| Code | 5318E | ||||||||||
| MA number | 56/0010/24-S | ||||||||||
| Product Form: | sol iru 14x1,112 ml/25 mg (striek.inj.napl skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | IBSA Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 30.01.2024 |
| Validity: | 30.01.2029 |
| SPC: |
SPC_Prolutex_05.2025.pdf
|
| PIL: |
PIL_Prolutex_08.2025.pdf
|
| Safety feature | Yes |
| Data update: | 12.02.2024 |
