| Code | 5613E | ||||||||||
| MA number | 44/0030/24-S | ||||||||||
| Product Form: | tbl 120x250 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | AS Olpha, Latvia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.03.2024 |
| Validity: | 04.03.2029 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Abiraterone Olpha 250 mg tablety_08.2025.pdf
|
| SPC: |
SPC_Abiraterone Olpha 250 mg tablety_08.2025.pdf
|
| Safety feature | Yes |
| Data update: | 19.08.2025 |
