151 results
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP04-13-M01, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2017, Last updated: 20/03/2017, Compliance check: V, 19/10/2018Invented name Lucentis Active substance ranibizumab … EMEA- 000527-PIP04-13). What is Lucentis (ranibizumab), and how is … is it expected to work? Lucentis (ranibizumab) is a medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP03-13, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 06/08/2014, Last updated: 22/08/2014, Compliance check: XInvented name Lucentis Active substance ranibizumab … EMEA-000527-PIP03-13). What is Lucentis (ranibizumab), and how is … is it expected to work? Lucentis (ranibizumab) is a medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP02-10, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection – single-use vial, Solution for injection – single-use pre-filled syringe
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XInvented name Lucentis Active substance ranibizumab … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10 … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP01-08, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection – single-use vial, Solution for injection – single-use pre-filled syringe
Decision date: 07/09/2009, Last updated: 07/12/2009, Compliance check: XInvented name Lucentis Active substance ranibizumab … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08 … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP05-17, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 07/05/2018, Last updated: 22/11/2018, Compliance check: XInvented name Lucentis Active substance ranibizumab … Lucentis Lucentis ranibizumab ranibizumab ra … -
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Human medicine European public assessment report (EPAR): Lucentis (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative
Date of authorisation: 22/01/2007, Revision: 40, Authorised, Last updated: 10/01/2023Lucentis Eye Diseases Retinal Diseases Retinal … horised ranibizumab Overview Lucentis is a medicine used to treat … recognising faces. In adults, Lucentis is used to treat: ‘wet’ … -
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National expert: María Isabel Lucena, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 32.33 KB | PDF
María Isabel Lucena … María Isabel Lucena … INFORMATION Maria Isabel Lucena WORK EXPERIENCE 2008 … -
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Human medicine European public assessment report (EPAR): Byooviz (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,
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, Revision: 5, Authorised, Last updated: 05/01/2023
reference medicine for Byooviz is Lucentis. For more information on A … studies comparing Byooviz with Lucentis have shown that the The substance … highly similar to that in Lucentis in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 1, Authorised, Last updated: 05/10/2022
medicine for Ranivisio is Lucentis. For more information on A … comparing Ranivisio with Lucentis have shown that the The substance … highly similar to that in Lucentis in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Ximluci
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 29/11/2022
reference medicine for Ximluci is Lucentis. For more information on A … studies comparing Ximluci with Lucentis have shown that the The substance … highly similar to that in Lucentis in terms of structure, purity … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
CHMP, Last updated: 20/09/2019Docetaxel Zentiva, Dupixent, Lucentis, Remsima, Taxotere and Trulici … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
CHMP, Last updated: 26/07/2019Empliciti, Keytruda, Lonsurf, Lucentis, Soliris, Stelara, Tecentriq … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
CHMP, Last updated: 14/10/2016Lucentis … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013
CHMP, Last updated: 31/05/2013Glivec, Lucentis … -
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National expert: Alexandra Kozyreff, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.69 KB | PDF
- Curriculum Vitae - 20.08 KB | PDF
01/2012-12/2021 Novartis Lucentis ARMD, choroidal neovascularization … Abbvie (Allergan) Eylea, Lucentis, Ozurdex aged related macular … -
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National expert: Raúl J. Andrade, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 85.81 KB | PDF
- Curriculum Vitae - 38.85 KB | PDF
RAUL J ANDRADE, M ISABEL LUCENA, CAMILLA STEPHENS. Lymphocyte … MARIA R CABELLO, M ISABEL LUCENA, RAUL J ANDRADE. Herbal and … NEIL KAPLOWITZ, M ISABEL LUCENA, RAUL J ANDRADE. Comprehensive … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 March 2011
CHMP, Last updated: 18/03/2011Lucentis … docetaxel and carboplatin. • Lucentis (ranibizumab), from Novartis … -
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 24.27 KB | PDF
2130-2137. 7) M.C. Gaudiano, D. Lucente, E. Antoniella, P. Bertocchi … Gaudiano, E. Antoniella, D. Lucente, V. Crusco, M. Bartolomei … -
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National expert: Merete Blixenkrone-Møller, Danish Medicines Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 26.01 KB | PDF
V, Blixenkrone-Moller M, Elia G, Lucente MS, Cirone F, Decaro N, Nielsen … Blixenkrone-Moller M, Elia G, Lucente MS, Cirone F, Decaro N, Nielsen … outbreaks. Martella V, Elia G, Lucente S, Decaro N, Lorusso E, Banyai … -
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National expert: Maria Cristina Gaudiano, Italian Medicines Agency (updated)
- Declaration of interests - 79.9 KB | PDF
- Curriculum Vitae - 25.52 KB | PDF
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National expert: Patrizia Iacovacci, Italian Medicines Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 22.44 KB | PDF
Businco, P.G. Giampietro, P. Lucenti, F. Lucaroni, C. Pini, G … -
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National expert: Antonio Gomez-Outes, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 27.34 KB | PDF
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 October 2010
CHMP, Last updated: 22/10/2010Lucentis … European Union, for: • Lucentis (ranibizumab), from Novartis … -
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National expert: Javier Gisbert, European Medicines Agency (updated)
- Declaration of interests - 81.24 KB | PDF
- Curriculum Vitae - 24.45 KB | PDF
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Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023