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March 2017

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Date Content
31/03/2017Scientific guideline: Draft guideline on multiplicity issues in clinical trials, draft: consultation open
31/03/2017Multiplicity issues in clinical trials (updated)
31/03/2017Statistical methodology for the comparative assessment of quality attributes in drug development (updated)
31/03/2017Scientific guideline: Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open
31/03/2017Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance (updated)
31/03/2017Scientific guideline: Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man, draft: consultation open
31/03/2017Orphan designation:

Ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene

for the: Treatment of epidermolysis bullosa
31/03/2017Orphan designation:

Vemurafenib

for the: Treatment of Erdheim-Chester disease
31/03/2017Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 17, Authorised
31/03/2017Orphan designation:

Autologous T-cells transduced with lentiviral vector encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor

for the: Treatment of plasma cell myeloma
31/03/2017Orphan designation:

Humanised IgG4 monoclonal antibody to the human toll-like receptor type 2

for the: Treatment of myelodysplastic syndromes
31/03/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 4, Authorised
31/03/2017Orphan designation:

Iodine (131I) murine IgG1 monoclonal antibody against CD276

for the: Treatment of neuroblastoma
31/03/2017Human medicines European public assessment report (EPAR): Imbruvica,

ibrutinib

Revision: 8, Authorised
31/03/2017Orphan designation:

Soluble recombinant human fibroblast growth factor receptor 3

for the: Treatment of achondroplasia
31/03/2017Orphan designation:

Thalidomide

for the: Treatment of hereditary haemorrhagic telangiectasia
31/03/2017Good distribution practice
31/03/2017Good manufacturing practice
31/03/2017Compliance
31/03/2017Human medicines European public assessment report (EPAR): Xeljanz,

tofacitinib

Revision: 0, Authorised
31/03/2017Regulatory and procedural guideline: Formatted table template to be inserted in each referral procedural submission cover letter (updated)
31/03/2017Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 9, Authorised
31/03/2017Orphan designation:

propranolol hydrochloride

for the: Treatment of von Hippel-Lindau disease
31/03/2017Orphan designation:

Recombinant human club cell 10 KDa protein

for the: Treatment of bronchiolitis obliterans syndrome
31/03/2017Orphan designation:

Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt

for the: Treatment of primary ciliary dyskinesia
31/03/2017Orphan designation:

Tauroursodeoxycholic acid

for the: Treatment of amyotrophic lateral sclerosis
31/03/2017Orphan designation:

Fenfluramine hydrochloride

for the: Treatment of Lennox-Gastaut syndrome
31/03/2017Orphan designation:

N-(4-(1-cyanocyclopentyl)phenyl)-2-(4-pyridinylmethyl)amino-3-pyridinecarboxamide methanesulfonate

for the: Treatment of gastric cancer
31/03/2017Clinical development of fixed combination medicinal products (updated)
31/03/2017Orphan designation:

26 base synthetic single-stranded fully phosphorothioated 2'-O-methyl-RNA and DNA mixmer oligonucleotide-based compound

for the: Treatment of Dravet syndrome
31/03/2017Orphan designation:

5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine

for the: Treatment of diffuse large B-cell lymphoma
31/03/2017Scientific guideline: Guideline on clinical development of fixed combination medicinal products - Revision 2, adopted
31/03/2017HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population (updated)
31/03/2017Human medicines European public assessment report (EPAR): Azopt,

brinzolamide

Revision: 22, Authorised
31/03/2017Orphan designation:

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

for the: Treatment of cystic fibrosis
31/03/2017Orphan designation:

Alpha-tocopherol and ascorbic acid

for the: Treatment of fragile X syndrome
31/03/2017Fees payable to the European Medicines Agency (updated)
31/03/2017News and press releases: Regulatory information - adjusted fees for applications to EMA from 1 April 2017
31/03/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 57, Authorised
31/03/2017Human medicines European public assessment report (EPAR): Pedea,

ibuprofen

Revision: 12, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 10, Authorised
30/03/2017Human medicines European public assessment report (EPAR): ViraferonPeg,

peginterferon alfa-2b

Revision: 34, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Senshio,

ospemifene

Revision: 3, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Zalasta,

olanzapine

Revision: 14, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 24, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Wakix,

pitolisant

Revision: 2, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 14, Authorised
30/03/2017Human medicines European public assessment report (EPAR): HBVaxPro,

hepatitis-B vaccine (rDNA)

Revision: 23, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 12, Authorised
30/03/2017Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union, European Medicines Agency, London, UK, From: 03-Feb-2017, To: 03-Feb-2017 (updated)
30/03/2017Human medicines European public assessment report (EPAR): Cystagon,

mercaptamine bitartrate

Revision: 13, Authorised
30/03/2017Regulatory and procedural guideline: Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (Rev. 2), adopted
30/03/2017Regulatory and procedural guideline: Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (Rev. 2), adopted
30/03/2017Archive of development of good pharmacovigilance practices (updated)
30/03/2017Risk management (updated)
30/03/2017Questions and answers on the risk management plan (RMP) summary (updated)
30/03/2017Good pharmacovigilance practices (updated)
30/03/2017Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of module V on risk management systems finalised post-public consultation, related revision 2 of module XVI and revision 2 of module II on PSMF
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (Rev. 2)
30/03/2017Comments received from public consultation on good pharmacovigilance practices (GVP): Module V – Risk management systems (Rev. 2)
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators with tracked changes (Rev. 2)
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2), adopted (updated)
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2), adopted (updated)
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2), adopted (updated)
30/03/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file tracked changes (Rev. 2), adopted
30/03/2017Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae (updated)
30/03/2017Regulatory and procedural guideline: Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects, draft: consultation open
30/03/2017Quality Review of Documents veterinary product-information template version 8.1 (Hungarian version) (updated)
30/03/2017Quality Review of Documents veterinary product-information template version 8.1 (Norway version) (updated)
30/03/2017Quality Review of Documents veterinary product-information template version 8.1 (Iceland version) (updated)
30/03/2017PDCO work plan 2017
30/03/2017Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 2, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 11, Authorised
30/03/2017Human medicines European public assessment report (EPAR): BeneFIX,

nonacog alfa

Revision: 35, Authorised
30/03/2017Template letter of intent for request of scientific advice - veterinary (updated)
30/03/2017COMP meeting report on the review of applications for orphan designation: March 2017
30/03/2017Industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 25-Apr-2017, To: 25-Apr-2017
30/03/2017Human medicines European public assessment report (EPAR): Gardasil,

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

Revision: 34, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 22, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Suliqua,

insulin glargine / lixisenatide

Revision: 0, Authorised
30/03/2017Human medicines European public assessment report (EPAR): Cinryze,

C1 inhibitor (human)

Revision: 13, Authorised
30/03/2017SME info day on the new clinical trial regulation, European Medicines Agency, London, UK, From: 20-Mar-2017, To: 20-Mar-2017 (updated)
30/03/2017Human medicines European public assessment report (EPAR): Afstyla,

lonoctocog alfa

Revision: 0, Authorised
29/03/2017Plasma-master-file certifications (updated)
29/03/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 March 2017, adopted
29/03/2017PRIME: priority medicines (updated)
29/03/2017Human medicines European public assessment report (EPAR): Memantine Mylan,

memantine

Revision: 2, Authorised
29/03/2017Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 40, Authorised
29/03/2017Human medicines European public assessment report (EPAR): Rebetol,

ribavirin

Revision: 31, Authorised
29/03/2017Human medicines European public assessment report (EPAR): Ebilfumin,

oseltamivir

Revision: 4, Authorised
29/03/2017Human medicines European public assessment report (EPAR): Iressa,

gefitinib

Revision: 10, Authorised
29/03/2017Orphan designation:

Humanised single-chain monoclonal antibody against CD37 (otlertuzumab)

for the: Treatment chronic lymphocytic leukaemia (updated)
29/03/2017Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 5, Authorised
29/03/2017List of medicines under additional monitoring (updated)
29/03/2017Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 7, Authorised
29/03/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
29/03/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
29/03/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
29/03/2017Committee for Orphan Medicinal Products (COMP) meetings 2019, 2020 and 2021
29/03/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
29/03/2017List of medicinal products under additional monitoring (updated)
29/03/2017List of medicinal products under additional monitoring (updated)
29/03/2017Important medical event terms list version 20.0 (IME-List) (updated)
29/03/2017EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list (updated)
28/03/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
28/03/2017Agenda: Agenda - FP7 Small-population research methods projects and regulatory application workshop (updated)
28/03/2017Pharmacovigilance
28/03/2017Human medicines European public assessment report (EPAR): Zeffix,

lamivudine

Revision: 20, Authorised
28/03/2017What we publish on medicines and when (updated)
28/03/2017Human medicines European public assessment report (EPAR): Rasilamlo,

aliskiren / amlodipine

Revision: 7, Withdrawn
28/03/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 4, Authorised
28/03/2017CHMP ORGAM minutes for the meeting on 13 February 2017
27/03/2017Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 2, Authorised
27/03/2017Introduction of a 'regulatory contact point' for marketing authorisation holders (updated)
27/03/2017EudraVigilance registration: questions and answers (updated)
27/03/2017European Medicines Agency veterinary medicines info day, European Medicines Agency, London, UK, From: 16-Mar-2017, To: 17-Mar-2017 (updated)
27/03/2017Regulatory and procedural guideline: EudraVigilance registration: questions and answers (updated)
27/03/2017Report: Report - Workshop on measuring the impact of pharmacovigilance activities
27/03/2017Workshop on measuring the impact of pharmacovigilance activities, European Medicines Agency, London, UK, From: 05-Dec-2016, To: 06-Dec-2016 (updated)
27/03/2017Scientific guidelines with summary-of-product-characteristics recommendations (updated)
27/03/2017Report: Summary of Product Characteristics Advisory Group (SmPC AG) 6-year activity report (2016)
27/03/2017Agenda: Agenda - HMPC agenda of the 27-28 March 2017 meeting
27/03/2017Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 11, Authorised
27/03/2017Agenda: Agenda - European Medicines Agency veterinary medicines info day (updated)
24/03/2017Scientific guideline: Draft guidance on provision of data on antimicrobial use by animal species from national data collection systems, draft: consultation open
24/03/2017Questions and answers for the guidance on provision of data on antimicrobial use by animal species from national data collection systems (EMA/489035/2016)
24/03/2017Human medicines European public assessment report (EPAR): ATryn,

antithrombin alfa

Revision: 13, Authorised
24/03/2017Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 March 2017
24/03/2017Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
24/03/2017Referral: Article 31 referrals, Dienogest/ethinylestradiol-containing medicinal products indicated in acne,

dienogest / ethinylestradiol

(updated)
24/03/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 March 2017
24/03/2017Pending EC decision: Dintuximab beta Apeiron,

dinutuximab beta

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Opdivo,

nivolumab

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Refixia,

nonacog beta pegol

Opinion date: 23-Mar-2017
24/03/2017Withdrawn application: Enpaxiq,

pacritinib

Initial authorisation
24/03/2017Withdrawn application: Blectifor,

caffeine citrate

Initial authorisation
24/03/2017News and press releases: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
24/03/2017Pending EC decision: Zebinix,

eslicarbazepine acetate

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Elmiron,

pentosan polysulfate sodium

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Ivabradine Accord,

ivabradine

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Axumin,

fluciclovine (18F)

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Trumenba,

meningococcal group B vaccine (recombinant, adsorbed)

Opinion date: 23-Mar-2017
24/03/2017Pending EC decision: Keytruda,

pembrolizumab

Opinion date: 23-Mar-2017
24/03/2017Withdrawn application: Translarna,

ataluren

Post-authorisation
24/03/2017Referral: Article 31 referrals, Micro Therapeutic Research,

-

(updated)
24/03/2017Submission deadlines for orphan designations (updated)
24/03/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2017
24/03/2017Regulatory and procedural guideline: Deadlines for submission of applications for orphan-medicinal-product designation to the European Medicines Agency 2017/2018 (updated)
24/03/2017Informed consent for paediatric clinical trials in Europe 2015 (updated)
24/03/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.5) (updated)
24/03/2017Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 28, Authorised
24/03/2017News and press releases: EU recommendations for 2017/2018 seasonal flu vaccine composition
24/03/2017Regulatory and procedural guideline: Biologics Working Party (BWP) Ad-hoc Influenza Working Group: European Union recommendations for the seasonal influenza vaccine composition for the season 2017/2018
24/03/2017Plant testing strategy in the risk assessment for veterinary medicinal products (updated)
24/03/2017Overview of comments received on 'Guideline on the plant testing strategy for veterinary medicinal products' (EMA/CVMP/ERA/689041/2015)
24/03/2017Scientific guideline: Guideline on the plant testing strategy for veterinary medicinal products, adopted
24/03/2017Regulatory 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)
23/03/2017Q&A: Worksharing of variations (updated)
23/03/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: February 2017
23/03/2017Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva,

tenofovir disoproxil

Revision: 1, Authorised
23/03/2017Human medicines European public assessment report (EPAR): Rolufta,

umeclidinium

Revision: 0, Authorised
23/03/2017Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 13, Authorised
23/03/2017Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 13, Authorised
23/03/2017Human medicines European public assessment report (EPAR): Cerezyme,

imiglucerase

Revision: 21, Authorised
23/03/2017Translarna - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
23/03/2017Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 21, Authorised
23/03/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: autologous tumour-infiltrating lymphocytes
23/03/2017Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide : List of nationally authorised medicinal products - PSUSA/00010390/201607
23/03/2017Human medicines European public assessment report (EPAR): Insulatard,

insulin human (rDNA)

Revision: 15, Authorised
23/03/2017Agenda: Agenda - PDCO agenda of the 21-24 March 2017 meeting
23/03/2017EudraVigilance Expert Working Group (EV-EWG) work programme 2017
23/03/2017News and press releases: Use of big data to improve human and animal health
23/03/2017Overview of comments received on ‘ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) - questions and answers’
23/03/2017Human medicines European public assessment report (EPAR): Zykadia,

ceritinib

Revision: 6, Authorised
23/03/2017Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 8, Authorised
23/03/2017Anti-fraud strategy (updated)
22/03/2017Referral: Article 30 referrals, Lovenox and associated names,

enoxaparin

(updated)
22/03/2017News and press releases: Call for experts in anonymisation of clinical data
22/03/2017Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (updated)
22/03/2017Scientific guideline: Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents., draft: consultation open
22/03/2017Pharmaceutical quality of inhalation and nasal products (updated)
22/03/2017Scientific guideline: Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products, draft: consultation open
22/03/2017Selection of members of the Technical Anonymisation Group (TAG) - Call for applications
22/03/2017Selection of members of the Technical Anonymisation Group (TAG) - Public declaration of interests
22/03/2017First anniversary of PRIME: experience so far, European Medicines Agency, London, UK, From: 19-May-2017, To: 19-May-2017
22/03/2017News and press releases: First anniversary of PRIME – experience so far
22/03/2017EudraVigilance training (updated)
22/03/2017Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 7, Authorised
22/03/2017Veterinary medicine European public assessment report (EPAR): Porcilis PCV,

adjuvanted inactivated vaccine against porcine circovirus

Revision: 6, Authorised
22/03/2017Referral: Article 31 referrals, Factor VIII (updated)
22/03/2017Human medicines European public assessment report (EPAR): Colobreathe,

colistimethate sodium

Revision: 8, Authorised
22/03/2017Referral: Article 31 referrals, Intravenous iron-containing medicinal products,

ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose

(updated)
22/03/2017Veterinary medicine European public assessment report (EPAR): Nobivac L4,

Vaccine to prevent Leptospira infections in dogs

Revision: 3, Authorised
21/03/2017Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 21, Authorised
21/03/2017Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 8, Authorised
21/03/2017Human medicines European public assessment report (EPAR): Voriconazole Accord,

voriconazole

Revision: 7, Authorised
21/03/2017Template to change applicant name or details (updated)
21/03/2017Template for notification of change of the paediatric-investigation-plan / waiver applicant / addressee (updated)
21/03/2017Minutes of the CHMP meeting 23-26 January 2017
21/03/2017Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 15, Authorised
21/03/2017Human medicines European public assessment report (EPAR): Zyprexa,

olanzapine

Revision: 38, Authorised
21/03/2017Human medicines European public assessment report (EPAR): Protaphane,

insulin human (rDNA)

Revision: 13, Authorised
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Sirturo,

Bedaquiline (fumarate)

Therapeutic area: Infectious diseases (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Revolade,

Eltrombopag (olamine)

Therapeutic area: Haematology-Hemostaseology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,

Edoxaban (tosylate)

Therapeutic area: Cardiovascular diseases (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanised anti-IL-6 receptor (IL-6R) monoclonal antibody

Therapeutic area: Neurology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Zepatier,

Grazoprevir / elbasvir

Therapeutic area: Infectious diseases (updated)
20/03/2017Opinion/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)

Therapeutic area: Vaccines (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Opdivo,

Nivolumab

Therapeutic area: Oncology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Yervoy,

Ipilimumab

Therapeutic area: Oncology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Midostaurin

Therapeutic area: Oncology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ocrelizumab

Therapeutic area: Neurology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Lucentis,

Ranibizumab

Therapeutic area: Ophthalmology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

4-amino-1-[5-chloro-2,5-dideoxy-2-fluoro-3-O-(2-methylpropanoyl)-4-[[(2-methylpropanoyl)oxy]methyl]-α-L-lyxofuranosyl]-2(1H)-pyrimidinone (JNJ-64041575)

Therapeutic area: Infectious diseases (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Patiromer calcium

Therapeutic area: Other (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Nulojix,

Belatacept

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Bumetanide

Therapeutic area: Neurology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Terbinafine hydrochloride

Therapeutic area: Dermatology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Foster and associated names, Kantos and associated names, Kantos Master and associated names, Inuvair and associated names,

Beclometasone dipropionate / formoterol fumarate dihydrate

Therapeutic area: Pneumology-allergology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Budesonide

Therapeutic area: Pneumology-allergology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid,

Concentrate of proteolytic enzymes in bromelain

Therapeutic area: Dermatology/Other (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Descovy,

Emtricitabine / tenofovir alafenamide

Therapeutic area: Infectious diseases (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)

Therapeutic area: Neonatology-Paediactric Intensive care (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Idursulfase

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,

Paclitaxel

Therapeutic area: Oncology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Zydelig,

Idelalisib

Therapeutic area: Oncology (updated)
20/03/2017Opinion/decision on a Paediatric investigation plan (PIP): ,

Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104)

Therapeutic area: Gastroentology-Hepatology (updated)
20/03/2017Report: Medicinal products for human use: monthly figures - February 2017
20/03/2017Decision on rules concerning the handling of declared interests of national experts on secondment, trainees, interims and visiting experts of the European Medicines Agency (updated)
20/03/2017The new EudraVigilance System and the electronic reporting of the individual case safety in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 26-Jun-2017, To: 28-Jun-2017
20/03/2017Human medicines European public assessment report (EPAR): Oslif Breezhaler,

indacaterol

Revision: 9, Authorised
20/03/2017The new EudraVigilance System and the electronic reporting of the individual case safety in the ISO/ICH E2B(R3) format: hands-on training course , European Medicines Agency, London, UK, From: 21-Jun-2017, To: 23-Jun-2017
20/03/2017The new EudraVigilance System and the electronic reporting of the individual case safety in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 19-Jun-2017, To: 21-Jun-2017
20/03/2017Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 20, Authorised
20/03/2017The new EudraVigilance System and the electronic reporting of the individual case safety in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 14-Jun-2017, To: 16-Jun-2017
20/03/2017Human medicines European public assessment report (EPAR): Envarsus,

tacrolimus

Revision: 4, Authorised
20/03/2017The new EudraVigilance System and the electronic reporting of the individual case safety in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 12-Jun-2017, To: 14-Jun-2017
20/03/2017Notices of calls for tender - 2015 (updated)
20/03/2017Human medicines European public assessment report (EPAR): Ciambra,

pemetrexed

Revision: 1, Authorised
20/03/2017Committee for Medicinal Products for Human Use (CHMP): 20-23 March 2017, European Medicines Agency, London, UK, From: 20-Mar-2017, To: 23-Mar-2017 (updated)
20/03/2017Agenda: Agenda - CHMP agenda of the 20-23 March 2017
20/03/2017Excipients in the label and package leaflet of medicinal products for human use (updated)
20/03/2017Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm,

levetiracetam

Revision: 6, Authorised
20/03/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95 (updated)
20/03/2017Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 22, Authorised
20/03/2017Human 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: 32, Authorised
20/03/2017National experts on secondment (updated)
17/03/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 March 2017
17/03/2017Report: MUMS / limited market for veterinary medicines - 7th Annual report (01/01/2016 – 31/12/2016)
17/03/2017Report: 2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission
17/03/2017Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2017, adopted
17/03/2017Agenda: Agenda for the 95th meeting of the Management Board (updated)
17/03/2017Report: Summary of transfers of appropriations in budget 2016 - Period from 29 November 2016 to 13 December 2016
17/03/2017Regulatory and procedural guideline: Rules for reimbursement of expenses for delegates attending meetings with effect from 1 April 2017, adopted
17/03/2017Decision of the Management Board - On the appointment of the accounting officer of the European Medicines Agency
17/03/2017Outcome of written procedures finalised during the period from 17 November 2016 to 16 February 2017
17/03/2017Pending EC decision: Ingelvac PCV FLEX,

Porcine circovirus type 2 orf-2 protein minimum rp*1.0 maximum rp*3.75

Opinion date: 16-Mar-2017
17/03/2017Pending EC decision: Zeleris,

florfenicol / meloxicam

Opinion date: 16-Mar-2017
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Mirvetuximab soravtansine

Therapeutic area: Oncology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene

Therapeutic area: Haematology-Hemostaseology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

2-Hydroxypropyl-ß-cyclodextrin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
17/03/2017Pending EC decision: Zactran,

gamithromycin

Opinion date: 16-Mar-2017
17/03/2017Pending EC decision: Respiporc FLUpan H1N1,

influenza A virus/Jena/VI5258/2009 (PanH1N1), inactivated

Opinion date: 16-Mar-2017
17/03/2017Pending EC decision: Nexgard Spectra,

afoxolaner / milbemycin oxime

Opinion date: 16-Mar-2017
17/03/2017Pending EC decision: Novem,

meloxicam

Opinion date: 16-Mar-2017
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Doxorubicin (hydrochloride)

Therapeutic area: Oncology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Apolipoprotein A-1

Therapeutic area: Cardiovascular diseases
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Anti-(human calcitonin gene-related peptide receptor) human monoclonalantibody (AMG 334)

Therapeutic area: Neurology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Orencia,

Abatacept

Therapeutic area: Immunology-Rheumatology-Transplantation
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

(2-Hydroxyethyl)trimethylammonium 3-[2-fluoro-5-(2,3-difluoro-6-methoxybenzyloxy)-4- methoxyphenyl]-2,4-dioxo-1,2,3,4-tetrahydrothieno[3,4-d]pyrimidine-5-carboxylate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ambrisentan

Therapeutic area: Cardiovascular diseases
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Varicella-zoster virus (inactivated)

Therapeutic area: Vaccines
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

(1S, 3S, 4R)-4-[(3aS, 4R, 5S,7aS)-4-(aminomethyl)-7a-methyl-1-methylidene-octahydro-1H-inden-5-yl]-3-(hydroxymethyl)-4-methylcyclohexan-1-ol (acetic acid salt)

Therapeutic area: Uro-nephrology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Volanesorsen

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Esketamine (hydrochloride)

Therapeutic area: Psychiatry
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Hydrochlorothiazide / amlodipine (besylate) / candesartan (cilexetil)

Therapeutic area: Cardiovascular diseases
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Fc- and CDR-modified humanized monoclonal antibody against C5

Therapeutic area: Haematology-Hemostaseology
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Pegvaliase

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
17/03/2017News and press releases: EMA Management Board: highlights of March 2017 meeting
17/03/2017Minutes of the CVMP meeting of 14-16 February 2017
17/03/2017Orphan designation:

Sevuparin sodium

for the: Treatment of sickle cell disease (updated)
17/03/2017Nulojix (belatacept) supply shortage
17/03/2017Orphan designation:

Humanised monoclonal antibody against P-selectin

for the: Treatment of sickle-cell disease (updated)
17/03/2017Dexketoprofen: List of nationally authorised medicinal products - PSUSA/00000997/201510
17/03/2017Agenda: Agenda - CAT agenda of the 15-17 March 2017 meeting
17/03/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Vadadustat

Therapeutic area: Haematology-Hemostaseology
16/03/2017Rimexolone: List of nationally authorised medicinal products - PSUSA/00002647/201510
16/03/2017Budesonide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000449/201604 (updated)
16/03/2017Human medicines European public assessment report (EPAR): Terrosa,

teriparatide

Revision: 0, Authorised
16/03/2017Human medicines European public assessment report (EPAR): Levetiracetam Sun,

levetiracetam

Revision: 8, Authorised
16/03/2017Report: Applications for new human medicines under evaluation by the CHMP: March 2017
16/03/2017Conditions of employment (updated)
16/03/2017Human medicines European public assessment report (EPAR): Episalvan,

birch bark extract

Revision: 1, Authorised
16/03/2017Quality of medicines questions and answers: Part 1 (updated)
16/03/2017Human medicines European public assessment report (EPAR): Efient,

prasugrel

Revision: 13, Authorised
16/03/2017Orphan designation:

Chlormethine

for the: Treatment of cutaneous T-cell lymphoma (updated)
16/03/2017Workshop on the development of new medicines to treat tuberculosis, European Medicines Agency, London, UK, From: 25-Nov-2016, To: 25-Nov-2016 (updated)
16/03/2017Human medicines European public assessment report (EPAR): Copalia HCT,

amlodipine / valsartan / hydrochlorothiazide

Revision: 10, Authorised
16/03/2017Human medicines European public assessment report (EPAR): Ledaga,

chlormethine

Revision: 0, Authorised
16/03/2017Pending EC decision: Ledaga,

chlormethine

Opinion date: 15-Dec-2016 (updated)
16/03/2017Pending EC decision: Movymia,

teriparatide

Opinion date: 10-Nov-2016 (updated)
16/03/2017Human medicines European public assessment report (EPAR): Movymia,

teriparatide

Revision: 0, Authorised
16/03/2017Agenda: Agenda - SME info day on the new clinical trial regulation (updated)
16/03/2017Human medicines European public assessment report (EPAR): Olumiant,

baricitinib

Revision: 0, Authorised
16/03/2017Allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010475/201607
16/03/2017Desogestrel: List of nationally authorised medicinal products - PSUSA/00000966/201607
16/03/2017Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201608
16/03/2017Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201606
16/03/2017Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 33, Authorised
15/03/2017Substance, product, organisation, referentials (SPOR) - Glossary
15/03/2017Presentation - Organisations management service (OMS) and referentials management service and user acceptance testing (RMS UATs) - Webinar with all testers (Kepa Amutxastegi and Nuno Lopes)
15/03/2017Substance, product, organisation, referentials (SPOR) - Application program interface (API) specification (version 1.7)
15/03/2017Substance, product, organisation, referentials (SPOR) - Application program interface (API) schema
15/03/2017Launch of SPOR data management services
15/03/2017Human medicines European public assessment report (EPAR): Truberzi,

eluxadoline

Revision: 2, Authorised
15/03/2017Human medicines European public assessment report (EPAR): Aldurazyme,

laronidase

Revision: 14, Authorised
15/03/2017Mandate of the European Innovation Network
15/03/2017Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 19, Authorised
15/03/2017Human medicines European public assessment report (EPAR): Ameluz,

5-aminolevulinic acid hydrochloride

Revision: 10, Authorised
15/03/2017Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 10, Authorised
15/03/2017Regulatory and procedural guideline: Data protection statement for the public consultation on European Medicines Agency policy on access to documents
14/03/2017Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
14/03/2017Human medicines European public assessment report (EPAR): Mirvaso,

brimonidine

Revision: 6, Authorised
14/03/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 8, Authorised
14/03/2017Beclometasone / formoterol (inhalative application): List of nationally authorised medicinal products - PSUSA/00010068/201607
14/03/2017Poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated): List of nationally authorised medicinal products - PSUSA/00002458/201607
14/03/2017Minutes of the CAT meeting 18-20 January 2017
14/03/2017News and press releases: Release of documents on two medicines temporarily halted
14/03/2017Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 11, Authorised
14/03/2017DepoCyte (cytarabine) supply shortage (updated)
14/03/2017Human medicines European public assessment report (EPAR): Zyprexa Velotab,

olanzapine

Revision: 27, Authorised
14/03/2017Human medicines European public assessment report (EPAR): Bexsero,

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

Revision: 14, Authorised
14/03/2017Human medicines European public assessment report (EPAR): Retacrit,

epoetin zeta

Revision: 19, Authorised
14/03/2017Innovation in medicines (updated)
14/03/2017Orphan designation:

Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec)

for the: Treatment of retinitis pigmentosa (updated)
14/03/2017Agenda: Agenda - CVMP agenda of the 14-16 March 2017 meeting
14/03/2017Pre-authorisation guidance (updated)
14/03/2017Human post-authorisation Q&A: Introduction (updated)
14/03/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
14/03/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
14/03/2017European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated)
14/03/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
14/03/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
14/03/2017Influenza vaccines – submission and procedural requirements (updated)
14/03/2017Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201605
14/03/2017Misoprostol (gynaecological indication - labour induction): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010353/201605
14/03/2017Orphan designation:

Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec)

for the: Treatment of Leber’s congenital amaurosis (updated)
13/03/2017Human medicines European public assessment report (EPAR): Invanz,

ertapenem

Revision: 20, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 26, Authorised
13/03/2017Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201607
13/03/2017Agenda: Agenda - COMP agenda of the 14-15 March 2017
13/03/2017Orphan designation:

505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase

for the: Treatment of limb-girdle muscular dystrophy
13/03/2017Human medicines European public assessment report (EPAR): Lifmior,

etanercept

Revision: 0, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Hizentra,

human normal immunoglobulin (SCIg)

Revision: 14, Authorised
13/03/2017Orphan designation:

Humanised IgG4 monoclonal antibody to the human toll-like receptor type 2

for the: Treatment of pancreatic cancer
13/03/2017Human medicines European public assessment report (EPAR): Pemetrexed Hospira,

pemetrexed

Revision: 2, Authorised
13/03/2017Tamsulosin: List of nationally authorised medicinal products - PSUSA/00002847/201607
13/03/2017Pilocarpine / timolol: List of nationally authorised medicinal products - PSUSA/00002408/201607
13/03/2017Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 9, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 3, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 7, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 24, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 9, Authorised
13/03/2017Orphan designation:

Imatinib

for the: Treatment of acute respiratory distress syndrome (updated)
13/03/2017Orphan designation:

2-hydroxymethyl-2-methoxymethyl-1-azabicyclo[2,2,2]octan-3-one

for the: Treatment of ovarian cancer (updated)
13/03/2017Orphan designation:

2-Methoxymethyl-2-hydroxymethyl-1-azabicyclo[2,2,2]octan-3-one

for the: treatment of acute myeloid leukaemia (updated)
13/03/2017Orphan designation:

Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin / adeno-associated viral vector containing a rhodopsin gene

for the: Treatment of rhodopsin-linked retinitis pigmentosa (updated)
13/03/2017Human medicines European public assessment report (EPAR): Sovaldi,

sofosbuvir

Revision: 11, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Picato,

ingenol mebutate

Revision: 5, Authorised
13/03/2017Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 7, Authorised
10/03/2017News and press releases: Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
10/03/2017News and press releases: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations
10/03/2017News and press releases: EMA reviewing cancer medicine docetaxel
10/03/2017Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

10/03/2017Referral: Article 31 referrals, Gadolinium-containing contrast agents,

gadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid

(updated)
10/03/2017Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 20, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 4, Authorised
10/03/2017Nefopam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002131/201603
10/03/2017Nefopam: List of nationally authorised medicinal products - PSUSA/00002131/201603
10/03/2017Budesonide: List of nationally authorised medicinal products - PSUSA/00000449/201604
10/03/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
10/03/2017Fluticasone propionate / formoterol fumarate dehydrate : List of nationally authorised medicinal products - PSUSA/00010339/201607
10/03/2017Lovastatin: List of nationally authorised medicinal products - PSUSA/00010051/201607
10/03/2017News and press releases: Regulatory cooperation to improve global health
10/03/2017Newsletter: Human medicines highlights - March 2017
10/03/2017Human medicines European public assessment report (EPAR): Vemlidy,

tenofovir alafenamide

Revision: 0, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 5, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 15, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 21, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Velcade,

bortezomib

Revision: 39, Authorised
10/03/2017Human medicines European public assessment report (EPAR): Zypadhera,

olanzapine

Revision: 17, Authorised
10/03/2017Sulprostone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002828/201604
10/03/2017Sulprostone: List of nationally authorised medicinal products - PSUSA/00002828/201604
10/03/2017Treprostinil: List of nationally authorised medicinal products - PSUSA/00002828/201604
10/03/2017Treprostinil: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00003013/201605
09/03/2017Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 6, Authorised
09/03/2017Nicardipine: List of nationally authorised medicinal products - PSUSA/00002149/201605
09/03/2017Nicardipine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002149/201605
09/03/2017Nadifloxacin: List of nationally authorised medicinal products - PSUSA/00002102/201605
09/03/2017Nadifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002102/201605
09/03/2017Human medicines European public assessment report (EPAR): Desloratadine Actavis,

desloratadine

Revision: 7, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Palonosetron Hospira,

palonosetron

Revision: 1, Authorised
09/03/2017Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

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

(updated)
09/03/2017Human medicines European public assessment report (EPAR): Vectibix,

panitumumab

Revision: 26, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD),

caspofungin

Revision: 22, Authorised
09/03/2017Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live

Revision: 24, Authorised
09/03/2017Moxifloxacin (systemic use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009231/201605
09/03/2017Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201605
09/03/2017Human medicines European public assessment report (EPAR): Simulect,

basiliximab

Revision: 20, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Cystadrops,

mercaptamine

Revision: 1, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ),

docetaxel

Revision: 5, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Carbaglu,

carglumic acid

Revision: 15, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Bortezomib Hospira,

bortezomib

Revision: 1, Authorised
09/03/2017Herbal medicinal products: Cetraria, Lichen islandicus, Cetraria islandica (L.) Acharius s.l. (updated)
09/03/2017Herbal medicinal products: Ononis, Ononidis radix, Ononis spinosa L. (updated)
09/03/2017Health Technology Assessment Bodies information (updated)
09/03/2017Herbal medicinal products: Melaleuca, Melaleucae aetheroleum, Melaleuca alternifolia (Maiden and Betche) Cheel, and/or other spieces of Melaleuca (updated)
09/03/2017Herbal medicinal products: Panax, Ginseng radix, Panax ginseng C. A. Meyer. (updated)
09/03/2017Herbal medicinal products: Peumus, Boldi folium, Peumus boldus Molina (updated)
09/03/2017Veterinary medicine European public assessment report (EPAR): Stronghold Plus,

selamectin / sarolaner

Revision: 0, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Ketek,

telithromycin

Revision: 25, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Remsima,

infliximab

Revision: 9, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Wilzin,

zinc

Revision: 8, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 6, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Vedrop,

tocofersolan

Revision: 9, Authorised
09/03/2017Human medicines European public assessment report (EPAR): IntronA,

interferon alfa-2b

Revision: 27, Authorised
09/03/2017Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines, European Medicines Agency, London, UK, From: 28-Mar-2017, To: 28-Mar-2017
09/03/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 February 2017
09/03/2017Human medicines European public assessment report (EPAR): Olanzapine Apotex,

olanzapine

Revision: 7, Authorised
09/03/2017Human medicines European public assessment report (EPAR): Jetrea,

ocriplasmin

Revision: 7, Authorised
09/03/2017Report: 2016 activity report of the modelling and simulation working group (MSWG)
09/03/2017European Medicines Agency modelling and simulation working group plan 2017
08/03/2017Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 4, Authorised
08/03/2017Draft European Union herbal monograph on Mentha x piperita L., folium, draft: consultation open (updated)
08/03/2017Scientific guideline: Implementation strategy of ICH Q3D guideline, adopted
08/03/2017ICH Q3D Elemental impurities (updated)
08/03/2017Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 0, Authorised
08/03/2017Human medicines European public assessment report (EPAR): Zinplava,

bezlotoxumab

Revision: 0, Authorised
07/03/2017Training and resources for patients and consumers (updated)
07/03/2017Resources for healthcare professionals (updated)
07/03/2017Human medicines European public assessment report (EPAR): Oprymea,

pramipexole

Revision: 15, Authorised
07/03/2017News and press releases: Personalised medicines – focus on patients and healthcare professionals
07/03/2017Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines, European Medicines Agency, London, UK, From: 14-Mar-2017, To: 14-Mar-2017
06/03/2017Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017, European Medicines Agency, London, UK, From: 06-Mar-2017, To: 09-Mar-2017 (updated)
06/03/2017Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s.,

pregabalin

Revision: 0, Authorised
06/03/2017First 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 20-Jan-2017, To: 20-Jan-2017
06/03/2017Veterinary medicine European public assessment report (EPAR): Equioxx,

firocoxib

Revision: 6, Authorised
06/03/2017Herbal medicinal products: Combination: Species sedativae, Combination: Species sedativae
06/03/2017Herbal medicinal products: Combination: Species amarae, Combination: Species amarae
06/03/2017Herbal medicinal products: Combination: Species digestivae/stomachicae, Combination: Species digestivae/stomachicae
06/03/2017Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘nervous tensions and to aid sleep’, draft: consultation open
06/03/2017Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘loss of appetite’, draft: consultation open
06/03/2017Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘digestive disorders’, draft: consultation open
06/03/2017Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance (updated)
06/03/2017Quality of medicines questions and answers: Part 2 (updated)
06/03/2017PRAC recommendations on safety signals (updated)
06/03/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 February 2017 PRAC
06/03/2017List of signals discussed at the PRAC since September 2012 (updated)
06/03/2017PRAC recommendations on signals adopted at the PRAC meeting of 6-9 February 2017, adopted
06/03/2017Scientific guideline: Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V), draft: consultation open
06/03/2017Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 5, Authorised
06/03/2017Nominations to the European Union Telematics governance bodies (updated)
06/03/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
06/03/2017Agenda: Agenda - PRAC draft agenda of meeting 6-9 March 2017
03/03/2017Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 4, Authorised
03/03/2017Report: List of products granted eligibility to PRIME (updated)
03/03/2017Template for assessment report for the development of European Union herbal monographs and European Union list entries, adopted (updated)
03/03/2017Template for a European Union herbal monograph, adopted (updated)
03/03/2017Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work, adopted (updated)
03/03/2017Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 4, Authorised
03/03/2017Veterinary medicine European public assessment report (EPAR): Circovac,

adjuvanted inactivated vaccine against porcine circovirus type 2

Revision: 8, Authorised
03/03/2017Human medicines European public assessment report (EPAR): Ketoconazole HRA,

ketoconazole

Revision: 6, Authorised
03/03/2017Human medicines European public assessment report (EPAR): Kisplyx,

lenvatinib

Revision: 1, Authorised
03/03/2017Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 24, Authorised
03/03/2017Human medicines European public assessment report (EPAR): Mirapexin,

pramipexole

Revision: 30, Authorised
03/03/2017Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 17, Authorised
03/03/2017Human medicines European public assessment report (EPAR): Quinsair,

levofloxacin

Revision: 4, Authorised
03/03/2017Referral: Article 31 referrals, Vancomycin-containing medicines,

vancomycin

(updated)
03/03/2017Work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2017
03/03/2017Herbal medicinal products: Glycine, Soiae oleum raffinatum, Glycine max (L.) Merr. (updated)
03/03/2017Paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance (updated)
03/03/2017Abiraterone tablets 250 mg product-specific bioequivalence guidance (updated)
03/03/2017Vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance (updated)
03/03/2017Exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance (updated)
03/03/2017Vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance (updated)
02/03/2017Human medicines European public assessment report (EPAR): Duloxetine Lilly,

duloxetine

Revision: 3, Authorised
02/03/2017Human medicines European public assessment report (EPAR): Docetaxel Accord,

docetaxel

Revision: 7, Authorised
02/03/2017Human medicines European public assessment report (EPAR): Hetlioz,

tasimelteon

Revision: 1, Authorised
02/03/2017Veterinary medicine European public assessment report (EPAR): Procox,

emodepside / toltrazuril

Revision: 11, Authorised
02/03/2017Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 5, Authorised
02/03/2017Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/03/2017Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 5, Authorised
02/03/2017Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 17, Authorised
02/03/2017United States (updated)
02/03/2017News and press releases: European and US regulators agree on mutual recognition of inspections of medicines manufacturers
02/03/2017Mutual recognition with the United States (updated)
02/03/2017Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 4, Authorised
02/03/2017News and press releases: EMA website briefly unavailable on 3 March
02/03/2017European medicines agency Standard operating procedure (SOP): Standard operation procedure for handling of requests from a national competent authority to the CMDh for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (updated)
02/03/2017Regulatory and procedural guideline: Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products: pharmacovigilance requirements and EudraVigilance access - Note for clarification
02/03/2017Regulatory and procedural guideline: Guidance on triggers for inspections of bioequivalence trials: quick scan, adopted (updated)
02/03/2017EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 15-Mar-2017, To: 15-Mar-2017
02/03/2017EMA Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 30-Nov-2016, To: 30-Nov-2016 (updated)
01/03/2017Human medicines European public assessment report (EPAR): Ibandronic acid Accord,

ibandronic acid

Revision: 6, Authorised
01/03/2017Eligible patients and consumers organisations (updated)
01/03/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 February 2017, adopted
01/03/2017Human medicines European public assessment report (EPAR): Lantus,

insulin glargine

Revision: 30, Authorised
01/03/2017Veterinary medicine European public assessment report (EPAR): Porcilis PCV M Hyo,

porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Revision: 2, Authorised
01/03/2017Human medicines European public assessment report (EPAR): Sifrol,

pramipexole

Revision: 28, Authorised
01/03/2017Human medicines European public assessment report (EPAR): Docetaxel Kabi,

docetaxel

Revision: 7, Authorised
01/03/2017Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 13, Authorised
01/03/2017Information day on medication errors, European Medicines Agency, London, UK, From: 20-Oct-2016, To: 20-Oct-2016 (updated)
01/03/2017Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 27, Authorised
01/03/2017Human medicines European public assessment report (EPAR): Dacogen,

decitabine

Revision: 8, Authorised
01/03/2017Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira),

voriconazole

Revision: 3, Authorised
01/03/2017Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 29, Authorised