| Code | 8708D | ||||||||||
| MA number | 52/0252/21-S | ||||||||||
| Product Form: | sol por 1x200 ml/1200 mg (fľ.skl.hnedá+plast.odmer.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 52 - EXPECTORANTIA, MUCOLYTICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | 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: | 25.10.2021 |
| Validity: | 25.10.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_BROXIVAN 6 mg/ml perorálny roztok_12_2021.pdf
|
| SPC: |
SPC_BROXIVAN 6 mg/ml perorálny roztok_12_2021.pdf
|
| Safety feature | No |
| Data update: | 28.10.2021 |
