Code | 2051C | ||||||||||
MA number | 29/0462/15-S | ||||||||||
Product Form: | sol iru 8x0,30 ml/15 mg (striek.inj.skl.napl. s ihlou) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | pre-filled syringe | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 26.11.2015 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Injexate 50 mg_ml injekčný roztok naplnený v injekčnej striekačke_12.2023.pdf |
PIL: | PIL_Injexate 50 mg_ml injekčný roztok naplnený v injekčnej striekačke_03.2024.pdf |
Safety feature | Yes |
Data update: | 31.05.2022 |