonex,

mometasone furoate

(updated)
02/02/2015Questions and answers relating to procurement procedure: effectiveness and pharmacoepidemiology studies - EMA/2014/50/RE (updated)
02/02/2015Appendix 1 - Pharmacovigilance inspection report template
02/02/2015Appendix 2 - Pharmacovigilance inspection overview template
02/02/2015Appendix 3 - Pharmacovigilance inspection information collection template
02/02/2015Opinions on safety variations/Periodic Safety Update Reports adopted at the CHMP meeting of 19-22 January 2015
02/02/2015Organisational matters - CHMP meeting 19-22 January 2015
02/02/2015Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 19-22 January 2015
02/02/2015Guidelines and concept papers adopted during the CHMP meeting 19-22 January 2015
02/02/2015Report: Assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola (updated)
02/02/2015Mandate of the European network of paediatric research-European Medicines Agency working groups (updated)
02/02/2015Agenda: Agenda - European network of paediatric research at the European Medicines Agency coordinating group meeting by teleconference - 24 October 2014
02/02/2015Minutes of the annual European network of paediatric research at the European Medicines Agency members meeting - 26 June 2014
02/02/2015Minutes of the sixth European network of paediatric research at the European Medicines Agency coordinating group meeting - 27 June 2014
02/02/2015Report: Report on annual workshop of the European network of paediatric research at the European Medicines Agency - 26-27 June 2014
02/02/2015Agenda: Agenda - COMP agenda of the 10-12 February 2015 meeting