This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, South Africa, Spain, Turkey, UK.
The drug PULMOZYME contains one active pharmaceutical ingredient (API):
1
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UNII
953A26OA1Y - DORNASE ALFA
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| PULMOZYME Nebuliser solution | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| R05CB13 | Dornase alfa (desoxyribonuclease) | R Respiratory system → R05 Cough and cold preparations → R05C Expectorants, excl. combinations with cough suppressants → R05CB Mucolytics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 5704F, 6120D |
| BR | Câmara de Regulação do Mercado de Medicamentos | 529204301157318 |
| CA | Health Products and Food Branch | 02046733 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 233-MBE-0722, 28939-07-09 |
| EE | Ravimiamet | 1022960 |
| ES | Centro de información online de medicamentos de la AEMPS | 60326 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 148213 |
| FR | Base de données publique des médicaments | 60866491 |
| GB | Medicines & Healthcare Products Regulatory Agency | 37694 |
| HK | Department of Health Drug Office | 41444 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-587894223 |
| IE | Health Products Regulatory Authority | 88135 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6554 |
| JP | 医薬品医療機器総合機構 | 2290704G1024 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1002192 |
| MT | Medicines Authority | AA729/22702 |
| NL | Z-Index G-Standaard | 13824856 |
| NL | Z-Index G-Standaard, PRK | 92835 |
| NZ | Medicines and Medical Devices Safety Authority | 6948 |
| PL | Rejestru Produktów Leczniczych | 100056724 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W61214001 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699505751313 |
| US | FDA, National Drug Code | 50242-100 |
| ZA | Health Products Regulatory Authority | 28/30.4/0675 |
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