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PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets: Change history

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  • View Patient Information Leaflet (PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets)

    Last updated on this site: 20 Feb 2026

    To update the SmPC and package leaflet in-line with the reference product (Tracleer 62.5/125 mg film-coated tablets; EU procedure number: EMEA/H/C/000401/PSUR/0000257801).

    View change history

    • Changes: (Updated: 20 Feb 2026)

      To update the SmPC and package leaflet in-line with the reference product (Tracleer 62.5/125 mg film-coated tablets; EU procedure number: EMEA/H/C/000401/PSUR/0000257801).

    • Changes: (Updated: 08 Dec 2025)

      Variation type IAIN no: B.II.b.2.c.2 - Addition of a manufacturer responsible for importation and/or batch release - Including batch control/testing

      Addition of a site responsible for importation and batch release including batch control/testing of the product (physical, chemical and microbiological testing):

      Accord Healthcare single member S.A.

      64th Km National Road Athens,Lamia, Schimatari, 32009,

      Greece

      Variation type IAIN no: B.II.b.1.a - Replacement of a manufacturing site for part or all of the manufacturing process of the finished product - Secondary packaging site

      Replacement of a site responsible for secondary packaging of the product:

      from

      Prodlekpol Sp. z o.o. , 14, Matuszewska, 03-876 Warsaw, Poland

      to

      Synoptis Industrial Sp. z o.o., Ul. Rabowicka 15, Swarzedz, 62-020, Poland

    • Changes: (Updated: 06 Dec 2022)

      Update to pack information for 125mg

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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