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August 2014

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Date Content
21/08/2014News and press releases: European Medicines Agency closed 25 August 2014
21/08/2014Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 3, Authorised
21/08/2014Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 8, Authorised
21/08/2014Agenda: Agenda - COMP agenda of the 2-4 September 2014 meeting
21/08/2014PDCO monthly report of opinions on paediatric investigation plans and other activities 13-15 August 2014
21/08/2014Referral: Article 31 referrals, Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum,

bromocriptine

(updated)
21/08/2014News and press releases: CMDh endorses restricted use of bromocriptine for stopping breast milk production
20/08/2014Report: Medicinal products for human use: Monthly figures - July 2014
20/08/2014Draft template for the qualified person’s declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain 'the QP declaration template'
20/08/2014Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation' (updated)
20/08/2014Lamivudine / Zidovudine ViiV H-W-672-WS-544 (updated)
20/08/2014Human medicines European public assessment report (EPAR): Cholestagel,

colesevelam

Revision: 15, Authorised
20/08/2014Human medicines European public assessment report (EPAR): Gazyvaro,

obinutuzumab

Revision: 0, Authorised
19/08/2014Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 4, Authorised
19/08/2014Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 8, Authorised
19/08/2014Human medicines European public assessment report (EPAR): HBVaxPro,

hepatitis-B vaccine (rDNA)

Revision: 18, Authorised
19/08/2014Human medicines European public assessment report (EPAR): Rilutek,

riluzole

Revision: 19, Authorised
19/08/2014Human medicines European public assessment report (EPAR): Riluzole Zentiva,

riluzole

Revision: 3, Authorised
19/08/2014Regulatory and procedural guideline: Labelling-exemption requests under Article 63 of Directive 2001/83/EC examined by the Quality Review of Documents group
19/08/2014List of details of national competent authority to contact for requests of translation exemption falling under Article 63(3) of Directive 2001/83/EC and cases of shortages
19/08/2014Product-information templates (updated)
19/08/2014Exemptions to labelling and package-leaflet obligations
19/08/2014Regulatory and procedural guideline: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure
19/08/2014Publications (updated)
18/08/2014Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene),

pomalidomide

Revision: 2, Authorised
18/08/2014Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 9, Authorised
18/08/2014Notices of calls for tender - 2014 (updated)
18/08/2014Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 18, Authorised
18/08/2014Human medicines European public assessment report (EPAR): Remsima,

infliximab

Revision: 3, Authorised
18/08/2014MRL report: Cabergoline (bovine): European public maximum-residue-limit assessment report (EPMAR) - CVMP
18/08/2014MRL report: Clorsulon (bovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP
18/08/2014MRL report: Triclabendazole (all ruminants milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP
18/08/2014MRL report: Rafoxanide (bovine and ovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP
18/08/2014MRL report: Closantel (bovine and ovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP
15/08/2014Human medicines European public assessment report (EPAR): Xeristar,

duloxetine

Revision: 22, Authorised
15/08/2014Human medicines European public assessment report (EPAR): Cymbalta,

duloxetine

Revision: 21, Authorised
15/08/2014Veterinary medicine European public assessment report (EPAR): Osurnia,

terbinafine / florfenicol / betamethasone

Revision: 0, Authorised
15/08/2014Human medicines European public assessment report (EPAR): Leflunomide Winthrop,

leflunomide

Revision: 7, Authorised
15/08/2014Human medicines European public assessment report (EPAR): Arava,

leflunomide

Revision: 27, Authorised
15/08/2014Minutes - PDCO minutes of the 16-18 July 2014 meeting
15/08/2014Human medicines European public assessment report (EPAR): Olazax Disperzi,

olanzapine

Revision: 6, Authorised
15/08/2014Human medicines European public assessment report (EPAR): Visudyne,

verteporfin

Revision: 25, Authorised
15/08/2014Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 37, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 3, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Inlyta,

axitinib

Revision: 4, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Levetiracetam Teva,

levetiracetam

Revision: 7, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 27, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Sylvant,

siltuximab

Revision: 1, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 1, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 1, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 23, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Yttriga,

yttrium [90Y] chloride

Revision: 9, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 36, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 1, Authorised
14/08/2014Periodic safety update reports: questions and answers (updated)
14/08/2014Minutes of the COMP meeting 13-14 May 2014
14/08/2014Minutes of the COMP meeting 10-12 June 2014
14/08/2014Referral: Article 33, Fiprex,

fipronil

14/08/2014Withdrawn application: Folcepri,

etarfolatide

Initial authorisation (updated)
14/08/2014Withdrawn application: Neocepri,

folic acid

Initial authorisation (updated)
14/08/2014Withdrawn application: Vynfinit,

vintafolide

Initial authorisation (updated)
14/08/2014Human medicines European public assessment report (EPAR): Myclausen,

mycophenolate mofetil

Revision: 4, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Erbitux,

cetuximab

Revision: 23, Authorised
14/08/2014Referral: Article 13, Vasotop P,

ramipril

14/08/2014Human medicines European public assessment report (EPAR): Gardasil,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 26, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Silgard,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 24, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Kalydeco,

ivacaftor

Revision: 3, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 1, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Vizarsin,

sildenafil

Revision: 10, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Vaniqa,

eflornithine

Revision: 19, Authorised
14/08/2014Human medicines European public assessment report (EPAR): Inductos,

dibotermin alfa

Revision: 16, Authorised
14/08/2014Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise (updated)
14/08/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
14/08/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
13/08/2014Presubmission guidance: questions 21 to 30 (updated)
13/08/2014Presubmission guidance: questions 1 to 10 (updated)
13/08/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
13/08/2014Presubmission guidance: questions 41 to 50 (updated)
13/08/2014Presubmission guidance: questions 31 to 40 (updated)
13/08/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
13/08/2014Questions and answers on quality of herbal medicinal products / traditional herbal medicinal products (updated)
13/08/2014Agenda: Agenda - PDCO agenda of the 13-15 August 2014 meeting (updated)
13/08/2014Human medicines European public assessment report (EPAR): Tovanor Breezhaler,

glycopyrronium bromide

Revision: 4, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Ultibro Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 1, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Sildenafil ratiopharm,

sildenafil

Revision: 12, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Nuedexta,

dextromethorphan hydrobromide / quinidine sulfate

Revision: 1, Authorised
13/08/2014Referral: Article 35, Benzathine benzylpenicillin intended for administration to food producing species,

benzathine benzylpenicillin

13/08/2014Referral: Article 34, Dectomax injectable solution and its associated names,

doramectin

13/08/2014Referral: Article 33, Porcimectin Injection and its associated names,

ivermectin

13/08/2014Referral: Article 33, Bovimectin Injection and its associated names,

ivermectin

13/08/2014Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
13/08/2014Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 13, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 9, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Abilify Maintena,

aripiprazole

Revision: 2, Authorised
13/08/2014Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 1, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Sildenafil Actavis,

sildenafil

Revision: 6, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 8, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 2, Authorised
12/08/2014Type-II variations: questions and answers (updated)
12/08/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
12/08/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
12/08/2014Changing the (invented) name of a centrally authorised medicine: questions and answers (updated)
12/08/2014Renewals: questions and answers (updated)
12/08/2014Annual renewal of conditional marketing authorisations: questions and answers (updated)
12/08/2014Periodic safety update reports (updated)
12/08/2014Article-61(3) notifications: questions and answers (updated)
12/08/2014Other post-authorisation activities: questions and answers (updated)
12/08/2014Marketing and cessation notification: questions and answers (updated)
12/08/2014Withdrawn-product notification: questions and answers (updated)
12/08/2014Worksharing: questions and answers (updated)
12/08/2014Type-II-variation and extension applications: questions and answers (updated)
12/08/2014List of withdrawn medicinal products
12/08/2014Type-IA variations: questions and answers (updated)
12/08/2014Post-authorisation measures: questions and answers (updated)
12/08/2014Type-IB variations: questions and answers (updated)
12/08/2014Transfer of marketing authorisation: questions and answers (updated)
12/08/2014Submission of Article-46 paediatric studies: questions and answers (updated)
12/08/2014Post-authorisation safety studies: questions and answers (updated)
12/08/2014Template to be used to notify the EMA and concerned Member States of "withdrawn products" (updated)
12/08/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of presentation (updated)
12/08/2014Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

Revision: 0, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Leflunomide medac,

leflunomide

Revision: 8, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Bronchitol,

mannitol

Revision: 5, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif),

human normal immunoglobulin

Revision: 9, Authorised
12/08/2014Lamivudine ViiV H-W-673-WS-544 (updated)
12/08/2014Human medicines European public assessment report (EPAR): Cayston,

aztreonam

Revision: 8, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 4, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 9, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Vyndaqel,

tafamidis

Revision: 4, Authorised
12/08/2014Human medicines European public assessment report (EPAR): Epivir,

lamivudine

Revision: 29, Authorised
12/08/2014Referral: Article 13, Cobactan DC and its associated names,

cefquinome

12/08/2014Referral: Article 35, Micotil 300 and its associated names,

tilmicosin

12/08/2014Referral: Article 33, Cobactan IV 4.5% powder and solvent for solution for injection and its associated names,

cefquinome

12/08/2014Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 2, Authorised
11/08/2014Referral: Article 34, Eprinex pour-on and its associated names,

eprinomectin

11/08/2014Referral: Article 33, Orbax,

orbifloxacin

11/08/2014Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4R,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 0, Authorised
11/08/2014Human 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: 19, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Dificlir,

fidaxomicin

Revision: 6, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva,

lamivudine / zidovudine

Revision: 4, Authorised
11/08/2014Regulatory and procedural guideline: Initial notices for parallel distribution – July 2014
11/08/2014Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 4, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Fuzeon,

enfuvirtide

Revision: 16, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 22, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Betaferon,

interferon beta-1b

Revision: 24, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Zyprexa,

olanzapine

Revision: 32, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 1, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 17, Authorised
11/08/2014Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 1, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 3, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Extavia,

interferon beta-1b

Revision: 13, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Efavirenz Teva,

efavirenz

Revision: 3, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 3, Authorised
08/08/2014Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus,

indoxacarb / permethrin

Revision: 2, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 18, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Zerit,

stavudine

Revision: 26, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Optaflu,

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

Revision: 9, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 19, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Baraclude,

entecavir

Revision: 18, Authorised
08/08/2014List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
08/08/2014Regulatory and procedural guideline: National-competent-authority and European Medicines Agency requirements for submission of periodic safety update reports during the transitional period (updated)
08/08/2014Human medicines European public assessment report (EPAR): Zypadhera,

olanzapine

Revision: 11, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Pandemrix,

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

Revision: 16, Authorised
08/08/2014Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 15, Authorised
08/08/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2014 (updated)
07/08/2014Minutes of the CHMP meeting 23-26 June 2014
07/08/2014Newsletter: Human medicines highlights - July 2014
07/08/2014Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD),

caspofungin

Revision: 16, Authorised
07/08/2014Human medicines European public assessment report (EPAR): Aptivus,

tipranavir

Revision: 30, Authorised
07/08/2014Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 16, Authorised
07/08/2014Human Medicines Research and Development Support (updated)
07/08/2014Inspections and Human Medicines Pharmacovigilance (updated)
07/08/2014Information Technology (updated)
07/08/2014Advisory functions, Corporate Governance and Programme Management Office (updated)
07/08/2014Veterinary medicine European public assessment report (EPAR): Suvaxyn PCV,

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

Revision: 7, Authorised
07/08/2014Veterinary medicine European public assessment report (EPAR): Zactran,

gamithromycin

Revision: 7, Authorised
07/08/2014Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 6, Authorised
07/08/2014Human medicines European public assessment report (EPAR): Bexsero,

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

Revision: 3, Authorised
07/08/2014Herbal Medicinal Products: Humulus, Lupuli flos, Humulus lupulus L. (updated)
07/08/2014News and press releases: Europe to boost cooperation with international partners on generics
06/08/2014Human medicines European public assessment report (EPAR): Foclivia,

pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Revision: 2, Authorised
06/08/2014Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure (updated)
06/08/2014Annual report of the Pharmacovigilance Inspectors Working Group for 2013
06/08/2014Referral: Article 31 referrals, Emergency contraceptives,

evonorgestrel, ulipristal acetate

(updated)
06/08/2014Referral: Article 31 referrals, Caustinerf arsenical and Yranicid arsenical,

ephedrine hydrochloride, lidocaine and arsenous anhydride

(updated)
06/08/2014Herbal Medicinal Products: Fucus, Fucus vesiculosus, thallus, Fucus vesiculosus L. (updated)
06/08/2014Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 7, Authorised
06/08/2014Human medicines European public assessment report (EPAR): Diacomit,

stiripentol

Revision: 14, Authorised
06/08/2014Newsletter: News bulletin for pharmacovigilance programme update - Issue 1
06/08/2014National experts on secondment application form
06/08/2014Human medicines European public assessment report (EPAR): Lonquex,

lipegfilgrastim

Revision: 2, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 8, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 23, Authorised
05/08/2014Formatted table template to be inserted in application submission cover letters for veterinary procedures (updated)
05/08/2014Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 2, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Firmagon,

degarelix

Revision: 10, Authorised
05/08/2014Veterinary medicine European public assessment report (EPAR): Palladia,

toceranib

Revision: 5, Authorised
05/08/2014Attachment 2 for change of scientific opinion holder
05/08/2014Attachment 1 for change of scientific opinion holder
05/08/2014Cover letter for change of scientific opinion holder
05/08/2014Explanatory note - Letter of representation for referral procedure under Article 107i of Directive 2001/83/EC (updated)
05/08/2014Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC
05/08/2014Human medicines European public assessment report (EPAR): Rivastigmine Sandoz,

rivastigmine

Revision: 7, Authorised
05/08/2014Referral: Article 33, Avinew,

live Newcastle disease virus, VG/GA strain

05/08/2014Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 9, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Temomedac,

temozolomide

Revision: 7, Authorised
05/08/2014Referral: Article 78, Bayovac IBR Marker Vivum,

bovine Herpes Virus type 1 (BHV-1), strain Difivac (IBR-Marker Virus, gE-negative), modified live (attenuated) virus

05/08/2014Human medicines European public assessment report (EPAR): Temozolomide Sun,

temozolomide

Revision: 5, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 7, Authorised
05/08/2014Veterinary medicine European public assessment report (EPAR): Poulvac E. coli,

Escherichia coli lyophilisate for suspension for spray vaccination of chickens

Revision: 3, Authorised
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

recombinant human lysosomal acid lipase

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism/Gastroentology-Hepatology (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Sovaldi,

Sofosbuvir

Therapeutic area: Infectious diseases (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Taflotan and associated names,

Tafluprost

Therapeutic area: Ophthalmology (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrate protein

Therapeutic area: Diagnostic (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Insulin peglispro

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/08/2014Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 22, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Suboxone,

buprenorphine / naloxone

Revision: 10, Authorised
05/08/2014Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 8, Authorised
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

asfotase alfa

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ozenoxacin

Therapeutic area: Infectious diseases (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Apremilast

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Januvia,

sitagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Levemir,

Insulin detemir

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/08/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Tobi Podhaler,

Tobramycin

Therapeutic area: Pneumology-allergology/Infectious diseases (updated)
04/08/2014Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 3, Authorised
04/08/2014Human medicines European public assessment report (EPAR): Resolor,

prucalopride

Revision: 14, Authorised
04/08/2014Human medicines European public assessment report (EPAR): Nexium Control,

esomeprazole

Revision: 4, Authorised
04/08/2014Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 28, Authorised
04/08/2014News and press releases: European Medicines Agency consults on updates to its policy on access to EudraVigilance
04/08/2014Draft revision of EudraVigilance access policy for medicines for human use
04/08/2014Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals),

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

Revision: 5, Authorised
04/08/2014Herbal Medicinal Products: Hieracium, Pilosellae herba cum flore, Hieracium pilosella L. (updated)
04/08/2014Draft Community herbal monograph on Hieracium pilosella L., herba, draft: consultation open
04/08/2014Referral: Article 107i procedures, Methadone medicinal products for oral use containing povidone,

methadone

(updated)
04/08/2014Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 35, Authorised
04/08/2014Template for letter from marketing-authorisation holder (MAH) permitting the Agency to send certificates elsewhere than to MAH address, adopted (updated)
04/08/2014Scientific guideline: Concept paper on good genomics biomarker practices, draft: consultation open
04/08/2014Application form for European Medicines Agency certificates of medicinal products (updated)
04/08/2014Human medicines European public assessment report (EPAR): Prepandrix,

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

Revision: 9, Authorised
04/08/2014Referral: Article 31 referrals, Zolpidem-containing medicines,

zolpidem

(updated)
01/08/2014Regulatory and procedural guideline: Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of veterinary medicinal products
01/08/2014Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 15, Authorised
01/08/2014Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 21-24 July 2014 (updated)
01/08/2014Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 12, Authorised
01/08/2014Scientific guideline: Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics, draft: consultation open
01/08/2014Human medicines European public assessment report (EPAR): Rivastigmine Hexal,

rivastigmine

Revision: 7, Authorised
01/08/2014Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 31, Authorised
01/08/2014Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises, adopted (updated)
01/08/2014Human medicines European public assessment report (EPAR): Hexyon,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 2, Authorised
01/08/2014News and press releases: Antimicrobial resistance – European Medicines Agency releases draft advice on the impact on public health and animal health of the use of antibiotics in animals
01/08/2014Answer to the second, third and fourth requests from the European Commission for scientific advice on the impact on public health and animal health of the use of antibiotics in animals
01/08/2014Overview of preliminary comments received on public consultation on the request to the European Medicines Agency from the European Commission for scientific advice on the impact on public health and animal health of the use of antibiotics in animals
01/08/2014Use of antibiotics in animals: impact on public health and animal health
01/08/2014Referral: Article 29 paediatrics, Crestor and associated names,

 rosuvastatin

01/08/2014Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 5, Authorised
01/08/2014Scientific guideline: Concept paper on revision of guideline on epidemiological data on blood-transmissible infections, draft: consultation open
01/08/2014Human medicines European public assessment report (EPAR): Xenical,

orlistat

Revision: 18, Authorised
01/08/2014Plasma Master File (PMF) Epidemiology, European Medicines Agency, London, UK, From: 18-Nov-2014, To: 19-Nov-2014
01/08/2014Human medicines European public assessment report (EPAR): Halaven,

eribulin

Revision: 7, Authorised
01/08/2014Scientific guideline: Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use, draft: consultation open
01/08/2014Human medicines European public assessment report (EPAR): Aerius,

desloratadine

Revision: 30, Authorised
01/08/2014How to find us (updated)
01/08/2014Recruitment at the European Medicines Agency