Code | 8927D | ||||||||||
MA number | 87/0277/21-S | ||||||||||
Product Form: | sol iru 3x3ml/30 mg (striek.inj.skl.napl.+3 ihly-multibal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 29.10.2021 |
Validity: | 29.10.2026 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Icatibant Glenmark 30 mg sol iru_10_2021.pdf |
SPC: | SPC_Icatibant Glenmark 30 mg sol iru_10_2021.pdf |
Safety feature | Yes |
Data update: | 05.11.2021 |