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July 2014

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30/07/2014Human medicines European public assessment report (EPAR): Zomarist,

vildagliptin / metformin

Revision: 10, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Jalra,

vildagliptin

Revision: 9, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Topotecan Actavis,

topotecan

Revision: 5, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 3, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 2, Authorised
30/07/2014List of medicinal products under additional monitoring (updated)
30/07/2014List of medicinal products under additional monitoring (updated)
30/07/2014Annex X - List of domperidone-containing medicinal products in the European Union
30/07/2014Annex X - List of domperidone-containing medicinal products in the European Union
30/07/2014Human medicines European public assessment report (EPAR): Javlor,

vinflunine

Revision: 6, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Eucreas,

vildagliptin / metformin

Revision: 9, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 10, Authorised
30/07/2014Q&A: Transfer (updated)
30/07/2014Q&A: Grouping of variations (updated)
30/07/2014Q&A: Type IA variations (updated)
30/07/2014Q&A: Renewals (updated)
30/07/2014Q&A: Extension applications (updated)
30/07/2014Q&A: Type IB variations (updated)
30/07/2014Q&A: Worksharing of variations (updated)
30/07/2014Human medicines European public assessment report (EPAR): Galvus,

vildagliptin

Revision: 9, Authorised
30/07/2014Q&A: Type II variations (updated)
30/07/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for Audit programmes and internal audits conducted by the Audit Advisory Function (updated)
30/07/2014Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 3, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Somatropin Biopartners,

somatropin

Revision: 1, Authorised
30/07/2014Human medicines European public assessment report (EPAR): Cystagon,

mercaptamine bitartrate

Revision: 11, Authorised
30/07/2014European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) joint meeting , European Medicines Agency, London, From: 03-Jun-2014, To: 03-Jun-2014 (updated)
30/07/2014Annex II: Expression of interest form
30/07/2014Annex III: Draft donation agreement
30/07/2014Annex I: Catalogue of assets for donation
30/07/2014Procurement at the Agency (updated)
30/07/2014Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 June 2014
30/07/2014Agenda: Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 June 2014 (updated)
30/07/2014List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 June 2014
30/07/2014Agenda: Agenda - CAT agenda of the 17-18 July 2014 meeting
30/07/2014Minutes of the CAT meeting 19-20 June 2014
30/07/2014CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2014 meeting
29/07/2014Human medicines European public assessment report (EPAR): Revasc,

desirudin

Revision: 12, Withdrawn
29/07/2014European Medicines Agency pharmacovigilance system manual
29/07/2014Organisational matters - CHMP meeting 21-24 July 2014
29/07/2014Opinions on safety variations/PSURs adopted at the CHMP meeting of 21-24 July 2014
29/07/2014Guidelines and concept papers adopted during the CHMP meeting 21-24 July 2014
29/07/2014Application for authorisation to engage in an occupation after leaving the European Medicines Agency - National Expert on Secondment (updated)
29/07/2014Human medicines European public assessment report (EPAR): Dacogen,

decitabine

Revision: 3, Authorised
29/07/2014Human medicines European public assessment report (EPAR): Somavert,

pegvisomant

Revision: 8, Authorised
29/07/2014Human medicines European public assessment report (EPAR): Cystadane,

betaine anhydrous

Revision: 6, Authorised
29/07/2014Human medicines European public assessment report (EPAR): Kineret,

anakinra

Revision: 18, Authorised
29/07/2014Application for authorisation to engage in an occupation after leaving the European Medicines Agency - Trainee (updated)
29/07/2014Application for authorisation to engage in an occupation after leaving the European Medicines Agency - Article 16 of the Staff Regulations (updated)
29/07/2014Human medicines European public assessment report (EPAR): Metalyse,

tenecteplase

Revision: 13, Authorised
29/07/2014Human medicines European public assessment report (EPAR): Voriconazole Accord,

voriconazole

Revision: 2, Authorised
29/07/2014Minutes - PDCO minutes of the 18-20 June 2014 meeting
29/07/2014Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 1, Authorised
29/07/2014PDCO monthly report of opinions on paediatric investigation plans and other activities 16-18 July 2014
29/07/2014Donation of EMA assets no. EMA/2014/28/IS (updated)
29/07/2014List of signals discussed at the PRAC since September 2012 (updated)
29/07/2014PRAC recommendations on signals adopted at the PRAC meeting of 7-10 July 2014
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Votrient,

Pazopanib

Therapeutic area: Oncology (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ceftazidime / avibactam

Therapeutic area: Infectious diseases (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

PEGylated recombinant factor VIII

Therapeutic area: Haematology-Hemostaseology (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Daclizumab

Therapeutic area: Neurology (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldrich Syndrom Protein gene

Therapeutic area: Haematology-Hemostaseology/Immunology-Rheumatology-Transplantation (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant fusion protein linking human coagulation factor IX with human albumin

Therapeutic area: Haematology-Hemostaseology (updated)
28/07/2014Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 1, Authorised
28/07/2014Application form: Call for expressions of interest for drug safety studies (updated)
28/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Valdoxan, Thymanax,

Agomelatine

Therapeutic area: Psychiatry (updated)
28/07/2014Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 9, Authorised
28/07/2014Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 11, Authorised
28/07/2014Human medicines European public assessment report (EPAR): Avonex,

interferon beta-1a

Revision: 20, Authorised
28/07/2014Human medicines European public assessment report (EPAR): Rebif,

interferon beta-1a

Revision: 28, Authorised
28/07/2014Human medicines European public assessment report (EPAR): Tasmar,

tolcapone

Revision: 18, Authorised
28/07/2014Agenda: Agenda - Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus
28/07/2014Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus, European Medicines Agency, London, UK, From: 28-Oct-2014, To: 29-Oct-2014
28/07/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for requesting exceptions and recording of non-compliance events (updated)
28/07/2014Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand),

oxybutynin

Revision: 12, Authorised
28/07/2014Inventory of herbal substances for assessment (updated)
25/07/2014Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 may 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
25/07/2014European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - Workshop on benefit-risk communication, European Medicines Agency, London, UK, From: 17-Sep-2014, To: 17-Sep-2014
25/07/2014European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 16-Sep-2014, To: 16-Sep-2014
25/07/2014Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 1, Authorised
25/07/2014Timetable: Periodic safety update reports (PSURs) (updated)
25/07/2014Human medicines European public assessment report (EPAR): Intanza,

influenza vaccine (split virion, inactivated)

Revision: 11, Authorised
25/07/2014News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
25/07/2014News and press releases: European Medicines Agency recommends approval of two new treatment options for rare cancers
25/07/2014Pending EC decision: Baraclude,

entecavir

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Xultophy,

insulin degludec / liraglutide

Opinion date: 24-Jul-2014
25/07/2014Overview of invented names reviewed in July 2014 by the Name Review Group (NRG) adopted at the CHMP meeting of 21-24 July 2014
25/07/2014Scientific advice and protocol assistance adopted during the CHMP meeting 21–24 July 2014
25/07/2014Pending EC decision: Imbruvica,

Ibrutinib

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Ecalta,

anidulafungin

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Busulfan Fresenius Kabi,

Busulfan

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Busilvex,

busulfan

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Zydelig,

idelalisib

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Accofil,

Filgrastim

Opinion date: 24-Sep-2014
25/07/2014Pending EC decision: Ozurdex,

dexamethasone

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: RoActemra,

tocilizumab

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Xgeva,

denosumab

Opinion date: 24-Jul-2014
25/07/2014Pending EC decision: Humira,

adalimumab

Opinion date: 24-Jul-2014
25/07/2014Withdrawn application: Neofordex,

dexamethasone

Initial authorisation
25/07/2014Orphan designation:

N-carbamyl-L-glutamic acid

for the: Treatment of N-acetylglutamate synthetase (NAGS) deficiency (updated)
25/07/2014News and press releases: World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines
24/07/2014Human medicines European public assessment report (EPAR): Olanzapine Cipla (previously Olanzapine Neopharma),

olanzapine

Revision: 12, Withdrawn
24/07/2014Herbal Medicinal Products: Matricaria, Matricariae aetheroleum, Matricaria recutita L. (updated)
24/07/2014Herbal Medicinal Products: Matricaria, Matricariae flos, Matricaria recutita L. (updated)
24/07/2014Draft Community herbal monograph on Matricaria recutita L., flos , draft: consultation open
24/07/2014Draft Community herbal monograph on Matricaria recutita L., aetheroleum, draft: consultation open
24/07/2014Herbal Medicinal Products: Juniperus, Juniperi summitates, Juniperus communis L.
24/07/2014Herbal Medicinal Products: Gentiana , Gentianae radix, Gentiana lutea L. (updated)
24/07/2014Herbal Medicinal Products: Equisetum, Equiseti herba, Equisetum arvense L. (updated)
24/07/2014Recommendations on minor-use-minor-species and limited-market classifications (updated)
24/07/2014Herbal Medicinal Products: Curcuma, Curcumae longae rhizoma, Curcuma longa L. (updated)
24/07/2014Herbal Medicinal Products: Centaurium, Centaurii herba, Centaurium erythraea Rafn (updated)
24/07/2014Call for scientific data for use in HMPC assessment work on Juniperus communis L., summitates, draft: consultation open
24/07/2014Call for scientific data for use in HMPC assessment work on Equisetum arvense L., herba, draft: consultation open
24/07/2014Call for scientific data for use in HMPC assessment work on Curcuma longa L., rhizoma, draft: consultation open
24/07/2014Call for scientific data for use in HMPC assessment work on Artemisia absinthium L., herba, draft: consultation open
24/07/2014Call for scientific data for use in HMPC assessment work on Centaurium erythraea Rafn, herba, draft: consultation open
24/07/2014Call for scientific data for use in HMPC assessment work on Gentiana lutea L., radix, draft: consultation open
24/07/2014Pharmacovigilance legislation (updated)
24/07/2014News and press releases: European Medicines Agency launches public consultation on rules of procedures for public hearings
24/07/2014Implementation of the pharmacovigilance legislation (updated)
24/07/2014Regulatory and procedural guideline: Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC), draft: consultation open
24/07/2014Submission of comments on 'Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)' (EMA/624809/2013)
24/07/2014News and press releases: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
24/07/2014Referral: Article 31 referrals, Emergency contraceptives,

evonorgestrel, ulipristal acetate

24/07/2014News and press releases: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
24/07/2014Referral: Article 107i procedures, Methadone medicinal products for oral use containing povidone (updated)
24/07/2014Formatted table template to be inserted in each procedural submission cover letter (updated)
24/07/2014Herbal Medicinal Products: Artemisia, Absinthii herba, Artemisia absinthium L. (updated)
23/07/2014Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 9, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Ristaben,

sitagliptin

Revision: 9, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Tolura,

telmisartan

Revision: 4, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma,

telmisartan

Revision: 2, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Telmisartan Teva,

telmisartan

Revision: 4, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Telmisartan Actavis,

telmisartan

Revision: 4, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Tesavel,

sitagliptin

Revision: 13, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Conbriza,

bazedoxifene

Revision: 7, Authorised
23/07/2014Scientific guideline: Combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
23/07/2014Agenda: Agenda - CHMP agenda of the 21-24 July 2014 meeting (updated)
23/07/2014Human medicines European public assessment report (EPAR): Forsteo,

teriparatide

Revision: 15, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Januvia,

sitagliptin

Revision: 15, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Xelevia,

sitagliptin

Revision: 16, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 14, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Velmetia,

sitagliptin / metformin

Revision: 15, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Tolucombi,

telmisartan / hydrochlorothiazide

Revision: 1, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Actelsar HCT,

telmisartan / hydrochlorothiazide

Revision: 1, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 14, Authorised
23/07/2014Veterinary medicine European public assessment report (EPAR): Melosus,

meloxicam

Revision: 4, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane),

para-aminosalicylic acid

Revision: 1, Authorised
23/07/2014Scientific guideline: Combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
23/07/2014Scientific guideline: List of changes to combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2014, adopted (updated)
23/07/2014Overview of comments received on guideline on the demonstration of palatability of veterinary medicinal products
23/07/2014Scientific guideline: Concept paper on use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal health, draft: consultation open
23/07/2014Scientific guideline: Guideline on the demonstration of palatability of veterinary medicinal products, adopted
23/07/2014Call for comments on standard lists for EudraVigilance Veterinary (updated)
23/07/2014Guidance notes on the use of Veterinary Dictionary for Drug Related Affairs terminology for reporting suspected adverse reactions in animals and humans (updated)
23/07/2014Veterinary medicine European public assessment report (EPAR): Cerenia,

maropitant citrate

Revision: 13, Authorised
23/07/2014News and press releases: Regulatory information – new formatted table template to be used in selected veterinary procedural submission cover letters
23/07/2014Formatted table template to be inserted in application submission cover letters for veterinary procedures
23/07/2014Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 7, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 7, Authorised
23/07/2014Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 29, Authorised
22/07/2014Acronyms and abbreviations used in PRAC minutes (updated)
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant human beta-glucuronidase (rhGUS, UX003)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Freeze-dried culture of Lactobacillus casei subspecies rhamnosus Döderleini (Lcr35)

Therapeutic area:
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Amoxicillin (in combination with clarithromycin + metronidazole + pantoprazole)

Therapeutic area: Infectious diseases/Gastroentology-Hepatology
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(11beta,17beta)-17-hydroxy-11-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Lesinurad

Therapeutic area: Immunology-Rheumatology-Transplantation
22/07/2014Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 17, Authorised
22/07/2014Human medicines European public assessment report (EPAR): Remicade,

infliximab

Revision: 41, Authorised
22/07/2014COMP meeting report on the review of applications for orphan designation: July 2014
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Amlodipine besilate / ramipril

Therapeutic area: Cardiovascular diseases
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Doxylamine (succinate) / pyridoxine (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
22/07/2014Nominations to the European Union Telematics governance bodies (updated)
22/07/2014Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Clarithromycin (in combination with amoxicillin + metronidazole + pantoprazole)

Therapeutic area: Infectious diseases/Gastroentology-Hepatology
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Metronidazole (in combination with amoxicillin + clarithromycin + pantoprazole)

Therapeutic area: Infectious diseases/Gastroentology-Hepatology
22/07/2014Herbal Medicinal Products: Arnica, Arnicae flos, Arnica montana L. (updated)
22/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Pantoprazole (in combination with amoxicillin + clarithromycin + metronidazole)

Therapeutic area: Infectious diseases/Gastroentology-Hepatology
21/07/2014Withdrawn application: Aivlosin,

tylvalosin

Post-authorisation
21/07/2014Minutes of the PRAC meeting 10-13 June 2014
18/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

5-(4,6-dimethyl-1H-benzimidazol-2-yl)-4-methyl-N-[3-(1-methyl-4-piperidinyl)propyl]-2-pyrimidinamine 2,3-dihydroxybutanedioate hydrate (1:0.5:4) (JNJ-38518168)

Therapeutic area: Immunology-Rheumatology-Transplantation
18/07/2014Scientific guideline: Concept paper on transferring quality control methods validated in collaborative trials to a product/laboratory specific context, draft: consultation open
18/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Adeno-associated viral vector serotype 9 containing human sulfamidase gene

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
18/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Gevokizumab

Therapeutic area: Ophthalmology
18/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Anamorelin (hydrochloride)

Therapeutic area: Other
18/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Blinatumomab

Therapeutic area: Oncology
17/07/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
17/07/2014Agenda: Agenda - PDCO agenda of the 16-18 July 2014 meeting
17/07/2014Human medicines European public assessment report (EPAR): Xyrem,

sodium oxybate

Revision: 20, Authorised
17/07/2014Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 16, Authorised
17/07/2014CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2014 meeting
16/07/2014Human medicines European public assessment report (EPAR): Carbaglu,

carglumic acid

Revision: 10, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Fertavid,

follitropin beta

Revision: 6, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Zeffix,

lamivudine

Revision: 16, Authorised
16/07/2014Veterinary medicine European public assessment report (EPAR): Bovilis BTV8,

bluetongue virus serotype 8

Revision: 3, Authorised
16/07/2014Scientific guideline: Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation, adopted
16/07/2014Scientific guideline: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients, draft: consultation open
16/07/2014Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 3, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 3, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 6, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Copalia HCT,

amlodipine / valsartan / hydrochlorothiazide

Revision: 6, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Exforge HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 6, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Valdoxan,

agomelatine

Revision: 12, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 10, Authorised
16/07/2014Orphan designation:

Recombinant human alpha-1-microglobulin

for the: Treatment of pre eclampsia
16/07/2014Orphan designation:

Norursodeoxycholic acid

for the: Treatment of primary sclerosing cholangitis
16/07/2014Human medicines European public assessment report (EPAR): Protelos,

strontium ranelate

Revision: 16, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Osseor,

strontium ranelate

Revision: 16, Authorised
16/07/2014Human medicines European public assessment report (EPAR): Ammonaps,

sodium phenylbutyrate

Revision: 13, Authorised
16/07/2014Orphan designation:

Mixture of two adeno-associated viral vectors serotype 8 containing the 5’-half sequence of human MYO7A gene and the 3’-half sequence of human MYO7A gene

for the: Treatment of Usher syndrome
16/07/2014Orphan designation:

Mixture of two adeno-associated viral vectors of serotye 8 containing the 5’-half sequence of human ABCA4 gene and the 3’-half sequence of human ABCA4 gene

for the: Treatment of Stargardt's disease
16/07/2014Orphan designation:

Isavuconazonium sulfate

for the: Treatment of invasive aspergillosis
16/07/2014News and press releases: European Medicines Agency recommends 14 medicines for use in animals in first half of 2014
16/07/2014Orphan designation:

Humanised Fc engineered monoclonal antibody against CD19

for the: Treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma
16/07/2014CVMP opinion trends - first half of 2014
15/07/2014Orphan designation:

Beloranib

for the: Treatment of Prader-Willi syndrome
15/07/2014Orphan designation:

Afamelanotide

for the: Treatment of familial benign chronic pemphigus (Hailey-Hailey disease)
15/07/2014Orphan designation:

Adeno-associated viral vector serotype 2 containing the human REP1 gene

for the: Treatment of choroideraemia
15/07/2014Orphan designation:

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

for the: Treatment of cystic fibrosis
15/07/2014Withdrawn application: Simponi,

golimumab

Post-authorisation
15/07/2014Human medicines European public assessment report (EPAR): Vipidia,

alogliptin benzoate

Revision: 1, Authorised
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Pegasys,

Peginterferon alfa-2a

Therapeutic area: Infectious diseases (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Trajenta,

Linagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Mepolizumab

Therapeutic area: Pneumology-allergology (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant human monoclonal antibody to human interleukin-17A of the IgG1/kappa-class (AIN457)

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Isentress,

Raltegravir

Therapeutic area: Infectious diseases (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Lubiprostone

Therapeutic area: Gastroentology-Hepatology (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Fycompa,

Perampanel

Therapeutic area: Neurology (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Ruconest,

Conestat alfa

Therapeutic area: Other (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Fibrinogen (human plasma-derived)

Therapeutic area: Haematology-Hemostaseology (updated)
15/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Humira,

Adalimumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Gastroentology-Hepatology (updated)
15/07/2014Human medicines European public assessment report (EPAR): Vipdomet,

alogliptin / metformin

Revision: 1, Authorised
15/07/2014Human medicines European public assessment report (EPAR): Prevenar,

pneumococcal saccharide conjugated vaccine, adsorbed

Revision: 20, Authorised
15/07/2014Herbal Medicinal Products: Myroxylon balsamum, Balsamum peruvianum, Myroxylon balsamum (L.) Harms var. perierae (Royle) Harms
14/07/2014Human medicines European public assessment report (EPAR): NexoBrid,

concentrate of proteolytic enzymes enriched in bromelain

Revision: 3, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 17, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Relistor,

methylnaltrexone bromide

Revision: 9, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Omnitrope,

somatropin

Revision: 9, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Byetta,

exenatide

Revision: 13, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Glustin,

pioglitazone

Revision: 22, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group),

pioglitazone

Revision: 3, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Actos,

pioglitazone

Revision: 22, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 4, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Ibandronic Acid Teva,

ibandronic acid

Revision: 2, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 1, Authorised
14/07/2014Human medicines European public assessment report (EPAR): Incresync,

alogliptin / pioglitazone

Revision: 1, Authorised
14/07/2014Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification - Step 5, adopted
14/07/2014Human medicines European public assessment report (EPAR): Pioglitazone Accord,

pioglitazone

Revision: 1, Authorised
14/07/2014Orphan designation:

Temocillin sodium

for the: Treatment of Burkholderia cepacia lung infection in cystic fibrosis (updated)
14/07/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ocrelizumab

Therapeutic area: Neurology (updated)
14/07/2014Human medicines European public assessment report (EPAR): Paglitaz,

pioglitazone

Revision: 1, Authorised
14/07/2014Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units – general chapter - Step 4, adopted (updated)
14/07/2014Orphan designation:

Recombinant human N-acetylgalactosamine-6-sulfatase

for the: Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome) (updated)
14/07/2014Human medicines European public assessment report (EPAR): Pioglitazone Krka,

pioglitazone

Revision: 1, Authorised
14/07/2014Regulatory and procedural guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S10 on photosafety evaluation of pharmaceuticals - Step 5, adopted (updated)
14/07/2014Orphan designation:

Recombinant human interleukin-7

for the: Treatment of progressive multifocal leukoencephalopathy (updated)
14/07/2014HMPC meeting report on Community herbal monographs, guidelines and other activities - 30 June - 1 July 2014
14/07/2014Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 1, Authorised
14/07/2014Report: Medicinal products for human use: Monthly figures - June 2014
14/07/2014News and press releases: Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies
14/07/2014Referral: Article 31 referrals, Renin-angiotensin-system (RAS)-acting agents,

captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril

(updated)
14/07/2014Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
14/07/2014Scientific guideline: ICH guideline M5 on data elements and standards for drug dictionaries, draft: consultation closed (updated)
11/07/2014Orphan designation:

Nitisinone

for the: Treatment of alkaptonuria (updated)
11/07/2014Orphan designation:

Methotrexate (oral liquid)

for the: Treatment of acute lymphoblastic leukaemia (updated)
11/07/2014Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 8, Authorised
11/07/2014Referral: Article 20 procedures, Iclusig,

ponatinib

(updated)
11/07/2014Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

(updated)
11/07/2014Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproic acid, valproate semisodium, valpromide

(updated)
11/07/2014Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 10, Authorised
11/07/2014Orphan designation:

Filgrastim

for the: Treatment of amyotrophic lateral sclerosis (updated)
11/07/2014Human medicines European public assessment report (EPAR): Arixtra,

fondaparinux sodium

Revision: 23, Authorised
11/07/2014Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 11, Authorised
11/07/2014Orphan designation:

Chlormethine

for the: Treatment of cutaneous T-cell lymphoma (updated)
11/07/2014Human medicines European public assessment report (EPAR): Angiox,

bivalirudin

Revision: 17, Authorised
11/07/2014Orphan designation:

Chimeric anti-interleukin-6 monoclonal antibody

for the: Treatment of Castleman's disease (updated)
11/07/2014Human medicines European public assessment report (EPAR): Brilique,

ticagrelor

Revision: 5, Authorised
11/07/2014Public statement: Public statement on Preotact: Withdrawal of the marketing authorisation in the European Union
11/07/2014Minutes of the CVMP meeting of 3-5 June 2014
11/07/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 July 2014
11/07/2014Pending EC decision: Nobilis IB Primo QX,

live avian infectious bronchitis virus strain D388

Opinion date: 10-Jul-2014
11/07/2014MRL pending EC decision: Tylvalosin - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014MRL pending EC decision: Tulathromycin - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014MRL pending EC decision: Doxycycline - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014MRL pending EC decision: Methylprednisolone - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014MRL pending EC decision: Hexaflumuron - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014MRL pending EC decision: Gamithromycin - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/07/2014Minutes of the HMPC 5-6 May 2014 meeting
11/07/2014Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 5, Authorised
11/07/2014Human medicines European public assessment report (EPAR): Ibandronic acid Accord,

ibandronic acid

Revision: 1, Authorised
11/07/2014Report: Workshop report - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates (factor VIII and factor IX) with respect to potency assays used for labelling and testing of post-infusion samples
11/07/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2014
11/07/2014Referral: Article 31 referrals, Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum,

bromocriptine

(updated)
11/07/2014Human medicines European public assessment report (EPAR): Imprida,

amlodipine / valsartan

Revision: 15, Authorised
11/07/2014Minutes of the European Medicines Agency and EUnetHTA meeting - May 2014 (updated)
11/07/2014Human medicines European public assessment report (EPAR): Ibandronic Acid Sandoz,

ibandronic acid

Revision: 1, Authorised
11/07/2014Report: EBV-specific T cells in suspension in human albumin
11/07/2014Report: Viral solution for injection of HSV-1 derived oncolytic virus
11/07/2014Report: Viable autologous adipose tissue-derived mesenchymal stem cells
11/07/2014Report: Autologous antigen-specific regulatory T lymphocytes suspended in a cryopreservation medium
11/07/2014Orphan designation:

Carfilzomib

for the: Treatment of multiple myeloma (updated)
11/07/2014Human medicines European public assessment report (EPAR): Mimpara,

cinacalcet

Revision: 13, Authorised
11/07/2014Orphan designation:

Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene

for the: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency (updated)
10/07/2014Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 15, Authorised
10/07/2014Human medicines European public assessment report (EPAR): Iasibon,

ibandronic acid

Revision: 2, Authorised
10/07/2014Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 14, Authorised
10/07/2014Orphan designation:

Ambrisentan

for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (updated)
10/07/2014Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 15, Authorised
10/07/2014Withdrawn application: Ditelos,

strontium ranelate / colecalciferol

Initial authorisation (updated)
10/07/2014Withdrawn application: Issarlos,

strontium ranelate / colecalciferol

Initial authorisation (updated)
10/07/2014Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 3, Authorised
10/07/2014Orphan designation:

4-(4-methoxy-phenylamino)-6-Methylcarbamyl-quinoline-3-carboxylic acid

for the: Prevention of scarring post glaucoma filtration surgery
10/07/2014Orphan designation:

Autologous dendritic cells pulsed with RNA from glioma stem cells

for the: Treatment of glioma
10/07/2014Orphan designation:

Lutetium (177Lu) edotreotide

for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours
10/07/2014Orphan designation:

Adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1

for the: Treatment of choroideraemia
10/07/2014Orphan designation:

Plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a non-viral, cationic lipid based gene transfer agent

for the: Treatment of cystic fibrosis
10/07/2014Orphan designation:

177Lu-tetraxetan-tetulomab

for the: Treatment of follicular lymphoma
10/07/2014Orphan designation:

Recombinant human alpha 1 chain homotrimer of type VII collagen

for the: Treatment of epidermolysis bullosa
10/07/2014Orphan designation:

Paclitaxel-succinate-Arg-Arg-Leu-Ser-Tyr-Ser-Arg-Arg-Arg-Phe

for the: Treatment of glioma
10/07/2014Orphan designation:

Aganirsen

for the: Treatment of central retinal vein occlusion
10/07/2014Orphan designation:

(5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one

for the: Treatment of biliary tract cancer
10/07/2014Orphan designation:

Isavuconazonium sulfate

for the: Treatment of mucormycosis
10/07/2014News and press releases: European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014
10/07/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2014
10/07/2014News and press releases: Registration opens for workshop on clinical trial design in neuromyelitis optica to facilitate global medicine development in a rare and serious disease
10/07/2014Human medicines European public assessment report (EPAR): Ovitrelle,

choriogonadotropin alfa

Revision: 16, Authorised
09/07/2014Report: Medicinal products for human use: Monthly figures - May 2014
09/07/2014Veterinary medicine European public assessment report (EPAR): Econor,

valnemulin

Revision: 16, Authorised
09/07/2014News and press releases: Management Board delays formal adoption of EMA publication of clinical trial data policy to October 2014
09/07/2014Publications (updated)
09/07/2014Human medicines European public assessment report (EPAR): Luveris,

lutropin alfa

Revision: 16, Authorised
09/07/2014Detailed 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)
09/07/2014Detailed 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)
09/07/2014European Medicines Agency splitting of the full presentation name of the medicinal product best practice: Procedure and principles to handle product name in the EudraVigilance Medicinal Product Dictionary (XEVMPD) (updated)
09/07/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types (updated)
09/07/2014Electronic submission of Article 57(2) data: questions and answers (updated)
09/07/2014Human medicines European public assessment report (EPAR): Mekinist,

trametinib

Revision: 0, Authorised
09/07/2014Regulatory and procedural guideline: Initial notices for parallel distribution – June 2014
09/07/2014Report: Applications for new human medicines under evaluation by the CHMP: July 2014
09/07/2014Orphan designation:

Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene

for the: Treatment of mucopolysaccharidosis IIIA (Sanfilippo A syndrome)
09/07/2014CHMP opinion trends - first half of 2014
09/07/2014Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 33, Authorised
09/07/2014Mandate and objectives for the EMA Working Party on Quality Review of Documents (QRD)
08/07/2014Presubmission guidance: questions 1 to 10 (updated)
08/07/2014Mandate, objectives and rules of procedure for the Name Review Group (NRG)
08/07/2014Explanatory note - Letter of representation for referral procedure under Article 107i of Directive 2001/83/EC (updated)
08/07/2014Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC (updated)
08/07/2014Newsletter: Human medicines highlights - June 2014
08/07/2014Reinforcing communication with patients and healthcare professionals, Belgrade, Serbia, From: 23-Jun-2014, To: 23-Jun-2014 (updated)
08/07/2014Agenda: Agenda - CVMP agenda of the 8-10 July 2014 meeting
07/07/2014Agenda: Agenda - PRAC draft agenda of meeting 7-10 July 2014
07/07/2014Workshop on risk based quality management in clinical trials 2-3 December 2013: Summaries of the presentations
07/07/2014Agenda: Agenda - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders
07/07/2014Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders, European Medicines Agency, London, UK, From: 10-Oct-2014, To: 10-Oct-2014
07/07/2014Registration form - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders
07/07/2014Ombrabulin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
07/07/2014Coordinating group of European network of paediatric research at the European Medicines Agency (updated)
07/07/2014Sixth annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 26-Jun-2014, To: 27-Jun-2014 (updated)
04/07/2014Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 12, Authorised
04/07/2014Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 17, Authorised
04/07/2014Shortages catalogue (updated)
04/07/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for identification of vendor late payments and processing of accrued default interest
03/07/2014Agenda: Agenda - COMP agenda of the 8-10 July 2014 meeting
03/07/2014Transfer of marketing authorisation: questions and answers (updated)
03/07/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
03/07/2014Human medicines European public assessment report (EPAR): HBVaxPro,

hepatitis-B vaccine (rDNA)

Revision: 17, Authorised
03/07/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
03/07/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
03/07/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
03/07/2014Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live, oral

Revision: 17, Authorised
03/07/2014How to submit a scientific advice or protocol assistance request (updated)
03/07/2014Human medicines European public assessment report (EPAR): Clopidogrel Krka,

clopidogrel

Revision: 6, Authorised
02/07/2014Removal of an orphan designation
02/07/2014Application form for orphan-medicinal-product designation (updated)
02/07/2014Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
02/07/2014Human medicines European public assessment report (EPAR): Ipreziv,

azilsartan medoxomil

Revision: 2, Authorised
02/07/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for handling invoice payment within deadline of 30 days (rapporteurs' and inspectors' payments) (updated)
02/07/2014Human medicines European public assessment report (EPAR): NovoNorm,

repaglinide

Revision: 12, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Incivo,

telaprevir

Revision: 14, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 8, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Vectibix,

panitumumab

Revision: 18, Authorised
02/07/2014Human medicines European public assessment report (EPAR): NovoSeven,

eptacog alfa (activated)

Revision: 29, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 15, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Edarbi,

azilsartan medoxomil

Revision: 2, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Starlix,

nateglinide

Revision: 10, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.,

clopidogrel

Revision: 3, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Bondronat,

ibandronic acid

Revision: 20, Authorised
02/07/2014Human medicines European public assessment report (EPAR): Preotact,

parathyroid hormone (rDNA)

Revision: 4, Withdrawn
02/07/2014Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 9, Authorised
01/07/2014Withdrawn application: Protelos,

strontium ranelate

Post-authorisation (updated)
01/07/2014Withdrawn application: Osseor,

strontium ranelate

Post-authorisation (updated)
01/07/2014Human medicines European public assessment report (EPAR): M-M-RVAXPRO,

measles, mumps and rubella vaccine (live)

Revision: 12, Authorised
01/07/2014Human medicines European public assessment report (EPAR): NovoMix,

insulin aspart

Revision: 22, Authorised
01/07/2014Guidelines and concept papers adopted during the CHMP meeting 23-26 June 2014
01/07/2014Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 23-26 June 2014
01/07/2014Opinions on safety variations/periodic safety update reports adopted during the CHMP meeting 23-26 June 2014
01/07/2014Organisational matters - CHMP meeting 23-26 June 2014
01/07/2014Minutes of the CAT meeting 15-16 May 2014
01/07/2014Minutes of the CHMP meeting 19–22 May 2014
01/07/2014Human medicines European public assessment report (EPAR): Grepid,

clopidogrel

Revision: 10, Authorised
01/07/2014Human medicines European public assessment report (EPAR): Zylagren,

clopidogrel

Revision: 5, Authorised
01/07/2014Human medicines European public assessment report (EPAR): Zyllt,

clopidogrel

Revision: 5, Authorised
01/07/2014Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 9, Authorised
01/07/2014Human medicines European public assessment report (EPAR): Pramipexole Accord,

pramipexole

Revision: 2, Authorised
01/07/2014Report: Report on budgetary and financial management: Financial year 2013
01/07/2014Report: Annual accounts: Financial year 2013
01/07/2014Report: European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2012
01/07/2014PRAC recommendations on signals adopted at the PRAC meeting of 10-13 June 2014
01/07/2014Appendix V - Adverse-drug-reaction reporting details (updated)
01/07/2014National competent authorities (veterinary) (updated)
01/07/2014National competent authorities (human) (updated)
01/07/2014Office move: 1 August 2014
01/07/2014Scientific guideline: Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency, draft: consultation open
01/07/2014Agenda: Agenda - HMPC agenda of the 30 June - 1 July 2014 meeting