Tacrolimus

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Description

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  

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Pharma licensing Out-licensing (offer)

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