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	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 more about Lonapegsomatropin

Medication package inserts

Below package inserts are available for further reading:

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

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