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OLATALIN (dorzolamide/timolol) - Open-angle glaucoma or pseudoexfoliative glaucoma
Reason for request
Summary of opinion
Favourable opinion for reimbursement in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.
No clinical added value of the new forms compared to the reference medicinal product, COSOPT 20 mg/mL + 5 mg/mL (dorzolamide, timolol) eye drops, solution in single-dose containers, and the other preservative-free eye drop solutions containing dorzolamide 20 mg/mL and timolol 5 mg/mL (COSTEC, COSIDIME and DUALKOPT).
Clinical Benefit
| Substantial |
The Committee considers that the clinical benefit of OLATALIN 20 mg/mL + 5 mg/mL (dorzolamide, timolol) eye drops, solution is substantial in the MA indication.
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Clinical Added Value
| no clinical added value |
The proprietary medicinal product OLATALIN 20 mg/mL + 5 mg/mL (dorzolamide, timolol) eye drops, solution is a hybrid that does not provide any clinical added value (CAV V) compared to the reference medicinal product, COSOPT 20 mg/mL + 5 mg/mL (dorzolamide, timolol) eye drops, solution in single-dose containers, and the other preservative-free eye drop solutions containing dorzolamide 20 mg/mL and timolol 5 mg/mL (COSTEC, COSIDIME and DUALKOPT). |
