| Code | 27289 | ||||||||||
| MA number | 64/0600/97-S | ||||||||||
| Product Form: | int opu 1x5 ml (fľ.PE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Immedica Pharma AB, Sweden | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | dropper bottle PE | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 16.12.1997 |
| SPC: |
SPC_Betoptic S_10.2022.pdf
|
| PIL: |
PIL_Betoptic S_09.2023.pdf
|
| Safety feature | Yes |
| Data update: | 16.04.2018 |
