| Code | 0846F | ||||||||||
| MA number | 64/0273/25-S | ||||||||||
| Product Form: | int plg 1x8 ml/160 mg (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Bausch + Lomb Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| 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: | 26.08.2025 |
| Validity: | 26.08.2030 |
| SPC: |
SPC_Carteol NEO 20 mg_ml očné roztokové kvapky s predĺženým uvoľňovaním_08_2025.pdf
|
| PIL: |
PIL_Carteol NEO 20 mg_ml očné roztokové kvapky s predĺženým uvoľňovaním_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 28.08.2025 |
