| Name |
Budosan 4 mg čepići |
| Marketing Authorisation Number |
HR-H-837692946 |
| Active Substance |
budezonid |
| Composition |
jedan čepić sadrži 4 mg budezonida |
| Pharmaceutical Form |
čepić |
| Manufacturer |
Dr. Falk Pharma GmbH, Freiburg, Njemačka |
| Marketing Authorisation Holder |
Dr. Falk Pharma GmbH, Leinenweberstraße 5, Freiburg, Njemačka |
| Marketing Authorisation Date |
25.10.2023 |
| MA Period of Validity |
25.10.2028 |
| Classification Number |
UP/I-530-09/23-01/48 |
| Registration Number |
381-12-01/171-23-06 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A07EA06 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
