Q3158583 (Q3158583): Difference between revisions
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(Created claim: summary (P836): This project aims to give continuity to the policy on the development of generic medicinal products and aims to develop new EFGs for the treatment of life-impact pathologies in adult patients._x000D_ _x000D_ 7 new generic medicinal products are included in different therapeutic areas. Two of these relate to pathologies of the nervous system, namely agomelatin in 25 mg coated tablets for the treatment of major depression in adults, and lacosamide...) |
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This project aims to give continuity to the policy on the development of generic medicinal products and aims to develop new EFGs for the treatment of life-impact pathologies in adult patients._x000D_ _x000D_ 7 new generic medicinal products are included in different therapeutic areas. Two of these relate to pathologies of the nervous system, namely agomelatin in 25 mg coated tablets for the treatment of major depression in adults, and lacosamide as 4-dose-coated tablets (50 mg, 100 mg, 150 mg and 200 mg) for the treatment of partial-onset seizures in patients with epilepsy._x000D_ _x000D_ It is also proposed to develop two specialties for the treatment of diseases caused by infectious agents: daptomycin in lyophilised 350 mg and 500 mg vials, indicated for the treatment of complicated skin infections and soft parts, and infectious endocarditis due to Staphylococcus aureus, as well as emtricitabine/tenofovir in 200 mg/245 mg coated tablets indicated in antiretroviral combination therapy for the treatment of HIV-infected adults._x000D_ _x000D_ The other three specialties, although not in common therapeutic areas, are aimed at the treatment of diseases with high incidence in the third age. Specifically, bortezomib in vials of 1 mg, 2 mg and 3.5 mg is indicated for the treatment of adult patients with progressing multiple myeloma, which is prevalent in over 65 years. Cinacalcet will also be developed as 30 mg, 60 mg and 90 mg coated tablets for the treatment of secondary hyperparathyroidism in patients with chronic renal impairment on dialysis. Finally, the development of tamsulosin/dutasteride in 0.4 mg/0.5mg hard capsules is envisaged for the treatment of moderate to severe symptoms of benign prostate hyperplasia (English) | |||||||||||||||
| Property / summary: This project aims to give continuity to the policy on the development of generic medicinal products and aims to develop new EFGs for the treatment of life-impact pathologies in adult patients._x000D_ _x000D_ 7 new generic medicinal products are included in different therapeutic areas. Two of these relate to pathologies of the nervous system, namely agomelatin in 25 mg coated tablets for the treatment of major depression in adults, and lacosamide as 4-dose-coated tablets (50 mg, 100 mg, 150 mg and 200 mg) for the treatment of partial-onset seizures in patients with epilepsy._x000D_ _x000D_ It is also proposed to develop two specialties for the treatment of diseases caused by infectious agents: daptomycin in lyophilised 350 mg and 500 mg vials, indicated for the treatment of complicated skin infections and soft parts, and infectious endocarditis due to Staphylococcus aureus, as well as emtricitabine/tenofovir in 200 mg/245 mg coated tablets indicated in antiretroviral combination therapy for the treatment of HIV-infected adults._x000D_ _x000D_ The other three specialties, although not in common therapeutic areas, are aimed at the treatment of diseases with high incidence in the third age. Specifically, bortezomib in vials of 1 mg, 2 mg and 3.5 mg is indicated for the treatment of adult patients with progressing multiple myeloma, which is prevalent in over 65 years. Cinacalcet will also be developed as 30 mg, 60 mg and 90 mg coated tablets for the treatment of secondary hyperparathyroidism in patients with chronic renal impairment on dialysis. Finally, the development of tamsulosin/dutasteride in 0.4 mg/0.5mg hard capsules is envisaged for the treatment of moderate to severe symptoms of benign prostate hyperplasia (English) / rank | |||||||||||||||
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| Property / summary: This project aims to give continuity to the policy on the development of generic medicinal products and aims to develop new EFGs for the treatment of life-impact pathologies in adult patients._x000D_ _x000D_ 7 new generic medicinal products are included in different therapeutic areas. Two of these relate to pathologies of the nervous system, namely agomelatin in 25 mg coated tablets for the treatment of major depression in adults, and lacosamide as 4-dose-coated tablets (50 mg, 100 mg, 150 mg and 200 mg) for the treatment of partial-onset seizures in patients with epilepsy._x000D_ _x000D_ It is also proposed to develop two specialties for the treatment of diseases caused by infectious agents: daptomycin in lyophilised 350 mg and 500 mg vials, indicated for the treatment of complicated skin infections and soft parts, and infectious endocarditis due to Staphylococcus aureus, as well as emtricitabine/tenofovir in 200 mg/245 mg coated tablets indicated in antiretroviral combination therapy for the treatment of HIV-infected adults._x000D_ _x000D_ The other three specialties, although not in common therapeutic areas, are aimed at the treatment of diseases with high incidence in the third age. Specifically, bortezomib in vials of 1 mg, 2 mg and 3.5 mg is indicated for the treatment of adult patients with progressing multiple myeloma, which is prevalent in over 65 years. Cinacalcet will also be developed as 30 mg, 60 mg and 90 mg coated tablets for the treatment of secondary hyperparathyroidism in patients with chronic renal impairment on dialysis. Finally, the development of tamsulosin/dutasteride in 0.4 mg/0.5mg hard capsules is envisaged for the treatment of moderate to severe symptoms of benign prostate hyperplasia (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 15:38, 12 October 2021
Project Q3158583 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3158583 in Spain |
Statements
1,448,279.0 Euro
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2,896,558.0 Euro
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50.0 percent
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29 December 2014
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30 September 2017
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LABORATORIOS NORMON, S.A.
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40°36'23.69"N, 3°42'23.51"W
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28903
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El presente proyecto pretende dar continuidad a la política de desarrollo de especialidades farmacéuticas genéricas y persigue el desarrollo de nuevas EFG para el tratamiento de patologías de impacto vital en paciente adulto._x000D_ _x000D_ Se incluyen 7 nuevas especialidades farmacéuticas genéricas en diferentes áreas terapéuticas. Dos de ellas corresponden a patologías del sistema nervioso, concretamente agomelatina en comprimidos recubiertos de 25mg para el tratamiento de depresión mayor en adultos, y lacosamida en comprimidos recubiertos de 4 dosis diferentes (50mg, 100mg, 150mg y 200mg) para el tratamiento de las crisis de inicio parcial en pacientes con epilepsia._x000D_ _x000D_ También se propone el desarrollo de dos especialidades para el tratamiento de enfermedades causadas por agentes infecciosos: daptomicina en viales liofilizados de 350mg y 500mg, indicado para el tratamiento de infecciones complicadas de la piel y partes blandas, y de endocarditis infecciosa debida a Staphylococcus aureus, así como emtricitabina/tenofovir en comprimidos recubiertos de 200mg/245mg indicado en terapia de combinación antiretroviral para el tratamiento de adultos infectados por VIH._x000D_ _x000D_ Las otras tres especialidades, si bien no pertenecen a áreas terapéuticas comunes, están dirigidas al tratamiento de enfermedades cuya incidencia es alta en la tercera edad. En concreto, bortezomib en viales de 1mg, 2mg y 3,5mg es indicado para el tratamiento de pacientes adultos con mieloma múltiple en progresión, dolencia que es prevalente en mayores de 65 años. Asimismo, se desarrollará cinacalcet en comprimidos recubiertos de 30mg, 60mg y 90 mg, indicado para el tratamiento del hiperparatiroidismo secundario en pacientes con insuficiencia renal crónica en diálisis. Por último, se contempla el desarrollo de tamsulosina/dutasterida en cápsulas duras de 0,4mg/0,5mg, indicada para el tratamiento de los síntomas de moderados a graves de la hiperplasia benigna de próstata (Spanish)
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This project aims to give continuity to the policy on the development of generic medicinal products and aims to develop new EFGs for the treatment of life-impact pathologies in adult patients._x000D_ _x000D_ 7 new generic medicinal products are included in different therapeutic areas. Two of these relate to pathologies of the nervous system, namely agomelatin in 25 mg coated tablets for the treatment of major depression in adults, and lacosamide as 4-dose-coated tablets (50 mg, 100 mg, 150 mg and 200 mg) for the treatment of partial-onset seizures in patients with epilepsy._x000D_ _x000D_ It is also proposed to develop two specialties for the treatment of diseases caused by infectious agents: daptomycin in lyophilised 350 mg and 500 mg vials, indicated for the treatment of complicated skin infections and soft parts, and infectious endocarditis due to Staphylococcus aureus, as well as emtricitabine/tenofovir in 200 mg/245 mg coated tablets indicated in antiretroviral combination therapy for the treatment of HIV-infected adults._x000D_ _x000D_ The other three specialties, although not in common therapeutic areas, are aimed at the treatment of diseases with high incidence in the third age. Specifically, bortezomib in vials of 1 mg, 2 mg and 3.5 mg is indicated for the treatment of adult patients with progressing multiple myeloma, which is prevalent in over 65 years. Cinacalcet will also be developed as 30 mg, 60 mg and 90 mg coated tablets for the treatment of secondary hyperparathyroidism in patients with chronic renal impairment on dialysis. Finally, the development of tamsulosin/dutasteride in 0.4 mg/0.5mg hard capsules is envisaged for the treatment of moderate to severe symptoms of benign prostate hyperplasia (English)
12 October 2021
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Tres Cantos
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Identifiers
IDI-20150114
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