Judgment of the General Court (Eighth Chamber) of 2 September 2026.#Ferring Pharmaceuticals A/S v European Commission.#Medicinal products for human use – Generic medicinal products – Marketing authorisation for the medicinal product for human use Degarelix Accord – degarelix acetate – Lack of bioequivalence study with the reference medicinal product – Article 10(1) and (2) of Directive 2001/83/EC – Manifest error of assessment – Principle of good administration.#Case T-12/24.

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Official record CELEX 62024TJ0012 from European Union at Court of Justice of the European Union. Dated 2 September 2026. Status: decided.

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1. 2 September 2026

   Decided

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• Judgment of the General Court (Eighth Chamber) of 2 September 2026.#Ferring Pharmaceuticals A/S v European Commission.#Medicinal products for human use – Generic medicinal products – Marketing authorisation for the medicinal product for human use Degarelix Accord – degarelix acetate – Lack of bioequivalence study with the reference medicinal product – Article 10(1) and (2) of Directive 2001/83/EC – Manifest error of assessment – Principle of good administration.#Case T-12/24.

  judgment · EN · 2 September 2026

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• Arrêt du Tribunal (huitième chambre) du 2 septembre 2026.#Ferring Pharmaceuticals A/S contre Commission européenne.#Médicaments à usage humain – Médicaments génériques – Autorisation de mise sur le marché du médicament à usage humain Degarelix Accord – acétate de dégarélix – Absence d’étude de bioéquivalence avec le médicament de référence – Article 10, paragraphes 1 et 2, de la directive 2001/83/CE – Erreur manifeste d’appréciation – Principe de bonne administration.#Affaire T-12/24.

  judgment · FR · 2 September 2026

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