Tacrolimus
Popular SaleDescription
We offer a dossier for registration of Tacrolimus in capsules of 3 doses.
| Tacrolimus 0.5 mg capsule | Tacrolimus 1 mg capsule | Tacrolimus 5mg capsule | Number of Pages | ||
| Number of Pages | Number of Pages | Number of Pages | Number of Pages | ||
| CTD | 2.854 | 2.850 | 2.850 | 8.554 | |
| M1 | 45 | 45 | 45 | 135 | |
| M2 | - | ||||
| 2.1. | 5 | 5 | 5 | 15 | |
| 2.2. | 1 | 1 | 1 | 3 | |
| 2.3.A. | 1 | 1 | 1 | 3 | |
| 2.3.P. | 29 | 25 | 25 | 79 | |
| 2.3.S. | 36 | 36 | 36 | 108 | |
| 2.4. | 1 | 1 | 1 | 3 | |
| 2.4.+ PCR | 45 | 45 | 45 | 135 | |
| M3 | - | ||||
| 3.1. | 4 | 4 | 4 | 12 | |
| 3.2.A. | 1 | 1 | 1 | 3 | |
| 3.2.S. | 269 | 269 | 269 | 807 | |
| 3.2.P.1. | 1 | 1 | 1 | 3 | |
| 3.2.P.2. | 36 | 34 | 34 | 104 | |
| 3.2.P.3. | 6 | 6 | 6 | 18 | |
| 3.2.P.3.5. | 14 | 14 | 14 | 42 | |
| 3.2.P.4. | 3 | 3 | 3 | 9 | |
| 3.2.P.4.1 | 12 | 12 | 12 | 36 | |
| 3.2.P.4.4. | 4 | 4 | 4 | 12 | |
| 3.2.P.4.5. | 2 | 2 | 2 | 6 | |
| 3.2.P.5. | 20 | 21 | 21 | 62 | |
| 3.2.P.5.3. | 221 | 221 | 221 | 663 | |
| 3.2.P.5.4. | 3 | 3 | 3 | 9 | |
| 3.2.P.6. | 1 | 1 | 1 | 3 | |
| 3.2.P.6.1. | 1 | 1 | 1 | 3 | |
| 3.2.P.7. | 3 | 3 | 3 | 9 | |
| 3.2.P.7.1. | 11 | 11 | 11 | 33 | |
| 3.2.P.8. | 5 | 6 | 6 | 17 | |
| 3.2.P.8.2. | 10 | 10 | 10 | 30 | |
| 3.2.P.8.3. | 6 | 6 | 6 | 18 | |
| M4 | 203 | 203 | 203 | 609 | |
| M5 | - | ||||
| M5 | 1 | 1 | 1 | 3 | |
| M5 BE | 1613 | 1613 | 1613 | 4.839 | |
| DMF | 241 | 241 | 241 | 723 |
More details
| Name | Description |
|---|---|
| Pharma licensing | Out-licensing (offer) |