19888 results
-
List item
Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,
, Revision: 21, Authorised, Last updated: 10/02/2023
Filgrastim Hexal Agranulocytosis Leukopenia Leukocyte Disorders Hematologic … on the European Medicines Agency website. European public … responsible for preparing the Agency's opinions on questions concerning … -
List item
Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … Overview On 21 July 2011, Hexal AG officially notified the Committee … authorisation for Ibandronic Acid Hexal, for the prevention of skeletal … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 27/02/2023
Temozolomide Hexal Cancer Neuroectodermal … details Name Temozolomide Hexal Agency product number EMEA/H/C/001127 … Marketing-authorisation holder Hexal AG Revision 17 Date of issue … -
List item
Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022Rivastigmine Hexal Nervous System Diseases Central … EPAR). What is Rivastigmine Hexal? Rivastigmine Hexal is a medicine containing … company that makes Exelon has agreed that its scientific data … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Hexal
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012
Clopidogrel Hexal Peripheral Vascular Diseases Acute … details Name Clopidogrel Hexal Agency product number EMEA/H/C/001139 … Website www.ema.europa.eu An agency of the European Union … -
List item
Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 22, Authorised, Last updated: 09/10/2019
Epoetin Alfa Hexal Female Urogenital Diseases Female … Epoetin Alfa Hexal is a medicine used for the … defective). Epoetin Alfa Hexal is used when patients are … -
List item
Herbal medicinal product: Agni casti fructus
Vitex agnus-castus L., Agnus Castus Fruit, F: Assessment finalised, Last updated: 22/10/2018Agni casti fructus Urinary tract … monographs and preparing the Agency’s opinions on questions relating … monographs and preparing the Agency’s opinions on questions relating … -
List item
Herbal medicinal product: Agrimoniae herba
Agrimonia eupatoria L., Agrimony, F: Assessment finalised, Last updated: 20/02/2023Agrimoniae herba Mouth and throat disorders Skin … monographs and preparing the Agency’s opinions on questions relating … monographs and preparing the Agency’s opinions on questions relating … -
List item
Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 24, Authorised, Last updated: 08/08/2022Authorised Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Thymanax. It explains how the Agency assessed the medicine to … -
List item
Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022Authorised Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Valdoxan. It explains how the Agency assessed the medicine to … -
List item
Human medicine European public assessment report (EPAR): Fabrazyme
agalsidase beta, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 34, Authorised, Last updated: 03/04/2023agalsidase beta … Fabrazyme, INN-agalsidase beta EMA/65766/2013 EMEA/H/C/000370 … the public Fabrazyme agalsidase beta This is a summary … -
List item
Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Refused Agomelatine Overview On 27 July 2006 … European Medicines Agency Evaluation of Medicines … International Nonproprietary Name: Agomelatine Procedure No. EMEA/H/C/656 … -
List item
Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Refused Agomelatine Overview On 27 July 2006 … European Medicines Agency Evaluation of Medicines … International Nonproprietary Name: Agomelatine Procedure No. EMEA/H/C/656 … -
List item
Human medicine European public assessment report (EPAR): Replagal
agalsidase alfa, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 28, Authorised, Last updated: 20/09/2022agalsidase alfa … Replagal, INN-agalsidase alfa 30 Churchill … 5EU ● United Kingdom An agency of the European Union … -
List item
Press release: Hexal AG withdraws its marketing authorisation application for Ibandronic acid Hexal (ibandronic acid)
Last updated: 27/07/2011Hexal AG withdraws its marketing authorisation … application for Ibandronic acid Hexal (ibandronic acid … Hexal AG withdraws its marketing authorisation … -
List item
Veterinary medicine European public assessment report (EPAR): Porcilis ColiClos
Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT, Pigs
Date of authorisation: 14/06/2012, Revision: 5, Authorised, Last updated: 26/06/2020passive immunity to the progeny against Escherichia coli and Clostridium perfringens … offspring with protection against infections caused by E. coli … defences) how to defend itself against a disease. Porcilis ColiClos … -
List item
Herbal medicinal product: Agropyri repentis rhizoma
Agropyron repens (L.) P. Beauv., Couch grass rhizome, F: Assessment finalised, Last updated: 03/10/2022Agropyri repentis rhizoma Urinary … rview The European Medicines Agency is currently developing this … this information. Key facts Agropyri repentis rhizomaCouch grass … -
List item
Human medicine European public assessment report (EPAR): Agenerase
amprenavir, HIV Infections
Date of authorisation: 20/10/2000, Revision: 18, Withdrawn, Last updated: 21/06/2011Agenerase HIV Infections … Agenerase … Website www.ema.europa.eu An agency of the European Union … -
List item
Orphan designation: Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen for: Treatment of ovarian cancer
Date of designation: 09/07/2003, Withdrawn, Last updated: 13/01/2014rine anti-idiotypic antibody against OC125 antibody against CA125 antigen … Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen for the treatment … Control Biomedical Laboratories AG, Germany, for murine anti-idiotypic … -
List item
Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, Calves, neonatal less than 12 hrs of age
Date of authorisation: 29/03/1999, Revision: 15, Authorised, Last updated: 20/10/2021calves less than 12 hours of age Overview Locatim is a veterinary … ● The Netherlands An agency of the European Union … © European Medicines Agency, 2021. Reproduction is authorised … -
List item
Orphan designation: Aganirsen for: Treatment of central retinal vein occlusion
Date of designation: 10/06/2014, Positive, Last updated: 10/07/2014Aganirsen … opinion on orphan designation Aganirsen for the treatment of central … 4HB ● United Kingdom An agency of the European Union … -
List item
Orphan designation: Humanised IgG1 monoclonal antibody against TfR1 conjugated to double stranded siRNA oligonucleotide against DMPK via a non-cleavable linker for: Treatment of myotonic disorders
Date of designation: 20/08/2021, Positive, Last updated: 09/01/2023IgG1 monoclonal antibody against TfR1 conjugated to double … stranded siRNA oligonucleotide against DMPK via a non-cleavable … ● The Netherlands An agency of the European Union … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Agomelatine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001181-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2021, Last updated: 23/11/2021, Compliance check: XValdoxan and associated names Agomelatine PsychiatryP/0115/2021EMEA-001181-PIP01-11-M06 … application for modification of an agreed PIP Decision P/0115/2021 … acceptance of a modification of an agreed paediatric investigation … -
List item
Orphan designation: Aglatimagene besadenovec for: Treatment of glioma
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023Aglatimagene besadenovec … ● The Netherlands An agency of the European Union … © European Medicines Agency, 2022. Reproduction is authorised … -
List item
Veterinary medicine European public assessment report (EPAR): Equilis Te
tetanus toxoid, Horses
Date of authorisation: 08/07/2005, Revision: 8, Authorised, Last updated: 15/02/2021Authorised Adjuvanted vaccine against tetanus Overview Equilis … horses from six months of age against tetanus to prevent mortality … apart. To retain protection against tetanus, horses need to be …