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Opinion/decision on a Paediatric investigation plan (PIP): Antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000156-PIP01-07-M02, Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2011, Last updated: 08/04/2011, Compliance check: V, 17/01/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: Human normal immunoglobulin, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 29/07/2011, Last updated: 15/09/2011, Compliance check: V, 15/10/2012 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001797-PIP01-15-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/01/2018, Last updated: 19/04/2018, Compliance check: V, 21/09/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion influenza virus type A, H1N1, influenza virus type A, H3N2, influenza virus type B, Victoria lineage, influenza virus type B, Yamagata lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000817-PIP02-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/07/2013, Last updated: 19/01/2012, Compliance check: V, 21/04/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tiotropium bromide (monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000035-PIP01-07-M05, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Solution for inhalation via the Respimat inhaler
Decision date: 04/06/2012, Last updated: 23/07/2012, Compliance check: V, 21/08/2012 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000300-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 19/08/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nomegestrol acetate, 17 beta-estradiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000250-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/03/2010, Last updated: 28/07/2010, Compliance check: V, 21/05/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigen: Pertussis toxoid, Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000500-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 07/03/2015, Last updated: 25/03/2015, Compliance check: V, 27/05/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tiotropium bromide (monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000035-PIP02-09-M02, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution, Inhalation powder, Capsule, hard
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: V, 27/05/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): elvitegravir, emtricitabine, tenofovir disoproxil (as fumarate), cobicistat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000970-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2016, Last updated: 19/01/2017, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Latanoprost
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: Latanoprost, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/11/2009, Last updated: 23/12/2009, Compliance check: V, 19/03/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001110-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 20/07/2012, Last updated: 22/08/2012, Compliance check: V, 11/10/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Gadobutrol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-000994-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2012, Last updated: 04/02/2014, Compliance check: V, 20/06/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozenoxacin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000981-PIP01-10-M04, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 08/07/2014, Last updated: 05/08/2014, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000005-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate liquid dosage form
Decision date: 26/06/2009, Last updated: 22/10/2009, Compliance check: V, 21/08/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000830-PIP02-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 03/12/2015, Last updated: 02/02/2016, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 29/09/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP02-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 05/06/2015, Last updated: 06/07/2015, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human-papillomavirus-type-6 L1 protein, human-papillomavirus-type-11 L1 protein, human-papillomavirus-type-16 L1 protein, human-papillomavirus-type-18 L1 protein, human-papillomavirus-type-31 L1 protein, human-papillomavirus-type-33 L1 protein, human-papillomavirus-type-45 L1 protein, human-papillomavirus-type-52 L1 protein, human-papillomavirus-type-58 L1 protein
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000654-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 02/09/2013, Last updated: 08/10/2013, Compliance check: V, 17/01/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Unituxin, Dinutuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001285-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/08/2016, Last updated: 27/10/2016, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): recombinant L-asparaginase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000013-PIP01-07-M03, Route(s) of administration: Intravenous use, Intramuscular use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 14/06/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: Rosuvastatin (calcium), Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/11/2010, Last updated: 07/12/2009, Compliance check: V, 11/10/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): ciclosporin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000575-PIP01-09-M03, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, emulsion
Decision date: 10/07/2015, Last updated: 24/08/2015, Compliance check: V, 29/04/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Damoctocog alfa pegol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001229-PIP01-11-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 10/07/2017, Last updated: 26/07/2017, Compliance check: V, 18/08/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen (human plasma-derived)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000457-PIP02-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for infusion
Decision date: 11/06/2014, Last updated: 15/07/2014, Compliance check: V, 16/12/2016