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Bimatoprost-Timolol/Pharmathen 0.3mg/mL + 5mg/mL, Preservative Free, Eye drops solution, multidose container 2.3.R Regional Information /For Eu, p.1

2.3.R REGIONAL INFORMATION/ FOR EU - Process Validation Scheme for the Drug Product

Process validation protocol for Bimatoprost-Timolol/Pharmathen 0.3mg/mL + 5mg/mL, Preservative Free, Eye drops solution, multidose container is enclosed in Module 3, Section 3.2.R. “Regional Information/ For EU”.

- Medical Device Not applicable

- Certificates of Suitability

Current Certificate of Suitability Timolol maleate by FDC is enclosed in Module 3, Section 3.2.R. “Regional Information/ For EU”.

- Medicinal Products containing or using in the manufacturing process materials of animal and/or human origin

The excipients used in the manufacture of Bimatoprost-Timolol/Pharmathen 0.3mg/mL + 5mg/mL, Preservative Free, Eye drops solution, multidose container do not pose a TSE risk.

Information supporting this statement is provided in Module 3, Section 3.2.R.

“Regional Information/ For EU”.

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