| Code | 8234E | ||||||||||
| MA number | 56/0329/24-S | ||||||||||
| Product Form: | tbl 20x25 mg (blis. PVC/PVDC-Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Olikla s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| 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(3) hybrid application |
| MA issued: | 06.12.2024 |
| Validity: | 06.12.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Prednisone Olikla_12.2024.pdf
|
| PIL: |
PIL_Prednisone Olikla_12_2024.pdf
|
| Safety feature | Yes |
| Data update: | 09.12.2024 |
