1) To register change in the storage conditions of the finished
product CAMCEVI 42 mg prolonged-release suspension for
injection from "Store in a refrigerator (2°C - 8°C). Store in the
original package in order to protect from light" to "Store in a
refrigerator (2°C - 8°C). Store in the original package in order
to protect from light. Once outside the refrigerator this product
may be stored in its original packaging at room temperature
(below 25°C) for up to eight weeks, discard if not used within
eight weeks.".
Consequently, section 6.4 of the SmPC has been updated.
2) To register change in the storage conditions of the finished
product CAMCEVI 21 mg prolonged-release suspension for
injection from "Store in a refrigerator (2°C - 8°C). Store in the
original package in order to protect from light" to "Store in a
refrigerator (2°C - 8°C). Store in the original package in order
to protect from light. Once outside the refrigerator this product
may be stored in its original packaging at room temperature
(below 25°C) for up to eight weeks, discard if not used within
eight weeks".Consequently, section 6.4 of the SmPC has been
updated.
3) To update section 2 of the SmPC to include details of
deliverable volume for Camcevi 21 mg.
4) To update section 2 of the SmPC to include details of
deliverable volume for Camcevi 42 mg.
In addition, editorial changes have been made to the section
6.6 of the SmPC and Package leaflet for Camcevi 42 mg.