PIL- Brinzolamide/timolol Accord 10mg/ml + 5mg/ml Eye Drops, Suspension: Change history
View Patient Information Leaflet (PIL- Brinzolamide/timolol Accord 10mg/ml + 5mg/ml Eye Drops, Suspension)
Last updated on this site: 18 Dec 2023
Description of update:
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, Fritz-Kotz-Strasse 12 + 16, 51674 Wiehl, Germany.
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, John-Deere-Straße 1 + 3, 76646 Bruchsal, Germany
IB, B.II.e.2.z Change in the irradiation dose and bioburden limit of the primary packaging (bottle, dropper and cap) adopted by the new alternative sites. The gamma irradiation dose is changed from 25 - 45 KGy, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to 17.5 - 50 kGy to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
The bioburden limit is changed from Max 50 CFU, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to Max 9 CFU to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
IB, B.II.e.4.c Change of the shape/dimensions of the 5 ml pack size, where the size/capacity of the LDPE bottle is changed from 5 ml to 10 ml. The dimensions of the bottle are changed from 42.1 - 42.7 mm (5 ml capacity) to 51.8 ± 0.4mm (10 ml capacity).
PIL sections updated: 6 only.
Last updated on this site: 18 Dec 2023
Description of update:
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, Fritz-Kotz-Strasse 12 + 16, 51674 Wiehl, Germany.
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, John-Deere-Straße 1 + 3, 76646 Bruchsal, Germany
IB, B.II.e.2.z Change in the irradiation dose and bioburden limit of the primary packaging (bottle, dropper and cap) adopted by the new alternative sites. The gamma irradiation dose is changed from 25 - 45 KGy, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to 17.5 - 50 kGy to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
The bioburden limit is changed from Max 50 CFU, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to Max 9 CFU to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
IB, B.II.e.4.c Change of the shape/dimensions of the 5 ml pack size, where the size/capacity of the LDPE bottle is changed from 5 ml to 10 ml. The dimensions of the bottle are changed from 42.1 - 42.7 mm (5 ml capacity) to 51.8 ± 0.4mm (10 ml capacity).
PIL sections updated: 6 only.
-
Changes: (Updated: 18 Dec 2023)
Description of update:
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, Fritz-Kotz-Strasse 12 + 16, 51674 Wiehl, Germany.
IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, John-Deere-Straße 1 + 3, 76646 Bruchsal, Germany
IB, B.II.e.2.z Change in the irradiation dose and bioburden limit of the primary packaging (bottle, dropper and cap) adopted by the new alternative sites. The gamma irradiation dose is changed from 25 - 45 KGy, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to 17.5 - 50 kGy to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
The bioburden limit is changed from Max 50 CFU, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to Max 9 CFU to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).
IB, B.II.e.4.c Change of the shape/dimensions of the 5 ml pack size, where the size/capacity of the LDPE bottle is changed from 5 ml to 10 ml. The dimensions of the bottle are changed from 42.1 - 42.7 mm (5 ml capacity) to 51.8 ± 0.4mm (10 ml capacity).
PIL sections updated: 6 only.
-
Changes: (Updated: 06 Jul 2023)
Variation Description: Update to product information for Brinzolamide/Timolol Accord in line with the information of Reference product (AZARGA, 10mg/ml + 5mg/ml, eye drops, suspension; MAH: Novartis Europharm Limited; EMA procedure number: EMEA/H/C/000960).
PIL sections updated – heading, introduction, 2,4 and 6
-
Changes: (Updated: 27 Jan 2023)
Variation Description: To update SmPC sections 4.4 and 4.8, and PIL in-line with the wordings of PSUSA procedure (EMEA/H/C/PSUSA/00000432/202108) for Stevens-Johnson syndrome and toxic epidermal necrolysis.
PIL sections updated – 2, 3, 4 and 6.
-
Changes: (Updated: 20 Sep 2022)
Initial upload