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May 2015

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22/05/2015Minutes of the CHMP meeting 20-23 April 2015
22/05/2015Report: Applications for new human medicines under evaluation by the CHMP: May 2015
22/05/2015Orphan designation:

Nitric oxide

for the: Treatment of cystic fibrosis
22/05/2015Orphan designation:

Xenon

for the: Treatment of perinatal asphyxia
22/05/2015Orphan designation:

Sodium 2-hydroxylinoleate

for the: Treatment of neuroblastoma
22/05/2015Orphan designation:

Recombinant human mesencephalic astrocyte-derived neurotrophic factor

for the: Treatment of retinitis pigmentosa
22/05/2015Orphan designation:

Adeno-associated viral vector serotype 5 containing the human CHM gene

for the: Treatment of choroideremia
22/05/2015European Medicines Agency workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease, European Medicines Agency, London, From: 29-Jun-2015, To: 29-Jun-2015
22/05/2015Agenda: Agenda - European Medicines Agency-industry stakeholders platform meeting on paediatric medicines (updated)
22/05/2015European Medicines Agency-industry stakeholders platform meeting on paediatric medicines, European Medicines Agency, London, UK, From: 11-May-2015, To: 11-May-2015 (updated)
22/05/2015Committee for Orphan Medicinal Products (COMP) work plan 2015
22/05/2015Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 1, Authorised
22/05/2015Tygacil (tigecycline) supply shortage
22/05/2015HMPC meeting report on Community herbal monographs, guidelines and other activities - 4-5 May 2015 (updated)
22/05/2015News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015
22/05/2015News and press releases: First-in-class treatment to lower cholesterol
22/05/2015News and press releases: New treatment option recommended for patients with advanced melanoma
22/05/2015News and press releases: New treatment option for patients with advanced lung cancer
22/05/2015News and press releases: EMA recommends treatment for rare cancer in children
22/05/2015News and press releases: First medicine for rare blood cancer
22/05/2015News and press releases: GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies
22/05/2015News and press releases: Updated advice on use of high-dose ibuprofen
22/05/2015Pending EC decision: Nivolumab BMS,

nivolumab

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Kuvan,

sapropterin

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Fycompa,

perampanel

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Keytruda,

pembrolizumab

Opinion date: 21-May-2015
22/05/2015Referral: Article 31 referrals, Ibuprofen- and dexibuprofen-containing medicines,

ibuprofen and dexibuprofen

(updated)
22/05/2015Withdrawn application: Aripiprazole Mylan,

aripiprazole

Initial authorisation
22/05/2015Pending EC decision: Stelara,

ustekinumab

Opinion date: 21-May-2015
22/05/2015Referral: Article 31 referrals, GVK Biosciences (updated)
22/05/2015Pending EC decision: Unituxin,

dinutuximab

Opinion date: 21-May-2015
22/05/2015Scientific advice and protocol assistance adopted during the CHMP meeting 18 – 21 May 2015
22/05/2015Pending EC decision: Repatha,

evolocumab

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Bortezomib Accord,

bortezomib

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Xultophy,

insulin degludec / liraglutide

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Pregabalin Zentiva,

pregabalin

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Omidria,

phenylephrine hydrochloride / ketorolac trometamol

Opinion date: 21-May-2015
22/05/2015Withdrawn application: Corluxin,

mifepristone

Initial authorisation
22/05/2015Pending EC decision: Imbruvica,

ibrutinib

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Simponi,

golimumab

Opinion date: 21-May-2015
22/05/2015Pending EC decision: Evotaz,

atazanavir / cobicistat

Opinion date: 21-May-2015
22/05/2015Orphan designation:

Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis(1,1-dimethylethyl) monohydrochloride

for the: Treatment of Huntington’s disease
22/05/2015Orphan designation:

Recombinant monoclonal IgG1 antibody against T-cell immune response cDNA 7

for the: Prevention of graft rejection following solid organ transplantation
22/05/2015Orphan designation:

Rintatolimod

for the: Treatment of Ebola virus disease
21/05/2015Orphan designation:

Rimeporide

for the: Treatment of Duchenne muscular dystrophy
21/05/2015News and press releases: European Medicines Agency closed 25 May 2015
21/05/2015Orphan designation:

1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride

for the: Treatment of tularaemia
21/05/2015Orphan designation:

Human reovirus type-3 Dearing strain

for the: Treatment of pancreatic cancer
21/05/2015Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK),

orlistat

Revision: 12, Authorised
21/05/2015Orphan designation:

1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride

for the: Treatment of cryptococcosis
21/05/2015Agenda: Agenda - Workshop on the therapeutic use of bacteriophages
21/05/2015Workshop on the therapeutic use of bacteriophages, European Medicines Agency, London, UK, From: 08-Jun-2015, To: 08-Jun-2015
21/05/2015News and press releases: Exploring new ways to fight antimicrobial resistance
21/05/2015Orphan designation:

Lenalidomide

for the: Treatment of marginal zone lymphoma
21/05/2015Orphan designation:

Fluciclovine (18F)

for the: Diagnosis of glioma
21/05/2015Human medicines European public assessment report (EPAR): Myfenax,

mycophenolate mofetil

Revision: 14, Authorised
21/05/2015Day 180 list of outstanding issues template rev5.15
21/05/2015Pharmacovigilance Risk Assessment Committee (PRAC) Day 94 rapporteur risk managment plan assessment report template rev5.15
21/05/2015Assessment templates and guidance (updated)
21/05/2015Day 120 list of questions template rev5.15
21/05/2015Day 80 joint response assessment report - Overview template rev5.15
21/05/2015Regulatory and procedural guideline: Day 80 joint response assessment report - Overview guidance rev5.15
21/05/2015Day 80 joint response assessment report - Non-clinical template rev5.15
21/05/2015Regulatory and procedural guideline: Day 80 joint response assessment report - Non-clinical guidance rev5.15
21/05/2015Day 80 joint response assessment report - Clinical template rev5.15
21/05/2015Regulatory and procedural guideline: Day 80 joint response assessment report - Clinical guidance rev5.15
21/05/2015Day 180 joint response assessment report - Overview template rev5.15
21/05/2015Day 180 joint response assessment report - Non-clinical template rev5.15
21/05/2015Day 180 joint response assessment report - Clinical template rev5.15
21/05/2015Day 150 joint response assessment report - Overview template rev5.15
21/05/2015Day 150 joint response assessment report - Clinical template rev5.15
21/05/2015Day 150 joint response assessment report - Non-clinical template rev5.15
21/05/2015Orphan designation:

Ecothiopate iodide

for the: Treatment of Stargardt’s disease
20/05/2015News and press releases: Facilitating the development of gene therapies
20/05/2015Scientific guideline: Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products, draft: consultation open
20/05/2015Agenda: Agenda - CAT agenda of the 12-13 May 2015 meeting
20/05/2015Human medicines European public assessment report (EPAR): Optruma,

raloxifene

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

vedolizumab

Revision: 1, Authorised
20/05/2015Human medicines European public assessment report (EPAR): Vimizim,

elosulfase alfa

Revision: 3, Authorised
20/05/2015Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 3, Authorised
20/05/2015Regulatory and procedural guideline: Guidance for implementation of eligibility requirements
20/05/2015Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 17, Authorised
20/05/2015Agenda: Agenda - PDCO agenda of the 20-22 May 2015 meeting
20/05/2015Minutes of the PRAC meeting 7-10 April 2015
20/05/2015Minutes of the COMP meeting 14-16 April 2015
20/05/2015Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 16, Authorised
20/05/2015Withdrawal assessment report for Ketoconazole AID-SCFM, adopted
20/05/2015Withdrawn application: Ketoconazole AID-SCFM,

ketoconazole

Initial authorisation (updated)
20/05/2015Human medicines European public assessment report (EPAR): Suboxone,

buprenorphine / naloxone

Revision: 11, Authorised
20/05/2015Human medicines European public assessment report (EPAR): Hizentra,

human normal immunoglobulin (SCIg)

Revision: 11, Authorised
20/05/2015Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC), European Medicines Agency, London, UK, From: 18-May-2015, To: 19-May-2015 (updated)
20/05/2015Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 11, Authorised
19/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Trulicity,

Dulaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
19/05/2015Human medicines European public assessment report (EPAR): Faslodex,

fulvestrant

Revision: 13, Authorised
19/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Nulojix,

Belatacept

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
19/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant human N-acetylglucosaminidase (rhNAGLU)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
19/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ezetimibe / atorvastatin (calcium trihydrate)

Therapeutic area: Cardiovascular diseases
19/05/2015Changing the name or address of a sponsor
19/05/2015Orphan designation:

Trientine tetrahydrochloride

for the: Treatment of Wilson's disease
19/05/2015Orphan designation:

Adeno-associated viral vector serotype 9 containing the human glucocerebrosidase gene

for the: Treatment of Gaucher disease (updated)
19/05/2015COMP meeting report on the review of applications for orphan designation: May 2015
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Coagulation factor VIIa (recombinant) for treatment of congenital coagulation disorders and treatment of acquired haemophilia
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Perindopril / amlodipine for treatment of hypertension
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Efinaconazole for treatment of onychomycosis
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Olipudase alfa for treatment of Niemann-Pick disease
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Ceftriaxone / sulbactam for treatment of bacterial infections
19/05/2015Public summary of the evaluation of a proposed paediatric investigation plan: Eravacycline for the treatment of complicated intra-abdominal infections and for the treatment of urinary tract infections
19/05/2015Orphan designation:

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

for the: Treatment of adenovirus infection following haematopoietic stem cell transplantation
19/05/2015Orphan designation:

Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus

for the: Treatment of Epstein-Barr virus infection following haematopoietic stem cell transplantation
19/05/2015Human medicines European public assessment report (EPAR): Sustiva,

efavirenz

Revision: 39, Authorised
19/05/2015Report: Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States (updated)
19/05/2015Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
19/05/2015Regulatory and procedural guideline: Initial notices for parallel distribution - April 2015
19/05/2015Veterinary medicine European public assessment report (EPAR): Apoquel,

oclacitinib maleate

Revision: 2, Authorised
19/05/2015Referral: Article 31 referrals, Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease,

beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate

(updated)
19/05/2015Human medicines European public assessment report (EPAR): Provenge,

autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)

Revision: 1, Withdrawn
19/05/2015Agenda: Agenda - CHMP agenda of the 18-21 May 2015 meeting
19/05/2015Human medicines European public assessment report (EPAR): Helicobacter Test INFAI,

13C-urea

Revision: 14, Authorised
19/05/2015Human medicines European public assessment report (EPAR): Adenuric,

febuxostat

Revision: 12, Authorised
19/05/2015Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 29, Authorised
19/05/2015Human medicines European public assessment report (EPAR): Xelevia,

sitagliptin

Revision: 18, Authorised
19/05/2015Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 34, Authorised
19/05/2015Minutes of the HMPC 9-10 March 2015 meeting
19/05/2015Detailed 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)
19/05/2015Detailed 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)
19/05/2015Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004 (updated)
19/05/2015Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information (updated)
19/05/2015New vacancy: Temporary Agent, Security Officer
18/05/2015Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin),

insulin glargine

Revision: 20, Authorised
18/05/2015Human medicines European public assessment report (EPAR): Lantus,

insulin glargine

Revision: 25, Authorised
18/05/2015Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 21, Authorised
18/05/2015Note on the removal of the target animal batch safety test (TABST) from European Pharmacopoeia monographs
18/05/2015Worksharing: questions and answers (updated)
18/05/2015Type-IB variations: questions and answers (updated)
18/05/2015Type-IA variations: questions and answers (updated)
18/05/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
18/05/2015Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
18/05/2015Referral: Article 31 referrals, Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients,

codeine

(updated)
18/05/2015Type-II variations: questions and answers (updated)
18/05/2015International Cooperation - European Medicines Agency
18/05/2015Applying for EU marketing authorisation for medicinal products for veterinary use
18/05/2015Supporting regulatory science outside the EU - The Article 58 procedure
18/05/2015European Medicines Agency 1995-2015 - Working together for safe and effective medicines
18/05/2015Applying for European Union marketing authorisation for medicinal products for human use (updated)
18/05/2015Overview of the European Medicines Agency’s role, activities and priorities for 2015 (updated)
18/05/2015Business pipeline (updated)
18/05/2015Career opportunities at the European Medicines Agency (updated)
18/05/2015The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (updated)
18/05/2015Environmental risk-assessment of medicines (updated)
18/05/2015Better medicines for children (updated)
18/05/2015Pharmacovigilance (updated)
18/05/2015Orphan-medicinal-product designation (updated)
18/05/2015SME Office - Addressing the needs of small and medium-sized enterprises (updated)
18/05/2015Trainee programme at the European Medicines Agency (updated)
18/05/2015Human medicines European public assessment report (EPAR): Cervarix,

human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)

Revision: 20, Authorised
18/05/2015Human medicines European public assessment report (EPAR): Prometax,

rivastigmine

Revision: 29, Authorised
18/05/2015EMA fees query form (updated)
18/05/2015Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 16, Authorised
18/05/2015Electronic submission of Article 57(2) data: questions and answers (updated)
18/05/2015Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 26, Authorised
18/05/2015Report: Report of the Committee for Advanced Therapies (CAT) meeting with interested parties
18/05/2015Agenda: Agenda - Committee for Advanced Therapies (CAT) meeting with interested parties
13/05/2015Veterinary medicine European public assessment report (EPAR): Draxxin,

tulathromycin

Revision: 14, Authorised
13/05/2015PRAC recommendations on safety signals (updated)
13/05/2015Orphan designation:

Metreleptin

for the: Treatment of familial partial lipodystrophy (updated)
13/05/2015Orphan designation:

Metreleptin

for the: Treatment of Lawrence syndrome (updated)
13/05/2015Orphan designation:

Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E

for the: Treatment of Hodgkin lymphoma (updated)
13/05/2015Orphan designation:

Repertaxin L-lysine salt

for the: Prevention of delayed graft function in organ transplant (updated)
13/05/2015Orphan designation:

Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E

for the: Treatment of anaplastic large cell lymphoma (updated)
13/05/2015Orphan designation:

Recombinant human acid ceramidase

for the: Treatment of Farber disease (updated)
13/05/2015Orphan designation:

Recombinant human nerve growth factor

for the: Treatment of retinitis pigmentosa (updated)
13/05/2015Orphan designation:

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

for the: Treatment of necrotising soft tissue infections (updated)
13/05/2015Orphan designation:

Reparixin

for the: Prevention of graft loss in pancreatic islet transplantation (updated)
13/05/2015Orphan designation:

Metreleptin

for the: Treatment of Berardinelli-Seip syndrome (updated)
13/05/2015Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 36, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Exelon,

rivastigmine

Revision: 33, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 1, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Omnitrope,

somatropin

Revision: 10, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 11, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 3, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 34, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 24, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 1, Authorised
13/05/2015Human medicines European public assessment report (EPAR): Anoro,

umeclidinium bromide / vilanterol

Revision: 1, Authorised
13/05/2015Orphan designation:

Carboxypeptidase G2

for the: Adjunctive treatment in patients at risk of methotrexate toxicity (updated)
13/05/2015Orphan designation:

Brentuximab vedotin

for the: Treatment of cutaneous T-cell lymphoma (updated)
13/05/2015Orphan 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) (updated)
13/05/2015Orphan designation:

Adenovirus-associated viral vector serotype 10 carrying the human N-sulfoglucosamine sulfohydrolase and sulfatase modifying factor 1 cDNAs

for the: Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) (updated)
13/05/2015Orphan designation:

Metreleptin

for the: Treatment of Barraquer-Simons syndrome (updated)
13/05/2015Orphan designation:

Humanised IgG1 kappa antibody against serum amyloid A and AL amyloid

for the: Treatment of amyloid light-chain amyloidosis (updated)
13/05/2015Orphan designation:

Doxorubicin(6-maleimidocaproyl)hydrazone

for the: Treatment of soft tissue sarcoma (updated)
13/05/2015Orphan designation:

Ixazomib

for the: Treatment of systemic light chain amyloidosis (updated)
13/05/2015Orphan designation:

Ciclosporin

for the: Treatment of vernal keratoconjunctivitis (updated)
13/05/2015Orphan designation:

Ciclosporin

for the: Treatment of herpes simplex virus stromal keratitis (updated)
13/05/2015Orphan designation:

Ciclosporin

for the: Prevention of corneal graft rejection (updated)
13/05/2015Orphan designation:

11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

for the: Treatment of primary myelofibrosis (updated)
13/05/2015Scientific guideline: Draft guideline on clinical development of fixed combination medicinal products, draft: consultation open
13/05/2015Orphan designation:

11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

for the: Treatment of post-essential thrombocythaemia myelofibrosis (updated)
13/05/2015Orphan designation:

11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

for the: Treatment of post-polycythaemia vera myelofibrosis (updated)
13/05/2015Orphan designation:

2-iminobiotin

for the: Treatment of perinatal asphyxia (updated)
13/05/2015Orphan designation:

2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid

for the: Treatment of multiple myeloma (updated)
12/05/2015News and press releases: European Medicines Agency closed 14-15 May 2015
12/05/2015Human medicines European public assessment report (EPAR): Pravafenix,

fenofibrate / pravastatin

Revision: 3, Authorised
12/05/2015Committee for Advanced Therapies (CAT) meeting with interested parties, European Medicines Agency, London, UK, From: 11-Dec-2014, To: 11-Dec-2014
12/05/2015Regulatory and procedural guideline: Member States' contact points for translation review (updated)
12/05/2015Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 15, Authorised
12/05/2015Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 18, Authorised
12/05/2015Policy 78: EMA environmental policy
12/05/2015Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 18, Authorised
12/05/2015Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2015
12/05/2015List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
12/05/2015Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
12/05/2015Human medicines European public assessment report (EPAR): Trobalt,

retigabine

Revision: 9, Authorised
12/05/2015Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance
12/05/2015News and press releases: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
12/05/2015Human medicines European public assessment report (EPAR): Byetta,

exenatide

Revision: 17, Authorised
12/05/2015Human medicines European public assessment report (EPAR): Evra,

norelgestromin / ethinyl estradiol

Revision: 16, Authorised
12/05/2015Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 4, Authorised
12/05/2015Orphan designation:

Tolvaptan

for the: Treatment of autosomal dominant polycystic kidney disease (updated)
12/05/2015Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 38, Authorised
11/05/2015Agenda: Agenda and registration form for: Joint Joint Drug Information Association/European Medicines Agency information day on post-authorisation studies (PAS) (updated)
11/05/2015Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 1, Authorised
11/05/2015Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 26, Authorised
11/05/2015Human medicines European public assessment report (EPAR): Emend,

aprepitant

Revision: 19, Authorised
11/05/2015Orphan designation:

Tideglusib

for the: Treatment of fragile X syndrome
11/05/2015Orphan designation:

Sodium 3-[(4aR,6R,7R,7aS)-7-hydroxy-2-oxido-2-sulfanylidene-4a,6,7,7a-tetrahydro-4H-furo [3,2-d][1,3,2] dioxaphosphinin-6-yl]-2-bromo-6-phenyl-5H-imidazo[1,2-a]purin-9-one

for the: Treatment of retinitis pigmentosa
11/05/2015Minutes of the CVMP meeting of 8-10 April 2015
11/05/2015Orphan designation:

Recombinant human monoclonal antibody binding to vascular adhesion protein-1

for the: Treatment of primary sclerosing cholangitis
11/05/2015Orphan designation:

Melphalan flufenamide

for the: Treatment of plasma cell myeloma
11/05/2015Orphan designation:

Lenvatinib

for the: Treatment of hepatocellular carcinoma
11/05/2015Orphan designation:

Recombinant human club cell 10 KDa protein

for the: Prevention of bronchopulmonary dysplasia
11/05/2015Orphan designation:

Human plasma-derived alpha-1 proteinase inhibitor

for the: Treatment of graft-versus-host disease
11/05/2015Orphan designation:

Humanised anti-folate receptor 1 monoclonal antibody conjugated to maytansinoid DM4

for the: Treatment of ovarian cancer
11/05/2015Orphan designation:

Gallium (68Ga)-edotreotide

for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
11/05/2015Orphan designation:

Human reovirus type 3 Dearing strain

for the: Treatment of ovarian cancer
11/05/2015Human medicines European public assessment report (EPAR): Sildenafil Actavis,

sildenafil

Revision: 8, Authorised
11/05/2015Veterinary medicine European public assessment report (EPAR): Oncept IL-2,

feline interleukin-2 recombinant canarypox virus (vCP1338 virus)

Revision: 1, Authorised
11/05/2015Inventory of paediatric therapeutic needs - Endocrinology
11/05/2015Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 20, Authorised
11/05/2015Inventory of paediatric therapeutic needs - Gastroenterology
11/05/2015European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
11/05/2015Questionnaire for the PDCO members on involvement of children, adolescents, their parents, carers or legal representatives and members representing patients' organisations in the activities of the PDCO
11/05/2015Presentation - Results from the questionnaire to PDCO members
11/05/2015Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 7, Authorised
11/05/2015Human medicines European public assessment report (EPAR): Abraxane,

paclitaxel

Revision: 17, Authorised
11/05/2015Human medicines European public assessment report (EPAR): CellCept,

mycophenolate mofetil

Revision: 24, Authorised
11/05/2015Orphan designation:

Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector

for the: Treatment of epidermolysis bullosa
11/05/2015Orphan designation:

Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector

for the: Treatment of epidermolysis bullosa
11/05/2015Orphan designation:

Autologous adipose tissue-derived stromal vascular fraction cells

for the: Treatment of systemic sclerosis
11/05/2015Orphan designation:

Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA

for the: Treatment of Huntington’s disease
11/05/2015Orphan designation:

Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL17A1-encoding retroviral vector

for the: Treatment of epidermolysis bullosa
11/05/2015Orphan designation:

Enoxacin

for the: Treatment of amyotrophic lateral sclerosis
11/05/2015Orphan designation:

[5-(5-chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine hydrochloride

for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type
11/05/2015Orphan designation:

5'-ASCSASTSCSASGSTSCSTSGSASUSASASGSCSTSA-3'

for the: Treatment of Alport syndrome
11/05/2015Orphan designation:

5,10,15,20-tetrakis(2,6-difluoro-3-N-methylsulfamoylphenyl)bacteriochlorin

for the: Treatment of biliary tract cancer
11/05/2015Orphan designation:

6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-benzoxazin-4-one

for the: Treatment of Netherton syndrome
08/05/2015Orphan designation:

Tositumomab

for the: Treatment of follicular lymphoma (updated)
08/05/2015European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for processing of annual update notifications for parallel distribution
08/05/2015Template to be used to notify the European Medcines Agency and concerned Member States of 'withdrawn products' (updated)
08/05/2015Human medicines European public assessment report (EPAR): Lojuxta,

lomitapide

Revision: 4, Authorised
08/05/2015Pending EC decision: Canigen L4,

Canine leptospirosis vaccine (inactivated)

Opinion date: 07-May-2015
08/05/2015CVMP summary of positive opinion for Canigen L4, adopted
08/05/2015Regulatory 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)
08/05/2015MRL pending EC decision: Diflubenzuron - Summary opinion of the CVMP on the estabilishment of maximum residue limits
08/05/2015CVMP summary of positive opinion for Innovax-ILT, adopted
08/05/2015MRL pending EC decision: Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts) - Summary opinion of the CVMP on the estabilishment of maximum residue limits
08/05/2015MRL pending EC decision: Sisapronil - Summary opinion of the CVMP on the estabilishment of maximum residue limits
08/05/2015Scenesse : EPAR - Public assessment report, adopted (updated)
08/05/2015Pending EC decision: Innovax-ILT,

Avian infectious laryngotracheitis and Marek’s disease vaccine (live)

Opinion date: 07-May-2015
08/05/2015Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 5, Authorised
08/05/2015Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 11, Authorised
08/05/2015Human medicines European public assessment report (EPAR): Betmiga,

mirabegron

Revision: 5, Authorised
08/05/2015Recombinant human monoclonal antibody to human interleukin (IL)-17A - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
08/05/2015Newsletter: Human medicines highlights - April 2015
08/05/2015News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 May 2015
08/05/2015Orphan designation:

Ruxolitinib

for the: Treatment of polycythaemia vera (updated)
08/05/2015Orphan designation:

Ziconotide (intraspinal use)

for the: Treatment of chronic pain requiring intraspinal analgesia (updated)
08/05/2015Orphan designation:

Nitisinone

for the: Treatment of tyrosinaemia type 1 (updated)
08/05/2015Human medicines European public assessment report (EPAR): Ivemend,

fosaprepitant

Revision: 14, Authorised
08/05/2015Orphan designation:

Glutathione-pegylated liposomal doxorubicin hydrochloride

for the: Treatment of glioma (updated)
08/05/2015Orphan designation:

Iodine (131I) tositumomab

for the: Treatment of follicular lymphoma (updated)
08/05/2015Orphan designation:

Lestaurtinib

for the: Treatment of acute myeloid leukaemia (updated)
08/05/2015Orphan designation:

Levofloxacin hemihydrate

for the: Treatment of cystic fibrosis (updated)
08/05/2015Orphan designation:

Mixture of recombinant human IgG1 monoclonal antibodies against human cytomegalovirus envelope glycoproteins

for the: Prevention of congenital cytomegalovirus infection following primary cytomegalovirus infection (updated)
08/05/2015Orphan designation:

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

for the: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns (updated)
08/05/2015News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2015
08/05/2015Referral: Article 20 procedures, Tysabri,

natalizumab

08/05/2015Human medicines European public assessment report (EPAR): Urorec,

silodosin

Revision: 11, Authorised
08/05/2015Orphan designation:

Allogeneic ex-vivo-expanded umbilical-cord blood cells

for the: Treatment of acute myeloid leukaemia (updated)
08/05/2015Orphan designation:

Allogeneic ex-vivo-expanded umbilical-cord blood cells

for the: Treatment of Hodgkin’s lymphoma (updated)
08/05/2015Orphan designation:

Allogeneic ex-vivo-expanded umbilical-cord blood cells

for the: Treatment of acute lymphoblastic leukaemia (updated)
08/05/2015Orphan designation:

Allogeneic ex-vivo-expanded umbilical-cord blood cells

for the: Treatment of myelodysplastic syndromes (updated)
08/05/2015Orphan designation:

Allogeneic ex-vivo-expanded umbilical-cord blood cells

for the: Treatment of chronic myeloid leukaemia (updated)
08/05/2015Orphan designation:

2,3,4,5 Tetrahydro-2,8-dimethyl-5-[2-(6-methyl-3-pyridinyl)ethyl]-1H-pyrido[4,3-b]indole dihydrochloride

for the: Treatment of Huntington's disease (updated)
08/05/2015Orphan 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)
08/05/2015Orphan 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)
08/05/2015Orphan designation:

5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester

for the: Treatment of neonatal brain injury (updated)
08/05/2015Human medicines European public assessment report (EPAR): Temozolomide Sandoz,

temozolomide

Revision: 12, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 5, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 27, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Ceprotin,

human protein C

Revision: 9, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Epivir,

lamivudine

Revision: 31, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 3, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 4, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Corlentor,

ivabradine

Revision: 18, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Ozurdex,

dexamethasone

Revision: 6, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Menveo,

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

Revision: 14, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 19, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 2, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Procoralan,

ivabradine

Revision: 16, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Aclasta,

zoledronic acid

Revision: 19, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 16, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Travatan,

travoprost

Revision: 23, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 35, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Ikervis,

ciclosporin

Revision: 0, Authorised
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Anti programmed death-ligand 1 (PD-L1) monoclonal antibody (MPDL3280A)

Therapeutic area: Oncology
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ibuprofen / Codeine

Therapeutic area: Pain
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Autologous bone marrow-derived cardiopoietic stem cells

Therapeutic area: Cardiovascular diseases
07/05/2015European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for evaluation of veterinary medicinal products containing or consisting of genetically modified organisms (updated)
07/05/2015European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products (updated)
07/05/2015Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs), adopted
07/05/2015Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP, adopted
07/05/2015Work instructions for departure procedure for all staff members, adopted
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

A derivative of 2-methyl-6-(5-methyl-3-phenyl-isoxazol-4-ylmethoxy)-pyridine (RG1662)

Therapeutic area: Psychiatry
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Tetrabenazine (ADV6979)

Therapeutic area: Neurology
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Forxiga,

Dapagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Canakinumab

Therapeutic area: Immunology-Rheumatology-Transplantation
07/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Ilaris,

Canakinumab

Therapeutic area: Immunology-Rheumatology-Transplantation
07/05/2015Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz),

levodopa / carbidopa / entacapone

Revision: 2, Authorised
07/05/2015Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 12, Authorised
07/05/2015Handling conflicts of interests (updated)
07/05/2015Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 9, Authorised
06/05/2015Herbal Medicinal Products: Eschscholzia, Eschscholziae herba, Eschscholzia california Cham. (updated)
06/05/2015Human medicines European public assessment report (EPAR): Raloxifene Teva,

raloxifene

Revision: 4, Authorised
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Retosiban

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/05/2015Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
06/05/2015Nominations to the European Union Telematics governance bodies (updated)
06/05/2015Quality of medicines questions and answers: Part 2 (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Glibenclamide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism/Other (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Evolocumab

Therapeutic area: Cardiovascular diseases (updated)
06/05/2015Doripenem monohydrate - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Obeticholic acid (6 alpha-ethylchenodeoxycholic acid)

Therapeutic area: Gastroentology-Hepatology (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Damoctocog alfa pegol

Therapeutic area: Haematology-Hemostaseology (updated)
06/05/2015Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 27, Authorised
06/05/2015Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 7, Authorised
06/05/2015Human medicines European public assessment report (EPAR): Victoza,

liraglutide

Revision: 12, Authorised
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): ,

Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins

Therapeutic area: Dermatology/Ophthalmology/Neurology
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Triumeq,

Dolutegravir / abacavir / lamivudine

Therapeutic area: Infectious diseases (updated)
06/05/2015Human medicines European public assessment report (EPAR): Lonquex,

lipegfilgrastim

Revision: 5, Authorised
06/05/2015Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 2, Authorised
06/05/2015Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 9, Authorised
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Valdoxan, Thymanax,

Agomelatine

Therapeutic area: Psychiatry (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Invokana,

Canagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Vimizim (elosulfase alfa),

Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Sirturo,

Bedaquiline (fumarate)

Therapeutic area: Infectious diseases (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Benlysta,

Belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
06/05/2015Minutes of the 87th meeting of the Management Board
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Dolutegravir

Therapeutic area: Infectious diseases (updated)
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Januvia,

Sitagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
06/05/2015Ferumoxytol - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/05/2015Opinion/decision on a Paediatric Investigation Plan (PIP): Rienso,

Ferumoxytol

Therapeutic area: Haematology-Hemostaseology (updated)
06/05/2015News and press releases: EMA tightens rules on 'revolving door' for committee members and experts
06/05/2015Regulatory and procedural guideline: Procedural guidance on inclusion of declared interests in the European Medicines Agency’s electronic declaration of interests form (for scientific committees’ members and experts) (updated)
06/05/2015European Medicines Agency breach of trust procedure on conflicts of interests for scientific-committee members and experts (updated)
06/05/2015Regulatory and procedural guideline: Guidance on the handling of declarations of interests in case of a scientific committee member/other (scientific) forum member’s intention to become an employee in a pharmaceutical company, adopted
06/05/2015European Medicines Agency policy on the handling of declarations of interests of scientific committees’ members and experts (updated)
05/05/2015Vectibix : EPAR - Summary for the public (updated)
05/05/2015CVMP interested parties’ meeting, European Medicines Agency, London, UK, From: 06-May-2015, To: 06-May-2015
05/05/2015Agenda: CVMP interested parties’ meeting
05/05/2015Agenda: Agenda - CVMP agenda of the 5-7 May 2015 meeting
05/05/2015Agenda: Agenda - PRAC draft agenda of meeting 4-7 May 2015
05/05/2015Human medicines European public assessment report (EPAR): Effentora,

fentanyl

Revision: 15, Authorised
05/05/2015Human medicines European public assessment report (EPAR): Velmetia,

sitagliptin / metformin

Revision: 17, Authorised
05/05/2015Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

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

fenofibrate / simvastatin

Revision: 3, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 15, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 5, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 10, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 19, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Lysodren,

mitotane

Revision: 11, Authorised
04/05/2015Agenda: Agenda - HMPC agenda of the 4-5 May 2015 meeting
04/05/2015Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 0, Authorised
04/05/2015Human medicines European public assessment report (EPAR): Orbactiv,

oritavancin

Revision: 0, Authorised
04/05/2015Report: 2014 annual report on EudraVigilance for the European Parliament, the Council and the Commission
04/05/2015Third industry stakeholder platform: operation of European Union pharmacovigilance legislation, European Medicines Agency, London, UK, From: 13-Mar-2015, To: 13-Mar-2015 (updated)
04/05/2015CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2015 meeting
04/05/2015Work plan for the Pharmacovigilance Inspectors Working Group for 2015
04/05/2015Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C, European Medicines Agency, London, UK, From: 09-Dec-2014, To: 09-Dec-2014 (updated)
04/05/2015European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms, European Medicines Agency, London, UK, From: 30-Apr-2015, To: 30-Apr-2015 (updated)
04/05/2015Agenda: Agenda - COMP agenda of the 12-13 May 2015 meeting