570 results
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium Cardiovascular … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13) PDF … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15 … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/228/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/226/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/227/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, hydrochlorothiazide, 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-002104-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: XActive substance Olmesartan medoxomil hydrochlorothiazide Amlodipine … product specific waiver for olmesartan medoxomil / amlodipine (besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
List item
Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022Authorised azilsartan medoxomil Overview This is a summary … active substance azilsartan medoxomil. It is available as tablets … substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin-II-receptor … -
List item
Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,
, Revision: 4, Withdrawn, Last updated: 19/12/2014
Withdrawn azilsartan medoxomil Overview The marketing authorisation … gt;IprezivEMEA/H/C/002517Azilsartan medoxomilazilsartan medoxomilHypertensionC09CA09 This medicine is under additional … for Ipreziv (azilsartan medoxomil) in the European Union (EU … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000237-PIP01-08-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 16/02/2023, Compliance check: XActive substance Azilsartan medoxomil Therapeutic area Cardiovascular … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … -
List item
Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -
List item
Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 10, Authorised, Last updated: 16/01/2023Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … Levodopa/Carbidopa/Entacapone Sandoz) : EPAR - All Authorised presentations … Levodopa/Carbidopa/Entacapone Sandoz) : EPAR - Procedural steps … -
List item
Human medicine European public assessment report (EPAR): Rivastigmine Sandoz (updated)
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 14, Authorised, Last updated: 25/09/2023Rivastigmine Sandoz Nervous System Diseases Central … Rivastigmine Sandoz … Rivastigmine Sandoz, INN-rivastigmine … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Azilsartan medoxomil, chlortalidone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001294-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Azilsartan medoxomil chlortalidone Cardiovascular … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294 … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294-PIP01-12 … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 16, Authorised, Last updated: 13/06/2023
Pregabalin Sandoz Mental Disorders Nervous … report (EPAR) for Pregabalin Sandoz. It explains how the Agency … on how to use Pregabalin Sandoz. For practical information … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
Temozolomide Sandoz Cancer Neuroectodermal … Temozolomide Sandoz … statement Temozolomide Sandoz (temozolomide) Withdrawal … -
List item
Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
Aripiprazole Sandoz Schizophrenia Spectrum and … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Sandoz
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 2, Withdrawn, Last updated: 26/10/2011
Clopidogrel Sandoz Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel Sandoz … Clopidogrel Sandoz (clopidogrel) Withdrawal … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 13/06/2023
Pregabalin Sandoz GmbH Mental Disorders Nervous … report (EPAR) for Pregabalin Sandoz GmbH. It explains how the … on how to use Pregabalin Sandoz GmbH. For practical information … -
List item
Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … Pemetrexed Sandoz … for the public Pemetrexed Sandoz pemetrexed This is a summary … -
List item
Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
Ibandronic Acid Sandoz Skin and Connective Tissue … Ibandronic Acid Sandoz … public Ibandronic Acid Sandoz ibandronic acid This document … -
List item
Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
List item
Referral: Methylphenidate Sandoz
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 Sandoz … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the … -
List item
Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … of the medicine Budesonide Sandoz. The Agency's Committee for … the benefits of Budesonide Sandoz outweigh its risks, and the … -
List item
Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … medicinal product Calcium Sandoz Effervescent tablets, 500/1000 … benefit/risk ratio of Calcium Sandoz Effervescent tablets, 500/1000 …