| Code | 1448E | ||||||||||
| MA number | 36/0188/22-S | ||||||||||
| Product Form: | sol por 1x100 ml/600 mg (fľ.skl.jantár. + odmerka PP) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 36 - ANTITUSSICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.07.2022 |
| Validity: | 11.07.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Ditustat Neo_11/2023.pdf
|
| SPC: |
SPC_Ditustat Neo_05/2025.pdf
|
| Safety feature | Unknown |
| Data update: | 13.05.2025 |
