| Code | 6453E | ||||||||||
| MA number | 64/0308/22-S | ||||||||||
| Product Form: | int opo 1x10 ml (obal LDPE viacdávk.vo vre.PE/Al/PE/PET) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Laboratoires THEA, France | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | multidose container | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 12.12.2022 |
| Validity: | 12.12.2027 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Zamisept_06/2024.pdf
|
| SPC: |
SPC_Zamisept_06/2024.pdf
|
| Safety feature | Yes |
| Data update: | 31.05.2024 |
