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233 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
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Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001157-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 12/09/2018, Last updated: 21/09/2021, Compliance check: V, 23/08/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Velphoro, Sucroferric oxyhydroxide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001061-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Chewable tablet
Decision date: 17/07/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecentriq, atezolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001638-PIP01-14-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 12/06/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dacogen, Decitabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000555-PIP01-09-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 09/08/2017, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Revatio, sildenafil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000671-PIP01-09-M10, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution, Solution for injection
Decision date: 03/01/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Latuda, Lurasidone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001230-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002147-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): octenidine dihydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001514-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Lozenge
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
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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: 21/09/2021, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mepolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000069-PIP04-13-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection or infusion, Solution for injection
Decision date: 12/09/2018, Last updated: 21/09/2021, Compliance check: V, 28/02/2020 -
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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: 21/09/2021, Compliance check: V, 31/01/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Januvia, sitagliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000470-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/10/2019, Last updated: 21/09/2021, Compliance check: V, 28/02/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lubiprostone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000245-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 28/02/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate), Olopatadine (hydrochloride) (GSP 301 NS)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-002514-PIP01-18, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nplate, romiplostim
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000653-PIP01-09-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 11/08/2017, Last updated: 21/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonafarnib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002516-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/07/2019, Last updated: 20/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Aclasta, zoledronic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000057-PIP01-07-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/01/2020, Last updated: 16/09/2021, Compliance check: V, 30/04/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000366-PIP02-09-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 16/09/2021, Compliance check: V, 30/04/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonquex, lipegfilgrastim
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001019-PIP01-10-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/01/2020, Last updated: 16/09/2021, Compliance check: V, 30/04/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dengvaxia, Live, attenuated, chimeric dengue virus, serotype 1, Live, attenuated, chimeric dengue virus, serotype 2, live, attenuated, chimeric dengue virus, serotype 3, Live, attenuated, chimeric dengue virus, serotype 4
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001545-PIP01-13-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for suspension for injection
Decision date: 21/02/2020, Last updated: 16/09/2021, Compliance check: V, 29/05/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Votrient, pazopanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000601-PIP01-09-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 11/09/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology; Ophthalmology
PIP number: EMEA-001039-PIP02-12-M04, Route(s) of administration: Intraglandular use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 30/03/2020, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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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: 16/09/2021, Compliance check: V, 24/07/2020