16471 results
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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): 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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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): 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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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 … or contact your doctor or pharmacist. How does Clopidogrel Viatris … Clopidogrel Viatris. As for every medicine, the company provided … -
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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 … -
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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-PIP03-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 15/08/2008, Last updated: 22/08/2014, Compliance check: XActive substance everolimus Therapeutic area Oncology … number EMEA-000019-PIP03-08 Pharmaceutical form(s) Tablet Condition(s … product specific waiver for everolimus (EMEA-000197-PIP01-08 … -
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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-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: XActive substance everolimus Therapeutic area Oncology … number EMEA-000019-PIP01-07 Pharmaceutical form(s) Tablet Condition(s … Microsoft Word - Decision Everolimus 000019-PIP01-07 European … -
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Orphan designation: everolimus for: Treatment of gastric cancer
Date of designation: 30/08/2011, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastric … opinion on orphan designation Everolimus for the treatment of gastric … -
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Orphan designation: everolimus for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/11/2007, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … -
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Orphan designation: everolimus for: Treatment of renal-cell carcinoma
Date of designation: 05/06/2007, Withdrawn, Last updated: 06/09/2011everolimus … smop everolimus Rev.3 30 Churchill … opinion on orphan designation Everolimus for the treatment of renal … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the marketing … market exclusivity under pharmaceutical legislation (typically 10 … -
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Withdrawn application: Lacosamide Pain UCB Pharma
lacosamide, date of withdrawal: 25/09/2008, Initial authorisation, Last updated: 26/09/2008Lacosamide Pain UCB Pharma: Withdrawn application … for Lacosamide Pain UCB Pharma International non-proprietary … On 25 September 2008, UCB Pharma S.A. officially notified … -
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Withdrawn application: Oportuzumab monatox DLRC Pharma Services
oportuzumab monatox, date of withdrawal: 20/08/2021, Initial authorisation, Last updated: 20/10/2021Oportuzumab monatox DLRC Pharma Services: Withdrawn applicati … Oportuzumab monatox DLRC Pharma Services: Withdrawal of the … Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox … -
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Human medicine European public assessment report (EPAR): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022Rivastigmine 1 A Pharma Nervous System Diseases Central … or contact your doctor or pharmacist. If you want more information … What is Rivastigmine 1 A Pharma? Rivastigmine 1 A Pharma is a medicine containing … -
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Herbal medicinal product: Helichrysi flos
Helichrysum arenarium (L.) Moench, Sandy everlasting, F: Assessment finalised, Last updated: 02/05/2023the medicinal uses of sandy everlasting. The Committee on Herbal Medicinal … medicines containing sandy everlasting. This summary is not intended … medicines containing sandy everlasting. For practical information … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn at the … documents Pregabalin Mylan Pharma : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma
Telmisartan, Hypertension
Date of authorisation: 03/10/2011,, Revision: 10, Authorised, Last updated: 26/10/2021
Telmisartan Teva Pharma Cardiovascular Diseases Vascular … Telmisartan Teva Pharma … market exclusivity under pharmaceutical legislation (typically 10 … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … statement on Docetaxel Teva Pharma 7 Westferry Circus … -
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Human medicine European public assessment report (EPAR): Natalizumab Elan Pharma
natalizumab, Crohn Disease
Date of refusal: 11/01/2008, Refused, Last updated: 25/01/2008Natalizumab Elan Pharma Crohn Disease … product Natalizumab Elan Pharma concentrate for solution … for authorisation is Elan Pharma International Ltd. The applicant …