Code | 92275 | ||||||||||
MA number | 56/0202/05-S | ||||||||||
Product Form: | sol inj 1x1,5 ml/5 mg (náplň skl.) | ||||||||||
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: | glass cartrige | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 19.07.2005 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Norditropin SimpleXx_5 mg_10 mg_12_2022.pdf |
PIL: | PIL_Norditropin_SimpleXx_5 mg_12_2022.pdf |
Safety feature | Yes |
Data update: | 06.06.2018 |