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PRODUCT DETAIL

Lonapegsomatropin Ascendis Pharma 3,6 mg prášok a rozpúšťadlo na injekčný roztok v náplni

Code 9572D
MA number EU/1/21/1607/002
Product Form: plv iol 4x3,6 mg+4x0,329 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
H01C HYPOTHALAMIC HORMONES
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: 09.05.2022
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