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Active substance / international non-proprietary name (INN) / common name

Medicine

Summaries of opinion Remove Summaries of opinion filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter

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PIP decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (1) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter W: decision granting a waiver in all age groups for all conditions or indications (4) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

PIP condition / indication

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PIP compliance check

Yes (4) Apply Yes filter

Compliance procedure number

Medicine type

Conditional approval Remove Conditional approval filter Accelerated assessment (29) Apply Accelerated assessment filter Additional monitoring (159) Apply Additional monitoring filter Biosimilar (1) Apply Biosimilar filter Exceptional circumstances (13) Apply Exceptional circumstances filter Orphan medicine (81) Apply Orphan medicine filter

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