6750 results
Keyword Sildenafil Germed Remove keyword
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,
, Revision: 17, Authorised, Last updated: 06/10/2020
Sildenafil ratiopharm Erectile Dysfunct … Authorised sildenafil Overview This is a summary … assessment report (EPAR) for sildenafil. It explains how the Committee … -
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 14, Authorised, Last updated: 12/05/2021
Sildenafil Actavis Erectile Dysfunction … Authorised sildenafil Overview This is a summary … part of the EPAR). What is Sildenafil Actavis Sildenafil Actavis is a medicine that … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 15, Authorised, Last updated: 13/10/2020
Sildenafil Teva Erectile Dysfunction … Authorised sildenafil Overview This is a summary … assessment report (EPAR) for Sildenafil Teva. It explains how the … -
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 16, Authorised, Last updated: 05/03/2021
sildenafil … for the public Vizarsin sildenafil This is a summary of the … contains the active substance sildenafil. It is available as film-coated … -
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021
Authorised sildenafil Overview This is a summary … 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): Revatio
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 41, Authorised, Last updated: 04/12/2020Authorised sildenafil Overview This is a summary … contains the active substance sildenafil. How is Revatio used? Revatio … active substance in Revatio, sildenafil, belongs to a group of medicines … -
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 4, Authorised, Last updated: 26/11/2020
Authorised sildenafil Overview This is a summary … 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: 36, Authorised, Last updated: 26/11/2020Authorised sildenafil Overview This is a summary … contains the active substance sildenafil. It is available as tablets … active ingredient in Viagra, sildenafil, belongs to a group of medicines … -
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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: 16/04/2019, Compliance check: XKey facts Revatio sildenafil OtherP/0016/2019EMEA-000671-PIP01-09-M10 … paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M10 … Revatio Revatio sildenafil sildenafil sildenafil … -
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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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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 first decision: 20/06/2017, Positive, Last updated: 17/07/2017BV, the Netherlands, for sildenafil for the treatment of congenital … medicine expected to work? Sildenafil is expected to be given during … becoming too high after birth. Sildenafil is already authorised in … -
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Orphan designation: sildenafil citrate for: treatment of postcardiotomy right ventricular failure
Date of first decision: 26/11/2010, Positive, Last updated: 23/10/2018Limited, United Kingdom, for sildenafil citrate for the treatment … medicine expected to work? Sildenafil is a medicine that has been … the heart to the lungs). Sildenafil works by blocking an enzyme … -
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Orphan designation: sildenafil citrate for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of first decision: 12/12/2003, Expired, Last updated: 19/01/2016Limited, United Kingdom, for sildenafil citrate for the treatment … thromboembolic pulmonary hypertension. Sildenafil citrate has been authorised … orphan drug designation. Sildenafil citrate might be of potential … -
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Opinion/decision on a Paediatric investigation plan (PIP): gallium (68Ga) chloride, germanium (68Ge) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001102-PIP01-10, Route(s) of administration: Other use, Pharmaceutical form(s): Radionuclide generator
Decision date: 08/06/2011, Last updated: 14/07/2011, Compliance check: Xfacts gallium (68Ga) chloride germanium (68Ge) chloride OtherP/133/2011EMEA-001102-PIP01-10 … regaffairs.radiopharma@ezag.de Germany +49 30941084282 +49 30941084160 … Gallium [68 Ga] Chloride / Germanium [68 Ge] Chloride (EMEA-001102-PIP01-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): germanium (68Ge) chloride, gallium (68Ga) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002436-PIP01-18, Pharmaceutical form(s): Radionuclide generator
Decision date: 03/01/2019, Last updated: 24/04/2019, Compliance check: XKey facts germanium (68Ge) chloride gallium (68Ga … product specific waiver for Germanium (68Ge) chloride / Gallium … germanium (68Ge) chloride gallium … -
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National expert: Katarzyna Germel, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.45 KB | PDF
Katarzyna Germel … Katarzyna Germel … Vitae PERSONAL INFORMATION Katarzyna Germel WORK EXPERIENCE March 2020 … -
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Non-clinical testing for inadvertent germline transmission of gene transfer vectors
Last updated: 17/11/2005ical testing for inadvertent germline transmission of gene transfer … non-clinical inadvertent germline transmission testing needed … NfG - nonclinical testing - germline transmission European …
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ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors
Last updated: 01/11/2006address the risk of inadvertent germline integration of gene therapy … addressing risks for inadvertent germline integration. It provides …
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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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News: European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies
Last updated: 19/05/2014European Medicines Agency and German Society for Transfusion Medicine … Advanced Therapies (CAT) and the German Society for Transfusion Medicine … in collaboration with the German Stem Cell Network (GSCN … -
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The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, Germany
one-by-one EDV-GmbH, Berlin, Germany, from 24/09/2018 to 26/09/2018, Last updated: 14/06/2018training course, Berlin, Germany … one-by-one EDV-GmbH, Berlin, Germany This hands-on training course … one-by-one EDV-GmbH, Berlin, Germany Course # 18515 OVERVIEW EudraVigilance … -
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Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products successfully to the market
Dresden, Germany, 11/09/2014, Last updated: 21/10/2014Advanced Therapies (CAT) and the German Society for Transfusion Medicine … 11/09/2014 Dresden, Germany The workshop is co-organised … Advanced Therapies (CAT) and the German Society for Transfusion Medicine … -
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Orphan designation: Sodium nitrite for: Treatment of pulmonary arterial hypertension
Date of first decision: 05/03/2012, Positive, Last updated: 06/07/2012Representative Service GmbH, Germany, for sodium nitrite for the … bosentan, epoprostenol, iloprost, sildenafil, tadalafil and treprostinil … Representative Service GmbH, Germany, for sodium nitrite for the … -
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Orphan designation: Ralinepag for: Treatment of pulmonary arterial hypertension
Date of first decision: 11/01/2019, Positive, Last updated: 24/04/2019Unither Therapeutik GmbH, Germany in April 2019. What is pulmonary … macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … 64546 Moerfelden-Walldorf Germany Tel. +49 6105 27137 For contact …