2 Inclusion of API description & origin
4.1 Inclusion of paediatric age range
4.2 Text clarifications
4.4 Inclusion of warning using immunosuppressive combinations increasing the susceptibility to infection and warning in 4.2 that simulect must not be used unless a patient is certain to receive a graft is included here.
4.5 trade name replaced by generic name
4.6 text clarified
4.8 trade name replaced with generic name. Frequency of post marketing adverse reactions deleted.
5.1 5.2 trade replaced with generic name
6.1 headings included
6.3 text clarified
6.5 addl information on type of glass is deleted
6.6 additional precaution inspecting reconstituted samples and statement on disposal included