| Code | 2016C | ||||||||||
| MA number | 64/0501/16-S | ||||||||||
| Product Form: | int opo 1x6 ml (fľ.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 07.12.2016 |
| SPC: |
SPC_Monopost_očná roztoková instilácia_05.2022.pdf
|
| PIL: |
PIL_MONOPOST 50 mikrogramov_ml očná roztoková instilácia int opo_03.2024.pdf
|
| Safety feature | Yes |
| Data update: | 29.03.2022 |
