16799 results
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … Website www.ema.europa.eu An agency of the European Union … © European Medicines Agency, 2011. Reproduction is authorised … -
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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: 11, Authorised, Last updated: 17/11/2020Rivastigmine Hexal Dementia Alzheimer Disease Parkinson … section 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): Temozolomide Hexal
temozolomide, Glioma, Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 16, Authorised, Last updated: 22/07/2020
Temozolomide Hexal Glioma Glioblastoma … Report (EPAR) for Temozolomide Hexal. It explains how the Committee … conditions of use for Temozolomide Hexal. Expand section Collapse section … -
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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: 16, Authorised, Last updated: 10/10/2019
Filgrastim Hexal Neutropenia Hematopoietic … section What is Filgrastim Hexal? Filgrastim Hexal is a solution for injection … million units). Filgrastim Hexal is a ‘biosimilar medicine' … -
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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Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012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 … details Name Clopidogrel Hexal Agency product number EMEA/H/C/001139 … Website www.ema.europa.eu An agency of the European Union … -
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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 Anemia Kidney Failure … 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: 25/02/2020Agni casti fructus Urinary tract … Agni casti fructus … of the monograph on Vitex agnus-castus L., fructus 14 October … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 22, Authorised, Last updated: 14/01/2021Agomelatine … Valdoxan, INN-agomelatine 30 Churchill Place … 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 authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 22, Authorised, Last updated: 14/01/2021Agomelatine … 5EU ● United Kingdom An agency of the European Union … © European Medicines Agency, 2016. Reproduction is authorised … -
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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 … Agrimoniae herba … Assessment report on Agrimonia eupatoria L., herba 6 … -
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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: 27/07/2006Agomelatine … 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: 27/07/2006Agomelatine … 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): Fabrazyme
agalsidase beta, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 29, Authorised, Last updated: 03/11/2020Authorised 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: 22, Authorised, Last updated: 31/01/2018Authorised agalsidase alfa 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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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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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 … Website www.ema.europa.eu An agency of the European Union … © European Medicines Agency, 2012. Reproduction is authorised … -
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Herbal medicinal product: Agropyri repentis rhizoma
Agropyron repens (L.) P. Beauv., Couch grass rhizome, F: Assessment finalised, Last updated: 31/01/2020Agropyri repentis rhizoma Urinary … Agropyri repentis rhizoma … Agropyron repens - monograph … -
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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 … Agenerase … Website www.ema.europa.eu An agency of the European Union … -
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Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli) (updated)
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: 13, Authorised, Last updated: 23/02/2021calves less than 12 hours of age … ● The Netherlands An agency of the European Union … © European Medicines Agency, 2021. Reproduction is authorised … -
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Orphan designation: Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen for: Treatment of ovarian cancer
Date of first decision: 09/07/2003, Withdrawn, Last updated: 13/01/2014Control Biomedical Laboratories AG, Germany, for murine anti-idiotypic … murine anti-idiotypic antibody against OC125 antibody against CA125 antigen (ACA125) for … most ovarian cancers grow again and respond moderately or … -
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Orphan designation: Aganirsen for: Treatment of central retinal vein occlusion
Date of first decision: 10/06/2014, Positive, Last updated: 10/07/2014Gene Signal SAS, France, for aganirsen for the treatment of central … information to show that aganirsen might be of significant benefit … medicine expected to work? Aganirsen is an 'antisense oligonucleotide' … -
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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-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/12/2019, Last updated: 01/04/2020, Compliance check: Xassociated names Active substance Agomelatine Therapeutic area Psychiatry … application for modification of an agreed PIP … Agomelatine … -
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Veterinary medicine European public assessment report (EPAR): Equilis Te (updated)
tetanus toxoid, Horses
Date of authorisation: 08/07/2005, Revision: 8, Authorised, Last updated: 15/02/2021Adjuvanted vaccine against tetanus … ● The Netherlands An agency of the European Union … © European Medicines Agency, 2021. Reproduction is authorised … -
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Orphan designation: Agammaglobulinaemia tyrosine kinase for: Treatment of pemphigus
Date of first decision: 12/12/2017, Positive, Last updated: 27/08/2020Ltd, United Kingdom, for agammaglobulinaemia tyrosine kinase (also known … opinion on orphan designation Agammaglobulinaemia tyrosine kinase for the treatment … 5EU ● United Kingdom An agency of the European Union … -
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Orphan designation: human monoclonal antibody against activin A for: Treatment of fibrodysplasia ossificans progressiva
Date of first decision: 18/11/2016, Positive, Last updated: 06/01/2020human monoclonal antibody against activin A (also known as … Human monoclonal antibody against activin A for the treatment … 5EU ● United Kingdom An agency of the European Union …