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PRODUCT DETAIL

Skytrofa 4,3 mg prášok a rozpúšťadlo na injekčný roztok v náplni

Code 9573D
MA number EU/1/21/1607/003
Product Form: plv iol 4x4,3 mg+4x0,388 ml solv.+6xihla (náplň dvojkom.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
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
H01AC09 Lonapegsomatropin
Shelf life: 36
Container: double-chamber glass cartrige
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 11.01.2022
Validity: 11.01.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 08.09.2022
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