| Code | 0594F | ||||||||||
| MA number | 56/0244/25-S | ||||||||||
| Product Form: | sol inj 1x1000 mg/4 ml (liek.skl. jant.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sun Pharmaceutical Industries Europe B.V. , Netherland | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | amber glass container | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.08.2025 |
| Validity: | 16.08.2030 |
| PIL: |
PIL_Testosterone undecanoate SUN 1 000 mg_4 ml injekčný roztok_07_2025.pdf
|
| SPC: |
SPC_Testosterone undecanoate SUN 1 000 mg_4 ml injekčný roztok_07_2025.pdf
|
| Safety feature | Yes |
| Data update: | 19.08.2025 |
