| Code | 9556C | ||||||||||
| MA number | 64/0355/18-S | ||||||||||
| Product Form: | int opo 1x10 ml (fľ.LDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Santen Oy, Finland | ||||||||||
| 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 8(3) application - new active substance |
| MA issued: | 26.10.2018 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_COSOPT Multi Dose Free 20 mgml+5 mgml_int opo_04.2023.pdf
|
| SPC: |
SPC_COSOPT Multi Dose Free 20 mgml_5 mgml int opo_04.2023.pdf
|
| Safety feature | Yes |
| Data update: | 21.04.2023 |
