1408 results
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Human medicine European public assessment report (EPAR): Sildenafil Actavis
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 16, Authorised, Last updated: 01/06/2023
Sildenafil Actavis Male Urogenital … Sildenafil Actavis … Sildenafil Actavis, INN sildenafil EMA/482355/2014 EMEA/H/C/001090 … -
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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 … Sildenafil Teva … Sildenafil Teva, INN sildenafil 7 Westferry Circus … -
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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Withdrawn application: Sildenafil FGK
sildenafil, date of withdrawal: 19/07/2021, Initial authorisation, Last updated: 05/10/2021Sildenafil FGK: Withdrawn application … marketing authorisation of Sildenafil FGK sildenafil) FGK Representative Service … marketing authorisation of Sildenafil FGK for the treatment of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): Viagra (updated)
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 … medicine. active substance sildenafil. It is a ‘ A generic medicine … other medicines containing sildenafil should therefore be used … -
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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
sildenafil … Granpidam, INN: sildenafil EMA/622310/2016 EMEA/H/C/004289 … for the public Granpidam sildenafil This is a summary of the … -
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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): Revatio
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 49, Authorised, Last updated: 21/03/2023sildenafil … for the public Revatio sildenafil This is a summary of the … contains the active substance sildenafil. How is Revatio used? Revatio … -
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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 … Public statement on Patrex (sildenafil): Non-renewal of the marketing … PUBLIC STATEMENT ON PATREX (sildenafil) NON-RENEWAL OF THE … -
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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 … 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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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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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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Press release: Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription
Last updated: 20/11/2008authorisation for Viagra 50 mg (sildenafil) from prescription-only to … for the medicine Viagra (sildenafil) 50 mg film-coated tablets … authorisation for Viagra 50 mg (sildenafil) from prescription-only to … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … any fractures or any spinal compression. Zometa has also been compared … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 01/06/2023
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
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Human medicine European public assessment report (EPAR): Evicel
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 18, Authorised, Last updated: 11/05/2023compared Evicel with manual compression (applying direct pressure … received Evicel or manual compression. The second study compared … patients treated with manual compression (28 out of 72). During abdominal …