| Code | 5341E | ||||||||||
| MA number | 64/0006/24-S | ||||||||||
| Product Form: | int opo 1x5 ml/500 mg (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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: | 09.02.2024 |
| Validity: | 09.02.2029 |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Phenylephrine Olikla 100 mg/ml očné roztokové kvapky_int opo_02/2024_REG.pdf
|
| PIL: |
PIL_Phenylephrine Olikla 100 mg/ml očné roztokové kvapky_int opo_02/2024_REG.pdf
|
| Safety feature | Yes |
| Data update: | 18.02.2024 |
