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 |