16375 results
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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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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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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
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, 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): 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 … Viatris Clopidogrel Mylan Pharma received a The approval to … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the marketing … market exclusivity under pharmaceutical legislation (typically 10 … -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Withdrawn application: Lacosamide Pain UCB Pharma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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Orphan designation: Ramiprilat for: Treatment of Stargardt's disease
Date of designation: 12/03/2013, Positive, Last updated: 17/01/2023Ramiprilat Overview On 12 March 2013 … European Commission to Iris Pharma, France, for ramiprilat for the treatment of Stargardt's … was transferred to Blue-Reg Pharma Consult, France, in January … -
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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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Referral: Tritace
ramipril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 24/04/2009Recommendation provided by Pharmacovigilance Risk Assessment Committee … active substance in Tritace, ramipril, is an angiotensin-converting … Protect Startset, Delix P, Ramipril Winthrop … -
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Referral: Vasotop P
ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014Recommendation provided by Pharmacovigilance Risk Assessment Committee … contain the active ingredient ramipril at concentrations of 0.625 … and 2.5 mg respectively. Ramipril is an angiotensin-converting … -
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Referral: Tritazide
ramipril, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 14/04/2009Recommendation provided by Pharmacovigilance Risk Assessment Committee … contains two active substances, ramipril and hydrochlorothiazide Ramipril is an angiotensin converting … Tritazide tablets containing ramipril and hydrochlorothiazide 2.5/12.5 … -
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Referral: Rambis and associated names (updated)
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023authorisation of Rambis (ramipril / bisoprolol) in the EU On … combination of two medicines called ramipril and bisoprolol. Rambis contains … bisoprolol. Rambis contains both ramipril and bisoprolol and is intended … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, bisoprolol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002531-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: XActive substance Ramipril bisoprolol Therapeutic area … number EMEA-002531-PIP01-18 Pharmaceutical form(s) Tablet Condition(s … for public enquiries Midas Pharma GmbH E-mail: pv@midas … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002081-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 05/05/2017, Last updated: 04/07/2017, Compliance check: XKey facts Ramipril indapamide Cardiovascular … of hypertension Oral use Pharmaceutical Works Polpharma SA Poland … product-specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000887-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/136/2010EMEA-000887-PIP01-10 … hypertension Oral use EGIS Pharmaceuticals PLC E-mail: registry@egis.hu … specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: XKey facts Rosuvastatin Ramipril Cardiovascular diseasesP/0343/2019EMEA-002569-PIP04-19 … metabolism disorders Oral use EGIS Pharmaceuticals PLC Tel. +36 18032414 E-mail … waiver for rosuvastatin / ramipril (EMEA-002569-PIP01-19) PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: XKey facts Rosuvastatin Ramipril Cardiovascular diseasesP/0343/2019EMEA-002569-PIP04-19 … metabolism disorders Oral use EGIS Pharmaceuticals PLC Tel. +36 18032414 E-mail … waiver for rosuvastatin / ramipril (EMEA-002569-PIP01-19) PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): telmisartan, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000045-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/02/2008, Last updated: 15/02/2008, Compliance check: XActive substance telmisartan Ramipril Therapeutic area Cardiovascular … number EMEA-000045-PIP01-07 Pharmaceutical form(s) Tablet Condition(s … substance: Telmisartan / ramipril (fixed combination) Condition(s … -
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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 … EPAR) for Telmisartan Teva Pharma. It explains how the The committee … use for Telmisartan Teva Pharma. What is Telmisartan Teva Pharma? Telmisartan Teva Pharma is a medicine that contains … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, atorvastatin, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002416-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 29/01/2019, Last updated: 25/04/2019, Compliance check: XActive substance Ramipril atorvastatin amlodipine Therapeutic … number EMEA-002416-PIP01-18 Pharmaceutical form(s) Tablet Condition(s … for public enquiries Midas Pharma GmbH E-mail: pv@midas … -
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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): Clopidogrel 1A Pharma
clopidogrel, Peripheral Vascular Diseases
Date of authorisation: 28/07/2009,, Revision: 1, Withdrawn, Last updated: 28/02/2011
Clopidogrel 1A Pharma Peripheral Vascular Diseases … authorisation for Clopidogrel 1A Pharma has been withdrawn at the … documents Clopidogrel 1A Pharma : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Acino Pharma
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 1, Withdrawn, Last updated: 26/07/2012
Clopidogrel Acino Pharma Peripheral Vascular Diseases Stroke Myocardial … authorisation for Clopidogrel Acino Pharma has been withdrawn at the … documents Clopidogrel Acino Pharma : EPAR - Summary for the … -
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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 …