147 results
Keyword tadalafil Remove keyword
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Human medicine European public assessment report (EPAR): Tadalafil Lilly
tadalafil, Erectile Dysfunction
Date of authorisation: 22/03/2017, Revision: 2, Authorised, Last updated: 19/02/2020summary for the public Tadalafil Lilly tadalafil This is a summary of the … assessment report (EPAR) for Tadalafil Lilly. It explains how the … practical advice on how to use Tadalafil Lilly. For practical information … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,
, Revision: 11, Authorised, Last updated: 17/01/2020
Tadalafil Mylan, INN tadalafil 30 Churchill Place … summary for the public Tadalafil Mylan tadalafil This is a summary of the … assessment report (EPAR) for Tadalafil Mylan. It explains how the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cialis, tadalafil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000452-PIP02-10-M05, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Oral suspension
Decision date: 07/11/2018, Last updated: 14/02/2019, Compliance check: XCialis Adcirca (previously Tadalafil Lilly) Adcirca Active substance … Adcirca Active substance tadalafil Therapeutic area Cardiovascular … Cialis Adcirca (previously Tadalafil Lilly) Cialis Adcirca (previously … -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 12, Authorised, Last updated: 21/02/2020for the public Adcirca1 tadalafil This is a summary of the … contains the active substance tadalafil. It is available as tablets … if 1 Previously known as Tadalafil Lilly. 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 4, Authorised, Last updated: 15/01/2020
Talmanco, INN-tadalafil 30 Churchill Place … for the public Talmanco1 tadalafil This is a summary of the … contains the active substance tadalafil. Talmanco is a ‘generic … -
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Human medicine European public assessment report (EPAR): Cialis
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 27, Authorised, Last updated: 20/02/2020CIALIS, INN - Tadalafil EMA/475324/2015 EMEA/H/C/000436 … for the public Cialis tadalafil This is a summary of the … containing the active substance tadalafil. It is available as tablets … -
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Opinion/decision on a Paediatric investigation plan (PIP): Macitentan, tadalafil
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001961-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: Xspecific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16 … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16) in … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16) in … -
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Tadalafil product-specific bioequivalence guidance
Last updated: 01/02/2018Tadalafil product-specific bioequivalence … Tadalafil product-specific bioequivalence …
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Human medicine European public assessment report (EPAR): Volibris
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 20, Authorised, Last updated: 16/07/2019the medicine is used with tadalafil (another medicine for PAH … combination of Volibris (10 mg) and tadalafil has been compared with either … compared with either Volibris or tadalafil alone in another main study … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 1, Authorised, Last updated: 20/03/2020
the medicine is used with tadalafil (another medicine for PAH … -
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Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester for: Treatment of pulmonary arterial hypertension
Date of first decision: 20/04/2017, Positive, Last updated: 13/05/2019macitentan, riociguat, sildenafil, tadalafil and treprostinil. Surgery … combination of ambrisentan with tadalafil. This assumption will need … macitentan, riociguat, sildenafil, tadalafil and treprostinil. Surgery … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017
CHMP, Last updated: 27/01/2017Tadalafil Lilly … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016
CHMP, Last updated: 11/11/2016Tadalafil Generics … -
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National expert: Ulrike Schara, European Medicines Agency (updated)
- Declaration of interests - 84.07 KB | PDF
- Curriculum Vitae - 111.3 KB | PDF
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National expert: Eeva Sofia Leinonen, Finnish Medicines Agency (updated)
- Declaration of interests - 79.62 KB | PDF
- Curriculum Vitae - 92.83 KB | PDF
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 17/03/2017, Compliance check: Xwaiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16 … waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16) in … waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16) in … -
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News: EMA promotes consistent development of bioequivalence studies through product-specific guidance
CHMP, Last updated: 15/11/2013repaglinide; sirolimus; sorafenib; tadalafil; telithromycin; voriconazole … -
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National expert: Jose Augusto Guimaraes Morais, European Medicines Agency (updated)
- Declaration of interests - 80.56 KB | PDF
- Curriculum Vitae - 89.75 KB | PDF
RATIOPHARM and TEVA PHARMA tadalafil male erectile disfunction … -
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Orphan designation: Macitentan for: Treatment of pulmonary arterial hypertension
Date of first decision: 27/09/2011, Positive, Last updated: 12/10/2018included bosentan, ambrisentan, tadalafil, sildenafil, iloprost, epoprostenol … included bosentan, ambrisentan, tadalafil, sildenafil, iloprost, epoprostenol … -
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National expert: Laura Galatti, Italian Medicines Agency (updated)
- Declaration of interests - 79.61 KB | PDF
- Curriculum Vitae - 73.93 KB | PDF
Giustini SE. Interaction between tadalafil and itraconazole. Ann Pharmacother … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Tadalafil Mylan … -
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Orphan designation: N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide for: Treatment of pulmonary arterial hypertension
Date of first decision: 22/02/2018, Positive, Last updated: 08/04/2020riociguat, selexipag, sildenafil, tadalafil and treprostinil. Lung transplantation … riociguat, selexipag, sildenafil, tadalafil and treprostinil. Lung transplantation … -
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Orphan designation: Ubenimex for: Treatment of pulmonary arterial hypertension
Date of first decision: 21/03/2016, Positive, Last updated: 19/08/2019macitentan, riociguat, sildenafil, tadalafil and treprostinil. Surgery … macitentan, riociguat, sildenafil, tadalafil and treprostinil. Surgery … -
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National expert: Gabriella Passacquale, Italian Medicines Agency (updated)
- Declaration of interests - 80.74 KB | PDF
- Curriculum Vitae - 103.73 KB | PDF
Phosphodiesterase type 5 with tadalafil is associated to an improved … -
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Orphan designation: Ralinepag for: Treatment of pulmonary arterial hypertension
Date of first decision: 11/01/2019, Positive, Last updated: 24/04/2019riociguat, selexipag, sildenafil, tadalafil and treprostinil. Some patients …