| Code | 3740D | ||||||||||
| MA number | 64/0045/20-S | ||||||||||
| Product Form: | int opo 1x10 ml (fľ.PE s kvapkadlom) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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 10(3) hybrid application |
| MA issued: | 13.03.2020 |
| Validity: | 13.03.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Dokument: |
VHS_súhrn_Olopatadine UNIMED PHARMA.pdf
|
| Dokument: |
VHS_Olopatadine UNIMED PHARMA.pdf
|
| PIL: |
PIL_Olopatadine UNIMED PHARMA 1 mg_ml int opo_03.2023.pdf
|
| SPC: |
SPC_Olopatadine UNIMED PHARMA 1 mg_ml int opo_03.2023.pdf
|
| Safety feature | Yes |
| Data update: | 28.03.2023 |
