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July 2012

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31/07/2012Human medicines European Public Assessment Report (EPAR): Gardasil,

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

Revision: 20, Authorised
31/07/2012Withdrawn application: Velcade,

bortezomib

Post-authorisation
31/07/2012Overview of comments received on the guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus (CPMP/EWP/1080/00 Rev. 1)
31/07/2012Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector Lenti-D encoding the human ABCD1 gene
31/07/2012Scientific guideline: Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors, draft: consultation open
31/07/2012Scientific guideline: Draft guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration, draft: consultation open
31/07/2012Extended EudraVigilance medicinal product report message (XEVPRM): Frequently asked questions and answers (FAQs) (updated)
31/07/2012Extended EudraVigilance product report message (XEVMPD) organisations, version 10.0 (updated)
31/07/2012Extended EudraVigilance product report message (XEVMPD) substances, version 11.0 (updated)
30/07/2012Human medicines European Public Assessment Report (EPAR): Menveo,

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

Revision: 6, Authorised
30/07/2012Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies: July 2012 meeting
30/07/2012Work instructions for Processing interim agency invoices following interim timesheets, adopted
30/07/2012Human medicines European Public Assessment Report (EPAR): Vimpat,

lacosamide

Revision: 9, Authorised
30/07/2012Human medicines European Public Assessment Report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 6, Authorised
30/07/2012Human medicines European Public Assessment Report (EPAR): Levodopa/Carbidopa/Entacapone Orion,

levodopa / carbidopa / entacapone

Revision: 1, Authorised
30/07/2012Human medicines European Public Assessment Report (EPAR): Levetiracetam ratiopharm,

levetiracetam

Revision: 2, Authorised
30/07/2012Human medicines European Public Assessment Report (EPAR): Levetiracetam Teva,

levetiracetam

Revision: 4, Authorised
30/07/2012European Union - Japan orphan medicines cooperation
30/07/2012Report: Report on interactions between the Japanese Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA)
30/07/2012News and press releases: European Medicines Agency sees benefits of interaction with Japanese regulators
30/07/2012Electronic submission of veterinary dossiers: Questions and answers (updated)
30/07/2012Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human dermal fibroblasts
27/07/2012Questions and answers on implementation of pharmacovigilance legislation (updated)
27/07/2012Regulatory and procedural guideline: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation (updated)
27/07/2012News and press releases: European Medicines Agency publishes policy on changing scope of paediatric investigation plans
27/07/2012European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions
27/07/2012News and press releases: World Hepatitis Day: 28 July 2012
27/07/2012Human medicines European Public Assessment Report (EPAR): Refludan,

lepirudin

Revision: 15, Withdrawn
27/07/2012Work instructions for corrigendum and correction of a PDCO opinion and Agency’s decision, adopted
27/07/2012Work instructions for electronic and paper master files for paediatric-investigation-plan and waiver applications and compliance checks, adopted (updated)
27/07/2012Human medicines European Public Assessment Report (EPAR): Ixiaro,

Japanese encephalitis vaccine (inactivated, adsorbed)

Revision: 3, Authorised
27/07/2012Human medicines European Public Assessment Report (EPAR): Targretin,

bexarotene

Revision: 10, Authorised
27/07/2012Human medicines European Public Assessment Report (EPAR): Topotecan Hospira,

topotecan

Revision: 2, Authorised
27/07/2012Human medicines European Public Assessment Report (EPAR): Olanzapine Glenmark,

olanzapine

Revision: 5, Authorised
27/07/2012Human medicines European Public Assessment Report (EPAR): Olazax,

olanzapine

Revision: 4, Authorised
27/07/2012Questions and answers relating to banking service EMA/2012/01/FI-AC (updated)
27/07/2012Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 16-19 July 2012
27/07/2012News and press releases: Electronic application forms fully available for use
26/07/2012News and press releases: European Medicines Agency website unavailable 20.00 to 24.00 Friday 27 July
26/07/2012Human medicines European Public Assessment Report (EPAR): Clopidogrel Acino Pharma GmbH,

clopidogrel

Revision: 1, Withdrawn
26/07/2012Human medicines European Public Assessment Report (EPAR): Clopidogrel Acino Pharma,

clopidogrel

Revision: 1, Withdrawn
26/07/2012Human medicines European Public Assessment Report (EPAR): Clopidogrel Hexal,

clopidogrel

Revision: 2, Withdrawn
26/07/2012News and press releases: Two further modules on good pharmacovigilance practices released for public consultation
26/07/2012Scientific guideline: Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits, draft: consultation open
26/07/2012Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with public consultation launch of draft modules IV and XV
26/07/2012Submission of comments on 'good pharmacovigilance practices module IV – Pharmacovigilance audits' (EMA/228028/2012)
26/07/2012Scientific guideline: Guideline on good pharmacovigilance practices: Module XV – Safety communication, draft: consultation open
26/07/2012Submission of comments on 'good pharmacovigilance practices module XV – Safety communication' (EMA/118465/2012)
26/07/2012Human medicines European Public Assessment Report (EPAR): Kepivance,

palifermin

Revision: 16, Authorised
26/07/2012News and press releases: European Medicines Agency bids farewell to CHMP Pharmacovigilance Working Party
26/07/2012Report: Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - July 2012
26/07/2012Report: Cumulative index of Pharmacovigilance Working Party monthly reports (updated)
26/07/2012Human medicines European Public Assessment Report (EPAR): Clopidogrel ratiopharm,

clopidogrel

Revision: 3, Authorised
26/07/2012Human medicines European Public Assessment Report (EPAR): Clopidogrel ratiopharm GmbH,

clopidogrel

Revision: 3, Authorised
26/07/2012Human medicines European Public Assessment Report (EPAR): Temodal,

temozolomide

Revision: 21, Authorised
26/07/2012Human medicines European Public Assessment Report (EPAR): Cancidas (previously Caspofungin MSD),

caspofungin

Revision: 13, Authorised
26/07/2012Human medicines European Public Assessment Report (EPAR): Ecalta,

anidulafungin

Revision: 9, Authorised
26/07/2012Human medicines European Public Assessment Report (EPAR): Vfend,

voriconazole

Revision: 24, Authorised
26/07/2012European Medicines Agency workshop with European Union pharmaceutical industry associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004, European Medicines Agency, London, UK, From: 12-Sep-2012, To: 12-Sep-2012
26/07/2012Human medicines European Public Assessment Report (EPAR): Karvezide,

irbesartan / hydrochlorothiazide

Revision: 27, Authorised
25/07/2012Human medicines European Public Assessment Report (EPAR): Mozobil,

plerixafor

Revision: 5, Authorised
25/07/2012Human medicines European Public Assessment Report (EPAR): Prezista,

darunavir

Revision: 22, Authorised
25/07/2012Human medicines European Public Assessment Report (EPAR): Reyataz,

atazanavir sulphate

Revision: 31, Authorised
25/07/2012Report: Significant benefit of orphan drugs: concepts and future developments
25/07/2012News and press releases: Report available on activities on medicines for children during 2011
25/07/2012Human medicines European Public Assessment Report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 1, Authorised
25/07/2012Guidelines and concept papers adopted during the July 2012 CHMP meeting
25/07/2012Opinions on safety variations adopted during the July 2012 CHMP meeting
25/07/2012Organisational matters - CHMP meeting 16-19 July 2012
25/07/2012Human medicines European Public Assessment Report (EPAR): Evoltra,

clofarabine

Revision: 14, Authorised
25/07/2012Human medicines European Public Assessment Report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 2, Authorised
25/07/2012Human medicines European Public Assessment Report (EPAR): Trisenox,

arsenic trioxide

Revision: 14, Authorised
25/07/2012Orphan designation:

4,6,8-Trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one

25/07/2012European Medicines Agency Standard Operating Procedure (SOP): Standard operating procedure for handling of possible safety signals from other regulatory authorities
25/07/2012CVMP monthly report of application procedures, guidelines and related documents: June 2012
25/07/2012Scientific guideline: Guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine, draft: consultation open
25/07/2012Scientific guideline: Revised concept paper on the need for revision of the position on the replacement of animal studies by in-vitro models, draft: consultation open
25/07/2012Scientific guideline: Concept paper for revision of the guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products, draft: consultation open
25/07/2012Scientific guideline: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL36(R): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological acceptable daily intake, adopted
25/07/2012Scientific guideline: Recommendation to marketing authorisation holders, highlighting the need to ensure compliance with 3Rs methods described in the European Pharmacopoeia, adopted
25/07/2012Question and answers on the CVMP guideline on testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMEA/CVMP/005/00-Rev 2) (updated)
24/07/2012News and press releases: European Medicines Agency publishes sources for orphan-disease prevalence data
24/07/2012Relevant sources for orphan disease prevalence data
24/07/2012Human medicines European Public Assessment Report (EPAR): Humira,

adalimumab

Revision: 28, Authorised
24/07/2012Work instructions for checking licences for parallel distribution, adopted (updated)
24/07/2012Work instructions for determination of the fee for a parallel distribution notification, adopted (updated)
24/07/2012International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M8 electronic common technical document - questions and answers: Step 5 (updated)
24/07/2012Orphan designation:

Ramucirumab: hepatocellular carcinoma

24/07/2012Orphan designation:

Givinostat

24/07/2012Orphan designation:

Ramucirumab: gastric cancer

24/07/2012Orphan designation:

2S, 4R ketoconazole

24/07/2012Orphan designation:

Talarozole: recessive X-linked ichthyosis

24/07/2012Orphan designation:

Ataluren

24/07/2012Orphan designation:

Eculizumab

24/07/2012Orphan designation:

Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene

24/07/2012Orphan designation:

Human erythrocytes encapsulating inositol hexaphosphate

24/07/2012Orphan designation:

Talarozole: autosomal recessive congenital ichthyosis

24/07/2012Orphan designation:

16-base single-stranded peptide nucleic acid oligonucleotide linked to 7-amino acid peptide

24/07/2012Orphan designation:

Recombinant human interleukin-7

24/07/2012Orphan designation:

Levoglutamide

24/07/2012Human medicines European Public Assessment Report (EPAR): Vidaza,

azacitidine

Revision: 8, Authorised
24/07/2012Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B: Annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bulk density and tapped density of powders – general chapter
24/07/2012Orphan designation:

Talarozole: keratinopathic ichthyosis

24/07/2012Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E3: Questions and answers (R1)
23/07/2012Human medicines European Public Assessment Report (EPAR): Sprimeo HCT,

aliskiren / hydrochlorothiazide

Revision: 0, Withdrawn
23/07/2012Human medicines European Public Assessment Report (EPAR): Sprimeo,

aliskiren

Revision: 5, Withdrawn
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ozenoxacin

Therapeutic area: Infectious diseases
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Viread,

Tenofovir (disoproxil fumarate)

Therapeutic area: Infectious diseases
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Modified grass pollen extract

Therapeutic area: Pneumology-allergology
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Ilaris,

Canakinumab

Therapeutic area: Immunology-Rheumatology-Transplantation
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Sycrest,

Asenapine (maleate)

Therapeutic area: Psychiatry
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Vfend,

Voriconazole

Therapeutic area: Infectious diseases
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Spiriva Respimat and associated names,

Tiotropium bromide (monohydrate)

Therapeutic area: Pneumology-allergology
23/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Orfadin,

Nitisinone

Therapeutic area:
23/07/2012Human medicines European Public Assessment Report (EPAR): Brinavess,

vernakalant hydrochloride

Revision: 2, Authorised
23/07/2012Regulatory and procedural guideline: Compilation of Community procedures on inspections and exchange of information, adopted (updated)
23/07/2012Referral: Article 34, Milaxyn Plus,

praziquantel, pyrantel and febantel

23/07/2012Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP) (updated)
23/07/2012Extended EudraVigilance product report message (XEVMPD) units of measurement, version 6.0 (updated)
23/07/2012Referral: Article 6 (12) referrals, Valproat Ratiopharm Chrono,

valproic acid / valproate

23/07/2012Work instructions for European Medicines Agency rules, guidelines and policies related to staff matters, staff regulations and staff policy, adopted (updated)
23/07/2012European Medicines Agency Standard Operating Procedure (SOP): Standard operating procedure for safety monitoring of centrally authorised products (veterinary) (updated)
23/07/2012Work instructions for filing of personnel documents in personal and / or salary file, adopted (updated)
23/07/2012Work instructions for signature of agency timesheets, adopted (updated)
23/07/2012Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes (updated)
20/07/2012Withdrawn application: Mulsevo,

semuloparin sodium

Initial authorisation
20/07/2012Workshop on clinical trial data and transparency, European Medicines Agency, London, UK, From: 22-Nov-2012, To: 22-Nov-2012
20/07/2012News and press releases: Registration open for workshop on access to clinical trial data and transparency
20/07/2012Referral: Article 36 referrals, Preflucel,

influenza vaccine, purified antigen

20/07/2012Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus)
20/07/2012Start of Community reviews - CHMP meeting of 16-19 July 2012
20/07/2012News and press releases: European Medicines Agency recommends limiting long-term use of calcitonin medicines
20/07/2012Referral: Article 31 referrals, Calcitonin,

calcitonin

20/07/2012News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
20/07/2012Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, United States
20/07/2012Pending EC decision: Glybera,

alipogene tiparvovec

Opinion date: 19-Jul-2012
20/07/2012Positive opinion on the marketing authorisation of Glybera (alipogene tiparvovec)
20/07/2012News and press releases: European Medicines Agency recommends first gene therapy for approval
20/07/2012Pending EC decision: Ozurdex,

dexamethasone

Opinion date: 19-Jul-2012
20/07/2012Pending EC decision: Pradaxa,

dabigatran etexilate

Opinion date: 19-Jul-2012
20/07/2012Pending EC decision: Prezista,

darunavir

Opinion date: 19-Jul-2012
20/07/2012Referral: Article 29 referrals, Glimepirida Parke-Davis,

glimepiride

20/07/2012Referral: Article 29 referrals, Mometasone Furoate Sandoz,

mometasone furoate

20/07/2012Pending EC decision: Adcetris,

brentuximab vedotin

Opinion date: 19-Jul-2012
20/07/2012Pending EC decision: Humira,

adalimumab

Opinion date: 19-Jul-2012
20/07/2012Pending EC decision: Xalkori,

crizotinib

Opinion date: 19-Jul-2012
20/07/2012Scientific advice and protocol assistance - Adopted during the CHMP meeting 16-19 July 2012
20/07/2012Pending EC decision: Istodax,

romidepsin

Opinion date: 19-Jul-2012
20/07/2012Pending EC decision: Dacogen,

decitabine

Opinion date: 19-Jul-2012
19/07/2012Regulatory and procedural guideline: Dossier requirements: Members of the CAT (updated)
19/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Masitinib (mesylate)

Therapeutic area: Oncology
19/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Amlodipine (besilate) / valsartan

Therapeutic area: Cardiovascular diseases
19/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Angiox,

Bivalirudin

Therapeutic area: Cardiovascular diseases
19/07/2012News and press releases: European Medicines Agency publishes video explaining pharmacovigilance legislation
19/07/2012European Medicines Agency Standard Operating Procedure (SOP): Standard operating procedure for Processing of parallel distribution initial notifications
19/07/2012Work instructions for Regulatory check of initial notifications of parallel distribution, adopted
19/07/2012Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
19/07/2012News and press releases: European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)
19/07/2012Referral: Article 35, All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits,

tilmicosin

19/07/2012Opinion/decision on a Paediatric Investigation Plan (PIP): Simponi,

Golimumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Gastroentology-Hepatology
18/07/2012Minutes - PDCO minutes of the 6-8 June 2012 meeting
18/07/2012Agenda: Agenda - PRAC draft agenda of the inaugural plenary meeting 19-20 July 2012
18/07/2012Agenda: Agenda - PDCO agenda of the 6-8 June 2012 meeting
18/07/2012News and press releases: European Medicines Agency announces plan to publish committee agendas and minutes
18/07/2012Agenda: Agenda - PDCO agenda of the 4-6 July 2012 meeting
18/07/2012PDCO: Agendas, minutes and meeting reports (updated)
18/07/2012PRAC: Agendas, minutes and highlights
18/07/2012Human medicines European Public Assessment Report (EPAR): Sebivo,

telbivudine

Revision: 14, Authorised
18/07/2012Veterinary medicine European Public Assessment Report (EPAR): Ingelvac CircoFLEX,

inactivated porcine circovirus vaccine

Revision: 6, Authorised
18/07/2012Human medicines European Public Assessment Report (EPAR): NeoRecormon,

epoetin beta

Revision: 19, Authorised
18/07/2012Human medicines European Public Assessment Report (EPAR): Simulect,

basiliximab

Revision: 14, Authorised
18/07/2012Withdrawn application: Egrifta,

tesamorelin

Initial authorisation
17/07/2012Human medicines European Public Assessment Report (EPAR): Siklos,

hydroxycarbamide

Revision: 8, Authorised
17/07/2012European 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)
17/07/2012Veterinary medicine European Public Assessment Report (EPAR): Nobilis IB 4-91,

live attenuated vaccine against avian infectious bronchitis

Revision: 7, Authorised
17/07/2012Annual report of the Good Clinical Practice Inspections Working Group 2010
17/07/2012Annual report of the Good Clinical Practice Inspections Working Group 2011
17/07/2012Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation: July 2012
17/07/2012Report: Meeting report - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on improved potency assays for inactivated influenza vaccines held on 12 December 2011
16/07/2012Draft Quality Review of Documents human product information annotated template: revision of the product information, draft: consultation open
16/07/2012News and press releases: European Medicines Agency launches consultation on pharmacovigilance changes to product information
16/07/2012Documents for public consultation (updated)
16/07/2012Organisation chart of the European Medicines Agency (updated)
16/07/2012Directorate (updated)
16/07/2012News and press releases: European Medicines Agency appoints Head of International and European Cooperation
16/07/2012Veterinary medicine European Public Assessment Report (EPAR): Meloxidyl,

meloxicam

Revision: 9, Authorised
16/07/2012European Medicines Agency Standard Operating Procedure (SOP): Standard operating procedure on organisation of Paediatric Committee meetings
16/07/2012Overview of comments received on 'guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells'
13/07/2012Human medicines European Public Assessment Report (EPAR): Abraxane,

paclitaxel

Revision: 8, Authorised
13/07/2012Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies: June 2012 meeting
13/07/2012News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 July 2012
13/07/2012MRL pending EC decision: Manganese carbonate - Summary opinion of the CVMP on the establishment of maximum residue limits
13/07/2012Pending EC decision: Onsior,

robenacoxib

Opinion date: 11-Jul-2012
13/07/2012Template: letter of access - Annex 2
13/07/2012Overview of comments received on setting specifications for related impurities in antibiotics
13/07/2012Scientific guideline: Adopted guideline on setting specifications for related impurities in antibiotics
13/07/2012Scientific guideline: Adopted guideline on active-substance-master-file procedure (revision 3), adopted
13/07/2012Overview of comments received on draft guideline on active-substance-master-file procedure (revision 3)
13/07/2012PDCO monthly report of opinions on paediatric investigation plans: 4-6 July 2012
13/07/2012Annual report of the Pharmacovigilance Inspectors Working Group for 2011
13/07/2012Work plan for the Pharmacovigilance Inspectors Working Group for 2012
12/07/2012Human medicines European Public Assessment Report (EPAR): Intanza,

influenza vaccine (split virion, inactivated)

Revision: 7, Authorised
12/07/2012Human medicines European Public Assessment Report (EPAR): Tasigna,

nilotinib

Revision: 17, Authorised
12/07/2012Regulatory and procedural guideline: The dates of 2013 Scientific Advice Working Party meetings and deadlines for scientific advice or protocol assistance request submissions
12/07/2012Human medicines European Public Assessment Report (EPAR): Javlor,

vinflunine

Revision: 3, Authorised
12/07/2012Human medicines European Public Assessment Report (EPAR): RotaTeq,

rotavirus vaccine, live, oral

Revision: 12, Authorised
12/07/2012Human medicines European Public Assessment Report (EPAR): IDflu,

influenza vaccine (split virion, inactivated)

Revision: 5, Authorised
11/07/2012Veterinary medicine European Public Assessment Report (EPAR): Vaxxitek HVT+IBD,

live vaccine against infectious bursal disease and Marek's disease

Revision: 8, Authorised
11/07/2012Human medicines European Public Assessment Report (EPAR): DuoCover,

clopidogrel / acetylsalicylic acid

Revision: 4, Authorised
11/07/2012Human medicines European Public Assessment Report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 3, Authorised
11/07/2012Work instructions for publication of the monthly and annual overview of parallel distribution notices issued by the European Medicines Agency, adopted (updated)
11/07/2012Addendum no. 1 to the cooperation between the Pharmaceutical Inspection Cooperation Scheme and the European Medicines Agency of 28 December 2010
11/07/2012Work instructions for preparation for publication of annexes to the CHMP meeting highlights by the CHMP secretariat and Community Procedures section , adopted (updated)
11/07/2012Confidentiality commitment from the Pharmaceutical Inspection Co-operation Scheme not to disclose non-public information shared by the European Medicines Agency
11/07/2012Newsletter: News bulletin for small and medium-sized enterprises - Issue 20
11/07/2012Report: European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2010
11/07/2012Report: Report on budgetary and financial management: Financial year 2011
11/07/2012Report: Annual accounts: Financial year 2011
11/07/2012Human medicines European Public Assessment Report (EPAR): Desloratadine Teva,

desloratadine

Revision: 1, Authorised
11/07/2012Human medicines European Public Assessment Report (EPAR): Cimzia,

certolizumab pegol

Revision: 5, Authorised
10/07/2012Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous oral mucosa cells seeded onto a membrane
10/07/2012Regulatory and procedural guideline: The dates of 2012 Scientific Advice Working Party meetings and deadlines for scientific advice or protocol assistance request submissions, adopted (updated)
10/07/2012Human medicines European Public Assessment Report (EPAR): Votubia,

everolimus

Revision: 2, Authorised
10/07/2012Human medicines European Public Assessment Report (EPAR): Zyprexa,

olanzapine

Revision: 28, Authorised
10/07/2012Human medicines European Public Assessment Report (EPAR): Zypadhera,

olanzapine

Revision: 6, Authorised
10/07/2012Human medicines European Public Assessment Report (EPAR): Sycrest,

asenapine

Revision: 4, Authorised
10/07/2012Human medicines European Public Assessment Report (EPAR): Zyprexa Velotab,

olanzapine

Revision: 21, Authorised
10/07/2012Regulatory and procedural guideline: Initial notices for parallel distribution – June 2012
10/07/2012Appendix III to the Quality Review of Documents templates for human medicinal products (updated)
10/07/2012Appendix III to the Quality Review of Documents templates for human medicinal products (Croatian) (updated)
10/07/2012Herbal Medicinal Products: Tilia, Tiliae flos, Tilia cordata Miller, Tila platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures
10/07/2012Human medicines European Public Assessment Report (EPAR): Invirase,

saquinavir

Revision: 35, Authorised
09/07/2012Herbal Medicinal Products: Tilia, Tiliae tomentosae flos, Tilia tomentosa Moench
09/07/2012Presentation - Training report 2011 - Training and professional development (updated)
09/07/2012News and press releases: Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)
09/07/2012Human medicines European Public Assessment Report (EPAR): Soliris,

eculizumab

Revision: 8, Authorised
09/07/2012News and press releases: New call for patient and healthcare-professional representatives on European Medicines Agency committees
09/07/2012Report: Applications for new human medicines under evaluation by the CHMP: July 2012
09/07/2012Human medicines European Public Assessment Report (EPAR): Vizarsin,

sildenafil

Revision: 4, Authorised
06/07/2012Human medicines European Public Assessment Report (EPAR): Tractocile,

atosiban

Revision: 16, Authorised
06/07/2012Human medicines European Public Assessment Report (EPAR): Urorec,

silodosin

Revision: 6, Authorised
06/07/2012News and press releases: European Medicines Agency updates guideline on drug interactions
06/07/2012Orphan designation:

Allogeneic human dendritic cells derived from a CD34+ progenitor cell line

06/07/2012Orphan designation:

Sodium nitrite

06/07/2012Orphan designation:

Chimeric monoclonal antibody against kappa myeloma antigen

06/07/2012Withdrawn application: Revlimid,

lenalidomide

Post-authorisation
06/07/2012Human medicines European Public Assessment Report (EPAR): Lucentis,

ranibizumab

Revision: 14, Authorised
06/07/2012Human medicines European Public Assessment Report (EPAR): Gilenya,

fingolimod

Revision: 3, Authorised
06/07/2012Report: Medicinal products for human use: Monthly figures - May 2012
06/07/2012Human medicines European Public Assessment Report (EPAR): Rienso,

ferumoxytol

Revision: 0, Authorised
06/07/2012Summary - European Medicines Agency workshop with European Union pharmaceutical industry associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No.726/2004
06/07/2012News and press releases: European Medicines Agency finalises update to Parkinson's disease guideline
06/07/2012European Medcines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP), European Medicines Agency, London, UK, From: 07-May-2012, To: 07-May-2012
06/07/2012Human medicines European Public Assessment Report (EPAR): Tarceva,

erlotinib

Revision: 14, Authorised
06/07/2012Human medicines European Public Assessment Report (EPAR): RoActemra,

tocilizumab

Revision: 8, Authorised
06/07/2012Timetable: Periodic safety update reports (PSURs)
06/07/2012Scientific guideline: Guideline on the investigation of drug interactions, adopted
06/07/2012Scientific guideline: Questions and answers on additional clarification for inclusion criteria in the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease revision 2
06/07/2012Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease, adopted
06/07/2012Orphan designation:

Chlormethine

06/07/2012Human medicines European Public Assessment Report (EPAR): Protopic,

tacrolimus

Revision: 14, Authorised
06/07/2012Orphan designation:

Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin

05/07/2012Electronic submission of information on medicines (updated)
05/07/2012News and press releases: European Medicines Agency encourages companies to use electronic application tools
05/07/2012Human medicines European Public Assessment Report (EPAR): Avastin,

bevacizumab

Revision: 27, Authorised
05/07/2012Referral: Article 33, Prontax 5 mg/ml pour-on solution for cattle,

doramectin

05/07/2012Referral: Article 33, Prontax 10 mg/ml solution for injection for cattle, sheep and pigs,

doramectin

05/07/2012News and press releases: European Medicines Agency urges companies to submit Croatian product information for checking
05/07/2012Human medicines European Public Assessment Report (EPAR): Advagraf,

tacrolimus

Revision: 12, Authorised
05/07/2012Human medicines European Public Assessment Report (EPAR): Flebogamma DIF (previously Flebogammadif),

human normal immunoglobulin

Revision: 6, Authorised
05/07/2012European Medicines Agency meeting and holiday dates 2013
05/07/2012New European Union pharmacovigilance legislation – Key concepts
04/07/2012Orphan designation:

Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA

04/07/2012Orphan designation:

Polyinosine-polycytidylic acid coupled with the polycationic polyethyleneimine

04/07/2012Orphan designation:

Adenovirus-associated vector containing human Fas-c gene

04/07/2012News and press releases: European Medicines Agency announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements
04/07/2012Orphan designation:

1-(4-{4-Amino-7-[1-(2-hydroxyethyl)-1H-pyrazol-4-yl] thieno [3,2-c]pyridin-3-yl}phenyl)-3-(3-fluorophenyl)urea

04/07/2012Orphan designation:

Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene

04/07/2012Orphan designation:

Letermovir

04/07/2012Orphan designation:

N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide: meningioma

04/07/2012Orphan designation:

N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide: schwannoma

04/07/2012Extended EudraVigilance product report message (XEVMPD) pharmaceutical dose forms, version 4.0 (updated)
04/07/2012Human medicines European Public Assessment Report (EPAR): Temozolomide Sandoz,

temozolomide

Revision: 5, Authorised
04/07/2012Human medicines European Public Assessment Report (EPAR): Jevtana,

cabazitaxel

Revision: 3, Authorised
04/07/2012Human medicines European Public Assessment Report (EPAR): ReFacto AF (previously ReFacto),

moroctocog alfa

Revision: 21, Authorised
04/07/2012Human medicines European Public Assessment Report (EPAR): Temozolomide Teva,

temozolomide

Revision: 6, Authorised
04/07/2012Human medicines European Public Assessment Report (EPAR): Temozolomide Hospira,

temozolomide

Revision: 3, Authorised
04/07/2012Human medicines European Public Assessment Report (EPAR): Temozolomide Hexal,

temozolomide

Revision: 4, Authorised
04/07/2012News and press releases: European Medicines Agency releases new additional guidance for development of antibacterials for public consultation
04/07/2012Scientific guideline: Draft addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data, draft: consultation open
04/07/2012Withdrawn application: Draxxin,

tulathromycin

Post-authorisation
04/07/2012Orphan designation:

Everolimus

03/07/2012Newsletter: Human medicines highlights - June 2012
03/07/2012News and press releases: Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)
03/07/2012Referral: Article 29 referrals, Docetaxel Teva Generics,

docetaxel

03/07/2012Withdrawn application: Pioglitazone Teva Generics,

pioglitazone

Initial authorisation
03/07/2012Human medicines European Public Assessment Report (EPAR): Nivestim,

filgrastim

Revision: 3, Authorised
03/07/2012Human medicines European Public Assessment Report (EPAR): Neulasta,

pegfilgrastim

Revision: 17, Authorised
03/07/2012Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) (updated)
02/07/2012Regulatory and procedural guideline: Guideline on the processing of renewals in the centralised procedure, adopted (updated)
02/07/2012Overview of comments received on 'guideline for the processing of renewals in the centralised procedure'
02/07/2012News and press releases: European Medicines Agency finalises update to guideline on renewals
02/07/2012Human medicines European Public Assessment Report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 10, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Invanz,

ertapenem

Revision: 15, Authorised
02/07/2012News and press releases: New pharmacovigilance legislation comes into operation
02/07/2012Workshop on endpoints for cystic fibrosis clinical trials, European Medicines Agency, London, UK, From: 27-Sep-2012, To: 28-Sep-2012
02/07/2012Human medicines European Public Assessment Report (EPAR): Zyllt,

clopidogrel

Revision: 3, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Yervoy,

ipilimumab

Revision: 1, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Karvea,

irbesartan

Revision: 27, Authorised
02/07/2012Declaration of interests: Enrica Alteri
02/07/2012News and press releases: European Medicines Agency welcomes new Head of Safety and Efficacy of Medicines
02/07/2012Human Medicines Development and Evaluation (updated)
02/07/2012Human medicines European Public Assessment Report (EPAR): Fasturtec,

rasburicase

Revision: 14, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 12, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Abseamed,

epoetin alfa

Revision: 13, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Binocrit,

epoetin alfa

Revision: 12, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Atriance,

nelarabine

Revision: 9, Authorised
02/07/2012Human medicines European Public Assessment Report (EPAR): Levitra,

vardenafil

Revision: 19, Authorised
02/07/2012Patient Health Protection (updated)
02/07/2012PRAC: Overview
02/07/2012Countdown to July 2012 - The establishment and functioning of the Pharmacovigilance Risk Assessment Committee
02/07/2012Pharmacovigilance Risk Assessment Committee (PRAC)
02/07/2012PRAC meetings
02/07/2012Legal notice (updated)