PULMOZYME

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Dornase alfa UNII 953A26OA1Y - DORNASE ALFA

Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum. Read about Dornase alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PULMOZYME Nebuliser solution	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
R05CB13	Dornase alfa (desoxyribonuclease)	R Respiratory system → R05 Cough and cold preparations → R05C Expectorants, excl. combinations with cough suppressants → R05CB Mucolytics
Discover more medicines within R05CB13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 5704F, 6120D
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529204301157318
Country: CA	Health Products and Food Branch	Identifier(s): 02046733
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 233-MBE-0722, 28939-07-09
Country: EE	Ravimiamet	Identifier(s): 1022960
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 60326
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 148213
Country: FR	Base de données publique des médicaments	Identifier(s): 60866491
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 37694
Country: HK	Department of Health Drug Office	Identifier(s): 41444
Country: IE	Health Products Regulatory Authority	Identifier(s): 88135
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6554
Country: JP	医薬品医療機器総合機構	Identifier(s): 2290704G1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1002192
Country: MT	Medicines Authority	Identifier(s): AA729/22702
Country: NL	Z-Index G-Standaard	Identifier(s): 13824856
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 92835
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 6948
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100056724
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W61214001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505751313
Country: US	FDA, National Drug Code	Identifier(s): 50242-100
Country: ZA	Health Products Regulatory Authority	Identifier(s): 28/30.4/0675