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October 2016

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28/10/2016Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

(updated)
28/10/2016Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 52, Authorised
28/10/2016Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 5, Authorised
28/10/2016Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 8, Authorised
28/10/2016Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 1, Authorised
28/10/2016Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201603
28/10/2016Butoconazole: List of nationally authorised medicinal products - PSUSA/00000471/201602
28/10/2016Pimecrolimus: List of nationally authorised medicinal products - PSUSA/00002411/201603
28/10/2016Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201603
28/10/2016Nicorandil: List of nationally authorised medicinal products - PSUSA/00002152/201602
28/10/2016Ethinylestradiol / gestodene (except for transdermal application): List of nationally authorised medicinal products - PSUSA/00001308/201603
28/10/2016Agenda: Agenda - First webinar on regulatory and procedural aspects of type I variations
28/10/2016First webinar on regulatory and procedural aspects of type I variations, European Medicines Agency, London, UK, From: 15-Nov-2016, To: 15-Nov-2016
28/10/2016Referral: Article 20 procedures, SGLT2 inhibitors (previously Canagliflozin),

canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin

(updated)
28/10/2016PRAC recommendations on signals adopted at the PRAC meeting of 30 August-2 September 2016, adopted (updated)
28/10/2016Referral: Article 31 referrals, Factor VIII (updated)
28/10/2016Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
28/10/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24-27 October 2016
28/10/2016Agenda: Agenda - Enpr-EMA Coordinating group members meeting 6 October 2016
28/10/2016Presentation - Proposal for an Enpr-EMA webinar (John Watson)
28/10/2016Report: Report of the 2016 annual workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 2-3 June 2016
28/10/2016Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem)
28/10/2016Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members - 3 June 2016
28/10/2016Minutes of the 2016 annual meeting of Enpr-EMA members - 3 June 2016
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Ramipril / amlodipine / hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
28/10/2016EMA Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 30-Nov-2016, To: 30-Nov-2016
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Cathine (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / Rosuvastatin

Therapeutic area: Cardiovascular diseases
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Lusutrombopag

Therapeutic area: Haematology-Hemostaseology
28/10/2016Herbal medicinal products: Combination; maximum 4 out of 13 possible genera, Species diureticae, Combination; maximum 4 out of 13 possible plants
28/10/2016Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 15, Authorised
28/10/2016Training session for patients and consumers interested in EMA activities, European Medicines Agency, London, UK, From: 29-Nov-2016, To: 29-Nov-2016
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Cabotegravir

Therapeutic area: Infectious diseases/Gastroentology-Hepatology
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-
3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)

Therapeutic area: Infectious diseases
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274)

Therapeutic area: Other
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Semaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Risankizumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Dermatology/Pneumology-allergology/Gastroentology-Hepatology
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Keytruda,

Pembrolizumab

Therapeutic area: Oncology
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Bexagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Nusinersen

Therapeutic area: Neurology (updated)
28/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Constella,

linaclotide

Therapeutic area: Gastroentology-Hepatology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Kuvan,

Sapropterin dihydrochloride

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Cerliponase alfa

Therapeutic area: Neurology (updated)
27/10/2016Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 5, Authorised
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Entyvio,

Vedolizumab

Therapeutic area: Gastroentology-Hepatology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Amitiza,

Lubiprostone

Therapeutic area: Gastroentology-Hepatology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Repatha,

Evolocumab

Therapeutic area: Cardiovascular diseases (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Brexpiprazole

Therapeutic area: Psychiatry (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Talz,

Ixekizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
27/10/2016News and press releases: EMA closed from 28 October to 3 November 2016
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Eurartesim,

Dihydroartemisinin / piperaquine phosphate anhydride

Therapeutic area: Infectious diseases (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Trulicity,

Dulaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Tenofovir alafenamide (as fumarate)

Therapeutic area: Infectious diseases (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Gilenya,

Fingolimod (hydrochloride)

Therapeutic area: Neurology (updated)
27/10/2016Human medicines European public assessment report (EPAR): Zerit,

stavudine

Revision: 30, Authorised
27/10/2016Newsletter: News bulletin for small and medium-sized enterprises - Issue 37
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Unituxin,

Dinutuximab

Therapeutic area: Oncology (updated)
27/10/2016Work instructions for European Pharmacovigilance Issues Tracking Tool (EPITT) user registration and management – Assessment of eligibility for an EPITT account, adopted (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Dermatology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Elobixibat

Therapeutic area: Gastroentology-Hepatology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Benralizumab

Therapeutic area: Pneumology-allergology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,

Brentuximab vedotin

Therapeutic area: Oncology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Latuda,

Lurasidone hydrochloride

Therapeutic area: Psychiatry (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Budesonide

Therapeutic area: Pneumology-allergology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,

Lumacaftor / ivacaftor

Therapeutic area: Other (updated)
27/10/2016Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 5, Authorised
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Ecalta,

Anidulafungin

Therapeutic area: Infectious diseases (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Zelboraf,

Vemurafenib

Therapeutic area: Oncology (updated)
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody

Therapeutic area: Cardiovascular diseases/Haematology-Hemostaseology
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Synflorix,

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

Therapeutic area: Vaccines (updated)
27/10/2016Human medicines European public assessment report (EPAR): Scintimun,

besilesomab

Revision: 5, Authorised
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Macitentan / tadalafil

Therapeutic area: Cardiovascular diseases
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

(S)-lactic acid

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Lesinurad / allopurinol

Therapeutic area: Immunology-Rheumatology-Transplantation
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine (besylate) / perindopril (erbumine) / indapamide

Therapeutic area: Cardiovascular diseases
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin (calcium) / Ezetimibe

Therapeutic area: Cardiovascular diseases
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): NovoEight,

turoctocog alpha

Therapeutic area: Haematology-Hemostaseology (updated)
27/10/2016Report: Medicinal products for human use: monthly figures - September 2016
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Edurant,

Rilpivirine (hydrochloride)

Therapeutic area: Infectious diseases (updated)
27/10/2016Human medicines European public assessment report (EPAR): Ristaben,

sitagliptin

Revision: 15, Authorised
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Allogeneic human neural stem cells genetically modified to express c-MycERTAM, a c-Myc and modified oestrogen receptor fusion protein (CTX0E03)

Therapeutic area: Neurology
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (BMS-986089)

Therapeutic area: Neurology
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Angiotensin II (LJPC-501)

Therapeutic area: Other
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Elafibranor

Therapeutic area: Gastroentology-Hepatology
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous cartilage derived cultured chondrocytes

Therapeutic area: Other
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one

Therapeutic area: Psychiatry
27/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation
26/10/2016Opinion/decision on a Paediatric investigation plan (PIP): Izinova (and associated names),

Sodium sulphate / potassium sulphate / magnesium sulphate heptahydrate (BLI800)

Therapeutic area: Gastroentology-Hepatology (updated)
26/10/2016Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (updated)
26/10/2016Hydromorphone: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001686/201511
26/10/2016Hydromorphone: List of nationally authorised medicinal products - PSUSA/00001686/201511
26/10/2016Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 1, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Neparvis,

sacubitril / valsartan

Revision: 2, Authorised
26/10/2016European Medicines Agency meeting and holiday dates 2016 (updated)
26/10/2016European Medicines Agency meeting and holiday dates 2018
26/10/2016Human medicines European public assessment report (EPAR): Triumeq,

abacavir sulfate / dolutegravir sodium / lamivudine

Revision: 6, Authorised
26/10/2016News and press releases: New search page for periodic safety update report single assessments (PSUSAs)
26/10/2016Human medicines European public assessment report (EPAR): Thorinane,

enoxaparin sodium

Revision: 0, Authorised
26/10/2016Treatment and prophylaxis of respiratory syncytial virus (RSV) infection
26/10/2016Human medicines European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka),

irbesartan

Revision: 8, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 12, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Adrovance,

alendronic acid / colecalciferol

Revision: 17, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 17, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 16, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Olazax Disperzi,

olanzapine

Revision: 7, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 13, Authorised
26/10/2016Human medicines European public assessment report (EPAR): Respreeza,

human alpha1-proteinase inhibitor

Revision: 2, Authorised
25/10/2016Paclitaxel: List of nationally authorised medicinal products - PSUSA/00002264/201512
25/10/2016Paclitaxel: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002264/201512
25/10/2016Botulinum toxin a - haemagglutinin complex: List of nationally authorised medicinal products - PSUSA/00000427/201512
25/10/2016Botulinum toxin a - haemagglutinin complex: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000427/201512
25/10/2016Cefoperazone: List of nationally authorised medicinal products - PSUSA/00000597/201601
25/10/2016Cefoperazone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00000597/201601
25/10/2016Human medicines European public assessment report (EPAR): Olazax,

olanzapine

Revision: 8, Authorised
25/10/2016Abilify-H-C-471-II-0110 : EPAR - Assessment Report - Variation, adopted
25/10/2016Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
25/10/2016Open clinical data - stakeholder quotes (updated)
25/10/2016List of signals discussed at the PRAC since September 2012 (updated)
25/10/2016PRAC recommendations on signals adopted at the PRAC meeting of 26-29 September 2016, adopted
25/10/2016Human medicines European public assessment report (EPAR): Myclausen,

mycophenolate mofetil

Revision: 11, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Orbactiv,

oritavancin

Revision: 2, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Somavert,

pegvisomant

Revision: 16, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 42, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka),

capecitabine

Revision: 7, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 19, Authorised
25/10/2016Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 10, Authorised
25/10/2016New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC
25/10/2016Human medicines European public assessment report (EPAR): Onivyde,

irinotecan hydrochloride trihydrate

Revision: 0, Authorised
24/10/2016Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 3, Authorised
24/10/2016Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 16, Authorised
24/10/2016Withdrawn application: Cokiera,

dasabuvir / ombitasvir / paritaprevir / ritonavir

Initial authorisation (updated)
24/10/2016Agenda: Agenda - PRAC draft agenda of meeting 24-27 October 2016
24/10/2016Human medicines European public assessment report (EPAR): Januvia,

sitagliptin

Revision: 20, Authorised
24/10/2016Human medicines European public assessment report (EPAR): Duloxetine Mylan,

duloxetine

Revision: 4, Authorised
24/10/2016News and press releases: Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November
24/10/2016News and press releases: How to make better use of patient registries to collect high-quality data on medicines
24/10/2016Patient registries (updated)
24/10/2016Human medicines European public assessment report (EPAR): Remsima,

infliximab

Revision: 8, Authorised
24/10/2016Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 2, Authorised
24/10/2016Pending EC decision: Onivyde,

irinotecan hydrochloride trihydrate

Opinion date: 21-Jul-2016 (updated)
21/10/2016Report: Scientific recommendation on classification of advanced therapy medicinal products: ex-vivo cultured and expanded human cord blood progenitor cells
21/10/2016Report: Scientific recommendation on classification of advanced therapy medicinal products: heterologous human adult liver-derived progenitor cells
21/10/2016Report: Scientific recommendation on classification of advanced therapy medicinal products: recombinant adeno-associated viral vector serotype 2 encoding the human aromatic L-amino acid decarboxylase gene
21/10/2016Report: Scientific recommendation on classification of advanced therapy medicinal products: recombinant adeno-associated viral vector serotype 8 (AAV8) encoding human glucose-6-phosphatase-α (G6Pase or G6PC)
21/10/2016Orphan designation:

Dexamethasone phosphate (iontophoretic solution, ocular use)

for the: Treatment of corneal graft rejection (updated)
21/10/2016Orphan designation:

Adeno-associated viral vector encoding an inducible short hairpin RNA targeting claudin-5 (prior to administration of 17-dimethylaminoethylamino-17-demethocygeldanamycin)

for the: Treatment of retinitis pigmentosa (updated)
21/10/2016Orphan designation:

Tralokinumab

for the: Treatment of idiopathic pulmonary fibrosis (updated)
21/10/2016Orphan designation:

Vincaleukoblastin-23-oic acid, O4-deacetyl-, 2-[(2-mercaptoethoxy)carbonyl]hydrazide, disulfide with N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-γ-glutamyl-L-α-aspartyl-L-arginyl-L-α-aspartyl-L-α-aspartyl-L-cysteine

for the: Treatment of ovarian cancer (updated)
21/10/2016Orphan designation:

(1-Methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate

for the: Treatment of soft-tissue sarcoma (updated)
21/10/2016Orphan designation:

Ciclosporin (inhalation use)

for the: Prevention of graft rejection after lung transplantation (updated)
21/10/2016Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 14, Authorised
21/10/2016Orphan designation:

2’-deoxyguanosylyl-(3’,5’-phosphoryl)-2’-deoxythymidylyl-(3’,5’-phosphoryl)- 2’-deoxyguanosylyl-(3’,5’-phosphoryl)-2’-deoxycytidylyl-(3’,5’-phosphoryl)-2’-deoxycytidylyl -(3’,5’-phosphoryl)-2’-deoxycytidylyl-(3’,5’-phosphoryl)-2’-deoxyguanosylyl...

for the: Treatment of diffuse large B-cell lymphoma (updated)
21/10/2016Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 25, Authorised
21/10/2016Human medicines European public assessment report (EPAR): Nordimet,

methotrexate

Revision: 1, Authorised
21/10/2016Human medicines European public assessment report (EPAR): Zutectra,

human hepatitis-B immunoglobulin

Revision: 11, Authorised
21/10/2016Orphan designation:

Denufosol tetrasodium

for the: Treatment of cystic fibrosis (updated)
21/10/2016Human medicines European public assessment report (EPAR): Praluent,

alirocumab

Revision: 5, Authorised
21/10/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
21/10/2016Human medicines European public assessment report (EPAR): Ketoconazole HRA,

ketoconazole

Revision: 4, Authorised
21/10/2016Influenza vaccines - non-clinical and clinical module (updated)
20/10/2016Human medicines European public assessment report (EPAR): Vectibix,

panitumumab

Revision: 24, Authorised
20/10/2016Orphan designation:

Obinutuzumab

for the: Treatment of marginal zone lymphoma (updated)
20/10/2016Orphan designation:

Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein

for the: Treatment of glioma (updated)
20/10/2016Orphan designation:

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

for the: Treatment of glioma (updated)
20/10/2016Orphan designation:

HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS)

for the: Treatment of renal cell carcinoma (updated)
20/10/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for European Pharmacovigilance Issues Tracking Tool user registration and management (updated)
20/10/2016Work instructions for user registration and management - Maintenance of the European Pharmacovigilance Issues Tracking Tool (EPITT) accounts and provision of trainings to users, adopted (updated)
20/10/2016Scientific guideline: Concept paper on good manufacturing practice and marketing authorisation holders , draft: consultation open (updated)
20/10/2016News and press releases: Opening up clinical data on new medicines
20/10/2016Background to clinical data publication policy (updated)
20/10/2016Support for industry on clinical data publication
20/10/2016Supporting SMEs (updated)
20/10/2016Transparency (updated)
20/10/2016Clinical data publication (updated)
20/10/2016Open clinical data - benefits for public health
20/10/2016Human medicines European public assessment report (EPAR): Vpriv,

velaglucerase alfa

Revision: 10, Authorised
20/10/2016Human medicines European public assessment report (EPAR): Rasilez HCT,

aliskiren / hydrochlorothiazide

Revision: 11, Authorised
20/10/2016Human medicines European public assessment report (EPAR): Evoltra,

clofarabine

Revision: 24, Authorised
20/10/2016Report: Survey report - European Medicines Agency (EMA) consultation on the proposal of a collaboration framework with academia
20/10/2016Scientific guideline: CVMP strategy on antimicrobials 2016-2020, adopted
20/10/2016Overview of comments received on 'CVMP strategy on antimicrobials 2016-2020' (EMA/CVMP/209189/2015)
20/10/2016Agenda: Agenda - Patient registries workshop (updated)
20/10/2016Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 23, Authorised
20/10/2016EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs, CCT venues, 40 Bank Street, Canary Wharf, London E14 5NR, From: 16-Dec-2016, To: 16-Dec-2016
20/10/2016Agenda: Programme of the EMA / EBE fifth annual regulatory conference on optimising the development of ATMPs to meet patient needs
20/10/2016Scientific guideline: Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency, adopted
20/10/2016Veterinary medicine European public assessment report (EPAR): Eravac,

Rabbit haemorrhagic disease vaccine (inactivated)

Revision: 0, Authorised
20/10/2016Antimicrobial resistance in veterinary medicine (updated)
20/10/2016Human medicines European public assessment report (EPAR): Ofev,

nintedanib

Revision: 3, Authorised
20/10/2016Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 10, Authorised
20/10/2016Information management
20/10/2016CHMP ORGAM minutes for the meeting on 3 October 2016
20/10/2016Monthly report on application procedures guidelines and related documents for veterinary medicines: September 2016
20/10/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2016
20/10/2016Minutes of the CHMP meeting 12-15 September 2016
20/10/2016Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 28, Authorised
19/10/2016List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
19/10/2016PRIME: priority medicines (updated)
19/10/2016Baclofen: List of nationally authorised medicinal products - PSUSA/00000293/201601
19/10/2016Botulinum neurotoxin type a (150 kd) free from complexing proteins: CMDh Scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009084/201512
19/10/2016Exametazime / technetium (99mTc) exametazime: List of nationally authorised medicinal products - PSUSA/00001344/201601
19/10/2016Propafenone: List of nationally authorised medicinal products - PSUSA/00002550/201601
19/10/2016Botulinum neurotoxin type a (150 kd) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201512
19/10/2016Amlodipine / atorvastatine: List of nationally authorised medicinal products - PSUSA/00000177/201601
19/10/2016Referral: Article 30 referrals, Durogesic and associated names,

fentanyl

(updated)
19/10/2016Report: List of products granted eligibility to PRIME
19/10/2016Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 October 2016, adopted
19/10/2016Business hours and holidays (updated)
19/10/2016News and press releases: Regulatory information – Updated SME user guide now available
19/10/2016Levothyroxine: List of nationally authorised medicinal products - PSUSA/00001860/201601
19/10/2016Etoposide: List of nationally authorised medicinal products - PSUSA/00001333/201602
19/10/2016Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201602
19/10/2016Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201601
19/10/2016Interferon gamma: List of nationally authorised medicinal products - PSUSA/00001760/201601
19/10/2016Human medicines European public assessment report (EPAR): Lantus,

insulin glargine

Revision: 29, Authorised
19/10/2016Doxazosin: CMDh Scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001169/201512
19/10/2016Acetylsalicylic acid: List of nationally authorised medicinal products - PSUSA/00000039/201602
19/10/2016Doxazosin: List of nationally authorised medicinal products - PSUSA/00001169/201512
19/10/2016Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201602
19/10/2016Human medicines European public assessment report (EPAR): Brilique,

ticagrelor

Revision: 9, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 6, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Aripiprazole Zentiva,

aripiprazole

Revision: 2, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 45, Authorised
19/10/2016Second annual scientific workshop at EMA: Applying regulatory science to neonates , European Medicines Agency, London, UK, From: 12-Sep-2016, To: 13-Sep-2016 (updated)
19/10/2016Human medicines European public assessment report (EPAR): Ibandronic Acid Sandoz,

ibandronic acid

Revision: 7, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Infanrix Hexa,

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Revision: 27, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 6, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 4, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 5, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Lymphoseek,

tilmanocept

Revision: 1, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 11, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 5, Authorised
19/10/2016Veterinary medicine European public assessment report (EPAR): Semintra,

telmisartan

Revision: 3, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Irbesartan Teva,

irbesartan

Revision: 9, Authorised
19/10/2016Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises, adopted (updated)
19/10/2016Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 8, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 19, Authorised
19/10/2016Veterinary medicine European public assessment report (EPAR): Equisolon,

Prednisolone

Revision: 3, Authorised
19/10/2016Human medicines European public assessment report (EPAR): Zyprexa,

olanzapine

Revision: 37, Authorised
18/10/2016Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 23, Authorised
18/10/2016Minutes of the COMP meeting 6-8 September 2016
18/10/2016HMPC: overview of assessment work – priority list (updated)
18/10/2016Overview of comments received on 'Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products’ (EMA/CHMP/594085/2015)
18/10/2016Minutes of the CVMP meeting of 6-8 September
18/10/2016Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 21, Authorised
17/10/2016Formatted table template to be inserted in each procedural submission cover letter (updated)
17/10/2016Agenda: Agenda - Innovative Medicines Initiative WEB-RADR project: mobile technologies and social media as new tools in pharmacovigilance workshop programme (updated)
17/10/20162016 EU GCP Inspectors Working Group Workshop, European Medicines Agency, London, UK, From: 17-Oct-2016, To: 19-Oct-2016
14/10/2016Herbal medicinal products: Arctostaphylos, Uvae ursi folium, Arctostaphylos uva-ursi (L.) Spreng. (updated)
14/10/2016Herbal medicinal products: Thymus , Thymi herba, Thymus vulgaris L.; Thymus zygis L. (updated)
14/10/2016European Medicines Agency pharmacovigilance system manual (updated)
14/10/2016News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
14/10/2016News and press releases: New medicine for rare, chronic liver disease
14/10/2016News and press releases: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
14/10/2016News and press releases: EMA recommends measures to ensure safe use of Keppra oral solution
14/10/2016Overview of invented names reviewed in September 2016 by the Name Review Group adopted at the CHMP meeting of 10-13 October 2016, adopted
14/10/2016Pending EC decision: Cystadrops,

mercaptamine

Opinion date: 13-Oct-2016
14/10/2016Withdrawn application: Zemfirza,

cediranib

Initial authorisation
14/10/2016Withdrawn application: Pemetrexed ditromethamine Hospira,

pemetrexed

Initial authorisation
14/10/2016Pending EC decision: Ocaliva,

obeticholic acid

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Emtricitabine / Tenofovir disoproxil Krka,

emtricitabine / tenofovir disoproxil

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Lucentis,

ranibizumab

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Opdivo,

nivolumab

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Rekovelle,

follitropin delta

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Emtricitabine / Tenofovir disoproxil Mylan,

emtricitabine / tenofovir disoproxil

Opinion date: 13-Oct-2016
14/10/2016Withdrawn application: Ertapenem Hospira,

ertapenem

Initial authorisation
14/10/2016Pending EC decision: Tenofovir disoproxil Mylan,

tenofovir disoproxil

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Zebinix,

eslicarbazepine acetate

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: Trisenox,

arsenic trioxide

Opinion date: 13-Oct-2016
14/10/2016Pending EC decision: SomaKit TOC,

edotreotide

Opinion date: 14-Oct-2016
14/10/2016Pending EC decision: Venclyxto,

venetoclax

Opinion date: 13-Oct-2016
14/10/2016Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 19, Authorised
14/10/2016European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
14/10/2016News and press releases: Sales of veterinary antibiotics continue to decline in most European countries
14/10/2016Human medicines European public assessment report (EPAR): Olanzapine Apotex,

olanzapine

Revision: 5, Authorised
14/10/2016Report: Sixth ESVAC report: sales of veterinary antimicrobial agents in 29 European countries in 2014
14/10/2016Withdrawn application: Arikayce,

amikacin

Initial authorisation (updated)
13/10/2016COMP meeting report on the review of applications for orphan designation: October 2016
13/10/2016International Coalition of Medicines Regulatory Authorities (updated)
13/10/2016Template 1 - Orphan designation transfer form (updated)
13/10/2016News and press releases: First comprehensive overview of global initiatives on medicine regulation published
13/10/2016ICH E11 Clinical investigation of medicinal products in the paediatric population (updated)
13/10/2016Scientific guideline: ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b, draft: consultation open
13/10/2016Connecting the dots: Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives
13/10/2016Human medicines European public assessment report (EPAR): Kogenate Bayer,

octocog alfa

Revision: 28, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Bexsero,

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

Revision: 12, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 14, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Iressa,

gefitinib

Revision: 9, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Menveo,

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

Revision: 19, Authorised
13/10/2016Veterinary medicine European public assessment report (EPAR): Bovela,

bovine viral diarrhoea vaccine (modified, live)

Revision: 1, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 38, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 55, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 2, Authorised
13/10/2016Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 24, Authorised
12/10/2016Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 30, Authorised
12/10/2016Human medicines European public assessment report (EPAR): Stayveer,

bosentan monohydrate

Revision: 4, Authorised
12/10/2016Presentation - Implementing ISO ICSR-ICH E2B(R3): Submodule b - backwards and forwards conversion
12/10/2016EudraVigilance training (updated)
12/10/2016Human medicines European public assessment report (EPAR): Cabometyx ,

cabozantinib

Revision: 0, Authorised
12/10/2016Tenth stakeholder forum on the pharmacovigilance legislation, European Medicines Agency, UK, From: 21-Sep-2016, To: 21-Sep-2016 (updated)
11/10/2016Orphan designation:

Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA, covalently linked to a ligand containing three N-acetylgalactosamine residues

for the: Treatment of acute hepatic porphyria
11/10/2016Orphan designation:

6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate

for the: Treatment of mucopolysaccharidosis type I
11/10/2016Regulatory and procedural guideline: Reflection paper on the development of the European medicines web portal (updated)
11/10/2016Decision of the Executive Director on the rules governing the traineeship programme at the European Medicines Agency (updated)
11/10/2016Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

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

lenvatinib

Revision: 1, Authorised
11/10/2016Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 43, Authorised
11/10/2016Human medicines European public assessment report (EPAR): Protelos,

strontium ranelate

Revision: 18, Authorised
11/10/2016Human medicines European public assessment report (EPAR): Osseor,

strontium ranelate

Revision: 18, Authorised
11/10/2016Report: Outcome of the European Medicines Agency survey on centralised post-authorisation procedures 2015
10/10/2016Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 18, Authorised
10/10/2016Human medicines European public assessment report (EPAR): Orfadin,

nitisinone

Revision: 11, Authorised
10/10/2016Referral: Article 29(4) referrals, Diclofenac epolamine 50 mg tablets ,

diclofenac

(updated)
10/10/2016Current tenders for €135,000 or more (updated)
10/10/2016PRIME eligibility requests: 2017 deadlines for submission and timetable for assessment
10/10/2016Agenda: Agenda - CHMP agenda of the 10-13 October 2016
10/10/2016Orphan designation:

Fimaporfin

for the: Treatment of cholangiocarcinoma
10/10/2016Orphan designation:

Cannabidiol

for the: Treatment of graft-versus-host disease
10/10/2016Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 24, Authorised
10/10/2016Ex ante publicity of a negotiated procedure – EMA/2016/58/COM – Scientific, Technical and Medical eBooks
10/10/2016Human medicines European public assessment report (EPAR): Brinavess,

vernakalant hydrochloride

Revision: 9, Authorised
10/10/2016Revised EudraVigilance access policy: impact on stakeholders (updated)
10/10/2016Presentation - Introduction to training offering by European Medicines Agency: Training module PhV-M0 (updated)
10/10/2016Presentation - EudraVigilance components and functionality introduction: training module PhV-M2 (updated)
10/10/2016Presentation - Preparing for the simplified reporting of suspected adverse reactions in the European Union: training module PhV-M3 (updated)
10/10/2016Presentation - New EudraVigilance functionalities and the 2010 pharmacovigilance legislation – preparing for change: training module PhV-M1 (updated)
10/10/2016Presentation - Implementing ISO ICSR/ICH E2B(R3): key changes for pharmacovigilance - training module PhV-M2a (updated)
10/10/2016Report: Applications for new human medicines under evaluation by the CHMP: October 2016
07/10/2016Agenda: Agenda - CAT agenda of the 6-7 October 2016 meeting
07/10/2016EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation, European Medicines Agency, London, UK, From: 21-Nov-2016, To: 21-Nov-2016
07/10/2016Outcome of written procedures finalised during the period from 12 May 2016 to 6 September 2016
07/10/2016Agenda: Agenda for the 93rd meeting of the Management Board (updated)
07/10/2016Decision on amending budget No 1-2016
07/10/2016Summary of transfer of appropriations in the budget 2016
07/10/2016Report: Revision of budget structure from financial year 2017
07/10/2016News and press releases: EMA Management Board: highlights of October 2016 meeting
07/10/2016Management Board meeting: 5-6 October 2016, European Medicines Agency, London, UK, From: 05-Oct-2016, To: 06-Oct-2016 (updated)
07/10/2016Report: EudraVigilance veterinary / Signal detection and on-going related veterinary-information technology (IT) projects (updated)
07/10/2016Regulatory and procedural guideline: Pre-submission checklist for annual re-assessment of a marketing authorisation under exceptional circumstances application
07/10/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
07/10/2016Applicant / marketing authorisation holder change of contact person for product invented name / product number template (updated)
07/10/2016Regulatory and procedural guideline: Pre-submission checklist for 5-year renewal applications
07/10/2016Regulatory and procedural guideline: Pre-submission checklist for annual renewal of conditional marketing authorisation applications
07/10/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
07/10/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 2016
07/10/2016Pending EC decision: Cepedex,

dexmedetomidine hydrochloride

Opinion date: 06-Oct-2016
07/10/2016MRL pending EC decision: Fluralaner - Summary opinion of the CVMP on the establishment of maximum residue limits
07/10/2016Pending EC decision: VarroMed,

oxalic acid dihydrate / formic acid

Opinion date: 06-Oct-2016
07/10/2016Pending EC decision: Halagon,

halofuginone

Opinion date: 06-Oct-2016
07/10/2016News and press releases: New medicine to protect honey bees against Varroa mites
07/10/2016Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 11, Authorised
07/10/2016Qualification of novel methodologies for medicine development (updated)
07/10/2016Inventory of paediatric therapeutic needs - Respiratory
07/10/2016Response to public comments received on the ‘Inventory of paediatric therapeutic needs – Respiratory’
07/10/2016Referral: Article 31 referrals, Alkem (updated)
07/10/2016Outcomes of imposed non-interventional post-authorisation safety studies
07/10/2016Newsletter: Human medicines highlights - September 2016
06/10/2016Herbal medicinal products: Pimpinella, Anisi aetheroleum, Pimpinella anisum L. (updated)
06/10/2016Herbal medicinal products: Humulus, Lupuli flos, Humulus lupulus L. (updated)
06/10/2016Herbal medicinal products: Pimpinella, Anisi fructus, Pimpinella anisum L. (updated)
06/10/2016Herbal medicinal products: Passiflora, Passiflorae herba, Passiflora incarnata L. (updated)
06/10/2016Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 10, Authorised
06/10/2016Veterinary medicine European public assessment report (EPAR): Novem,

meloxicam

Revision: 9, Authorised
06/10/2016Herbal medicinal products: Primula, Primulae flos, Primula veris L.; Primula elatior (L.) Hill (updated)
06/10/2016News and press releases: IT systems unavailable from 28 October to 1 November 2016
06/10/2016Veterinary medicine European public assessment report (EPAR): ProZinc,

insulin human

Revision: 4, Authorised
06/10/2016Human medicines European public assessment report (EPAR): Incivo,

telaprevir

Revision: 19, Withdrawn
06/10/2016Human medicines European public assessment report (EPAR): Imbruvica,

ibrutinib

Revision: 7, Authorised
06/10/2016New vacancy: Temporary Agent (AD6), Liaison with patients, consumers and their organisations
06/10/2016New vacancy: Temporary Agent (AD5), Administrator, Head of Division Support
06/10/2016New vacancy: Temporary Agent (AD8), Scientific Officer
05/10/2016Human medicines European public assessment report (EPAR): Luminity,

perflutren

Revision: 10, Authorised
05/10/2016Regulatory and procedural guideline: Member States' contact points for translation review (v.6.3) (updated)
04/10/2016Agenda: Agenda - PRAC draft agenda of meeting 30 August – 2 September 2016 (updated)
04/10/2016Agenda: CHMP ORGAM agenda for the meeting on 3 October 2016
04/10/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 14-16 September 2016
04/10/2016Velactis : EPAR - Annex to the Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 45 of Regulation EC No 726 2004 for Velactis
04/10/2016Veterinary medicine European public assessment report (EPAR): Velactis,

cabergoline

Revision: 1, Suspended
04/10/2016Agenda: Agenda - Periodic safety update report information day (updated)
04/10/2016Good-manufacturing-practice and good-distribution-practice compliance (updated)
04/10/2016Human medicines European public assessment report (EPAR): Repaglinide Teva,

repaglinide

Revision: 7, Authorised
04/10/2016Agenda: Agenda - CVMP agenda of the 4-6 October 2016 meeting
03/10/2016Orphan designation:

Synthetic ribonucleic acid oligonucleotide directed against superoxide dismutase 1 messenger ribonucleic acid

for the: Treatment of amyotrophic lateral sclerosis
03/10/2016Orphan designation:

Recombinant humanised monoclonal antibody against human complement component C5a

for the: Treatment of graft-versus-host disease
03/10/2016Referral: Article 20 procedures, Zydelig,

idelalisib

(updated)
03/10/2016Orphan designation:

Recombinant human interleukin-12

for the: Treatment of acute radiation syndrome
03/10/2016Human medicines European public assessment report (EPAR): Colobreathe,

colistimethate sodium

Revision: 6, Authorised
03/10/2016Human medicines European public assessment report (EPAR): Efient,

prasugrel

Revision: 12, Authorised
03/10/2016Orphan designation:

Methotrexate

for the: Treatment of alkaptonuria
03/10/2016Orphan designation:

Temozolomide

for the: Treatment of glioma
03/10/2016Human medicines European public assessment report (EPAR): Hycamtin,

topotecan

Revision: 26, Authorised
03/10/2016Minutes of the HMPC 11-12 July 2016 meeting
03/10/2016Orphan designation:

Adenovirus-associated viral vector serotype 5 containing the human RPGR gene

for the: Treatment of retinitis pigmentosa
03/10/2016Human medicines European public assessment report (EPAR): Zykadia,

ceritinib

Revision: 4, Authorised
03/10/2016European medicines agency Standard operating procedure (SOP): Standard operation procedure for handling of requests from a national competent authority to the CMDh for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (updated)
03/10/2016Orphan designation:

L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser

for the: Prevention of graft loss in pancreatic islet transplantation
03/10/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents (updated)
03/10/2016Orphan designation:

Sodium benzoate

for the: Treatment of lysinuric protein intolerance
03/10/2016Orphan designation:

Cisplatin

for the: Treatment of malignant mesothelioma
03/10/2016Orphan designation:

Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene

for the: Treatment of Duchenne muscular dystrophy
03/10/2016Orphan designation:

Zoledronic acid

for the: Treatment of glioma
03/10/2016Orphan designation:

Recombinant human acid alpha-glucosidase conjugated with mannose-6-phosphate analogues

for the: Treatment of glycogen storage disease type II (Pompe’s disease)