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Medical Device Not applicable - Certificates of Suitability Please refer to dossier section 32-reg-info for the current Certificate of Suitability of Timolol maleate

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Travoprost-Timolol / Pharmathen (40micrograms/mL+5mg/mL) preservative free eye drops, solution in multi dose 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 Travoprost-Timolol/Pharmathen (40 micrograms/mL + 5 mg/ml) preservative free eye drops, solution in multi dose container is enclosed in section 32r-reg-info.

- Medical Device Not applicable

- Certificates of Suitability

Please refer to dossier section 32-reg-info for the current Certificate of Suitability of Timolol maleate.

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

Not applicable

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“Regional Information/ For EU

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