Code | 80454 | ||||||||||
MA number | 56/0564/09-S | ||||||||||
Product Form: | imp 3x5 mg (striek.inj.napl.plast.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | pre-filled syringe PP | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 25.09.2009 |
SPC: | SPC_Leuprorelin_5mg_08_2022.pdf |
PIL: | PIL_Leuprorelin_02_2023.pdf |
Safety feature | Yes |
Data update: | 29.05.2018 |