| Code | 5020D | ||||||||||
| MA number | 15/0117/20-S | ||||||||||
| Product Form: | tbl flm 16x500 mg/125 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| 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 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Penlac 500mg_125mg_tbl flm_02.2025.pdf
|
| SPC: |
SPC_Penlac 500mg_125mg_tbl flm_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 18.03.2025 |
