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PRODUCT DETAIL

Norditropin NordiFlex 10 mg/1,5 ml

Code 1679D
MA number 56/0172/19-S
Product Form: sol ira 1x1,5 ml (náplň skl.v napl.inj.pere)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
ATC:
H SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H01 PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H01A ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
H01AC Somatropin and somatropin agonists
H01AC01 Somatropin
Shelf life: 24
Container: glass cartridge in pre-filled pen
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 12.06.2019
Validity: 12.06.2024
MA renewed: Renewal application submitted
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Norditropin NordiFlex_5 mg_10 mg_12_2022.pdf  
PIL: PIL_Norditropin NordiFlex_10 mg_12_2022.pdf  
Dokument: DHPC_Norditropin Nordiflex_29.02.2024.pdf  
Safety feature Yes
Data update: 21.06.2019
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