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15 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Categories
Human Remove Human filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
PIP decision type
W: decision granting a waiver in all age groups for all conditions/indications Remove W: decision granting a waiver in all age groups for all conditions/indications filter
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
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001760-PIP01-15-M03, decision date: 22/03/2019, Last updated: 24/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-000713-PIP02-10-M05, decision date: 20/07/2018, Last updated: 28/11/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-001304-PIP03-17, decision date: 11/04/2018, Last updated: 25/07/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-000876-PIP06-15, decision date: 28/07/2016, Last updated: 20/04/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tagrisso,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-002125-PIP01-17, decision date: 09/08/2017, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vargatef,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001006-PIP03-16, decision date: 05/05/2017, Last updated: 03/07/2017, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-000876-PIP07-15, decision date: 01/09/2016, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001006-PIP02-15, decision date: 27/10/2015, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-000980-PIP02-15, decision date: 07/08/2015, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Empliciti,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-002377-PIP01-18, decision date: 13/08/2018, Last updated: 18/01/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001729-PIP02-18, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001806-PIP03-18, decision date: 15/05/2019, Last updated: 29/10/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-001006-PIP05-18, decision date: 17/04/2019, Last updated: 20/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex,
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-002152-PIP01-17, decision date: 15/06/2018, Last updated: 27/11/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-000980-PIP04-18, decision date: 08/10/2018, Last updated: 11/01/2019, compliance check: X