PIL- Betahistine dihydrochloride 8, 16mg Tablets: Change history
View Patient Information Leaflet (PIL- Betahistine dihydrochloride 8, 16mg Tablets)
Last updated on this site: 21 Nov 2025
The following change has been notified:
• Type IA (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
• Type IA (B.II.b.1.b) : To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for primary packaging site.
• Type IA (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
Last updated on this site: 21 Nov 2025
The following change has been notified:
• Type IA (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
• Type IA (B.II.b.1.b) : To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for primary packaging site.
• Type IA (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 21 Nov 2025)
The following change has been notified:
• Type IA (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.
• Type IA (B.II.b.1.b) : To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for primary packaging site.
• Type IA (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 21 Aug 2025)
Update to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1, and the PIL in line with information of reference product.
Variation approval 20/06/2025.
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Changes: (Updated: 20 Sep 2022)
Initial upload