Code | 3189E | ||||||||||
MA number | 56/0009/05-S | ||||||||||
Product Form: | plv iol 1x7,5 mg+1x solv. (striek.inj.napl."A"+striek.inj.napl."B"+ihla+konektor) | ||||||||||
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: |
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Shelf life: | 24 | ||||||||||
Container: | pre-filled syringe | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 04.02.2005 |
Pediatric contraindication: | Yes |
Dokument: | DHPC Leuprorelin - ELIGARD- 21 11 2014.pdf |
PIL: | PIL_Eligard_7.5mg_08_2022.pdf |
SPC: | SPC_Eligard_7.5mg_08_2022.pdf |
Safety feature | Yes |
Data update: | 28.02.2023 |