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CELEX 62023TJ0351

Judgment of the General Court (Fourth Chamber) of 24 September 2025.#Kern Pharma, SL v European Commission.#Medicinal products for human use – Variation of the marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use – Directive 2001/83/EC – Article 14(11) of Regulation (EC) No 726/2004 – Article 266 TFEU.#Case T-351/23.

decidedEuropean Union· Court of Justice of the European Union· EN

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24 September 2025

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Official record CELEX 62023TJ0351 from European Union at Court of Justice of the European Union. Dated 24 September 2025. Status: decided.

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Judgment of the General Court (Fourth Chamber) of 24 September 2025.#Kern Pharma, SL v European Commission.#Medicinal products for human use – Variation of the marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use – Directive 2001/83/EC – Article 14(11) of Regulation (EC) No 726/2004 – Article 266 TFEU.#Case T-351/23.

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  • Judgment of the General Court (Fourth Chamber) of 24 September 2025.#Kern Pharma, SL v European Commission.#Medicinal products for human use – Variation of the marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use – Directive 2001/83/EC – Article 14(11) of Regulation (EC) No 726/2004 – Article 266 TFEU.#Case T-351/23.

    judgment · EN · 24 September 2025

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  • Arrêt du Tribunal (quatrième chambre) du 24 septembre 2025.#Kern Pharma, SL contre Commission européenne.#Médicaments à usage humain – Modification de l’autorisation de mise sur le marché du médicament à usage humain Tecfidera – diméthyle fumarate – Directive 2001/83/CE – Article 14, paragraphe 11, du règlement (CE) no 726/2004 – Article 266 TFUE.#Affaire T-351/23.

    judgment · FR · 24 September 2025

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  • Tribunalens dom (fjärde avdelningen) av den 24 september 2025.#Kern Pharma, SL mot Europeiska kommissionen.#Mål T-351/23.

    judgment · SV · 24 September 2025

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  • Sodba Splošnega sodišča (četrti senat) z dne 24. septembra 2025.#Kern Pharma, SL proti Evropski komisiji.#Zdravila za uporabo v humani medicini – Sprememba dovoljenja za promet z zdravilom za uporabo v humani medicini Tecfidera – dimetil fumarat – Direktiva 2001/83/ES – Člen 14(11) Uredbe (ES) št. 726/2004 – Člen 266 PDEU.#Zadeva T-351/23.

    judgment · SL · 24 September 2025

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  • Rozsudok Všeobecného súdu (štvrtá komora) z 24. septembra 2025.#Kern Pharma, SL v. Európska komisia.#Vec T-351/23.

    judgment · SK · 24 September 2025

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  • Hotărârea Tribunalului (Camera a patra) din 24 septembrie 2025.#Kern Pharma, SL împotriva Comisiei Europene.#Cauza T-351/23.

    judgment · RO · 24 September 2025

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  • Acórdão do Tribunal Geral (Quarta Secção) de 24 de setembro de 2025.#Kern Pharma, SL contra Comissão Europeia.#Processo T-351/23.

    judgment · PT · 24 September 2025

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  • Wyrok Sądu (czwarta izba) z dnia 24 września 2025 r.#Kern Pharma, SL przeciwko Komisji Europejskiej.#Sprawa T-351/23.

    judgment · PL · 24 September 2025

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  • Arrest van het Gerecht (Vierde kamer) van 24 september 2025.#Kern Pharma, SL tegen Europese Commissie.#Geneesmiddelen voor menselijk gebruik – Wijziging van de vergunning voor het in de handel brengen van het geneesmiddel voor menselijk gebruik ‚Tecfidera – dimethylfumaraat’ – Richtlijn 2001/83/EG – Artikel 14, lid 11, van verordening (EG) nr. 726/2004 – Artikel 266 VWEU.#Zaak T-351/23.

    judgment · NL · 24 September 2025

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  • Sentenza tal-Qorti Ġenerali (Ir-Raba’ Awla) tal-24 ta’ Settembru 2025.#Kern Pharma, SL vs Il-Kummissjoni Ewropea.#Prodotti mediċinali għall-użu mill-bniedem – Emenda tal-awtorizzazzjoni għat‑tqegħid fis-suq tal-prodott mediċinali għall-użu mill-bniedem Tecfidera – dimethyl fumarate – Direttiva 2001/83/KE – Artikolu 14(11) tar-Regolament (KE) Nru 726/2004 – Artikolu 266 TFUE”.#Kawża T-351/23.

    judgment · MT · 24 September 2025

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  • Vispārējās tiesas spriedums (ceturtā palāta), 2025. gada 24. septembris.#Kern Pharma, SL pret Eiropas Komisiju.#Cilvēkiem paredzētas zāles – Cilvēkiem paredzētu zāļu “Tecfidera – dimetilfumarāts” tirdzniecības atļaujas grozījumi – Direktīva 2001/83/EK – Regulas (EK) Nr. 726/2004 14. panta 11. punkts – LESD 266. pants.#Lieta T-351/23.

    judgment · LV · 24 September 2025

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  • 2025 m. rugsėjo 24 d. Bendrojo Teismo (ketvirtoji kolegija) sprendimas.#Kern Pharma, SL prieš Europos Komisiją.#Žmonėms skirti vaistai – Žmonėms skirto vaisto „Tecfidera – dimetilfumaratas“ rinkodaros leidimo pakeitimas – Direktyva 2001/83/EB – Reglamento (EB) Nr. 726/2004 14 straipsnio 11 dalis – SESV 266 straipsnis.#Byla T-351/23.

    judgment · LT · 24 September 2025

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  • Sentenza del Tribunale (Quarta Sezione) del 24 settembre 2025.#Kern Pharma, SL contro Commissione europea.#Causa T-351/23.

    judgment · IT · 24 September 2025

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  • A Törvényszék ítélete (negyedik tanács), 2025. szeptember 24.#Kern Pharma, SL kontra Európai Bizottság.#T-351/23. sz. ügy.

    judgment · HU · 24 September 2025

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  • Presuda Općeg suda (četvrto vijeće) od 24. rujna 2025.#Kern Pharma, SL protiv Europske komisije.#Predmet T-351/23.

    judgment · HR · 24 September 2025

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  • Unionin yleisen tuomioistuimen tuomio (neljäs jaosto) 24.9.2025.#Kern Pharma, SL vastaan Euroopan komissio.#Ihmisille tarkoitetut lääkkeet – Ihmisille tarkoitetun lääkkeen Tecfidera - dimetyylifumaraatti myyntiluvan muuttaminen – Direktiivi 2001/83/EY – Asetuksen (EY) N:o 726/2004 14 artiklan 11 kohta – SEUT 266 artikla.#Asia T-351/23.

    judgment · FI · 24 September 2025

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  • Üldkohtu otsus (neljas koda), 24.9.2025.#Kern Pharma, SL versus Euroopa Komisjon.#Inimtervishoius kasutatavad ravimid – Inimtervishoius kasutatava ravimi Tecfidera - dimetüülfumaraat müügiloa muutmine – Direktiiv 2001/83/EÜ – Määruse (EÜ) nr 726/2004 artikli 14 lõige 11 – ELTL artikkel 266.#Kohtuasi T-351/23.

    judgment · ET · 24 September 2025

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  • Sentencia del Tribunal General (Sala Cuarta) de 24 de septiembre de 2025.#Kern Pharma, S. L., contra Comisión Europea.#Asunto T-351/23.

    judgment · ES · 24 September 2025

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  • Απόφαση του Γενικού Δικαστηρίου (τέταρτο τμήμα) της 24ης Σεπτεμβρίου 2025.#Kern Pharma, SL κατά Ευρωπαϊκής Επιτροπής.#Φάρμακα που προορίζονται για ανθρώπινη χρήση – Τροποποίηση της άδειας κυκλοφορίας του φαρμάκου για ανθρώπινη χρήση Tecfidera – φουμαρικού διμεθυλεστέρα – Οδηγία 2001/83/ΕΚ – Άρθρο 14, παράγραφος 11, του κανονισμού (ΕΚ) 726/2004 – Άρθρο 266 ΣΛΕΕ.#Υπόθεση T-351/23.

    judgment · EL · 24 September 2025

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  • Urteil des Gerichts (Vierte Kammer) vom 24. September 2025.#Kern Pharma, SL gegen Europäische Kommission.#Rechtssache T-351/23.

    judgment · DE · 24 September 2025

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  • Rettens dom (Fjerde Afdeling) af 24. september 2025.#Kern Pharma, SL mod Europa-Kommissionen.#Sag T-351/23.

    judgment · DA · 24 September 2025

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  • Rozsudek Tribunálu (čtvrtého senátu) ze dne 24. září 2025.#Kern Pharma, SL v. Evropská komise.#Věc T-351/23.

    judgment · CS · 24 September 2025

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  • Решение на Общия съд (четвърти състав) от 24 септември 2025 г.#Kern Pharma, SL срещу Европейска комисия.#Дело T-351/23.

    judgment · BG · 24 September 2025

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