PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets)
Last updated on this site: 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
Last updated on this site: 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: 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