SKYTROFA

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Ireland, Italy, Lithuania, Poland.

Active ingredients

The drug SKYTROFA contains one active pharmaceutical ingredient (API):

1
UNII OP35X9610Y - LONAPEGSOMATROPIN
 

Lonapegsomatropin is a long-acting ‘prodrug’ of somatropin. Lonapegsomatropin consists of the parent drug, somatropin, that is transiently conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker. The carrier has a shielding effect that minimizes renal excretion and receptor-mediated clearance of lonapegsomatropin.

 
Read more about Lonapegsomatropin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SKYTROFA Powder for solution for injection MPI, US: SPL/PLR FDA, National Drug Code (US)
 SKYTROFA Powder and solvent for solution for injection MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
H01AC09 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
Discover more medicines within H01AC09

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
EE Ravimiamet 1873920, 1873931, 1873942, 1873953, 1873964, 1873975, 1873986, 1873997, 1874000
IT Agenzia del Farmaco 049880014, 049880026, 049880038, 049880040, 049880053, 049880065, 049880077, 049880089, 049880091
LT Valstybinė vaistų kontrolės tarnyba 1094037, 1094038, 1094039, 1094040, 1094041, 1094042, 1094043, 1094044, 1094045
PL Rejestru Produktów Leczniczych 100467968, 100467975, 100467982, 100467990, 100468027, 100468034, 100468041, 100468059, 100468066
US FDA, National Drug Code 73362-003, 73362-004, 73362-005, 73362-006, 73362-007, 73362-008, 73362-009, 73362-010, 73362-011

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