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Opinion/decision on a Paediatric investigation plan (PIP): Voncento, Human coagulation factor VIII, von Willebrand factor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000312-PIP01-08-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection, Powder and solvent for solution for infusion
Decision date: 28/10/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Travatan, travoprost
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001271-PIP01-12-M01, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 29/11/2013, Last updated: 02/03/2018, Compliance check: V, 23/05/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tygacil, Tigecycline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000120-PIP01-07-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 24/10/2014, Last updated: 05/12/2014, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: Losartan potassium, Route(s) of administration: Oral route, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Firazyr, icatibant acetate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000408-PIP01-08-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2015, Last updated: 21/12/2016, Compliance check: V, 19/08/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ilaris, Canakinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000060-PIP05-14-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 30/10/2015, Last updated: 06/01/2016, Compliance check: V, 26/02/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Resolor, Prucalopride succinate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000459-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 18/12/2012, Last updated: 07/02/2013, Compliance check: V, 06/12/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Eurartesim, Artenimol, piperaquine phosphate anhydride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000153-PIP01-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 04/01/2018, Last updated: 17/04/2018, Compliance check: V, 26/01/2018 -
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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): Sodium benzylpenilloate, benzylpenicilloyl octa- L-lysine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-001398-PIP02-13, Route(s) of administration: Skin scarification, Intradermal use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/11/2013, Last updated: 06/01/2014, Compliance check: V, 12/09/2014 -
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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): ViraferonPeg, peginterferon alfa-2b
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000384-PIP01-08, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection in vial and in pre-filled pen
Decision date: 14/10/2008, Last updated: 24/11/2008, Compliance check: V, 17/10/2008 -
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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): Sutent, sunitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000342-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-001684-PIP01-14, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 02/10/2015, Last updated: 07/03/2019, Compliance check: V, 21/04/2017 -
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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): Levemir, Insulin detemir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000412-PIP01-08-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/07/2014, Last updated: 05/08/2014, Compliance check: V, 14/11/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP04-13-M01, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2017, Last updated: 20/03/2017, Compliance check: V, 19/10/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001139-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Baraclude, Entecavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000339-PIP02-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 16/05/2014, Last updated: 25/06/2014, Compliance check: V, 20/06/2014 -
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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): Kuvan, Sapropterin dihydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001476-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Soluble tablet, Powder for oral solution
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: V, 10/10/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ravicti, Glycerol phenylbutyrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000297-PIP02-12-M02, Route(s) of administration: Oral use, Gastroenteral use, Pharmaceutical form(s): Oral liquid
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: V, 21/09/2018