| Code | 0650D | ||||||||||
| MA number | 15/0059/19-S | ||||||||||
| Product Form: | tbl flm 50x600 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 08.03.2019 |
| PIL: |
PIL_APEL 600 mg filmom obalené tablety_marec_2019.docx
|
| SPC: |
SPC_APEL 600 mg filmom obalené tablety_02.2022.pdf
|
| Safety feature | Yes |
| Data update: | 19.03.2023 |
