| Product No | EMEA/H/C/000549 |
|---|---|
| Brand Name | Pedea |
| Nonproprietary Name | ibuprofen |
| API | Ibuprofen |
| ATC Code | C01EB16 |
| Indications | Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Recordati Rare Diseases |
| Status | Authorised(授权) |
| Authorization Date | 2004-07-28 |
| Version | 15 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information