GENERIC DRUG IN COMBINATION OF AN ALPHA-BLOCKER AND AN ANTICHOLINERGIC FOR THE TREATMENT OF SYMPTOMS OF BENIGN PROSTATE HYPERPLASIA (Q3173737): Difference between revisions

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(‎Removed claim: summary (P836): This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the ref...)
Property / summary
This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English)
 
Property / summary: This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English) / rank
Normal rank
 
Property / summary: This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English) / qualifier
point in time: 12 October 2021
Timestamp+2021-10-12T00:00:00Z
Timezone+00:00
CalendarGregorian
Precision1 day
Before0
After0
 

Revision as of 21:22, 12 October 2021

Project Q3173737 in Spain
Language Label Description Also known as
English
GENERIC DRUG IN COMBINATION OF AN ALPHA-BLOCKER AND AN ANTICHOLINERGIC FOR THE TREATMENT OF SYMPTOMS OF BENIGN PROSTATE HYPERPLASIA
Project Q3173737 in Spain

    Statements

    contained in NUTS
    Madrid
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    country
    Spain
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    EU contribution
    450,404.0 Euro
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    budget
    900,808.0 Euro
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    co-financing rate
    50.0 percent
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    start time
    16 November 2018
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    end time
    31 July 2021
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    beneficiary name (string)
    LABORATORIOS NORMON, S.A.
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    beneficiary
    Q3158582
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    coordinate location

    40°36'23.69"N, 3°42'23.51"W
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    postal code
    28903
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    summary
    El presente proyecto plantea el desarrollo de una nueva especialidad farmacéutica genérica de tamsulosina-solifenacina, comprimidos de liberación modificada, a una dosis de 0,4mg de tamsulosina y 6mg de solifenacina, para el tratamiento de los síntomas de llenado y vaciado asociados a la hiperplasia benigna de próstata (HBP)._x000D_ Actualmente no figura registrado ningún genérico de esta combinación en el mercado español y el desarrollo previsto deberá demostrar su bioequivalencia con la especialidad de referencia (Volutsa® / Vesomni® de Astellas Pharma, S.A.)._x000D_ El proyecto se enmarca en el desarrollo de medicamentos genéricos como medida de contención del gasto farmacéutico y para su ejecución se plantea el desarrollo de una formulación alternativa a la especialidad de referencia, mediante procedimientos galénicos alternativos y procesos de formulación y fabricación de la forma farmacéutica prevista que permitan respetar los derechos de patentes y propiedad industrial de la especialidad de referencia._x000D_ El medicamento de referencia está protegido por una patente de uso de la combinación de tamsulosina y solifenacina, y por otras 4 patentes de tecnología farmacéutica._x000D_ Se plantea diseñar un plan de desarrollo no infringente, desarrollando una formulación adecuada para una composición farmacéutica de liberación prolongada con polióxidos de etileno, excipientes y aglutinantes distintos a los reivindicados por patente. Las fases del desarrollo de la especialidad del proyecto se van a centrar en la formulación galénica de la nueva especialidad farmacéutica genérica, en la realización de los estudios de bioequivalencia y la preparación de la documentación para registro. NORMON contará con la colaboración de la Fundación de Investigación Biomédica del Hospital Universitario de la Princesa y de Anapharm Europe, S.L. para llevar a cabo los estudios de bioequivalencia y los bioanálisis asociados (Spanish)
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    location (string)
    Tres Cantos
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    Identifiers

    Spanish Kohesio ID
    IDI-20190021
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