1452 results
Keyword Bicalutamide Sun Remove keyword
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Referral: Bicalutamide 150 mg
bicalutamide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/05/2007, EC decision date: 03/09/2007, Last updated: 03/10/2007Bicalutamide 150 mg … medicines containing 150 mg bicalutamide, used orally (by mouth) for … all medicines containing bicalutamide 150 mg, both those that are … -
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Referral: Bicaluplex
bicalutamide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/09/2007, EC decision date: 22/11/2007, Last updated: 07/02/2008Non-Proprietary Name (INN): bicalutamide: Background information PDF … and associated names, INN-bicalutamide European Medicines … Non-Proprietary Name (INN): bicalutamide BACKGROUND INFORMATION … -
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Human medicine European public assessment report (EPAR): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Neuroendocrine Tumors
Date of authorisation: 11/02/2021,
, 
, Authorised, Last updated: 06/04/2021
Sunitinib Accord Gastrointestinal … Sunitinib Accord … EMA/18013/2021 EMEA/H/C/005419 Sunitinib Accord sunitinib) An overview of Sunitinib Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Sutent
sunitinib, Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Neuroendocrine Tumors
Date of authorisation: 19/07/2006, Revision: 38, Authorised, Last updated: 27/11/2019sunitinib … Sutent; INN-sunitinib 30 Churchill Place … for the public Sutent sunitinib This is a summary of the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sutent, sunitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000342-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: V, 29/06/2018Key facts Sutent sunitinib OncologyP/0147/2018EMEA-000342-PIP01-08-M07 … paediatric investigation plan for sunitinib (Sutent), (EMEA-000342-PIP01-08-M07 … Sutent Sutent sunitinib sunitinib sunitinib … -
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Withdrawn application: Sutent
sunitinib, date of withdrawal: 26/06/2018, Post-authorisation, Last updated: 17/08/2018authorisation for Sutent (sunitinib) On 26 June 2018, Pfizer … contains the active substance sunitinib. Further information on … active substance in Sutent, sunitinib, is a protein kinase inhibitor … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016Docetaxel SUN: Withdrawn application … application for Docetaxel Sun (docetaxel) On 6 June … docetaxel) On 6 June 2016, Sun Pharmaceutical Industries … -
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Withdrawn application: Doxorubicin SUN
doxorubicin, date of withdrawal: 20/07/2011, Initial authorisation, Last updated: 26/09/2011Doxorubicin SUN: Withdrawn application … application for Doxorubicin SUN (doxorubicin) On 20 Jul … doxorubicin) On 20 Jul 2011, Sun Pharmaceutical Industries … -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011Topotecan SUN: Withdrawn application … application for Topotecan SUN (topotecan) On 3 January … topotecan) On 3 January 2011, Sun Pharmaceutical Industries … -
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Withdrawn application: Repaglinide Sun
repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010Repaglinide Sun: Withdrawn application … application for Repaglinide Sun (repaglinide) On 23 March … repaglinide) On 23 March 2010, Sun Pharmaceutical Industries … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 01/03/2021
Bortezomib Sun Multiple Myeloma … Bortezomib Sun … Bortezomib SUN, INN-bortezomib 30 … -
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Human medicine European public assessment report (EPAR): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 14, Authorised, Last updated: 24/02/2021
Levetiracetam Sun Epilepsy … EPAR) for Levetiracetam Sun. It explains how the Committee … of use for Levetiracetam Sun. What is Levetiracetam Sun? Levetiracetam Sun is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy, Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,, Revision: 1, Authorised, Last updated: 22/10/2020
Sunosi Narcolepsy Sleep Apnea … orised solriamfetol Overview Sunosi is a medicine used to improve … disturbed night-time sleep. Sunosi is used in patients with … -
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Human medicine European public assessment report (EPAR): Temozolomide Sun
temozolomide, Glioma, Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 16, Authorised, Last updated: 22/04/2020
Temozolomide Sun Glioma Glioblastoma … Temozolomide Sun … Temozolomide SUN, INN-temozolomide … -
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms, Breast Neoplasms, Colonic Neoplasms, Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
Capecitabine SUN Stomach Neoplasms Breast … authorisation for Capecitabine SUN has been withdrawn at the … Summary documents Capecitabine SUN : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 8, Authorised, Last updated: 11/11/2020
Atosiban SUN Premature Birth … report (EPAR) for Atosiban SUN. It explains how the Agency … advice on how to use Atosiban SUN. For practical information … -
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Sunset-clause monitoring: questions and answers
Last updated: 01/01/2016Sunset-clause monitoring: questions and … holders (MAHs) may have on sunset-clause monitoring. It provides an …
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Referral: Budesonide SUN
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2020, EC decision date: 19/08/2020, Last updated: 16/09/2020Budesonide SUN … authorisation for Budesonide Sun (budesonide, nebuliser suspension … authorisation of Budesonide Sun and associated names cannot … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (doxorubicin hydrochloride)
CHMP, Last updated: 21/07/2011Sun Pharmaceutical Industries … application for Doxorubicin Sun (doxorubicin hydrochloride … been formally notified by Sun Pharmaceutical Industries … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan)
Last updated: 17/02/2011Sun Pharmaceutical Industries … application for Topotecan SUN (topotecan … been formally notified by Sun Pharmaceutical Industries … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Repaglinide SUN (repaglinide)
Last updated: 25/03/2010Sun Pharmaceutical Industries … application for Repaglinide SUN (repaglinide … been formally notified by Sun Pharmaceutical Industries … -
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National expert: Andreas Sundgren, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 77.02 KB | PDF
Andreas Sundgren … Andreas Sundgren … vitae PERSONAL INFORMATION Andreas Sundgren WORK EXPERIENCE March … -
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National expert: Katarina Sundberg, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 57.25 KB | PDF
Katarina Sundberg … Katarina Sundberg … vitae PERSONAL INFORMATION Katarina Sundberg WORK EXPERIENCE September … -
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National expert: Yuansheng Sun, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 16.35 KB | PDF
Yuansheng Sun … Yuansheng Sun … Vitae PERSONAL INFORMATION Yuansheng Sun WORK EXPERIENCE June 2001 … -
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National expert: Hildrun Sundseth, European Medicines Agency (updated)
- Declaration of interests - 80.34 KB | PDF
- Curriculum Vitae - 17.93 KB | PDF
Hildrun Sundseth … Hildrun Sundseth … Vitae PERSONAL INFORMATION Hildrun Sundseth WORK EXPERIENCE June 2004-July …