| Code | 0592F | ||||||||||
| MA number | 64/0245/25-S | ||||||||||
| Product Form: | int opo 1x10 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: |
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| Shelf life: | 9 | ||||||||||
| 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: | 09.07.2025 |
| Validity: | 09.07.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Cyclopentolate Olikla_int opo_07_2025_REG.pdf
|
| SPC: |
SPC_Cyclopentolate Olikla_int opo_07_2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 14.07.2025 |
