40 results
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Human medicine European public assessment report (EPAR): Pantecta Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 12/06/2009, Revision: 7, Withdrawn, Last updated: 15/11/2016Pantecta Control Gastroesophageal … marketing authorisation for Pantecta Control has been withdrawn … holder. Summary documents Pantecta Control : EPAR - Summary … -
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Referral: Pantoprazole Bluefish
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 09/03/2011on the reference medicine Pantecta. Why was Pantoprazole Bluefish … Pantoprazole Bluefish and Pantecta. Bioequivalence studies are … on the reference medicine Pantecta. Why was Pantoprazole Bluefish … -
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Referral: Pantoprazole Olinka (EMEA/H/A-29/1169)
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 08/03/2011on the reference medicine Pantecta. Why was Pantoprazole Olinka … comparing Pantoprazole Olinka and Pantecta. Bioequivalnce studies are … on the reference medicine Pantecta. Why was Pantoprazole Olinka … -
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Referral: Pantoprazole Olinka (EMEA/H/A-29/1170)
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 08/03/2011on the reference medicine Pantecta. Why was Pantoprazole Olinka … comparing Pantoprazole Olinka and Pantecta. Bioequivalnce studies are … on the reference medicine Pantecta. Why was Pantoprazole Olinka … -
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Referral: Protium
pantoprazole, associated names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20 / 40 / IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale, Zurcazol, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 15/04/2010, Last updated: 17/01/2012Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40 … Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40 … -
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Human medicine European public assessment report (EPAR): Pantoloc Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 18, Withdrawn, Last updated: 18/01/2022Control, Controloc Control, Pantecta Control and Pantozol Control … Control, Controloc Control, Pantecta Control and Pantozol Control … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19 November 2009
CHMP, Last updated: 20/11/2009to the reference medicine Pantecta. The Committee concluded that … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013Aurobindo 200mg capsule rigide gastroresistenti 200 mg Gastro-resistant … Aurobindo 250mg capsule rigide gastroresistenti 250 mg Gastro-resistant … Aurobindo 400mg capsule rigide gastroresistenti 400 mg Gastro-resistant … -
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Referral: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of cystinosis
Date of designation: 20/09/2010, Positive, Last updated: 10/10/2013 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
European Medicines Agency, London, UK, from 02/12/2013 to 05/12/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-8 July 2016
European Medicines Agency, London, UK, from 04/07/2016 to 08/07/2016, Last updated: 04/07/2016 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2015
European Medicines Agency, London, UK, from 07/04/2015 to 10/04/2015, Last updated: 20/05/2015 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2015
European Medicines Agency, London, UK, from 06/07/2015 to 09/07/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 March 2016
European Medicines Agency, London, UK, from 14/03/2016 to 17/03/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 January 2017
European Medicines Agency, London, UK, from 09/01/2017 to 12/01/2017, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2014
European Medicines Agency, London, UK, from 03/11/2014 to 06/11/2014, Last updated: 13/08/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018
European Medicines Agency, London, UK, from 23/04/2018 to 26/04/2018, Last updated: 08/06/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2016
European Medicines Agency, London, UK, from 28/11/2016 to 01/12/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 30 August - 2 September 2016
European Medicines Agency, London, UK, from 30/08/2016 to 02/09/2016, Last updated: 13/03/2014CONTROLOC CONTROL (CAP), PANTECTA CONTROL (CAP), PANTOLOC CONTROL …