343 results
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001319-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Candesartan cilexetil Amlodipine besilate … of hypertension Oral use Zentiva k.s. Czech Republic blanka.zoubkova@zentiva.com … for amlodipine (besylate) / candesartan (cilexetil) (EMEA-001319-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: XKey facts hydrochlorothiazide Candesartan cilexetil Amlodipine besilate … of hypertension Oral use Zentiva, k.s. Tel. +42 267242361 E-mail … for amlodipine (besylate) / candesartan (cilexetil) / hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 17, Authorised, Last updated: 27/11/2020previously Sevelamer carbonate Zentiva) Hyperphosphatemia Renal … previously Sevelamer carbonate Zentiva)EMEA/H/C/003971sevelamer carbonatesevelamer carbonateHyperphosphatemiaRenal … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … -
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Referral: Atacand
candesartan, associated names: Amias, Blopress, Kenzen, Racanda, Ratacand, Parapres, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 13/07/2010, Last updated: 16/03/2011active substance in Atacand, candesartan cilexetil, is an 'angiotensin … angiotensin II normally attaches, candesartan cilexetil stops the hormone … Atacand and associated names (candesartan cilexetil 2, 4, 8, 16 and … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Zentiva (previously Docetaxel Winthrop) Docetaxel … Docetaxel Winthrop) Docetaxel Zentiva (previously Docetaxel Winthro … -
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Referral: Atacand Plus
candesartan, hydrochlorothiazide, associated names: Atacand Zid, Blopresid, Blopress Comp, Blopress Plus, CoKenzen, Hytacand, Parapres Plus, Ratacand Plus, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 16/09/2010, Last updated: 21/09/2011contains two active substances candesartan cilexetil and hydrochlorothiazide … hypertension has no obvious cause. Candesartan is an 'angiotensin II receptor … angiotensin II normally attaches, candesartan stops the hormone having … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,
, Revision: 10, Authorised, Last updated: 14/09/2021
Pregabalin Zentiva Anxiety Disorders Epilepsy … report (EPAR) for Pregabalin Zentiva. It explains how the Agency … on how to use Pregabalin Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 8, Authorised, Last updated: 19/03/2021
Aripiprazole Zentiva Schizophrenia Bipolar Disor … report (EPAR) for Aripiprazole Zentiva. It explains how the Agency … on how to use Aripiprazole Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva
duloxetine, Anxiety Disorders; Depressive Disorder, Major; Neuralgia; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/02/2021
Duloxetine Zentiva Anxiety Disorders Depressive … report (EPAR) for Duloxetine Zentiva. It explains how the Agency … on how to use Duloxetine Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 11, Authorised, Last updated: 01/10/2020Riluzole Zentiva Amyotrophic Lateral Sclerosi … report (EPAR) for Riluzole Zentiva. It explains how the Committee … conditions of use for Riluzole Zentiva. What is Riluzole Zentiva? Riluzole Zentiva is a medicine containing … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan/Hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: XCandesartan/Hydrochlorothiazide Cardiovascular diseases … Comp and associated names Candesartan hydrochlorothiazide Cardiovascular … Cardiovascular diseasesP/4/2007Candesartan/Hydrochlorothiazide Tablet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan/Hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: XCandesartan/Hydrochlorothiazide Cardiovascular diseases … Plus and associated names Candesartan hydrochlorothiazide Cardiovascular … Cardiovascular diseasesP/3/2007Candesartan/Hydrochlorothiazide Tablet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablets, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: XCandesartan cilexetil Cardiovascular … Blopress and associated names Candesartan cilexetil Cardiovascular … the refusal of a waiver for candesartan cilexetil (Blopress and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablets, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: XCandesartan cilexetil Cardiovascular … Atacand and associated name Candesartan cilexetil Cardiovascular … the refusal of a waiver for candesartan cilexetil (Atacand and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002090-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: XKey facts Candesartan amlodipine Cardiovascular … product specific waiver for candesartan / amlodipine (EMEA-002090-PIP01-16 … product specific waiver for candesartan / amlodipine (EMEA-002090-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002014-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: XActive substance Candesartan amlodipine Therapeutic area … product specific waiver for candesartan / amlodipine (EMEA-002014-PIP01-16) 30 … product specific waiver for candesartan / amlodipine (EMEA-002014-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001711-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Tablet
Decision date: 06/03/2015, Last updated: 06/07/2015, Compliance check: XKey facts Candesartan amlodipine Cardiovascular … product-specific waiver for candesartan / amlodipine (EMEA-001711-PIP01-14 … product-specific waiver: Candesartan / amlodipine for treatment … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 8, Authorised, Last updated: 07/07/2021
Pregabalin Zentiva k.s. Anxiety Disorders Neur … report (EPAR) for Pregabalin Zentiva k.s. It explains how the … on how to use Pregabalin Zentiva k.s. For practical information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: Clopidogrel, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 22/09/2009, Last updated: 07/12/2009, Compliance check: XInvented name Clopidogrel Zentiva (previously Clopidogrel Winthrop … Clopidogrel Zentiva (previously Clopidogrel Winthrop) Clopidogrel … Clopidogrel Winthrop) Clopidogrel Zentiva (previously Clopidogrel Winth … -
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Human medicine European public assessment report (EPAR): Ivabradine Zentiva
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 11/11/2016,, Revision: 2, Authorised, Last updated: 06/03/2020
Ivabradine Zentiva Angina Pectoris Heart Failu … report (EPAR) for Ivabradine Zentiva. It explains how the Agency … on how to use Ivabradine Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop) (updated)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 26, Authorised, Last updated: 06/09/2021Irbesartan Zentiva (previously Irbesartan Winthr … report (EPAR) for Irbesartan Zentiva. It explains how the The committee … conditions of use for Irbesartan Zentiva. What is Irbesartan Zentiva? Irbesartan Zentiva is a medicine that contains … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002248-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Candesartan cilexetil Amlodipine besilate … product specific waiver for candesartan (cilexetil) / amlodipine … product specific waiver for candesartan (cilexetil) / amlodipine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001633-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2015, Last updated: 10/03/2015, Compliance check: XKey facts Candesartan cilexetil Amlodipine besilate … product specific waiver for candesartan (cilexetil) / amlodipine … product-specific waiver: Candesartan (cilexetil)/amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nifedipine, Candesartan cilexetil
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001252-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 29/05/2012, Last updated: 25/06/2012, Compliance check: XKey facts Nifedipine Candesartan cilexetil Cardiovascular … specific waiver for nifedipine / candesartan (cilexetil), (EMEA-001252 … specific waiver for nifedipine / candesartan (cilexetil), (EMEA-001252- PIP01-11 …