| Code | 9053C | ||||||||||
| MA number | 64/0312/18-S | ||||||||||
| Product Form: | int opu 3x5 ml (fľ.LDPE s HDPE uzáver.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Olikla s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| 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: | 19.09.2018 |
| Validity: | 19.09.2023 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Brinzolamid Olikla 10 mg_ml int opu_03/2024.pdf
|
| SPC: |
SPC_Brinzolamid Olikla 10 mg ml int opu_03/2024.pdf
|
| Safety feature | Yes |
| Data update: | 03.11.2022 |
