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Opinion/decision on a Paediatric investigation plan (PIP): 2-hydroxypropyl-ß-cyclodextrin (HP-ß-CD) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001866-PIP01-15-M03, decision date: 29/01/2019, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001862-PIP01-15-M01, decision date: 03/01/2019, last updated: 29/04/2019, 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) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMEA-001715-PIP01-14-M02, decision date: 25/02/2019, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fostemsavir (tromethamine) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001687-PIP01-14-M03, decision date: 29/01/2019, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (RO7239361) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001793-PIP01-15-M03, decision date: 29/01/2019, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Juluca, rilpivirine, dolutegravir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001750-PIP01-15-M02, decision date: 11/02/2019, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fevipiprant (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Pneumology-allergology, PIP number: EMEA-001315-PIP02-16, decision date: 11/04/2018, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Burosumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001659-PIP01-15-M03, decision date: 30/01/2018, last updated: 29/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001654-PIP01-14-M03, decision date: 03/01/2019, last updated: 26/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMEA-000669-PIP01-09-M02, decision date: 04/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan, regadenoson
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: EMEA-000410-PIP01-08-M04, decision date: 29/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-000402-PIP03-17-M03, decision date: 28/02/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revatio, sildenafil
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-000671-PIP01-09-M10, decision date: 03/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, dolutegravir
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-000409-PIP01-08-M05, decision date: 03/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-000310-PIP03-10-M03, decision date: 29/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: EMEA-000237-PIP01-08-M08, decision date: 29/01/2019, last updated: 16/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dienogest, ethinyl estradiol (LPRI-424)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-002229-PIP01-17-M01, decision date: 29/01/2019, last updated: 12/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-002141-PIP01-17-M01, decision date: 28/02/2019, last updated: 12/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001441-PIP01-13-M02, 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): Triumeq, dolutegravir, abacavir, lamivudine
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001219-PIP01-11-M04, decision date: 03/01/2019, last updated: 11/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir, cobicistat
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001280-PIP01-12-M02, decision date: 03/01/2019, last updated: 11/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-001146-PIP01-11-M04, decision date: 11/02/2019, last updated: 11/04/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate, potassium sulphate, magnesium sulphate heptahydrate (BLI800)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-000816-PIP02-10-M02, 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): Birch pollen extract
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-000809-PIP01-09-M01, 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): Entrectinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-002096-PIP01-16-M01, decision date: 04/01/2019, last updated: 09/04/2019, compliance check: X