Code | 5019D | ||||||||||
MA number | 15/0117/20-S | ||||||||||
Product Form: | tbl flm 15x500 mg/125 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 08.07.2020 |
Validity: | 08.07.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Penlac 500mg_125mg_tbl flm_05.2023.pdf |
SPC: | SPC_Penlac 500mg_125mg_tbl flm_05.2023.pdf |
Safety feature | Yes |
Data update: | 09.07.2020 |