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PRODUCT DETAIL

Fyremadel 0,25 mg/0,5 ml injekčný roztok v naplnenej injekčnej striekačke

Code 6629D
MA number 56/0035/21-S
Product Form: sol iru 1x0,25 mg/0,5 ml (striek.inj.skl.napl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Sun Pharmaceutical Industries Europe B.V. , Netherland
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
H01CC Anti-gonadotropin-releasing hormones
H01CC01 Ganirelix
Shelf life: 24
Container: pre-filled syringe
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 25.03.2021
Validity: 25.03.2026
SPC: SPC_Fyremadel_február_2021.doc  
PIL: PIL_Fyremadel_február_2021.doc  
Safety feature Yes
Data update: 30.03.2021
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