| Code | 0346F | ||||||||||
| MA number | 44/0233/25-S | ||||||||||
| Product Form: | cps mol 60x1x100 mg (blis. OPA/Al/PVC/Al) - jednotk.bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.06.2025 |
| Validity: | 28.06.2030 |
| PIL: |
PIL_Nintedanib STADA 100 mg_ cps mol_06/2025_REG.pdf
|
| SPC: |
SPC_Nintedanib STADA 100 mg_07.2025.pdf
|
| Safety feature | Yes |
| Data update: | 07.07.2025 |
