European Medicines Agency - What's New

14 Jul ' 09:06

14/07/10 Guide to the European Medicines Agency
Provides names and contact details of the Agency's management staff and brief descriptions of the role of each Unit. About Us Organisational structure

14/07/10 Organisation chart of the European Medicines Agency About Us Organisational structure

14/07/10 CHMP revised EPAR on: HumiraINN: adalimumabRev. 20 Human Medicines EPARs

14/07/10 Draft: ICH Topic Q 3 C (R4) Impurities: Guideline for residual solvents PDE Cumene Human Medicines
International Conference on Harmonisation (ICH) - Quality

14/07/10 Revision to: ICH Topic Q 3 C (R3) Impurities: Residual Solvents Human Medicines
International Conference on Harmonisation (ICH) - Quality

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14 Jul ' 04:32

14/07/10 CVMP revised EPAR on: MetacamINN: meloxicamRev. 9 Veterinary Medicines EPARs

14/07/10 May 2010 overview of initial notices for parallel distribution issued by European Medicines Agency Human Medicines Parallel Distribution - Post-authorisation guidance & documents

14/07/10 April 2010 overview of initial notices for parallel distribution issued by European Medicines Agency Human Medicines Parallel Distribution - Post-authorisation guidance & documents

14 July, 2010

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13 Jul ' 08:04

13/07/10 CHMP revised EPAR on: ViagraINN: sildenafilRev. 15 Human Medicines EPARs

13/07/10 CVMP revised EPAR on: SuprelorinINN: Deslorelin acetate Rev. 2 Veterinary Medicines EPARs

13 July, 2010

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12 Jul ' 13:36

12/07/10 Mandate, objectives and composition for the HMPC Quality Drafting Group (Q DG) About us HMPC - HMPC working parties and other groups - Quality Drafting Group

12/07/10
CHMP revised EPARs on:

AzilectINN: rasagilineRev. 8
MacugenINN: pegaptanib sodiumRev. 7
MirapexinINN: pramipexoleRev. 20
MirceraCommon name: methoxy polyethylene glycol-epoetin betaRev. 8
NevanacINN: nepafenacRev. 2
Pramipexole TevaINN: pramipexoleRev. 3
QutenzaINN: capsaicinRev. 3
SifrolINN: pramipexoleRev. 19
Human Medicines EPARs

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12 Jul ' 06:55

12/07/10 Draft reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development Human Medicines Scientific Guidelines - Multidisciplinary

12/07/10 MelovemINN: meloxicamRev. 2

CVMP revised EPARs on:
Veterinary Medicines EPARs

12 July, 2010

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09 Jul ' 17:44

CVMP revised EPAR on:

ProfenderINN: Emodepside & PraziquantelRev. 6QuadrisolINN: vedaprofenRev. 16
Veterinary Medicines

09/07/10
BonvivaINN: ibandronic acidRev. 14

EPARs

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09 Jul ' 05:36

09/07/10 New EMA Standard Operating Procedure: Input of risk level in the experts database and its evaluation Standard Operating Procedures and Work Instructions

09/07/10 Press Release - European Medicines Agency starts review of rosiglitazone-containing medicines Press Office

09/07/10
CHMP revised EPARs on:

RapamuneINN: sirolimusRev. 20
SutentINN: sunitinibRev. 11
ToriselINN: temsirolimusRev. 8
TyverbINN:lapatinib ditosylate monohydrate Rev. 5
Human Medicines

CVMP revised EPARs on:
Veterinary Medicines EPARs

9 July, 2010

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08 Jul ' 14:28

08/07/10
CVMP revised EPAR on:

CortavanceINN: hydrocortisone aceponateRev. 2
TrocoxilINN: MavacoxibRev. 2
Veterinary Medicines EPARs

08/07/10
Updated EMA Standard Operating Procedures on:

- Preparation and approval of new Standard Operating Procedures
- Review and revision of effective Standard Operating Procedures
- Preparation and approval of new Work Instructions
- Review and revision of effective Work Instructions
- Publication or withdrawal of SOPs and WINs
General Reporting Standard Operating Procedures and Work Instructions

08/07/10 Updated EMA Work Instructions on:
- Creating flow charts for SOPs and WINs
- Creating and maintaining SOP/WIN folders in EDMS General Reporting Standard Operating Procedures and Work Instructions

08/07/10
New CHMP EPARs on:

HumenzaCommon name: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
VotrientINN: pazopanib
Human Medicines EPARs

08/07/10 Adopted reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors Human Medicines Scientific guidelines - Multidisciplinary - Gene Therapy

08/07/10 Overview of comments received on 'Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors' Human Medicines Scientific guidelines - Multidisciplinary - Gene Therapy

08/07/10 Press Release - European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network Press Office

08/07/10
CHMP revised EPARs on:

BondenzaINN: ibandronic acidRev. 13
FosavanceINN: alendronate sodium/colecalciferolRev. 10
AloxiINN: palonosetronRev. 11
DepocyteINN: cytarabineRev. 10
OnsenalINN: celecoxibRev. 12
OpgenraINN: eptotermin alfaRev. 3
Human Medicines EPARs

08/07/10 Announcement of EMA priorities for adverse drug reaction research Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 European Medicines Agency 2010 Priorities for Drug Safety Research
Insulin/ insulin analogues and cancer Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 European Medicines Agency 2011 Priorities for Drug Safety Research
Anti diabetic drugs: Cardio/cerebrovascular adverse effect and pancreatitis/ pancreatic cancer Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 European Medicines Agency 2011 Priorities for Drug Safety Research
Epoetins and tumour progression, shortened survival, mortality and thromboembolic events Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 European Medicines Agency 2011 Priorities for Drug Safety Research
Asthma treatments (long and short-acting Beta agonists and anticholinergics): risk of myocardial ischaemia and long term safety, especially in children Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 European Medicines Agency 2011 Priorities for Drug Safety Research
Gadolinium-containing contrast agents and nephrogenic systemic fibrosis: Long-term consequences of retention in human skin and bone Human Medicines Pharmacovigilance guidelines and documents - Communications

08/07/10 Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders Human Medicines Scientific Guidelines - Clinical efficacy and safety

8 July, 2010

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06 Jul ' 12:34

06/07/10 Monthly report from the CAT's June meeting Press Office

06/07/10 Updated Briefing meeting request form Human Medicines Special Topics - Medicines and Emerging Science - Innovation Task Force

06/07/10 CVMP revised EPAR on: AdvocateINN: imidacloprid and moxidectinRev. 8 Veterinary Medicines EPARs

06/07/10
Revised CHMP EPARs on:

ArcalystINN: rilonacept Rev. 1
CrixivanINN: indinavirRev. 27
KiovigINN: human normal immunoglobulin (IVIg)Rev. 6
Avastin INN: bevacizumabRev. 15
Vidaza INN: azacitidineRev. 2
NonafactINN: human coagulation factor IXRev. 6
SolirisINN: eculizumabRev. 5
Human Medicines EPARs

06/07/10 Press Release - European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage Press Office

06/07/10 European Medicines Agency guidance for companies requesting scientific advice or protocol assistanceRev. 6 Human Medicines Application Procedures - Scientific Advice and Protocol Assistance

06/07/10 Monthly report from the CVMP June meeting Press Office

6 July, 2010

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05 Jul ' 11:55

05/07/10 Revised CVMP EPAR on: Ingelvac CircoFLEXCommon name: vaccine against porcine circovirus Rev. 2 Veterinary Medicines EPARs

05/07/10 New CHMP EPAR on: DocefrezINN: docetaxel Human Medicines EPARs

5 July, 2010

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European Medicines Agency - What's New

14 Jul ' 09:06

14 Jul ' 04:32

13 Jul ' 08:04

12 Jul ' 13:36

12 Jul ' 06:55

09 Jul ' 17:44

09 Jul ' 05:36

08 Jul ' 14:28

06 Jul ' 12:34

05 Jul ' 11:55

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14/07/10	Guide to the European Medicines Agency Provides names and contact details of the Agency's management staff and brief descriptions of the role of each Unit.	About Us	Organisational structure
14/07/10	Organisation chart of the European Medicines Agency	About Us	Organisational structure
14/07/10	CHMP revised EPAR on: HumiraINN: adalimumabRev. 20	Human Medicines	EPARs
14/07/10	Draft: ICH Topic Q 3 C (R4) Impurities: Guideline for residual solvents PDE Cumene	Human Medicines	International Conference on Harmonisation (ICH) - Quality
14/07/10	Revision to: ICH Topic Q 3 C (R3) Impurities: Residual Solvents	Human Medicines	International Conference on Harmonisation (ICH) - Quality

14/07/10	CVMP revised EPAR on: MetacamINN: meloxicamRev. 9	Veterinary Medicines	EPARs
14/07/10	May 2010 overview of initial notices for parallel distribution issued by European Medicines Agency	Human Medicines	Parallel Distribution - Post-authorisation guidance & documents
14/07/10	April 2010 overview of initial notices for parallel distribution issued by European Medicines Agency	Human Medicines	Parallel Distribution - Post-authorisation guidance & documents

13/07/10	CHMP revised EPAR on: ViagraINN: sildenafilRev. 15	Human Medicines	EPARs
13/07/10	CVMP revised EPAR on: SuprelorinINN: Deslorelin acetate Rev. 2	Veterinary Medicines	EPARs

12/07/10	Draft reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development	Human Medicines	Scientific Guidelines - Multidisciplinary
12/07/10	MelovemINN: meloxicamRev. 2
CVMP revised EPARs on:	Veterinary Medicines	EPARs

09/07/10	New EMA Standard Operating Procedure: Input of risk level in the experts database and its evaluation	Standard Operating Procedures and Work Instructions
09/07/10	Press Release - European Medicines Agency starts review of rosiglitazone-containing medicines	Press Office
09/07/10	CHMP revised EPARs on: RapamuneINN: sirolimusRev. 20 SutentINN: sunitinibRev. 11 ToriselINN: temsirolimusRev. 8 TyverbINN:lapatinib ditosylate monohydrate Rev. 5	Human Medicines
CVMP revised EPARs on:	Veterinary Medicines	EPARs

08/07/10	CVMP revised EPAR on: CortavanceINN: hydrocortisone aceponateRev. 2 TrocoxilINN: MavacoxibRev. 2	Veterinary Medicines	EPARs
08/07/10	Updated EMA Standard Operating Procedures on: - Preparation and approval of new Standard Operating Procedures - Review and revision of effective Standard Operating Procedures - Preparation and approval of new Work Instructions - Review and revision of effective Work Instructions - Publication or withdrawal of SOPs and WINs	General Reporting	Standard Operating Procedures and Work Instructions
08/07/10	Updated EMA Work Instructions on: - Creating flow charts for SOPs and WINs - Creating and maintaining SOP/WIN folders in EDMS	General Reporting	Standard Operating Procedures and Work Instructions
08/07/10	New CHMP EPARs on: HumenzaCommon name: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) VotrientINN: pazopanib	Human Medicines	EPARs
08/07/10	Adopted reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors	Human Medicines	Scientific guidelines - Multidisciplinary - Gene Therapy
08/07/10	Overview of comments received on 'Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors'	Human Medicines	Scientific guidelines - Multidisciplinary - Gene Therapy
08/07/10	Press Release - European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network	Press Office
08/07/10	CHMP revised EPARs on: BondenzaINN: ibandronic acidRev. 13 FosavanceINN: alendronate sodium/colecalciferolRev. 10 AloxiINN: palonosetronRev. 11 DepocyteINN: cytarabineRev. 10 OnsenalINN: celecoxibRev. 12 OpgenraINN: eptotermin alfaRev. 3	Human Medicines	EPARs
08/07/10	Announcement of EMA priorities for adverse drug reaction research	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	European Medicines Agency 2010 Priorities for Drug Safety Research Insulin/ insulin analogues and cancer	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	European Medicines Agency 2011 Priorities for Drug Safety Research Anti diabetic drugs: Cardio/cerebrovascular adverse effect and pancreatitis/ pancreatic cancer	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	European Medicines Agency 2011 Priorities for Drug Safety Research Epoetins and tumour progression, shortened survival, mortality and thromboembolic events	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	European Medicines Agency 2011 Priorities for Drug Safety Research Asthma treatments (long and short-acting Beta agonists and anticholinergics): risk of myocardial ischaemia and long term safety, especially in children	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	European Medicines Agency 2011 Priorities for Drug Safety Research Gadolinium-containing contrast agents and nephrogenic systemic fibrosis: Long-term consequences of retention in human skin and bone	Human Medicines	Pharmacovigilance guidelines and documents - Communications
08/07/10	Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders	Human Medicines	Scientific Guidelines - Clinical efficacy and safety

06/07/10	Monthly report from the CAT's June meeting	Press Office
06/07/10	Updated Briefing meeting request form	Human Medicines	Special Topics - Medicines and Emerging Science - Innovation Task Force
06/07/10	CVMP revised EPAR on: AdvocateINN: imidacloprid and moxidectinRev. 8	Veterinary Medicines	EPARs
06/07/10	Revised CHMP EPARs on: ArcalystINN: rilonacept Rev. 1 CrixivanINN: indinavirRev. 27 KiovigINN: human normal immunoglobulin (IVIg)Rev. 6 Avastin INN: bevacizumabRev. 15 Vidaza INN: azacitidineRev. 2 NonafactINN: human coagulation factor IXRev. 6 SolirisINN: eculizumabRev. 5	Human Medicines	EPARs
06/07/10	Press Release - European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage	Press Office
06/07/10	European Medicines Agency guidance for companies requesting scientific advice or protocol assistanceRev. 6	Human Medicines	Application Procedures - Scientific Advice and Protocol Assistance
06/07/10	Monthly report from the CVMP June meeting	Press Office

05/07/10	Revised CVMP EPAR on: Ingelvac CircoFLEXCommon name: vaccine against porcine circovirus Rev. 2	Veterinary Medicines	EPARs
05/07/10	New CHMP EPAR on: DocefrezINN: docetaxel	Human Medicines	EPARs