| Code | 6145D | ||||||||||
| MA number | 64/0270/20-S | ||||||||||
| Product Form: | int opo 1x15 ml/7,5 mg (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | McNeil Healthcare (Ireland) Limited, Ireland | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Visine Rapid 0,5 mg ml_int opo_11.2023.pdf
|
| PIL: |
PIL_Visine Rapid 0,5 mg/ml_05/2025.pdf
|
| Safety feature | No |
| Data update: | 07.07.2022 |
