|
Rationale for the combination
| ✓ | ✓ | ✓ | ✓ |
|
Balancing advantages and disadvantages of the combination
|
X
|
X
|
X
|
X
|
|
Marketing status in other countries
| ✓ | ✓ | ✓ | ✓ |
|
Analysis of literature data in the submission
|
X
|
X
|
X
|
X
|
|
Pharmaceutical development studies
|
X
|
X
|
X
|
X
|
|
Good Manufacturing Practice (GMP) certification of sites of manufacture
|
X
|
X
|
X
|
X
|
|
A full quality data set
|
X
|
X
|
X
|
X
|
|
Bioavailability data
|
-
|
-
|
X
|
-
|
|
Bioequivalence data
|
-
|
-
|
X
|
-
|
|
Preclinical pharmacology and safety
|
-
|
-
|
X
|
-
|
|
Clinical safety and efficacy
|
X
|
X
|
X
|
X
|
|
Product information
| ✓ | ✓ | ✓ | ✓ |
|
Plan for passive post marketing surveillance
|
X
|
X
|
X
|
X
|
|
Plan for active post marketing surveillance
|
X
|
X
|
X
|
X
|
|
Assurances
|
X
|
X
|
X
|
X
|
