| Code | 1770E | ||||||||||
| MA number | 64/0221/22-S | ||||||||||
| Product Form: | int opo 1x5 ml/30 mg (fľ.LDPE viacdávk.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Menarini International Operations Luxembourg S.A., Luxembourg | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 18.08.2022 |
| Validity: | 18.08.2027 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Omarit 6 mg_ml očné roztokové kvapky_08_2022.pdf
|
| SPC: |
SPC_Omarit 6 mg_ml očné roztokové kvapky_08_2022.pdf
|
| Safety feature | Yes |
| Data update: | 22.08.2022 |
