| Product No | EMEA/H/C/000247 |
|---|---|
| Brand Name | Cotronak |
| Nonproprietary Name | ribavirin |
| API | Ribavirin |
| ATC Code | J05AB04 |
| Indications | Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Schering-Plough Europe |
| Status | Withdrawn |
| Authorization Date | 1999-05-07 |
| Version | 4 |
| 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