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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): Abraxane, paclitaxel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001308-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 14/08/2018, Last updated: 19/12/2018, Compliance check: V, 21/09/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zinforo, Ceftaroline fosamil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000769-PIP01-09-M08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/06/2018, Last updated: 28/11/2018, Compliance check: V, 19/10/2018 -
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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 -
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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): 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): Orencia, Abatacept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000118-PIP02-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/03/2018, Last updated: 06/06/2018, Compliance check: V, 23/03/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dificlir, fidaxomicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000636-PIP01-09-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 16/03/2018, Last updated: 06/06/2018, Compliance check: V, 16/11/2018 -
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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): Vimpat, lacosamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000402-PIP02-11-M05, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Syrup, Solution for infusion
Decision date: 08/01/2018, Last updated: 17/04/2018, Compliance check: V, 27/07/2018 -
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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): 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): Ixiaro, Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000559-PIP01-09-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/10/2017, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mimpara, Cinacalcet (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000078-PIP01-07-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/05/2017, Last updated: 02/03/2018, Compliance check: V, 19/05/2017 -
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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): Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage), Split influenza virus, inactivated (B/Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001254-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/05/2017, Last updated: 02/03/2018, Compliance check: V, 23/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): vigabatrin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000717-PIP02-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Soluble tablet
Decision date: 16/03/2017, Last updated: 02/03/2018, Compliance check: V, 21/07/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human nerve growth factor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP01-14-M01, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 12/10/2016, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001039-PIP01-10-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 15/12/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nucala, Mepolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000069-PIP02-10-M08, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection / infusion, Solution for injection
Decision date: 11/08/2017, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
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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): 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): Gilenya, Fingolimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000087-PIP01-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/04/2017, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sycrest, Asenapine (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000228-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Sublingual tablet
Decision date: 24/11/2014, Last updated: 02/03/2018, Compliance check: V, 18/08/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sprycel, dasatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000567-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 16/02/2018, Last updated: 16/02/2018, Compliance check: V, 23/02/2018