722 results
Keyword Sildenafil Sandoz Remove keyword
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Referral: Methylphenidate Sandoz
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Sandoz … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the … -
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Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … of the medicine Budesonide Sandoz. The Agency's Committee for … the benefits of Budesonide Sandoz outweigh its risks, and the … -
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … medicinal product Calcium Sandoz Effervescent tablets, 500/1000 … benefit/risk ratio of Calcium Sandoz Effervescent tablets, 500/1000 … -
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Referral: Mometasone Furoate Sandoz
mometasone furoate, associated names: Mometasone Sandoz, Mometasone Sandoz 50, Mometasone Furoato Sandoz 50, Mommox, Nasometi, Fumomo 50, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 08/10/2012, Last updated: 24/01/2013Mometasone Furoate Sandoz … medicine Mometasone Furoate Sandoz. The Agency's Committee for … benefits of Mometasone Furoate Sandoz outweigh its risks, and that … -
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Referral: Loratadine Sandoz 10
loratadine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/05/2009, EC decision date: 06/08/2009, Last updated: 12/12/2009Loratadine Sandoz 10 … of the medicine Loratadine Sandoz 10. The Agency's Committee … the benefits of Loratadine Sandoz 10 do not outweigh its risks … -
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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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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 designation: 22/02/2018, Positive, Last updated: 08/04/2020macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … given in combination with sildenafil, was more effective at reducing … reducing blood pressure than sildenafil alone. This assumption will … -
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Orphan designation: Ubenimex for: Treatment of pulmonary arterial hypertension
Date of designation: 21/03/2016, Positive, Last updated: 19/08/2019iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … more than another medicine, sildenafil. This assumption will need … iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … -
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News: Public Statement on Viagra and Patrex
CHMP, Last updated: 22/04/1999pharmacokinetics of saquinavir and sildenafil and ritonavir and sildenafil when co-administered to healthy … steady state (500 mg bid) with sildenafil (100 mg single dose) resulted … pharmacokinetics of saquinavir and sildenafil and ritonavir and sildenafil when co-administered to healthy … -
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,
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, Revision: 8, Withdrawn, Last updated: 29/01/2021
Marketing-authorisation holder Sandoz GmbH Revision 8 Date of issue … marketing authorisation holder, Sandoz GmbH, which notified the … -
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 24, Authorised, Last updated: 04/10/2023
throughout the EU for Zarzio to Sandoz GmbH on 6 February 2009 … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022dimethyl fumarate Overview Sandoz GmbH withdrew its application … Dimherity (dimethyl fumarate) Sandoz GmbH withdrew its application … that, at this point of time, Sandoz GmbH has taken the decision … -
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, Revision: 13, Authorised, Last updated: 04/08/2023
Marketing-authorisation holder Sandoz GmbH Revision 13 Date of … this medicinal product is Sandoz GmbH. Erelzi will be available … -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
Marketing-authorisation holder Sandoz Pharmaceuticals d.d. Revision … -
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Orphan designation: Ralinepag for: Treatment of pulmonary arterial hypertension
Date of designation: 11/01/2019, Positive, Last updated: 13/02/2023macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … -
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Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib) for: Treatment of pulmonary arterial hypertension
Date of designation: 29/05/2019, Positive, Last updated: 30/09/2022macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … -
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Orphan designation: sotatercept for: Treatment of pulmonary arterial hypertension
Date of designation: 09/12/2020, Positive, Last updated: 26/04/2022macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … -
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, Revision: 9, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 12, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,, , Authorised, Last updated: 23/11/2023
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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 designation: 20/04/2017, Positive, Last updated: 13/05/2019iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … -
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Orphan designation: tacrolimus for: Treatment of pulmonary arterial hypertension
Date of designation: 23/08/2017, Positive, Last updated: 17/10/2017iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … -
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 14, Authorised, Last updated: 20/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 14 Date of … -
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 13, Authorised, Last updated: 20/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 13 Date of … -
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Orphan designation: Sodium nitrite for: Treatment of pulmonary arterial hypertension
Date of designation: 05/03/2012, Positive, Last updated: 06/07/2012bosentan, epoprostenol, iloprost, sildenafil, tadalafil and treprostinil … bosentan, epoprostenol, iloprost, sildenafil, tadalafil and treprostinil …