1803 results
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National expert: Andreas Sundgren, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 28.54 KB | PDF
Andreas Sundgren … Andreas Sundgren … Vitae Personal information Andreas Sundgren Work experience … -
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National expert: Anna Sundlöv, Medical Products Agency (updated)
- Declaration of interests - 44.7 KB | PDF
- Curriculum Vitae - 35.46 KB | PDF
Anna Sundlöv … Anna Sundlöv … Vitae Personal information Anna Sundlöv Work experience … -
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National expert: Kaisa Sunela, Finnish Medicines Agency (updated)
- Declaration of interests - 51.02 KB | PDF
- Curriculum Vitae - 34.87 KB | PDF
Kaisa Sunela … Kaisa Sunela … Vitae Personal information Kaisa Sunela Work experience … -
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National expert: Katarina Sundberg, Medical Products Agency (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 24.47 KB | PDF
Katarina Sundberg … Katarina Sundberg … Vitae Personal information Katarina Sundberg Work experience … -
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National expert: Yuansheng Sun, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 23.31 KB | PDF
Yuansheng Sun … Yuansheng Sun … Vitae Personal information Yuansheng Sun Work experience … -
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National expert: Hildrun Sundseth, European Medicines Agency (updated)
- Declaration of interests - 40.55 KB | PDF
- Curriculum Vitae - 24.17 KB | PDF
Hildrun Sundseth … Hildrun Sundseth … Vitae Personal information Hildrun Sundseth Work experience … -
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National expert: Per Anders Sundström, Medical Products Agency (updated)
- Declaration of interests - 39.73 KB | PDF
- Curriculum Vitae - 41.24 KB | PDF
Per Anders Sundström … Per Anders Sundström … Vitae Personal information Per Anders Sundström Work experience … -
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Sunitinib product-specific bioequivalence guidance
Last updated: 07/07/2015Sunitinib product-specific bioequivalence … Sunitinib product-specific bioequivalence … Sunitinib hard capsules 12.5, 25, 37.5 …
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Sunset clause monitoring: Regulatory and procedural guidance
Last updated: 01/01/2016Sunset clause monitoring: Regulatory … Sunset clause monitoring: Regulatory … Q&A - Sunset clause ext European …
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Notifying a change of marketing status and sunset clause (veterinary medicines)
Last updated: 29/07/2021change of marketing status and sunset clause (veterinary medicines … change of marketing status and sunset clause (veterinary medicines …
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Press release: Scenesse recommended for rare disease that causes intolerance to sunlight
CHMP, Last updated: 24/10/2014that causes intolerance to sunlight … that causes intolerance to sunlight … that causes intolerance to sunlight Patients involved in discussions … -
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News: European Medicines Agency website unavailable Sunday 1 December 2013
Last updated: 29/11/2013Agency website unavailable Sunday 1 December 2013 … between 9:00 and 17:00 on Sunday 1 December 2013 due to essential … -
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 19, Authorised, Last updated: 25/05/2023
compared with treatment using sunitinib, another cancer medicine … around 9 months in those given sunitinib. … compared with treatment using sunitinib, another cancer medicine … -
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Human medicine European public assessment report (EPAR): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 51, Authorised, Last updated: 03/04/2023for renal cell carcinoma, sunitinib. The results showed that in … lived longer than those given sunitinib. After 24 months, around 67 … compared with 53% in the sunitinib group. In addition, 42% of … -
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Human medicine European public assessment report (EPAR): Ameluz
5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 13/12/2011, Revision: 19, Authorised, Last updated: 23/03/2022growths caused by exposure to sunlight, which can lead to skin cancer … used to treat an area of sun-induced skin damage with multiple … forehead or scalp (an area of sun damage with several actinic … -
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Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,
, Revision: 15, Authorised, Last updated: 24/03/2023
another cancer medicine, sunitinib. The average time patients … versus 8 months in those given sunitinib. Longer follow-up is needed … another cancer medicine, sunitinib. The average time patients … -
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Human medicine European public assessment report (EPAR): Masican
masitinib, Gastrointestinal Stromal Tumors
Date of refusal: 04/07/2014,
, Refused, Last updated: 22/11/2013
and one group treated with sunitinib, another medicine of the same … designed to compare Masican with sunitinib and that it was difficult … longer than those treated with sunitinib, the possibility that this … -
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Human medicine European public assessment report (EPAR): Inlyta
axitinib, Carcinoma, Renal Cell
Date of authorisation: 03/09/2012, Revision: 14, Authorised, Last updated: 28/09/2021when treatment with Sutent (sunitinib) or ‘cytokines’ (other … cancer medicines such as sunitinib or cytokines had failed … with cytokines rather than sunitinib. What is the risk associated … -
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Human medicine European public assessment report (EPAR): Opdivo
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023another cancer medicine, sunitinib. After 24 months, 66.5% of … compared with 52.9% in the sunitinib group. In addition, 41.6 … of 416) of those receiving sunitinib. The time patients lived before … -
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , 
, Revision: 9, Authorised, Last updated: 04/11/2022
and during periods of high sunlight exposure, e.g. from spring … much protection from the sun is needed. Three implants … produced during exposure to sunlight to block the penetration … -
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Human medicine European public assessment report (EPAR): Stivarga
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 20, Authorised, Last updated: 08/03/2023treatment with imatinib and sunitinib and patients with HCC should … treatment with imatinib and sunitinib and patients with HCC should … -
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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 23, Authorised, Last updated: 17/03/2023photosensitivity reaction (sunburn-like reactions following exposure … photosensitivity reaction (sunburn-like reactions following exposure … -
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Human medicine European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD)
alendronic acid, colecalciferol, Osteoporosis, Postmenopausal
Date of authorisation: 16/10/2009, Revision: 17, Authorised, Last updated: 22/11/2021through exposure to natural sunlight. Vitamin D3, along with other … vitamin D3 through exposure to sunlight, it is included in Vantavo … through exposure to natural sunlight. Vitamin D3, along with other … -
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Human medicine European public assessment report (EPAR): Fosavance
alendronic acid, colecalciferol, Osteoporosis, Postmenopausal
Date of authorisation: 24/08/2005, Revision: 26, Authorised, Last updated: 11/11/2021through exposure to natural sunlight. Vitamin D 3 , along with … vitamin D 3 through exposure to sunlight, it is included in Fosavance … through exposure to natural sunlight. Vitamin D3, along with other … -
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Human medicine European public assessment report (EPAR): Adrovance
colecalciferol, alendronic acid (as sodium trihydrate), Osteoporosis, Postmenopausal
Date of authorisation: 04/01/2007, Revision: 24, Authorised, Last updated: 05/11/2021through exposure to natural sunlight. Vitamin D 3 , along with … vitamin D 3 through exposure to sunlight, it is included in Adrovance … through exposure to natural sunlight. Vitamin D3, along with other …