| Code | 3696E | ||||||||||
| MA number | 24/0144/23-S | ||||||||||
| Product Form: | tbl oro 50x1x20 mg (blis.OPA/Al/PVC/Al-perfor.-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 09.06.2023 |
| Validity: | 09.06.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Omarit 20 mg orodispergovateľné tablety_06_2023.pdf
|
| PIL: |
PIL_Omarit 20 mg orodispergovateľné tablety_06_2023.pdf
|
| Safety feature | Yes |
| Data update: | 12.06.2023 |
