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Opinion/decision on a Paediatric investigation plan (PIP): sonidegib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000880-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Powder and solvent for oral suspension
Decision date: 20/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001050-PIP01-10-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000694-PIP01-09-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000533-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 20/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000496-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000468-PIP02-12-M06, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Oral suspension, Gastro-resistant tablet, Gastro-resistant powder for oral suspension, Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000467-PIP01-08-M13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 18/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xgeva, denosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000145-PIP02-12-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/03/2020, Last updated: 31/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Simponi, Golimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000265-PIP02-11-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 16/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen, Naltrexone HCl, D-Sorbitol (PXT3003)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002164-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vamorolone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001794-PIP02-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001715-PIP01-14-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002359-PIP01-18-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 20/02/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vosoritide (BMN 111)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002033-PIP01-16-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/02/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001407-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): avapritinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002358-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lumasiran (ALN-GO1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002079-PIP01-16-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001822-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001613-PIP01-14-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Abrocitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002312-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 03/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 03/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001584-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 20/02/2020, Last updated: 12/06/2020, Compliance check: X