276 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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … Ibandronic Acid Hexal: Withdrawal of the marketing … authorisation) Ibandronic Acid Hexal ibandronic acid On … -
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Human medicine European public assessment report (EPAR): Temozolomide Hexal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 27/02/2023
Temozolomide Hexal Cancer Neuroectodermal … Report (EPAR) for Temozolomide Hexal. It explains how the Committee … conditions of use for Temozolomide Hexal. Summary documents Temozolomide … -
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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: 21, Authorised, Last updated: 10/02/2023
Filgrastim Hexal Agranulocytosis Leukopenia Leukocyte … EPAR). What is Filgrastim Hexal? Filgrastim Hexal is a solution for injection … million units). Filgrastim Hexal is a ‘ A medicine that … -
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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: 14, Authorised, Last updated: 13/10/2022Rivastigmine Hexal Nervous System Diseases Central … EPAR). What is Rivastigmine Hexal? Rivastigmine Hexal is a medicine containing … be used for Rivastigmine Hexal (‘informed consent’ … -
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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Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012
Clopidogrel Hexal Peripheral Vascular Diseases Acute … authorisation for Clopidogrel Hexal has been withdrawn at the … Summary documents Clopidogrel Hexal : EPAR - Summary for the … -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 … dossier The applicant Hexal Biotech Forschungs GmbH submitted … -
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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 … application for Ibandronic acid Hexal (ibandronic acid … Hexal AG withdraws its marketing … -
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Referral: Methylphenidate Hexal
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Hexal … medicine Methylphenidate Hexal. The Agency's Committee for … benefits of Methylphenidate Hexal outweigh its risks, and the … -
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Referral: Alendronate HEXAL
alendronic acid (as sodium alendronate trihydrate), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 13/04/2007, Last updated: 20/08/2007Alendronate HEXAL … decision Overview Alendronate HEXAL and associated names, 10 … post-menopausal osteoporosis. Hexal A/S submitted applications … -
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Referral: Lansoprazol HEXAL 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 15/09/2005Lansoprazol HEXAL 15 mg and 30 mg … decision Overview Lansoprazol HEXAL (lansoprazole) is a proton … Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously … -
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National expert: Heinz Wiendl, European Medicines Agency (updated)
- Declaration of interests - 87.64 KB | PDF
- Curriculum Vitae - 24.64 KB | PDF
Therapy 09/2022-(current) Hexal-Sandoz Multiple Sclerosis Therapy … -
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Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel … Pharma GmbH: EPAR Clopidogrel Hexal: EPAR Clopidogrel ratiopharm … Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm … -
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National expert: Mieke van der Meulen, Health And Youth Care Inspectorate (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 18.47 KB | PDF
2002-December 2003 Manager QA/QP Hexal Pharma Nederland B.V. (Netherlands) Create/maintain … -
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Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine, paracetamol, phenylephrine (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases; Oto-rhino-laryngology
PIP number: EMEA-003091-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 31/12/2021, Last updated: 14/03/2023, Compliance check: Xtract infections Oral use HEXAL AG Email: enquiries.paediatrics@sandoz.com … application submitted by Hexal AG on 9 August 2021 under … decision is addressed to HEXAL AG, Industriestrasse 25 … -
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Referral: Metamizole containing medicinal products
metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan … -
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 22, Authorised, Last updated: 10/02/2023
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National expert: Christoph Mueck, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 20.07 KB | PDF
Manager Quality Assurance HEXAL AG/Sandoz (Germany) Management … -
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News: Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease
CHMP, Last updated: 23/10/2007NeoRecormon, Binokrit, Epoetin Alfa Hexal, Abseamed) to submit an application … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Epoetin alfa Hexal, Kalydeco, Mekinist, Nucala … -
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram Ecitrix, Escitalopram Hexal Escitalopram Ratiopharm … B.V, CT-Arzneimittel GmbH, Hexal AG, Ratiopharm GmbH, Ratiopharm … Escitalopram Ecitrix, Escitalopram Hexal Escitalopram Ratiopharm … -
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Referral: Lansopon 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 13/10/2005was previously granted to Hexal AG in Finland on 7 November … was previously granted to Hexal AG in Finland on 7 November … hard Oral use Belgium - HEXAL AG Industriestraße 25 D-83607 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013
CHMP, Last updated: 26/07/2013Methylphenidate Hexal … -
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Press release: EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding
CHMP, Last updated: 14/12/2018Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan … -
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Referral: Sabumalin
salbutamol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 30/03/2009Why was Sabumalin reviewed? Hexal AG submitted Sabumalin to … was Sabumalin reviewed? Hexal AG submitted Sabumalin to … concentration) Belgium Hexal AG Industriestr. 25 83607 … -
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Referral: Sanohex
salbutamol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 30/03/2009Why was Sanohex reviewed? Hexal AG submitted Sanohex to the … Why was Sanohex reviewed? Hexal AG submitted Sanohex to the … Austria Hexal AG Industriestr. 25 83607 …