18669 results
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,
, Revision: 17, Authorised, Last updated: 24/06/2021
Filgrastim Hexal Agranulocytosis Leukopenia Leukocyte Disorders Hematologic … section What is Filgrastim Hexal? Filgrastim Hexal is a solution for injection … million units). Filgrastim Hexal is a ‘biosimilar medicine' … -
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … Overview On 21 July 2011, Hexal AG officially notified the Committee … authorisation for Ibandronic Acid Hexal, for the prevention of skeletal … -
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Authorised, Last updated: 30/05/2022
Temozolomide Hexal Cancer Neuroectodermal … Report (EPAR) for Temozolomide Hexal. It explains how the Committee … conditions of use for Temozolomide Hexal. What is Temozolomide Hexal? Temozolomide Hexal is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 12, Authorised, Last updated: 24/09/2021Rivastigmine 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 … -
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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Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012
Clopidogrel Hexal Peripheral Vascular Diseases Acute … authorisation for Clopidogrel Hexal has been withdrawn at the … Summary documents Clopidogrel Hexal : EPAR - Summary for the … -
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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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 23, Authorised, Last updated: 25/11/2021Authorised Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Valdoxan. It explains how the Agency assessed the medicine to … -
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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: 23, Authorised, Last updated: 24/11/2021Authorised Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Thymanax. It explains how the Agency assessed the medicine to … -
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Human medicine European public assessment report (EPAR): Fabrazyme (updated)
agalsidase beta, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 33, Authorised, Last updated: 15/06/2022Authorised agalsidase beta Overview This is a summary … on the European Medicines Agency website. European public … responsible for preparing the Agency's opinions on questions concerning … -
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Human medicine European public assessment report (EPAR): Replagal
agalsidase alfa, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 25, Authorised, Last updated: 13/05/2022agalsidase alfa … Replagal, INN-agalsidase alfa 30 Churchill … 5EU ● United Kingdom An agency of the European Union … -
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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 … -
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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 … -
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Herbal medicinal product: Agrimoniae herba
Agrimonia eupatoria L., Agrimony, F: Assessment finalised, Last updated: 03/08/2015Agrimoniae 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 … -
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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 … -
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Herbal medicinal product: Agropyri repentis rhizoma
Agropyron repens (L.) P. Beauv., Couch grass rhizome, F: Assessment finalised, Last updated: 30/07/2021Agropyri repentis rhizoma Urinary … rview The European Medicines Agency is currently developing this … this information. Key facts Agropyri repentis rhizomaCouch grass … -
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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 … -
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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 … marketing authorisation for Agenerase has been withdrawn at the … holder. Summary documents Agenerase : EPAR - Summary for the … -
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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 Overview Please … Control Biomedical Laboratories AG, Germany, for murine anti-idiotypic … murine anti-idiotypic antibody against OC125 antibody … -
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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 … -
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Orphan designation: Aganirsen for: Treatment of central retinal vein occlusion
Date of designation: 10/06/2014, Positive, Last updated: 10/07/2014Aganirsen Overview On 10 June 2014 … Gene Signal SAS, France, for aganirsen for the treatment of central … information to show that aganirsen might be of significant benefit … -
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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 … -
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Orphan designation: Agammaglobulinaemia tyrosine kinase for: Treatment of pemphigus
Date of designation: 12/12/2017, Withdrawn, Last updated: 15/11/2021Agammaglobulinaemia tyrosine kinase … 5EU ● United Kingdom An agency of the European Union … © European Medicines Agency, 2021. Reproduction is authorised … -
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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 … -
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Orphan designation: human monoclonal antibody against activin A for: Treatment of fibrodysplasia ossificans progressiva
Date of designation: 18/11/2016, Positive, Last updated: 07/10/2021human monoclonal antibody against activin A Overview On 18 … medicine intended for use against a rare condition. The medicine … human monoclonal antibody against activin A (also known as …