| Code | 2302D | ||||||||||
| MA number | 69/0252/19-S | ||||||||||
| Product Form: | aer nao 1x10 ml (fľ.HDPE s 3K sprej.pumpou) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE with nebuliser | ||||||||||
| Route of admin.: | Nasal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 21.08.2019 |
| Validity: | 21.08.2024 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Orinox Neo_aer nao_08/2019_REG.docx
|
| SPC: |
SPC_Orinox Neo_aer nao_08/2019_REG.docx
|
| Safety feature | No |
| Data update: | 21.08.2019 |
