Module232025

07/05/2025

Indication/condition

1. PIPs are done on conditions. One or more (therapeutic) indications may be covered by the same condition (e.g. condition: “Type II diabetes mellitus”, with several indications) 2. Within a given condition, PDCO may request paediatric development for an indication not pursued in adults 3. EMA/PDCO policy defining conditions vs. indications: policy-determination-conditions paediatric-investigation-plan-pip-waiver-scope pip-waiver

The Organisation for Professionals in Regulatory Affairs

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Indication/Condition

Example:

Anticoagulation product. Proposed indication: Prevention of thromboses in patients with atrial fibrillation Atrial fibrillation does not occur in children- but a product targeting thrombotic events may be used in children too

The Organisation for Professionals in Regulatory Affairs

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