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43 results
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Opinion/decision on a Paediatric investigation plan (PIP): Epclusa, Sofosbuvir, velpatasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001646-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 18/05/2018, Last updated: 28/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, Bedaquiline (fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 19/12/2018, Last updated: 18/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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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): Caprelsa, Vandetanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000052-PIP01-07-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/11/2013, Last updated: 06/01/2014, Compliance check: V, 20/06/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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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, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
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): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Exviera, Dasabuvir (sodium monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001439-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 15/06/2018, Last updated: 22/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001448-PIP01-13-M03, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/08/2018, Last updated: 31/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009 (Produced at Quebec manufacturing site)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001304-PIP02-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet, Tablet, Age-appropriate oral solid dosage form
Decision date: 12/06/2019, Last updated: 08/11/2019, 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): Maviret, glecaprevir, pibrentasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001832-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 17/04/2019, Last updated: 24/06/2019, 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: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP05-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/07/2018, Last updated: 22/11/2018, 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: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2012, Last updated: 02/03/2018, Compliance check: V, 02/06/2015 -
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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: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/10/2014, Last updated: 02/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP02-12-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/01/2020, Last updated: 11/06/2020, Compliance check: X