16693 results
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 17, Authorised, Last updated: 13/11/2023
Sildenafil Actavis Male Urogenital … Authorised sildenafil Overview This is a summary … or contact your doctor or pharmacist. If you want more information … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 17, Authorised, Last updated: 04/07/2022
Sildenafil Teva Male Urogenital Diseases Genital … assessment report (EPAR) for Sildenafil Teva. It explains how the … the conditions of use for Sildenafil Teva. Expand section Collapse … -
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 19, Authorised, Last updated: 24/06/2022
Sildenafil ratiopharm Male Urogenital … Authorised sildenafil Overview This is a summary … assessment report (EPAR) for sildenafil. It explains how the The committee … -
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Withdrawn application: Sildenafil FGK
sildenafil, date of withdrawal: 19/07/2021, Initial authorisation, Last updated: 05/10/2021Sildenafil FGK: Withdrawn application … marketing authorisation of Sildenafil FGK sildenafil) FGK Representative Service … marketing authorisation of Sildenafil FGK for the treatment of … -
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Human medicine European public assessment report (EPAR): Revatio (updated)
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 50, Authorised, Last updated: 20/11/2023Authorised sildenafil Overview This is a summary … or contact their doctor or pharmacist. What is Revatio and what … medicine. active substance sildenafil. How is Revatio used? Revatio … -
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 8, Authorised, Last updated: 11/04/2023
or contact their doctor or pharmacist. Expand section Collapse section … contains the active substance sildenafil. It is a ‘generic medicine’ … other medicines containing sildenafil should therefore be used … -
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Human medicine European public assessment report (EPAR): Viagra
sildenafil, Erectile Dysfunction
Date of authorisation: 13/09/1998, Revision: 45, Authorised, Last updated: 18/09/2023Authorised sildenafil Overview This is a summary … medicine. active substance sildenafil. It is available as tablets … active ingredient in Viagra, sildenafil, belongs to a group of medicines … -
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 7, Authorised, Last updated: 30/06/2023
Authorised sildenafil Overview This is a summary … or contact their doctor or pharmacist. What is Mysildecard and what … medicine. active substance sildenafil. It is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 19, Authorised, Last updated: 24/02/2023
Authorised sildenafil Overview This is a summary … medicine. active substance sildenafil. It is available as film-coated … active ingredient in Vizarsin, sildenafil, belongs to a group of medicines … -
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Human medicine European public assessment report (EPAR): Patrex
sildenafil, Erectile Dysfunction
Date of authorisation: 15/09/1998, Revision: 4, Withdrawn, Last updated: 18/08/2005Withdrawn sildenafil Overview The marketing authorisation … pages you wish to print. Pharmacotherapeutic group Urologicals Therapeutic … Public statement on Patrex (sildenafil): Non-renewal of the marketing … -
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Opinion/decision on a Paediatric investigation plan (PIP): Revatio, sildenafil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000671-PIP01-09-M10, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution, Solution for injection
Decision date: 03/01/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019Revatio Active substance sildenafil Therapeutic area Other Decision … EMEA-000671-PIP01-09-M10 Pharmaceutical form(s) Film-coated tablet … Revatio Revatio sildenafil sildenafil sildenafil … -
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Withdrawn application: Viagra
sildenafil, date of withdrawal: 19/11/2008, Post-authorisation, Last updated: 20/11/2008contains the active substance sildenafil. It is available as tablets … active ingredient in Viagra, sildenafil, belongs to a group of medicines … International Nonproprietary Name: Sildenafil citrate Procedure No … -
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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: 16, Authorised, Last updated: 08/09/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … EPAR) for Aripiprazole Mylan Pharma. It explains how the Agency … to use Aripiprazole Mylan Pharma. For practical information … -
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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) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
, 
, Revision: 4, Authorised, Last updated: 06/11/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma) … Lonapegsomatropin Ascendis Pharma (lonapegsomatropin) An … -
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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 … previously Clopidogrel Taw Pharma) … known as Clopidogrel Mylan Pharma and subsequently as Clopidogrel … -
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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: sildenafil for: Treatment of congenital diaphragmatic hernia
Date of designation: 20/06/2017, Positive, Last updated: 17/07/2017sildenafil … opinion on orphan designation Sildenafil for the treatment of congenital … opinion on orphan designation Sildenafil for the treatment of congenital … -
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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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Orphan designation: sildenafil citrate for: treatment of postcardiotomy right ventricular failure
Date of designation: 26/11/2010, Positive, Last updated: 23/10/2018sildenafil citrate … PSO 068-10 sildenafil citrate 7 Westferry … opinion on orphan designation Sildenafil citrate for the treatment … -
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Orphan designation: sildenafil citrate for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 12/12/2003, Expired, Last updated: 19/01/2016sildenafil citrate … ORPHAN DESIGNATION OF sildenafil citrate for the treatment … Limited, United Kingdom, for sildenafil citrate for the treatment … -
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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: 15, Authorised, Last updated: 21/06/2023Rivastigmine 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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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): 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 …