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

Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.

Date of approval: 01/10/2026

PIL sections updated: Heading, 2, 4, 5 and 6

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

Initial upload