7423 results
Keyword Tadalafil Germed Remove keyword
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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: 7, Authorised, Last updated: 09/06/2022
Talmanco (previously Tadalafil Generics) Respiratory Tract … Talmanco (previously Tadalafil Generics … Talmanco, INN-tadalafil 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 14, Authorised, Last updated: 30/06/2022
Tadalafil Mylan Mental Disorders Sexual … Authorised tadalafil Overview This is a summary … assessment report (EPAR) for Tadalafil Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Tadalafil Lilly
tadalafil, Erectile Dysfunction
Date of authorisation: 22/03/2017, Revision: 5, Authorised, Last updated: 17/11/2021Tadalafil Lilly Mental Disorders Sexual … Authorised tadalafil Overview This is a summary … assessment report (EPAR) for Tadalafil Lilly. 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-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral suspension
Decision date: 11/09/2020, Last updated: 08/07/2021, Compliance check: XCialis Adcirca (previously Tadalafil Lilly) Adcirca Active substance … Adcirca Active substance tadalafil Therapeutic area Cardiovascular … paediatric investigation plan for tadalafil (Adcirca, Cialis), (EMEA-000452-PIP02-10-M06 … -
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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: 14, Authorised, Last updated: 20/10/2021Adcirca (previously Tadalafil Lilly) Hypertension Vascular … Authorised tadalafil Overview This is a summary … medicine. active substance tadalafil. It is available as tablets … -
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Human medicine European public assessment report (EPAR): Cialis
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 30, Authorised, Last updated: 11/10/2021Authorised tadalafil Overview This is a summary … containing the active substance tadalafil. It is available as tablets … active substance of Cialis, tadalafil, belongs to a group of medicines … -
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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: XKey facts Macitentan tadalafil Cardiovascular diseasesP/0243/2016EMEA-001961-PIP01-16 … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16) PDF … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16 … -
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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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Tadalafil product-specific bioequivalence guidance
Last updated: 04/04/2022Tadalafil product-specific bioequivalence … Tadalafil product-specific bioequivalence … Tadalafil film-coated tablets 2.5 mg …
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Human medicine European public assessment report (EPAR): Bavencio (updated)
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 13, Authorised, Last updated: 26/07/2022
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … -
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Human medicine European public assessment report (EPAR): Gliolan (updated)
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … -
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Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 28, Authorised, Last updated: 22/07/2022Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … -
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 7, Authorised, Last updated: 14/07/2022
ancer Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal … -
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
Hexal Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/87.26 KB) (PDF/87.26 KB) German (PDF/86.58 KB) (PDF/86.58 … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
Sandoz Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/87.78 KB) (PDF/87.78 KB) German (PDF/86.53 KB) (PDF/86.53 … -
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Human medicine European public assessment report (EPAR): Imlygic
talimogene laherparepvec, Melanoma
Date of authorisation: 16/12/2015, Revision: 11, Authorised, Last updated: 21/04/2022Tissue Neoplasms Cancer Neoplasms, Germ Cell and Embryonal Nevi … PDF/78.96 KB) (PDF/78.96 KB) German (PDF/79.47 KB) (PDF/79.47 … -
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Human medicine European public assessment report (EPAR): Temomedac
temozolomide, Glioma; Glioblastoma
Date of authorisation: 25/01/2010,, Revision: 15, Authorised, Last updated: 28/03/2022
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/86.89 KB) (PDF/86.89 KB) German (PDF/85.23 KB) (PDF/85.23 … -
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 22, Authorised, Last updated: 21/03/2022
Accord Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/108.95 KB) (PDF/108.95 KB) German (PDF/86.56 KB) (PDF/86.56 … -
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Human medicine European public assessment report (EPAR): Temozolomide Sun
temozolomide, Glioma; Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 19, Authorised, Last updated: 17/03/2022
Sun Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/131.27 KB) (PDF/131.27 KB) German (PDF/131.57 KB) (PDF/131.57 … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Teva Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/102.5 KB) (PDF/102.5 KB) German (PDF/79.22 KB) (PDF/79.22 … -
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Human medicine European public assessment report (EPAR): Mektovi
binimetinib, Melanoma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 26/01/2022
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/67.98 KB) (PDF/67.98 KB) German (PDF/68.01 KB) (PDF/68.01 … -
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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 22, Authorised, Last updated: 24/11/2021Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/77.56 KB) (PDF/77.56 KB) German (PDF/57.24 KB) (PDF/57.24 … -
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Human medicine European public assessment report (EPAR): Tafinlar
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 27, Authorised, Last updated: 09/12/2021Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/108.45 KB) (PDF/108.45 KB) German (PDF/108.18 KB) (PDF/108.18 … -
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Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, Revision: 13, Authorised, Last updated: 01/07/2022
Xermelo Neoplasms, Germ Cell and Embryonal Neuroectodermal …