Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
|
|
|
- Rosa Woods
- 5 years ago
- Views:
Transcription
1 5 July 2017 EMA/430827/2017 Informaton Management Dvson Applcatons for new human medcnes under evaluaton by the Commttee for Medcnal Products for Human Use July 2017 Ths document lsts nformaton on applcatons for centralsed marketng authorsaton for human medcnes that the European Medcnes Agency has receved for evaluaton. It ncludes the nternatonal non-propretary names (INN) and therapeutc areas for all new nnovatve medcnes under evaluaton by the Commttee for Medcnal Products for Human Use (CHMP). For generc and bosmlar medcnes, t ncludes the INN (actve moety only, wth no nformaton on salt, ester or dervatve) and therapeutc area. Ths lst only ncludes nformaton for medcnes whose applcatons have been valdated at the tme the report was compled. The nformaton n ths report was compled on 5 July Informaton on desgnated orphan medcnes that are beng assessed for marketng authorsaton s also avalable n the monthly reports of the Commttee for Orphan Medcnal Products (COMP). Informaton n bold corresponds to new entres n the monthly lst. Entres are removed from ths lst once the medcne has receved a postve or negatve opnon from the CHMP or when the applcant has wthdrawn the applcaton. The Agency publshes nformaton on these opnons and wthdrawn applcatons on ts webste. Informaton on CHMP opnons s also publshed n the monthly CHMP hghlghts. 30 Churchll Place Canary Wharf London E14 5EU Unted Kngdom Telephone +44 (0) Facsmle +44 (0) Send a queston va our webste An agency of the European Unon European Medcnes Agency, Reproducton s authorsed provded the source s acknowledged.
2 Non-orphan medcnal products Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Abaloparatde Andexanet alfa Atezolzumab Benralzumab Betrxaban Bnmetnb Brexpprazole Brgatnb Cclosporn Darunavr (ethanolate) / cobcstat / emtrctabne / tenofovr alafenamde (fumarate) D-botn Dengue tetravalent vaccne (lve, attenuated) Dolutegravr (sodum) /rlpvrne (hydrochlorde) Duplumab Enclomfene (ctrate) Erenumab Ertuglflozn (L-pyroglutamc acd) Ertuglflozn (L-pyroglutamc acd) / metformn (hydrochlorde) Ertuglflozn (L-pyroglutamc acd) / staglptn (phosphate monohydrate) Etrnotecan pegol Flutcasone furoate / umecldnum (bromde) / vlanterol (trfenatate) Guselkumab Human fbrnogen / human thrombn Human herpesvrus 3 Iloperdone Melatonn Naldemedne (toslate) Calcum homeostass Other therapeutc medcnes Medcnes for obstructve arway dseases Antthrombotc medcnes Ophthalmologcals Vtamns Vaccnes Sex hormones and modulators of the gental system Analgescs Medcnes for obstructve arway dseases Anthemorrhagcs Vaccnes Medcnes for constpaton EMA/430827/2017 Page 2/5
3 Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Neratnb Ocrelzumab Padelporfn (d-potassum) Peramvr Prasterone Ruroctocog alfa pegol Semaglutde Srukumab Tldrakzumab Sex hormones and modulators of the gental system Anthemorrhagcs Non-orphan generc and bosmlar medcnal products Internatonal non-propretary name / Common Name Total number of applcatons Adalmumab 3 Anagrelde 1 Bevaczumab 2 Buprenorphne / naloxone Other nervous system medcnes 1 Carmustne 1 Darunavr 1 Doxorubcn 1 Efavrenz / emtrctabne / tenofovr 1 dsoproxl Entecavr 2 Fulvestrant Endocrne therapy 1 Hydrocortsone Cortcosterods for systemc use 1 Imatnb 1 Inflxmab 1 Insuln glargne 1 Lacosamde Antepleptcs 1 EMA/430827/2017 Page 3/5
4 Internatonal non-propretary name / Common Name Total number of applcatons Mglustat Other almentary tract and 1 metabolsm products Naloxone Other therapeutc medcnes 1 Ntsnone Other almentary tract and 1 metabolsm products Pegflgrastm Immunostmulants 3 Pemetrexed 1 Prasugrel Antthrombotc medcnes 1 Rtonavr 1 Rotgotne Ant-parknson medcnes 1 Sufentanl Anesthetcs 1 Tacrolmus 1 Tgecyclne Antbacterals for systemc use 1 Trastuzumab 4 Orphan medcnal products Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Avelumab Budesonde Burosumab Caplaczumab Cclosporn Eteplrsen Expanded human allogenec mesenchymal adult stem cells extracted from adpose tssue Gemtuzumab ozogamcn Glbenclamde Letermovr Lutetum (177Lu) dotatate Antdarrheals, ntestnal antnflammatory/antnfectve medcnes Medcnes for bone dseases Antthrombotc medcnes Ophthalmologcals Other medcnes for dsorders of the musculo-skeletal system Therapeutc radopharmaceutcals EMA/430827/2017 Page 4/5
5 Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Mastnb (mesylate) Metreleptn Mdostaurn Nraparb (tosylate monohydrate) Pacltaxel Pltdepsn Ropegnterferon alfa-2b Rucaparb (camsylate) Sodum benzoate Telotrstat (etprate) Velmanase alfa Vestrondase alfa Vable T-cells Voncog alfa Immunostmulants Antneoplastc and mmunomodulatng agents Anthemorrhagcs Applcaton beng revewed under EMA s accelerated assessment programme. EMA/430827/2017 Page 5/5
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
3 May 2017 EMA/283079/2017 Informaton Management Dvson Applcatons for new human medcnes under evaluaton by the Commttee for Medcnal Products for Human Use May 2017 Ths document lsts nformaton on applcatons
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
5 February 208 EMA/72847/208 Informaton Management Dvson Applcatons for new human medcnes under evaluaton by the Commttee for Medcnal Products for Human Use February 208 Ths document lsts nformaton on
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
2 July 208 EMA/482350/208 Corr. Informaton Management Dvson Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use July 208 Ths document lsts nformaton on applcatons
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
3 August 206 EMA/52958/206 Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use August 206 This document lists information
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
7 January 2016 EMA/6499/2016 Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use January 2016 This document lists
Biology 30 Take Home Quiz
Bology 30 Take Home Quz 1) Glucose levels n the blood are rased by the hormone and lowered by the hormone. a) nsuln glucagon b) glucagon nsuln c) nsuln calctonn d) calctonn nsuln 2) A fat soluble hormone
Initial (Full) Marketing Authorisation application accelerated assessment timetables
30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European
i-base Pocket size Pocket size Hepatitis C for people with HIV
Pocket sze Pocket sze -base Hepatts C for people wth HIV March 2017 Ths leaflet s about confecton wth both hepatts C (HCV) and HIV. Web lnks are for more nformaton. HIV s now easy to treat and HCV can
THIS IS AN OFFICIAL NH DHHS HEALTH ALERT
THIS IS AN OFFICIAL NH DHHS HEALTH ALERT Dstrbuted by the NH Health Alert Network Health.Alert@dhhs.nh.gov August 26, 2016 1430 EDT (2:30 PM EDT) NH-HAN 20160826 Recommendatons for Accurate Dagnoss of
Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance
31 May 2018 EMA/CHMP/158772/2016/Rev.1 Committee for Medicinal Products for Human Use (CHMP) Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg Draft Agreed by Pharmacokinetics Working Party April
For practical information about using Revlimid, patients should read the package leaflet or contact their doctor or pharmacist.
EMA/113870/2017 EMEA/H/C/000717 EPAR summary for the public lenalidomide This is a summary of the European public assessment report (EPAR) for. It explains how the Agency assessed the medicine to recommend
Interested parties (organisations or individuals) that commented on the draft document as released for consultation.
31 May 2018 EMA/CHMP/258276/2017 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on 'Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg productspecific bioequivalence
Class waiver list review
Class waiver list review Background, approach and outcome Consequences for regulatory submissions EMA Industry stakeholder platform on Paediatric medicines Presented by Ralf Herold on 11 May 2015 Paediatric
Supporting regulatory science outside the EU. The Article 58 procedure. An agency of the European Union
Supporting regulatory science outside the EU The Article 58 procedure An agency of the European Union What is the Article 58 procedure? EMA, through its scientific committees, can carry out scientific
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) Nathalie Bere and Maria Mavris Public Engagement Department EMA Training Day 21 November, 2017 An agency of the European Union What is the European Medicines Agency
List of nationally authorised medicinal products
10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
THE NATURAL HISTORY AND THE EFFECT OF PIVMECILLINAM IN LOWER URINARY TRACT INFECTION.
MET9401 SE 10May 2000 Page 13 of 154 2 SYNOPSS MET9401 SE THE NATURAL HSTORY AND THE EFFECT OF PVMECLLNAM N LOWER URNARY TRACT NFECTON. L A study of the natural hstory and the treatment effect wth pvmecllnam
List of nationally authorised medicinal products
21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division Active substance: felbamate Procedure no.: PSUSA/00010155/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
European Medicines Agency decision
EMA/156109/2018 European Medicines Agency decision P/0103/2018 of 19 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for plazomicin (sulfate) (EMEA-001639-PIP02-17)
Frequently asked questions
13 February 2017 EMA/527628/2011 Rev. 1 Directorate This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question
Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products
25 June 2013 rev. 1 1. Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human 1 Editorial revisions have been made to the table of
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
European Medicines Agency decision
EMA/497687/2017 European Medicines Agency decision P/0245/2017 of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for
Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
22 August 2018 EMA/242738/2018 Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients 5-6 September 2018 30 Churchill
European Medicines Agency decision
EMA/788583/2016 European Medicines Agency decision P/0363/2016 of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for dipalmitoylphosphatidylcholine
Draft Agreed by Pharmacokinetics Working Party February Adoption by CHMP for release for consultation 1 April 2016
15 December 2016 Committee for Medicinal Products for Human Use (CHMP) Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and
The 10 year EMA report on the EU regulation with a focus on oncology
The 10 year EMA report on the EU regulation with a focus on oncology 5 th Annual Paediatric Oncology Conference Presented by Koenraad Norga & Franca Ligas on 2 March 2017 An agency of the European Union
Interested parties (organisations or individuals) that commented on the draft document as released for consultation.
25 January 2018 EMA/CHMP/729976/2017 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence
Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings
3 March 2017 EMA/191955/2017 Stakeholders & Communication Division Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP 1. Background/Rationale A range of mechanisms have been
New product information wording Extracts from PRAC recommendations on signals
25 January 2018 EMA/PRAC/8436/2018 Pharmacovigilance Risk Assessment Committee (PRAC) New product information wording Extracts from PRAC recommendations on signals Adopted at the 8-11 January 2018 PRAC
MEDICAL CERTIFICATE ASSOCIATED WITH AN APPLICATION FOR A LICENCE TO DRIVE A HACKNEY CARRIAGE OR PRIVATE HIRE VEHICLE. Full name:... Date of Birth...
NEWCASTLE CITY COUNCIL Regulatory Servces and Publc Protecton Envronment and Regeneraton Drectorate, Cvc Centre,Newcastle upon Tyne,NE1 8PB Tel: (0191) 2783864; Fax: (0191) 2783868; Emal: lcensng@newcastle.gov.uk
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) Nathalie Bere Patient Relations Public Engagement Department EMA Training Day 29 November, 2016 An agency of the European Union What is the European Medicines Agency
RODWELL HOUSE WOUND ASSESSMENT
RODWELL HOUSE WOUND ASSESSMENT Resdent Name: Sute No: Wound Type: Locaton: Grade: Photograph Date Taken: Tssue Vablty: Wound Assessment Patent Label or Wrte Informaton Referrals Made (Please tck) RIO No
European Medicines Agency decision
EMA/120432/2017 European Medicines Agency decision P/0069/2017 of 3 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-001501-PIP01-13-M04) in
European Medicines Agency decision
EMA/565636/2017 European Medicines Agency decision P/0282/2017 of 4 October 2017 on the granting of a product specific waiver for ramucirumab (Cyramza), (EMEA-002074-PIP01-16) in accordance with Regulation
List of nationally authorised medicinal products
17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
25/04/2016 EMA/266665/2016 EMA confirms recommendations to minimise risk of brain infection PML with Tysabri More frequent MRI scans should be considered for patients at higher risk On 25 February 2016,
CHMP List of questions
28 June 2018 EMA/CHMP/346196/2018 To be addressed by the marketing authorisation holders for bacterial lysatescontaining medicinal products for respiratory conditions Referral under Article 31 of Directive
Opdivo (nivolumab) An overview of Opdivo and why it is authorised in the EU. What is Opdivo and what is it used for?
EMA/852560/2018 EMEA/H/C/003985 An overview of Opdivo and why it is authorised in the EU What is Opdivo and what is it used for? Opdivo is a cancer medicine used to treat the following: melanoma, a type
Joint Modelling Approaches in diabetes research. Francisco Gude Clinical Epidemiology Unit, Hospital Clínico Universitario de Santiago
Jont Modellng Approaches n dabetes research Clncal Epdemology Unt, Hosptal Clínco Unverstaro de Santago Outlne 1 Dabetes 2 Our research 3 Some applcatons Dabetes melltus Is a serous lfe-long health condton
European Medicines Agency decision
EMA/757977/2016 European Medicines Agency decision P/0364/2016 of 21 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for KEOC liquid extract ethanolic 30 per
List of nationally authorised medicinal products
10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
European Medicines Agency decision
EMA/75596/2018 European Medicines Agency decision P/0076/2018 of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for
European Medicines Agency decision
EMA/574564/2017 European Medicines Agency decision P/0278/2017 of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis vaccine (inactivated,
Update on public hearing
Update on public hearing PCWP/HCPWP joint meeting Presented by Juan Garcia Burgos on 0 September 017 Head of Public Engagement Department An agency of the European Union A public hearing provides An opportunity
WASHINGTON, D.C BEFORE THE OFFICE, ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS) UNITED STATES DEPARTMENT OF DEFENSE
ASSISTANT SECRETARY OF DEFENSE WASHINGTON, D.C. 20301 HEALTH AFFAIRS BEFORE THE OFFICE, ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS) UNITED STATES DEPARTMENT OF DEFENSE Appeal of Sponsor: SSN : 1 1
European Medicines Agency decision
EMA/761887/2015 European Medicines Agency decision P/0307/2015 of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for odanacatib (EMEA- 001123-PIP01-11-M03)
PRAC recommendations on signals
3 April 2018 1 EMA/PRAC/136563/2018 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 5-8 March 2018 PRAC meeting This document provides an overview of the recommendations adopted by the
European Medicines Agency decision
EMA/501681/2016 European Medicines Agency decision P/0213/2016 of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (EMEA- 001214-PIP01-11-M05)
Q&A on Off-Label Use. EMA Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015
Proposal in response to EFPIA paper of 3 rd October 2014 EMA Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015 Presented by Sabine Brosch (EMA) and Anja van
Standard operating procedure
Standard operating procedure Title: Preparation of an initial European Public Assessment Report (EPAR) for a human medicinal product following positive or negative opinion Status: PUBLIC Document no.:
List of nationally authorised medicinal products
5 May 2017 EMA/288255/2017 Human Medicines Evaluation Division Active substance: pilocarpine (ophthalmic formulation) Procedure no.: PSUSA/00002410/201608 30 Churchill Place Canary Wharf London E14 5EU
Inventory of paediatric therapeutic needs
8 September 2014 EMA/PDCO/358806/2013 Human Medicines Research and Development Support Nephro-urology Adopted by PDCO for release for consultation 19 July 2013 Start of public consultation 12 August 2013
European Medicines Agency decision
EMA/757980/2016 European Medicines Agency decision P/0313/2016 of 21 December 2016 on the agreement of a paediatric investigation plan for complex of povidone and iodine / dexamethasone (SHP640) (EMEA-001936-PIP01-16)
Regulatory requirements for universal flu vaccines Perspective from the EU regulators
Regulatory requirements for universal flu vaccines Perspective from the EU regulators EDUFLUVAC workshop 12-14 June Marco Cavaleri Head of Anti-infectives and Vaccines Scientific & Regulatory Management
European Medicines Agency decision
EMA/348027/2017 European Medicines Agency decision P/0166/2017 of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for aciclovir (Sitavig and associated names),
European Medicines Agency decision
EMA/654883/2017 European Medicines Agency decision P/0312/2017 of 30 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (EMEA- 001418-PIP01-13-M01)
PRAC recommendations on signals
22 February 2018 EMA/PRAC/59224/2018 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 5-8 February 2018 PRAC meeting This document provides an overview of the recommendations adopted by
Evaluation of Literature-based Discovery Systems
Evaluaton of Lterature-based Dscovery Systems Melha Yetsgen-Yldz 1 and Wanda Pratt 1,2 1 The Informaton School, Unversty of Washngton, Seattle, USA. 2 Bomedcal and Health Informatcs, School of Medcne,
European Medicines Agency decision
EMA/75416/2018 European Medicines Agency decision P/0042/2018 of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel), (EMEA-000567-PIP01-09-M05)
European Medicines Agency decision
EMA/38339/2017 European Medicines Agency decision P/0021/2017 of 3 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA- 001501-PIP02-13-M02)
European Medicines Agency decision
EMA/281879/2015 European Medicines Agency decision P/0097/2015 of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human
European Medicines Agency decision
EMA/398442/2016 European Medicines Agency decision P/0191/2016 of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan, Thymanax), (EMEA-001181-PIP01-11-M03)
Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases Draft
1 2 3 21 May 2015 EMA/CHMP/50549/2015 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular
List of nationally authorised medicinal products
26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain Procedure no.: PSUSA/00010223/201702 30 Churchill Place
European Medicines Agency decision
EMA/151867/2018 European Medicines Agency decision P/0107/2018 of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP01-11-M07)
Concept paper on a Guideline for allergen products development in moderate to low-sized study populations
1 2 3 4 5 6 7 13 December 2018 EMA/CHMP/251023/2018 Rheumatology / Immunology Working Party (RIWP) Concept paper on a Guideline for allergen products development in moderate to low-sized study populations
Standard operating procedure
Standard operating procedure Title: Early Notification System: procedure for advanced notification of emerging safety issues to EU regulatory network and international partners Status: PUBLIC Document
European Medicines Agency decision
EMA/741983/2016 European Medicines Agency decision P/0324/2016 of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M06)
EMA Extrapolation Framework Regulatory tools
EMA Extrapolation Framework Regulatory tools Workshop on extrapolation of efficacy and safety in medicine development across age groups Presented in London on 18 May 2016 by Paolo Tomasi MD PhD Head of
UnitedHealthcare Community Plan PDL Modifications
Date Posted Effectve Date Drug Name Generc Name Lalda Mesalamne Aprso Mesalamne Acton (/ / Modfcaton) Notes treatment of ulceratve colts. treatment of ulceratve colts. Afntor Dsperz Everolmus Added as
European Medicines Agency decision
EMA/785816/2015 European Medicines Agency decision P/0294/2015 of 3 December 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for
List of nationally authorised medicinal products
11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division Active substance: esomeprazole / naproxen Procedure no.: PSUSA/00001270/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
European Medicines Agency decision
EMA/357972/2017 European Medicines Agency decision P/0173/2017 of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (Colobreathe), (EMEA-000176-PIP01-07-M05)
Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018
4 December 2017 EMA/CHMP/CVMP/QWP/504882/2017 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Work plan for the joint CHMP/ CVMP Quality
European Medicines Agency decision
EMA/208387/2017 European Medicines Agency decision P/0089/2017 of 6 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin), (EMEA-000440-PIP02-11-M05)
List of nationally authorised medicinal products
08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
European Medicines Agency decision
EMA/848760/2017 European Medicines Agency decision P/0033/2018 of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M10)
Questions and answers on benzoic acid and benzoates used as excipients in medicinal products for human use
9 October 2017 EMA/CHMP/508189/2013 Committee for Human Medicinal Products (CHMP) Questions and answers on benzoic acid and benzoates d as excipients in medicinal products for human Draft agreed by Excipients
RHEUMATOID ARTHRITIS PATIENTS CANNOT ACCURATELY REPORT SIGNS OF INFLAMMATORY ACTIVITY
Brtsh Journal of Rheumatology 995;4:547-55 RHEUMATOID ARTHRITIS PATIENTS CANNOT ACCURATELY REPORT SIGNS OF INFLAMMATORY ACTIVITY S. E. HEWLETT, J. HAYNES, L. SHEPSTONE and J. R. KIRWAN Unversty of Brstol
European Medicines Agency decision
EMA/731087/2017 European Medicines Agency decision P/0341/2017 of 16 November 2017 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin
Systematic review and meta-analysis Tropical Medicine Nov, 4 th 2016
Systematc revew and meta-analyss Tropcal Medcne Nov, 4 th 2016 Ammarn Thakknstan, Ph.D. Secton for Clncal Epdemology and Bostatstcs Faculty of Medcne, Ramathbod Hosptal e-mal: ammarn.tha@mahdol.ac.th www.ceb-rama.org
WORK PLAN FOR THE EFFICACY WORKING PARTY (EWP) CHAIRPERSON: Barbara van Zwieten-Boot
European Medicines Agency London, 17 December 2009 EMA/CHMP/EWP/248088/2009 Rev. 1 WORK PLAN FOR THE EFFICACY WORKING PARTY (EWP) 2010 CHAIRPERSON: Barbara van Zwieten-Boot 1. MEETINGS SCHEDULED FOR 2010
EFFECT OF TOPICAL LIGNOCAINE ON THE SYMPATHODRENAL RESPONSES TO TRACHEAL INTUBATION
Br. J. Anaesth. (1987), 59, 300-304 EFFECT OF TOPICAL LIGNOCAINE ON THE SYMPATHODRENAL RESPONSES TO TRACHEAL INTUBATION D. R. DERBYSHIRE, G. SMITH AND K. J. ACHOLA Hypertenson and tachycarda assocated
European Medicines Agency decision
EMA/501874/2008 European Medicines Agency decision P/0303/2016 of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for
European Medicines Agency decision
EMA/279562/2017 European Medicines Agency decision P/0129/2017 of 8 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Split influenza virus, inactivated containing
European Medicines Agency decision
EMA/106209/2017 European Medicines Agency decision P/0074/2017 of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for
Lessons learned on the review of the labelling of pandemic vaccines
Lessons learned on the review of the labelling of pandemic vaccines Presented on 29-30 April 2015 by Thomas Girard Regulatory Affairs Officer Regulatory Affairs Office An agency of the European Union Problems
European Medicines Agency decision
EMA/776083/2014 European Medicines Agency decision P/0001/2015 of 7 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta) (EMEA-000498-PIP01-08-M04)
Paediatric Investigation Plans for treatment of osteoporosis
Paediatric Investigation Plans for treatment of osteoporosis Presentation to EMA expert meeting 2 June 2014 Presented by: Richard Veselý Scientific officer An agency of the European Union The European
Ependymal cells Cilia on one surface Movement of material or fluid over surface of the cell
2004 Bology GA 1: Wrtten examnaton 1 SPECIFIC INFMATION Secton A Multple-choce Ths table ndcates the approxmate percentage of students choosng each dstractor. The correct answer s the shaded alternatve.
European Medicines Agency decision
EMA/131632/2016 European Medicines Agency decision P/0082/2016 of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetracaine (hydrochloride) / oxymetazoline
European Medicines Agency decision
EMA/666038/2017 European Medicines Agency decision P/0323/2017 of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP05-15-M02)
List of nationally authorised medicinal products
28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol Procedure no.: PSUSA/00010245/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
Reflection paper on assessment of cardiovascular safety profile of medicinal products
25 February 2016 EMA/CHMP/50549/2015 Committee for Medicinal Products for Human Use (CHMP) Reflection paper on assessment of cardiovascular safety profile of medicinal products Draft agreed by Cardiovascular
European Medicines Agency decision
EMA/508734/2014 European Medicines Agency decision P/0246/2014 of 29 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for nanobody directed towards the
AlereTM. i Influenza A & B. Enter. Molecular results in less than 15 minutes
Molecular results n less than 15 mnutes Enter Transformng patent management sothermal amplfcaton technology gvng you molecular results, faster than ever before Improvng patent care Gvng you the confdence
Opinion of the HMPC on a European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma
EMA/HMPC/195629/2018 EMA/HMPC/M/H/0219 Committee on Herbal Medicinal Products (HMPC) Opinion of the HMPC on a European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma Opinion The HMPC,
Overview of comments received on the draft 'Information in the package leaflet for aspartame' (EMA/CHMP/134648/2015)
9 October 2017 EMA/CHMP/581993/2016 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on the draft 'Information in the package leaflet for aspartame' (EMA/CHMP/134648/2015)
European Medicines Agency decision
EMA/434825/2017 European Medicines Agency decision P/0235/2017 of 9 August 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for venetoclax (Venclyxto), (EMEA-002018-PIP02-16)