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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP01-08-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/07/2016, Last updated: 23/09/2016, Compliance check: V, 16/11/2018
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Opinion/decision on a Paediatric investigation plan (PIP): Cinryze, C1 inhibitor (human)

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000568-PIP01-09-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: V, 26/02/2016
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Opinion/decision on a Paediatric investigation plan (PIP): Strimvelis, Autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001289-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Cell suspension for infusion
Decision date: 06/08/2014, Last updated: 22/08/2014, Compliance check: V, 14/11/2014
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000463-PIP01-08-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 28/01/2012, Last updated: 23/02/2012, Compliance check: V, 09/03/2012