| Code | 9676E | ||||||||||
| MA number | 64/0130/25-S | ||||||||||
| Product Form: | int opu 1x10 mg/ml + 5 mg/ml (fľ. LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Olikla s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 29.04.2025 |
| Validity: | 29.04.2030 |
| SPC: |
SPC_Brinzolamid/timolol Olikla_int opu_04/2025_REG.pdf
|
| PIL: |
PIL_Brinzolamid/timolol Olikla_int opu_04/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 12.05.2025 |
