DAWNZERA

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

Active ingredients

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

1	Donidalorsen UNII ZD4D8M32TL - DONIDALORSEN
	Donidalorsen is a 2'-O-methoxyethyl–modified antisense oligonucleotide (ASO) conjugated to a triantennary N-acetylgalactosamine (GalNAc3) moiety that causes ribonuclease H1 (RNase H1) mediated degradation of prekallikrein (PKK) mRNA through selective binding to PKK mRNA, which results in reduced production of PKK protein. PKK is a pro-enzyme for plasma kallikrein, which results in the release of bradykinin, a potent vasodilator causing inflammation and swelling in hereditary angioedema (HAE).
	Read more about Donidalorsen

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DAWNZERA Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)
DAWNZERA 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
B06AC09		B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema
Discover more medicines within B06AC09

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	3143898, 3143900
IT	Agenzia del Farmaco	052816016, 052816028
LT	Valstybinė vaistų kontrolės tarnyba	1106001, 1106002
US	FDA, National Drug Code	71860-103