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Summaries of opinion Remove Summaries of opinion filter Paediatric investigation plans Remove Paediatric investigation plans filter Periodic safety update report single assessments Remove Periodic safety update report single assessments filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Opinions on medicines for use outside EU Remove Opinions on medicines for use outside EU filter European public assessment reports (EPAR) (1654) Apply European public assessment reports (EPAR) filter Withdrawn applications (275) Apply Withdrawn applications filter Orphan designations (2639) Apply Orphan designations filter Referrals (434) Apply Referrals filter Shortages (32) Apply Shortages filter

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P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (615) Apply 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 (795) Apply PM: decision on the application for modification of an agreed PIP filter RP: decision refers to a refusal on a proposed Paediatric Investigation Plan (19) Apply RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (11) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (34) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (924) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

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Accelerated assessment (38) Apply Accelerated assessment filter Additional monitoring (209) Apply Additional monitoring filter Biosimilar (6) Apply Biosimilar filter Conditional approval (48) Apply Conditional approval filter Exceptional circumstances (12) Apply Exceptional circumstances filter Generic (3) Apply Generic filter Orphan medicine (96) Apply Orphan medicine filter

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4742 results

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Medicine Paediatric investigation plans Remove Paediatric investigation plans filter Opinions on medicines for use outside EU Remove Opinions on medicines for use outside EU filter Summaries of opinion Remove Summaries of opinion filter Periodic safety update report single assessments Remove Periodic safety update report single assessments filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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List item

Summary of opinion: Tuznue

trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022
List item

Summary of opinion: Hervelous

trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022
List item

Summary of opinion: Tabrecta

capmatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022
List item

Summary of opinion: Retsevmo

selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022
List item

Summary of opinion: Cevenfacta

Eptacog beta (activated), opinion date: 19/05/2022, Positive, Last updated: 20/05/2022
List item

Summary of opinion: Upstaza

eladocagene exuparvovec, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022
List item

Summary of opinion: Ertapenem SUN

ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022
List item

Summary of opinion: Sunlenca

lenacapavir, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022
List item

Summary of opini

4742 results

Summary of opinion: Tuznue

Summary of opinion: Hervelous

Summary of opinion: Tabrecta

Summary of opinion: Retsevmo

Summary of opinion: Cevenfacta

Summary of opinion: Upstaza

Summary of opinion: Ertapenem SUN

Summary of opinion: Sunlenca

Summary of opini