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March 2017

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Date Content
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
23/03/2017Anti-fraud strategy (updated)
23/03/2017Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 8, Authorised
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
22/03/2017Scientific 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
22/03/2017Requirements 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)
22/03/2017Pharmaceutical 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) - Public declaration of interests
22/03/2017Selection of members of the Technical Anonymisation Group (TAG) - Call for applications
22/03/2017News and press releases: First anniversary of PRIME – experience so far
22/03/2017First anniversary of PRIME: experience so far, European Medicines Agency, London, UK, From: 19-May-2017, To: 19-May-2017
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): Rasilamlo,

aliskiren / amlodipine

Revision: 7, Withdrawn
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
20/03/2017Agenda: 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
20/03/2017Human medicines European public assessment report (EPAR): Zostavax,

zoster vaccine (live)

Revision: 23, 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: 2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission
17/03/2017Agenda: Agenda for the 95th meeting of the Management Board (updated)
17/03/2017Decision of the Management Board - On the appointment of the accounting officer of the European Medicines Agency
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
17/03/2017Outcome of written procedures finalised during the period from 17 November 2016 to 16 February 2017
17/03/2017Report: MUMS / limited market for veterinary medicines - 7th Annual report (01/01/2016 – 31/12/2016)
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
17/03/2017Management Board meeting: 16 March 2017, European Medicines Agency, London, UK, From: 16-Mar-2017, To: 16-Mar-2017 (updated)
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): -,

Pegvaliase

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

Fc- and CDR-modified humanized monoclonal antibody against C5

Therapeutic area: Haematology-Hemostaseology
17/03/2017News 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)
17/03/2017Referral: Article 31 referrals, Micro Therapeutic Research (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
16/03/2017Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201608
16/03/2017Desogestrel: List of nationally authorised medicinal products - PSUSA/00000966/201607
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
15/03/2017Presentation - 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) - Glossary
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
15/03/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 56, Authorised
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
14/03/2017SME Office - Addressing the needs of small and medium-sized enterprises (updated)
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
13/03/2017Human 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
13/03/2017Human 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
13/03/2017Orphan designation:

Imatinib

for the: Treatment of acute respiratory distress syndrome (updated)
13/03/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 9, Authorised
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:

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

for the: Treatment of ovarian cancer (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
09/03/2017Workshop 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
09/03/2017Human medicines European public assessment report (EPAR): IntronA,

interferon alfa-2b

Revision: 27, Authorised
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
09/03/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.4) (updated)
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
02/03/2017Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 6, Authorised
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
02/03/2017European Medicines Agency veterinary medicines info day, European Medicines Agency, London, UK, From: 16-Mar-2017, To: 17-Mar-2017 (updated)
02/03/2017Agenda: Agenda - European Medicines Agency veterinary medicines info day (updated)
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