1074 results
-
List item
National expert: Astri Lindgren-Mandahl, Medical Products Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.56 KB | PDF
Vitae PERSONAL INFORMATION Astri Lindgren-Mandahl WORK EXPERIENCE January … Lindgren-Mandahl 2020-12-17 Classified as … declaration of interests I, Astri Lindgren-Mandahl Organisation/Company: Medical … -
List item
National expert: Elin Lindhagen, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 23.42 KB | PDF
Vitae PERSONAL INFORMATION Elin Lindhagen WORK EXPERIENCE September … Wickström M, Larsson R, Lindhagen E. In vitro evaluation of … Medicine Agency 2. Norberg M, Lindhagen E, Kanduri M, Rickardson … -
List item
National expert: Ines Lindner, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.75 KB | PDF
- Curriculum Vitae - 17.68 KB | PDF
Vitae PERSONAL INFORMATION Ines Lindner WORK EXPERIENCE December … regulatory affairs Publications - Lindner I., Meier C, Url A., Unger … Agency May21;11-24. - Rehmann H., Awad WA., Lindner I., Hess M., Zentek J. Clostridium … -
List item
National expert: Eva M Lindberg, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 16.25 KB | PDF
Vitae PERSONAL INFORMATION Eva M Lindberg WORK EXPERIENCE August … Lindberg 2020-12-08 Classified as … declaration of interests I, Eva M Lindberg Organisation/Company: Swedish … -
List item
National expert: Linda Dalin, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 16.45 KB | PDF
Vitae PERSONAL INFORMATION Linda Dalin WORK EXPERIENCE February … declaration of interests I, Linda Dalin Organisation/Company … EMA website. Full Name: Linda Dalin Date: 2020-12-08 For … -
List item
National expert: Linda Trauffler, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.66 KB | PDF
Vitae PERSONAL INFORMATION Linda Trauffler WORK EXPERIENCE October … declaration of interests I, Linda Trauffler Organisation/Company … EMA website. Full Name: Linda Trauffler Date: 2020-12-07 For … -
List item
National expert: Linda Marchioro, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.21 KB | PDF
- Curriculum Vitae - 16.53 KB | PDF
Vitae PERSONAL INFORMATION Linda Marchioro WORK EXPERIENCE August … declaration of interests I, Linda Marchioro Organisation/Company … EMA website. Full Name: Linda Marchioro Date: 2020-12-15 For … -
List item
National expert: Cajsa Charlotta Lindberg, European Medicines Agency (updated)
- Declaration of interests - 80.69 KB | PDF
- Curriculum Vitae - 21.59 KB | PDF
INFORMATION Cajsa Charlotta Lindberg WORK EXPERIENCE December … Lindberg 2020-12-31 Classified as … interests I, Cajsa Charlotta Lindberg Organisation/Company: International … -
List item
National expert: Wim Van Linden, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.09 KB | PDF
Vitae PERSONAL INFORMATION Wim Van Linden WORK EXPERIENCE August … senior GMP inspector Wim Van Linden (Belgium) GMP inspections EDUCATION … Van Linden 2020-12-09 Classified as … -
List item
National expert: Linda van Orsouw, Health and Youth Care Inspectorate â Pharmaceutical Products (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.89 KB | PDF
Vitae PERSONAL INFORMATION Linda van Orsouw WORK EXPERIENCE September … declaration of interests I, Linda van Orsouw Organisation/Company … EMA website. Full Name: Linda van Orsouw Date: 2021-01-19 For … -
List item
National expert: Neal Lindsay Millar, European Medicines Agency (updated)
- Declaration of interests - 80.34 KB | PDF
- Curriculum Vitae - 21.03 KB | PDF
Vitae PERSONAL INFORMATION Neal Lindsay Millar WORK EXPERIENCE February … declaration of interests I, Neal Lindsay Millar Organisation/Company … Neal Lindsay Millar … -
List item
Orphan designation: propranolol hydrochloride for: Treatment of von Hippel-Lindau disease
Date of first decision: 27/02/2017, Positive, Last updated: 31/03/2017the treatment of von Hippel-Lindau disease. Expand section Collapse … section What is von Hippel-Lindau disease? Von Hippel Lindau disease is a genetic disease … patients with von Hippel-Lindau disease, the defective gene … -
List item
Human medicine European public assessment report (EPAR): Orlaam
levacetylmethadol, Opioid-Related Disorders
Date of authorisation: 01/07/1997, Withdrawn, Last updated: 30/06/2002treatment plan including medical, social and psychological … treatment plan including medical, social and psychological … -
List item
Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile for: Treatment of von Hippel-Lindau disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020the treatment of von Hippel-Lindau disease. Expand section Collapse … section What is von Hippel-Lindau disease? Von Hippel Lindau disease is a genetic disease … -
List item
Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 4, Authorised, Last updated: 30/09/2020years who are also receiving medical, social and psychological … dependence within a framework of medical, social and psychological … -
List item
Human medicine European public assessment report (EPAR): Suboxone (updated)
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 19, Authorised, Last updated: 26/02/2021age, who are also receiving medical, social and psychological … patient also receiving other medical, social and psychological … -
List item
National expert: Martin Hohenegger, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 81.14 KB | PDF
- Curriculum Vitae - 28.41 KB | PDF
31999-32007 8. JOCKERS, R., LINDER, M., HOHENEGGER, M., NANOFF … funding for trials related to medical/pharmaceutical products. I am a member … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com PM: decision on the application … -
List item
Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,
, Revision: 19, Authorised, Last updated: 24/02/2021
that can be triggered by medical, dental or surgical procedures … responding. For prevention before a medical, dental or surgical procedure … in patients undergoing a medical, surgical or dental procedure … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com Decision type PM: decision … -
List item
Human medicine European public assessment report (EPAR): Possia
ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome
Date of authorisation: 03/12/2010, Revision: 2, Withdrawn, Last updated: 22/04/2013including patients managed medically, and those who are managed … -
List item
Human medicine European public assessment report (EPAR): INOmax
Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency
Date of authorisation: 01/08/2001, Revision: 22, Authorised, Last updated: 15/01/2021marketing-authorisation holder is Linde Healthcare AB. The marketing … marketing authorisation holder is Linde Healthcare AB. The marketing … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Orkambi, Lumacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001582-PIP01-13-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 06/12/2019, Last updated: 02/04/2020, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com Decision type PM: decision … -
List item
Third European Medicines Agency-Medicines for Europe bilateral meeting
European Medicines Agency, Amsterdam, the Netherlands, 23/03/2020, Last updated: 10/03/2020Linda Malaguti Follow link linda.malaguti@ema.europa.eu …