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May 2013

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Date Content
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

surotomycin

Therapeutic area: Infectious diseases
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

chlormethine

Therapeutic area: Dermatology/Oncology
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

bedaquiline (fumarate)

Therapeutic area: Infectious diseases (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(3aR,4S,7aR)-Octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methyl ester

Therapeutic area: Neurology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Strattera,

atomoxetine (hydrochloride)

Therapeutic area: Psychiatry (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

recombinant l-asparaginase

Therapeutic area: Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

amlodipine (besilate) / losartan (potassium)

Therapeutic area: Cardiovascular diseases
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

voclosporin

Therapeutic area: Opthalmology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

ceftobiprole medocaril (sodium)

Therapeutic area: Infectious diseases (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Vesicare and associated names,

solifenacin (succinate)

Therapeutic area: Uro-nephrology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Procoralan,

ivabradine (hydrochloride)

Therapeutic area: Cardiovascular diseases (updated)
31/05/2013Agenda: Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

bucelipase alfa

Therapeutic area: Gastroentology-Hepatology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

treosulfan

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Constella,

linaclotide

Therapeutic area: Gastroentology-Hepatology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Vesicare and associated names,

solifenacin (succinate)

Therapeutic area: Uro-nephrology
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Pixuvri,

pixantrone (dimaleate)

Therapeutic area: Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Relenza,

zanamivir

Therapeutic area: Infectious diseases
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Abraxane,

paclitaxel

Therapeutic area: Oncology
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

recombinant human lysosomal acid lipase

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism/Gastroentology-Hepatology
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Tasigna,

nilotinib

Therapeutic area: Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Pegasys,

peginterferon alfa-2a

Therapeutic area: Infectious diseases (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

turoctocog alpha

Therapeutic area: Haematology-Hemostaseology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

canagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Victoza,

liraglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Tracleer,

bosentan

Therapeutic area: Cardiovascular diseases/Immunology-Rheumatology-Transplantation/Pneumology-allergology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

epratuzumab

Therapeutic area: Immunology-Rheumatology-Transplantation
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Isentress,

raltegravir

Therapeutic area: Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Gilenya,

fingolimod (hydrochloride)

Therapeutic area: Neurology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Prolia, Xgeva,

denosumab

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; escherichia coli) / Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; escherichia coli) (rLP2086)

Therapeutic area: Vaccines
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

bumetanide

Therapeutic area: Neurology
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Synagis,

palivizumab

Therapeutic area: Neonatology-Paediactric Intensive care
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

ceftazidime / avibactam

Therapeutic area: Infectious diseases
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

rdESAT-6 / rCFP-10

Therapeutic area: Diagnostic (updated)
31/05/2013European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 05-Jun-2013, To: 05-Jun-2013
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Dacogen,

decitabine

Therapeutic area: Oncology (updated)
31/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Corlentor,

ivabradine (hydrochloride)

Therapeutic area: Cardiovascular diseases (updated)
31/05/2013Healthcare Professionals' Working Group (HCPWG), European Medicines Agency, London, UK, From: 27-Feb-2013, To: 27-Feb-2013 (updated)
31/05/2013Patients' and Consumers' Working Party (PCWP) , European Medicines Agency, London, UK, From: 06-Jun-2013, To: 06-Jun-2013
31/05/2013Human medicines European Public Assessment Report (EPAR): Xagrid,

anagrelide

Revision: 19, Authorised
31/05/2013Human medicines European Public Assessment Report (EPAR): Xalkori,

crizotinib

Revision: 2, Authorised
31/05/2013Human medicines European Public Assessment Report (EPAR): Halaven,

eribulin

Revision: 4, Authorised
31/05/2013Agenda: Agenda - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting - June 2013
31/05/2013Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting, European Medicines Agency, London, UK, From: 05-Jun-2013, To: 05-Jun-2013
31/05/2013Agenda: Agenda - COMP agenda of the 11-13 June 2013 meeting
31/05/2013Minutes of the COMP meeting 16-17 April 2013
31/05/2013Regulatory and procedural guideline: National-competent-authority and European Medicines Agency requirements for periodic-safety-update-report submission during the transitional period (updated)
31/05/2013Template for a request for amendments of or addition of active substances or combinations of active substances to the European-Union-reference-date list (updated)
31/05/2013List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
31/05/2013List of European Union reference dates and frequency of submission of periodic safety update reports: Introductory cover note (updated)
31/05/2013CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2013 meeting
31/05/2013News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013
31/05/2013Pending EC decision: Voncento,

human coagulation factor VIII / Von Willebrand factor

Opinion date: 30-May-2013
31/05/2013News and press releases: European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma
31/05/2013Scientific advice and protocol assistance adopted during the CHMP meeting of 27-30 May 2013
31/05/2013Withdrawn application: Belviq,

lorcaserin hydrochloride

Initial authorisation
31/05/2013Outcome of review of new safety data on insulin glargine
31/05/2013Pending EC decision: Atosiban Sun,

atosiban

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Lonquex,

lipegfilgrasim

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Glivec,

imatinib

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Imvanex,

modified Vaccinia Ankara Virus

Opinion date: 30-May-2013
31/05/2013Questions and answers on the outcome of an extension of indication application for Lysodren (mitotane)
31/05/2013Pending EC decision: Somatropin Biopartners,

somatropin

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Lucentis,

ranibizumab

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Tysabri,

natalizumab

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Pomalidomide Celgene,

pomalidomide

Opinion date: 30-May-2013
31/05/2013Pending EC decision: Lojuxta,

lomitapide

Opinion date: 30-May-2013
31/05/2013Referral: Article 30 referrals, Targocid and associated names,

teicoplanin

31/05/2013Withdrawn application: Tysabri,

natalizumab

Post-authorisation
31/05/2013Referral: Article 31 referrals, Almitrine-containing medicines,

almitrine

(updated)
31/05/2013News and press releases: Oral almitrine to be withdrawn by EU Member States
31/05/2013Pending EC decision: Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Opinion date: 30-May-2013
31/05/2013News and press releases: European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy
30/05/2013Human medicines European Public Assessment Report (EPAR): Benlysta,

belimumab

Revision: 6, Authorised
30/05/2013Human medicines European Public Assessment Report (EPAR): Sildenafil ratiopharm,

sildenafil

Revision: 8, Authorised
30/05/2013Human medicines European Public Assessment Report (EPAR): Stocrin,

efavirenz

Revision: 30, Authorised
30/05/2013News and press releases: Guideline on the clinical development of medicines for the treatment of pain released for public consultation
30/05/2013Veterinary medicine European Public Assessment Report (EPAR): TruScient,

dibotermin alfa

Revision: 2, Authorised
30/05/2013Referral: Article 107i procedures, Cyproterone- and ethinylestradiol-containing medicines,

cyproterone / ethinylestradiol

(updated)
30/05/2013News and press releases: European Medicines Agency publishes guideline on clinical investigation of medicines for depression
30/05/2013Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of depression, adopted
30/05/2013News and press releases: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh
30/05/2013Scientific guideline: Draft guideline on the clinical development of medicinal products intended for the treatment of pain, draft: consultation open
30/05/2013Overview of comments received on 'Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk'
30/05/2013Scientific guideline: Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery, adopted
30/05/2013Human medicines European Public Assessment Report (EPAR): Evicel,

human fibrinogen / human thrombin

Revision: 6, Authorised
30/05/2013Start of community reviews - CHMP meeting of 27-30 May 2013
30/05/2013Human medicines European Public Assessment Report (EPAR): Sustiva,

efavirenz

Revision: 33, Authorised
30/05/2013Veterinary medicine European Public Assessment Report (EPAR): Nobivac Piro,

vaccine against babesiosis in dogs

Revision: 4, Withdrawn
29/05/2013Extended EudraVigilance product report message (XEVMPD) substances (updated)
29/05/2013Extended EudraVigilance product report message (XEVMPD) organisations (updated)
29/05/2013Minutes - PDCO minutes of the 10-12 April 2013 meeting
29/05/2013PDCO monthly report of opinions on paediatric investigation plans and other activities 15-17 May 2013
29/05/2013European Medicines Agency Standard Operating Procedure (SOP): Standard operating procedure for evaluation of veterinary medicinal products containing or consisting of genetically modified organisms (updated)
29/05/2013Veterinary medicine European Public Assessment Report (EPAR): Suvaxyn PCV,

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

Revision: 4, Authorised
29/05/2013Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, adopted (updated)
29/05/2013News and press releases: Comments invited on guideline for the demonstration of efficacy for veterinary medicines containing antimicrobials
29/05/2013Scientific guideline: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances, draft: consultation open
28/05/2013Report: Assessment report for Article 5(3) procedure: Octagam and associated names
28/05/2013Veterinary medicine European Public Assessment Report (EPAR): Poulvac E. coli,

Escherichia coli lyophilisate for suspension for spray vaccination of chickens

Revision: 1, Authorised
28/05/2013Veterinary medicine European Public Assessment Report (EPAR): Convenia,

cefovecin

Revision: 7, Authorised
28/05/2013Veterinary medicine European Public Assessment Report (EPAR): Draxxin,

tulathromycin

Revision: 9, Authorised
28/05/2013Regulatory and procedural guideline: Member States' contact points for translation review (updated)
28/05/2013Formatted table template to be inserted in each procedural submission cover letter (updated)
28/05/2013Current tenders for €60,000 or more (updated)
28/05/2013Agenda: Agenda and registration form - First information day on periodic safety update reports – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E2C(R2) periodic benefit-risk evaluation reports, 19 June 2013 (updated)
28/05/2013Veterinary medicine European Public Assessment Report (EPAR): Stronghold,

selamectin

Revision: 18, Authorised
28/05/2013Veterinary medicine European Public Assessment Report (EPAR): Quadrisol,

vedaprofen

Revision: 17, Authorised
27/05/2013Human medicines European Public Assessment Report (EPAR): Integrilin,

eptifibatide

Revision: 17, Authorised
27/05/2013Human medicines European Public Assessment Report (EPAR): Renvela,

sevelamer carbonate

Revision: 5, Authorised
27/05/2013Human medicines European Public Assessment Report (EPAR): Evra,

norelgestromin / ethinyl estradiol

Revision: 14, Authorised
27/05/2013Human medicines European Public Assessment Report (EPAR): Renagel,

sevelamer

Revision: 20, Authorised
27/05/2013Human medicines European Public Assessment Report (EPAR): Hepsera,

adefovir dipivoxil

Revision: 20, Authorised
27/05/2013Policy 56: Support to staff subject to external accusations and attacks
24/05/2013Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting, European Medicines Agency, London, UK, From: 27-Feb-2013, To: 28-Feb-2013 (updated)
24/05/2013Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
24/05/2013Inventory of herbal substances for assessment (updated)
24/05/2013HMPC: Overview of assessment work – priority list (updated)
24/05/2013Regulatory and procedural guideline: Guidance on format of the risk-management plan in the European Union – in integrated format (updated)
24/05/2013Regulatory and procedural guideline: Guidance on format of the risk-management plan in the European Union for generics (updated)
24/05/2013Regulatory and procedural guideline: Guidance on format of the risk-management plan in the European Union part VI: Summary of activities in the risk-management plan by product (updated)
24/05/2013Human medicines European Public Assessment Report (EPAR): Emselex,

darifenacin hydrobromide

Revision: 13, Authorised
24/05/2013MRL report: Monepantel (caprine and ovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP
24/05/2013Questions and answers: Good manufacturing practice (updated)
24/05/2013Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
24/05/2013Report: Medicinal products for human use: Monthly figures - April 2013
24/05/2013COMP meeting report on the review of applications for orphan designation: May 2013
23/05/2013Veterinary medicine European Public Assessment Report (EPAR): Equilis Prequenza Te,

vaccine against equine influenza and tetanus in horses

Revision: 7, Authorised
23/05/2013Veterinary medicine European Public Assessment Report (EPAR): Equilis Prequenza,

vaccine against equine influenza in horses

Revision: 7, Authorised
23/05/2013Human medicines European Public Assessment Report (EPAR): Eliquis,

apixaban

Revision: 2, Authorised
23/05/2013Human medicines European Public Assessment Report (EPAR): Helicobacter Test INFAI,

13C-urea

Revision: 11, Authorised
23/05/2013Human medicines European Public Assessment Report (EPAR): Dificlir,

fidaxomicin

Revision: 3, Authorised
23/05/2013Medication errors (updated)
23/05/2013News and press releases: European Medicines Agency issues six key recommendations to tackle the issue of medication errors
22/05/2013News and press releases: eSubmission Gateway or web client to become mandatory for all eCTD submissions through the centralised procedure in 2014
22/05/2013Report: Hearing with interested parties during Working Party on Community Monographs and Community List July 2006 meeting
22/05/2013Interested parties to the HMPC (updated)
22/05/2013Regulatory questions and answers on herbal medicinal products (updated)
22/05/2013Work instructions on the CHMP Meeting on Organisational Matters table of decisions and minutes, adopted (updated)
22/05/2013Work instructions on the CHMP Meeting on Organisational Matters agenda, adopted (updated)
21/05/2013EU 28: science, medicines, health - a regulatory system fit for the future, Dubrovnik, Croatia, From: 06-May-2013, To: 07-May-2013 (updated)
21/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Allogeneic bone-marrow-derived mesenchymal cells
21/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Alginate-encapsulated porcine pancreatic islet cells
21/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Naturally-occurring allogeneic donor lymphocytes
21/05/2013Human medicines European Public Assessment Report (EPAR): Maruxa,

memantine

Revision: 0, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Prepandrix,

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

Revision: 7, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop),

irbesartan / hydrochlorothiazide

Revision: 16, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Pumarix,

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

Revision: 2, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Soliris,

eculizumab

Revision: 9, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 14, Authorised
21/05/2013Veterinary medicine European Public Assessment Report (EPAR): Cerenia,

maropitant citrate

Revision: 11, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 9, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Karvezide,

irbesartan / hydrochlorothiazide

Revision: 28, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Zometa,

zoledronic acid

Revision: 19, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Competact,

pioglitazone / metformin

Revision: 11, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Irbesartan/Hydrochlorothiazide Teva,

irbesartan / hydrochlorothiazide

Revision: 5, Authorised
21/05/2013Referral: Article 107i procedures, Flupirtine-containing medicines,

flupirtine

(updated)
21/05/2013Referral: Article 31 referrals, Solutions for infusion containing hydroxyethyl starch,

hydroxyethyl starch

(updated)
21/05/2013Human medicines European Public Assessment Report (EPAR): Bydureon,

exenatide

Revision: 1, Authorised
21/05/2013Human medicines European Public Assessment Report (EPAR): Signifor,

pasireotide

Revision: 1, Authorised
17/05/2013News and press releases: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
17/05/2013News and press releases: International Clinical Trials Day: 20 May 2013
17/05/2013Human medicines European Public Assessment Report (EPAR): Lyrica,

pregabalin

Revision: 22, Authorised
17/05/2013Human medicines European Public Assessment Report (EPAR): Neulasta,

pegfilgrastim

Revision: 19, Authorised
17/05/2013Referral: Article 20 procedures, Tredaptive, Pelzont and Trevaclyn,

laropiprant / nicotinic acid

(updated)
17/05/2013Pending EC decision: Aftovaxpur DOE,

one to three inactivated, purified foot-and-mouth-disease viruses out of a set of seven (multistrain)

Opinion date: 16-May-2013
17/05/2013Withdrawal assessment report for Fanaptum, adopted
17/05/2013Pending EC decision: ProZinc,

insulin human

Opinion date: 16-May-2013
17/05/2013News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013
17/05/2013News and press releases: European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level
17/05/2013Referral: 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

17/05/2013Referral: Article 20 procedures, Protelos and Osseor,

strontium ranelate

17/05/2013News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
17/05/2013News and press releases: Benefits of Diane 35 and generics outweigh risks in specific patient group
17/05/2013CVMP monthly report of application procedures, guidelines and related documents: April 2013
17/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine Sandoz,

rivastigmine

Revision: 5, Authorised
17/05/2013Opinion template (annex I and II) (updated)
17/05/2013Human medicines European Public Assessment Report (EPAR): Qutenza,

capsaicin

Revision: 7, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Epivir,

lamivudine

Revision: 27, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Glustin,

pioglitazone

Revision: 20, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 10, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Actos,

pioglitazone

Revision: 20, Authorised
16/05/2013European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
16/05/2013Veterinary medicine European Public Assessment Report (EPAR): RevitaCAM,

meloxicam

Revision: 2, Authorised
16/05/2013Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 3, draft: consultation open (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): Grepid,

clopidogrel

Revision: 8, Authorised
16/05/2013Regulatory and procedural guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – General chapter - Step 4, adopted (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 16, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Trizivir,

abacavir (as sulfate) / lamivudine / zidovudine

Revision: 20, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine Hexal,

rivastigmine

Revision: 5, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Exelon,

rivastigmine

Revision: 27, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Pelzont,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013Human medicines European Public Assessment Report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 17, Authorised
16/05/2013Masivet : EPAR - All Authorised presentations (updated)
16/05/2013Human medicines European Public Assessment Report (EPAR): TachoSil,

human fibrinogen / human thrombin

Revision: 14, Authorised
16/05/2013Human medicines European Public Assessment Report (EPAR): Tredaptive,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013Human medicines European Public Assessment Report (EPAR): Amyvid,

florbetapir (18F)

Revision: 1, Authorised
16/05/2013News and press releases: European Medicines Agency closed 20 May 2013
16/05/2013Human medicines European Public Assessment Report (EPAR): Trevaclyn,

laropiprant / nicotinic acid

Revision: 11, Withdrawn
16/05/2013News and press releases: World Hypertension Day: 17 May 2013
16/05/2013Veterinary medicine European Public Assessment Report (EPAR): Ecoporc Shiga,

genetically modified Shiga-toxin-2e antigen

Revision: 0, Authorised
15/05/2013Draft inventory of paediatric medicines - Infectious diseases
15/05/2013Regulatory and procedural guideline: European Medicines Agency / PDCO standard paediatric investigation plan for allergen products for specific immunotherapy, adopted (updated)
15/05/2013Human medicines European Public Assessment Report (EPAR): Menveo,

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

Revision: 7, Authorised
15/05/2013Human medicines European Public Assessment Report (EPAR): Intelence,

etravirine

Revision: 12, Authorised
15/05/2013Human medicines European Public Assessment Report (EPAR): Vpriv,

velaglucerase alfa

Revision: 4, Authorised
15/05/2013Agenda: Agenda - PDCO agenda of the 15-17 May 2013 meeting
15/05/2013Report: Applications for new human medicines under evaluation by the CHMP: May 2013
14/05/2013Human medicines European Public Assessment Report (EPAR): Ziagen,

abacavir

Revision: 24, Authorised
14/05/2013Agenda: Agenda - PRAC draft agenda of meeting 13-16 May 2013
14/05/2013Human medicines European Public Assessment Report (EPAR): Ecansya (previously Capecitabine Krka),

capecitabine

Revision: 2, Authorised
14/05/2013Orphan designation:

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
14/05/2013Orphan designation:

Nintedanib

for the: Treatment of idiopathic pulmonary fibrosis
14/05/2013Orphan designation:

2-Hydroxypropyl-β-cyclodextrin

for the: Treatment of Niemann-Pick disease type C
14/05/2013Orphan designation:

4-[2-(6-Methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate

for the: Treatment of glioma
14/05/2013Orphan designation:

Lenvatinib

for the: Treatment of follicular thyroid cancer
14/05/2013Orphan designation:

R,S-O-(3-piperidino-2-hydroxy-1-propyl)-nicotinic acid amidoxime dihydrochloride

for the: Treatment of Duchenne muscular dystrophy
14/05/2013Orphan designation:

Lenvatinib

for the: Treatment of papillary thyroid cancer
14/05/2013Withdrawn application: Hyalograft C autograft,

characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffold

Initial authorisation (updated)
14/05/2013Herbal Medicinal Products: Phaseolus, Phaseoli fructus (sine semine), Phaseolus vulgaris L. (updated)
13/05/2013Notices of calls for tender - 2012 (updated)
13/05/2013PRAC rapporteur generic risk-management-plan assessment report - report template
13/05/2013Human medicines European Public Assessment Report (EPAR): Bondenza (previously Ibandronic Acid Roche),

ibandronic acid

Revision: 16, Withdrawn
13/05/2013PRAC rapporteur risk-management-plan assessment report - report template
13/05/2013PRAC rapporteur risk-management-plan update assessment report - report template
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): Meloxidolor,

meloxicam

Revision: 0, Authorised
13/05/2013Human medicines European Public Assessment Report (EPAR): Aprovel,

irbesartan

Revision: 28, Authorised
13/05/2013Human medicines European Public Assessment Report (EPAR): Karvea,

irbesartan

Revision: 28, Authorised
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): BTVPUR AlSap 1,

bluetongue-virus serotype-1 antigen

Revision: 2, Authorised
13/05/2013Veterinary medicine European Public Assessment Report (EPAR): BTVPUR AlSap 1-8,

bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen

Revision: 2, Authorised
13/05/2013Regulatory and procedural guideline: Initial notices for parallel distribution – April 2013
13/05/2013Referral: Article 31 referrals, Domperidone-containing medicines,

domperidone

(updated)
13/05/2013Referral: Article 31 referrals, Nicotinic acid,

nicotinic acid, acipimox, xantinol nicotinate

(updated)
13/05/2013Referral: Article 31 referrals, Diacerein-containing medicines for oral administration,

diacerein

(updated)
13/05/2013Medication-errors workshop - List of participants
13/05/2013Overview of comments received on 'Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products'
13/05/2013Regulatory and procedural guideline: Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products, adopted
13/05/2013European Union regulatory workshop on medication errors, European Medicines Agency, London, UK, From: 28-Feb-2013, To: 01-Mar-2013 (updated)
13/05/2013Report: Medication-errors workshop report
13/05/2013Work instructions for review of previously granted paediatric product-specific or class waivers, adopted
08/05/2013Healthcare professionals' organisations involved in the Agency's activities (updated)
08/05/2013Regulatory and procedural guideline: Procedural advice on appeal procedure for orphan-medicinal-product designation or review of orphan-designation criteria at the time of marketing authorisation (updated)
08/05/2013Referral: Article 107i procedures, Tetrazepam-containing medicines,

tetrazepam

(updated)
08/05/2013News and press releases: European Medicines Agency simplifies processing of fee reductions for orphan medicines
08/05/2013Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors (updated)
08/05/2013Plasma-master-file certifications (updated)
08/05/2013News and press releases: Comments invited on draft revised guideline on biosimilars
08/05/2013Human medicines European Public Assessment Report (EPAR): Prialt,

ziconotide

Revision: 15, Authorised
08/05/2013Report: Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States (updated)
08/05/2013Human medicines European Public Assessment Report (EPAR): Temozolomide Hospira,

temozolomide

Revision: 7, Authorised
08/05/2013News and press releases: New recommendations on the use of phthalates and parabens as excipients in human medicines released for public consultation
08/05/2013Scientific guideline: Draft guideline on the use of phthalates as excipients in human medicinal products, draft: consultation open
08/05/2013Scientific guideline: Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use, draft: consultation open
08/05/2013European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions (updated)
07/05/2013Human medicines European Public Assessment Report (EPAR): Trisenox,

arsenic trioxide

Revision: 16, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Incivo,

telaprevir

Revision: 7, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Reyataz,

atazanavir sulphate

Revision: 33, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Norvir,

ritonavir

Revision: 43, Authorised
07/05/2013Report: Summary of Product Characteristics Advisory Group two-year activity report (April 2011-November 2012)
07/05/2013News and press releases: European Medicines Agency closed 9-10 May 2013
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Teva,

olanzapine

Revision: 11, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Neopharma,

olanzapine

Revision: 8, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Olanzapine Mylan,

olanzapine

Revision: 7, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Zalasta,

olanzapine

Revision: 10, Authorised
07/05/2013Human medicines European Public Assessment Report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 12, Authorised
07/05/2013Newsletter: Human medicines highlights - April 2013
07/05/2013Agenda: Agenda - COMP agenda of the 14-15 May 2013 meeting
06/05/2013Regulatory and procedural guideline: Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products, adopted (updated)
06/05/2013Regulatory and procedural guideline: Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products, adopted (updated)
06/05/2013Regulatory and procedural guideline: Deadlines for submission of applications for orphan-medicinal-product designation to the European Medicines Agency 2013/2014 (updated)
06/05/2013Workshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency regulatory support pre- and post-authorisation, European Medicines Agency, London, UK, From: 26-Apr-2013, To: 26-Apr-2013 (updated)
06/05/2013Human medicines European Public Assessment Report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 13, Authorised
06/05/2013Minutes of the COMP meeting 12-13 March 2013
06/05/2013Human medicines European Public Assessment Report (EPAR): Capecitabine Teva,

capecitabine

Revision: 1, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Tyverb,

lapatinib

Revision: 17, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Cervarix,

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

Revision: 12, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Opgenra,

eptotermin alfa

Revision: 6, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Imatinib Actavis,

imatinib

Revision: 0, Authorised
06/05/2013Human medicines European Public Assessment Report (EPAR): Ribavirin BioPartners,

ribavirin

Revision: 2, Withdrawn
03/05/2013Human medicines European Public Assessment Report (EPAR): Capecitabine Medac,

capecitabine

Revision: 1, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Mepact,

mifamurtide

Revision: 8, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Rivastigmine 1 A Pharma,

rivastigmine

Revision: 5, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 10, Authorised
03/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells in autologous cell-enriched matrix for subcutaneous administration
03/05/2013Report: Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells for subcutaneous administration
03/05/2013Human medicines European Public Assessment Report (EPAR): Pantoloc Control,

pantoprazole

Revision: 5, Authorised
03/05/2013Workshop on paediatric investigation plans in type-2 diabetes mellitus, European Medicines Agency, London, UK, From: 25-Feb-2013, To: 25-Feb-2013 (updated)
03/05/2013Human medicines European Public Assessment Report (EPAR): Pantecta Control,

pantoprazole

Revision: 3, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Ruconest,

conestat alfa

Revision: 2, Authorised
03/05/2013Work instructions for scientific-advice / protocol-assistance peer review, adopted (updated)
03/05/2013Frequently asked questions about parallel distribution
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)

Therapeutic area: Infectious diseases
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

sialic acid

Therapeutic area: Other
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

bisoprolol / amlodipine

Therapeutic area: Cardiovascular diseases
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

lutetium [177 Lu]

Therapeutic area: Other
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

alendronic acid / colecalciferol

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

clonidine (hydrochloride)

Therapeutic area: Anaesthesiology
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

gabapentin

Therapeutic area: Pain
03/05/2013Human medicines European Public Assessment Report (EPAR): Victrelis,

boceprevir

Revision: 7, Authorised
03/05/2013Human medicines European Public Assessment Report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 2, Authorised
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

pegylated human recombinant factor VIII (BAX 855)

Therapeutic area: Haematology-Hemostaseology
03/05/2013Human medicines European Public Assessment Report (EPAR): IntronA,

interferon alfa-2b

Revision: 21, Authorised
03/05/2013Veterinary medicine European Public Assessment Report (EPAR): Prac-tic,

pyriprole

Revision: 6, Authorised
03/05/2013News and press releases: European Medicines Agency website unavailable Saturday 4 May
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Human medicines European Public Assessment Report (EPAR): Vedrop,

d-alpha-tocopherol

Revision: 4, Authorised
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Hexvix,

hexaminolevulinate

Therapeutic area: Diagnostic/Endocrinology, -gynacology-fertility-metabolism/Oncology
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Volibris,

ambrisentan

Therapeutic area: Cardiovascular diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

cilengitide

Therapeutic area: Oncology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

mepolizumab

Therapeutic area: Pneumology-allergology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Emend,

aprepitant

Therapeutic area: Oncology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

brivaracetam

Therapeutic area: Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

guanfacine (hydrochloride)

Therapeutic area: Psychiatry (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

dalbavancin

Therapeutic area: Infectious diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Votubia,

everolimus

Therapeutic area: Uro-nephrology/Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Lumigan, Latisse,

bimatoprost

Therapeutic area: Ophthalmology/Dermatology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Victrelis,

boceprevir

Therapeutic area: Infectious diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Onglyza,

saxagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Certican, Afinitor and associated names,

everolimus

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

elvitegravir

Therapeutic area: Infectious diseases (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Trobalt,

retigabine

Therapeutic area: Neurology (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

vedolizumab

Therapeutic area: Gastroentology-Hepatology (updated)
03/05/2013News and press releases: European Medicines Agency reorganisation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Benlysta,

belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): Palexia and associated names, Yantil and associated names, Tapentadol and associated names,

tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

baricitinib

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

anacetrapib

Therapeutic area: Cardiovascular diseases
03/05/2013Herbal Medicinal Products: Rubus, Rubi idaei folium, Rubus idaeus L. (updated)
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

sarilumab

Therapeutic area: Immunology-Rheumatology-Transplantation
03/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

oritavancin (diphosphate)

Therapeutic area: Dermatology/Infectious diseases
03/05/2013Human medicines European Public Assessment Report (EPAR): Avamys,

fluticasone furoate

Revision: 9, Authorised
02/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

etoxybamide

Therapeutic area: Neurology/Anaesthesiology
02/05/2013Opinion/decision on a Paediatric Investigation Plan (PIP): -,

asfotase alfa

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
02/05/2013Guidelines and concept papers adopted during the CHMP meeting 22-25 April 2013
02/05/2013Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 22-25 April 2013
02/05/2013Opinions on safety variations adopted at the CHMP meeting of 22-25 April 2013
02/05/2013Organisational matters - CHMP meeting 22-25 April 2013
02/05/2013Human medicines European Public Assessment Report (EPAR): Controloc Control,

pantoprazole

Revision: 3, Authorised
02/05/2013Human medicines European Public Assessment Report (EPAR): Somac Control,

pantoprazole

Revision: 4, Authorised
02/05/2013Human medicines European Public Assessment Report (EPAR): Pantozol Control,

pantoprazole

Revision: 3, Authorised
02/05/2013Scientific guideline: Draft guideline on similar biological medicinal products, draft: consultation open
02/05/2013Scientific guideline: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure, adopted (updated)
02/05/2013Referral: Article 13 referrals, Kantos Master,

beclomethasone dipropionate / formoterol fumarate

(updated)
02/05/2013Regulatory and procedural guideline: HMPC rules of procedure (updated)
02/05/2013Mandate, objectives and rules of procedure for the HMPC Working Party on Community Monographs and Community List (MLWP) (updated)