Code | 7329D | ||||||||||
MA number | 56/0108/21-S | ||||||||||
Product Form: | sol iru 1x0,5 ml/90 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: |
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Shelf life: | 24 | ||||||||||
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 |
SPC: | SPC_Mytolente_07_2024.pdf |
PIL: | PIL_Mytolente_07_2024.pdf |
Safety feature | Yes |
Data update: | 07.05.2021 |