| Code | 7331D | ||||||||||
| MA number | 56/0109/21-S | ||||||||||
| Product Form: | sol iru 1x0,5 ml/120 mg (striek.inj.napl.PP+ihla) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Amdipharm Limited, Ireland | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | pre-filled syringe PP | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 06.05.2021 |
| Validity: | 06.05.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Mytolente_06_2025.pdf
|
| PIL: |
PIL_Mytolente_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 09.07.2025 |
