161 results
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Human medicine European public assessment report (EPAR): Tadalafil Lilly (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 22/03/2017, Revision: 3, Authorised, Last updated: 01/03/2021Tadalafil Lilly Erectile Dysfunction … Authorised tadalafil Overview This is a summary … assessment report (EPAR) for Tadalafil Lilly. It explains how the … -
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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 Erectile Dysfunction … Tadalafil Mylan … Tadalafil Mylan, INN tadalafil 30 Churchill Place … -
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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) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 13, Authorised, Last updated: 10/02/2021Adcirca (previously Tadalafil Lilly) Hypertension, Pulmona … Adcirca (previously Tadalafil Lilly … for the public Adcirca1 tadalafil This is a summary of the … -
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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: 5, Authorised, Last updated: 01/12/2020
Talmanco (previously Tadalafil Generics) Hypertension … Talmanco (previously Tadalafil Generics … Talmanco, INN-tadalafil 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Cialis (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 28, Authorised, Last updated: 10/02/2021tadalafil … CIALIS, INN - Tadalafil EMA/475324/2015 EMEA/H/C/000436 … for the public Cialis tadalafil This is a summary of the … -
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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: XActive substance Macitentan tadalafil Therapeutic area Cardiovascular … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16 … 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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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan (updated)
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: 19/02/2021, Compliance check: Xwaiver for ambrisentan / tadalafil (EMEA-0020... PDF icon application/pdf … waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16 … waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16) in … -
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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 - 85.18 KB | PDF
- Curriculum Vitae - 37.6 KB | PDF
Landry J, Elashoff R, Cox D; Tadalafil DMD Study Group. A phase … placebo-controlled trial of tadalafil for Duchenne muscular dystrophy … -
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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: Paolo Colombo, Italian Medicines Agency (updated)
- Declaration of interests - 82.66 KB | PDF
- Curriculum Vitae - 24.47 KB | PDF
02/2020-(current) APHARM, Trento, ITA Tadalafil orodispersible tablets erectogen 2.3 … -
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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 - 79.78 KB | PDF
- Curriculum Vitae - 18.05 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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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, Authorised, Last updated: 16/02/2021
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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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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 6, Authorised, Last updated: 27/01/2021
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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 …