SKYTROFA

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

Active ingredients

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

1 Lonapegsomatropin 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 about Lonapegsomatropin

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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