| Code | 6857E | ||||||
| MA number | 92/0174/24-S | ||||||
| Product Form: | sir 1x100 ml (fľ.skl.hnedá + odmerka PP) | ||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||
| Type of procedure: | Mutual recognition procedure | ||||||
| MAH, country: | Phytopharm Klęka S.A., Poland | ||||||
| Therapeutic Class: | 92 - TRADIČNÉ RASTLINNÉ LIEKY | ||||||
| ATC: |
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| Shelf life: | 36 | ||||||
| Container: | brown glass bottle | ||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 16a traditional use registration for herbal medicinal product |
| MA issued: | 09.08.2024 |
| Validity: | 09.08.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Pelafen_sirup_07_2024.pdf
|
| PIL: |
PIL_Pelafen sirup_07_2024.pdf
|
| Safety feature | No |
| Data update: | 19.08.2024 |
