16423 results
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira)
pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 19/11/2015,
, Revision: 14, Authorised, Last updated: 21/09/2022
Pemetrexed Pfizer (previously Pemetrexed Hospira) Cancer Neoplasms Carcinoma … assessment report (EPAR) for Pemetrexed Hospira. It explains how … practical advice on how to use Pemetrexed Hospira. For practical information … -
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
Pemetrexed Krka Cancer Neoplasms Carcinoma … Pemetrexed Krka is a cancer medicine … platinum-based chemotherapy. Pemetrexed Krka contains the active … -
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 04/08/2010, Positive, Last updated: 29/05/2018everolimus … opinion on orphan designation Everolimus for the treatment of tuberous … Limited, United Kingdom, for everolimus for the treatment of tuberous … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … assessment report (EPAR) for Pemetrexed medac. It explains how the … practical advice on how to use Pemetrexed medac. For practical information … -
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
Pemetrexed Fresenius Kabi Cancer Neoplasms Carcinoma … assessment report (EPAR) for Pemetrexed Fresenius Kabi. It explains … practical advice on how to use Pemetrexed Fresenius Kabi. For practical … -
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
Pemetrexed Baxter Carcinoma, Bronchogenic Bronchial … Pemetrexed Baxter is used to treat two … platinum-based chemotherapy. Pemetrexed Baxter is a ‘generic medicine’ … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,
, Revision: 30, Authorised, Last updated: 27/06/2022
contains the active substance everolimus. Tuberous sclerosis is rare … once a day at the same time every day, consistently either … or contact your doctor or pharmacist. How does Votubia work? The … -
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Human medicine European public assessment report (EPAR): Afinitor
everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 30, Authorised, Last updated: 27/06/2022contains the active substance everolimus. Expand section Collapse section … be taken at the same time every day and consistently with … or contact your doctor or pharmacist. How does Afinitor work? The … -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 9, Authorised, Last updated: 03/11/2022
Pemetrexed Accord Carcinoma, Bronchogenic Bronchial … assessment report (EPAR) for Pemetrexed Accord. It explains how the … practical advice on how to use Pemetrexed Accord. For practical information … -
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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 … assessment report (EPAR) for Pemetrexed Sandoz. It explains how the … practical advice on how to use Pemetrexed Sandoz. For practical information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018Votubia Active substance everolimus Therapeutic area Neurology … EMEA-000019-PIP08-12-M03 Pharmaceutical form(s) Tablet Dispersible … paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Afinitor, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000019-PIP06-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 05/05/2014, Last updated: 11/06/2014, Compliance check: Xassociated names Active substance everolimus Therapeutic area Immunology-Rheumatology-Transplantation … EMEA-000019-PIP06-09-M05 Pharmaceutical form(s) Tablet Dispersible … paediatric investigation plan for everolimus (Afinitor, Certican and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016Votubia Active substance everolimus Therapeutic area Neurology … EMEA-000019-PIP02-07-M05 Pharmaceutical form(s) Tablet Dispersible … paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … -
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, Revision: 12, Authorised, Last updated: 18/01/2023Armisarte (previously Pemetrexed Actavis) Cancer Neoplasms Carcinoma … or contact their doctor or pharmacist. Expand section Collapse section … contains the active substance pemetrexed. How is Armisarte used? Armisarte … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
Pemetrexed Lilly Cancer Neoplasms Carcinoma … Pharmacotherapeutic group Antineoplastic agents … Malignant pleural mesothelioma Pemetrexed Lilly in combination with … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,, Revision: 7, Withdrawn, Last updated: 29/07/2021
Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) Carcinoma … Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited … EMEA/H/C/004488 Public statement Pemetrexed Pfizer Cessation of validity … -
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Human medicine European public assessment report (EPAR): Alimta
pemetrexed, Mesothelioma; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2004, Revision: 27, Authorised, Last updated: 03/05/2022contains the active substance pemetrexed. What is Alimta used for … weight). It is given once every three weeks as an infusion … active substance in Alimta, pemetrexed, is a cytotoxic medicine (a … -
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Human medicine European public assessment report (EPAR): Ciambra
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,, Revision: 6, Authorised, Last updated: 17/08/2022
or contact their doctor or pharmacist. Expand section Collapse section … contains the active substance pemetrexed. How is Ciambra used? Ciambra … weight). It is given once every three weeks as an infusion … -
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016Pemetrexed ditromethamine Hospira: Withdrawn … market exclusivity under pharmaceutical legislation (typically 10 … substance(s) it contains. The pharmaceutical legislation defines the … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
, , Revision: 3, Authorised, Last updated: 31/01/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma is a medicine that is used … Lonapegsomatropin Ascendis Pharma was designated an ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 15, Authorised, Last updated: 12/01/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) … market exclusivity under pharmaceutical legislation (typically 10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alimta, pemetrexed disodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000126-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 24/02/2009, Last updated: 23/04/2009, Compliance check: Xname Alimta Active substance pemetrexed disodium Therapeutic area … number EMEA-000126-PIP01-07 Pharmaceutical form(s) Powder for concentrate … product-specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07 … -
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
previously Clopidogrel Taw Pharma) Vascular Diseases Cardiovascular … Viatris, see the The leaflet in every pack of medicine that contains … or contact your doctor or pharmacist. How does Clopidogrel Viatris … -
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Orphan designation: lonapegsomatropin for: Treatment of growth hormone deficiency
Date of designation: 17/10/2019, Positive, Last updated: 17/02/2022European Commission to Ascendis Pharma Endocrinology Division A/S … Lonapegsomatropin Ascendis Pharma since 11 January 2022. Expand … Lonapegsomatropin Ascendis Pharma) Skytrofa (previously Lonapegsomatropin … -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP11-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: XActive substance everolimus Therapeutic area Oncology … number EMEA-000019-PIP11-14 Pharmaceutical form(s) Tablet Dispersible … product specific waiver for everolimus (Certican and associated …