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33 results
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir, paritaprevir, ritonavir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001440-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 12/08/2020, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Varuby, rolapitant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001768-PIP02-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olysio, simeprevir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000625-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zydelig, Idelalisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001350-PIP02-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate dispersible tablet
Decision date: 09/11/2018, Last updated: 28/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP04-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofigo, radium (223Ra) dichloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001986-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP02-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/03/2011, Last updated: 08/04/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 06/11/2008, Last updated: 07/01/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alecensa, Alectinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002431-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/12/2018, Last updated: 13/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kisqali, ribociclib succinate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002765-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/06/2020, Last updated: 09/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002146-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral dosage form, Tablet
Decision date: 03/01/2019, Last updated: 12/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002066-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Capsule, soft
Decision date: 14/04/2021, Last updated: 12/01/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, lanadelumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001864-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/04/2020, Last updated: 03/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, benralizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001214-PIP06-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate dosage form for parenteral use, Solution for injection
Decision date: 14/08/2020, Last updated: 18/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
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): Piqray, Alpelisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002016-PIP04-20, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001454-PIP05-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001588-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Empliciti, Elotuzumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002377-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
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): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP02-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
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): Lorviqua, Lorlatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002669-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/01/2021, Last updated: 29/09/2021, Compliance check: X