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19 results
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Opinion/decision on a Paediatric investigation plan (PIP): 1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Psychiatry
PIP number: EMEA-002222-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant tablet
Decision date: 08/11/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant modified human growth hormone
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001152-PIP02-16, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 05/05/2017, Last updated: 03/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Psychiatry
PIP number: EMEA-001742-PIP02-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 02/12/2016, Last updated: 27/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Other
PIP number: EMEA-001912-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 26/09/2016, Last updated: 27/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glycopyrronium bromide
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oto-rhino-laryngology
PIP number: P/0343/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2014, Last updated: 23/02/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiox, Bivalirudin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001065-PIP01-10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 18/06/2012, Last updated: 19/07/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl citrate
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Pain
PIP number: Fentanyl citrate, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, Solution
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Live bacterium B. thetaiotaomicron
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Gastroentology-Hepatology
PIP number: Live bacterium B. thetaiotaomicron, Route(s) of administration: Oral use, Pharmaceutical form(s): Live Bacteria in an Enteric Coated Capsule
Decision date: 21/08/2009, Last updated: 22/10/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Ophthalmology
PIP number: EMEA-002423-PIP01-18, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Ophthalmic insert
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP03-18, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 25/07/2019, Last updated: 12/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertactin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Infectious diseases
PIP number: EMEA-002343-PIP01-18, Route(s) of administration: Intramuscular use,
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone (sodium phosphate), levofloxacin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-002375-PIP02-18, Route(s) of administration: Auricular use, Pharmaceutical form(s): Ear drops, solution
Decision date: 17/07/2019, Last updated: 13/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): brimonidine
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Ophthalmology
PIP number: EMEA-002558-PIP01-19, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): eflornithine (hydrochloride monohydrate), sulindac
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oncology
PIP number: EMEA-001518-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 06/12/2019, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oncology
PIP number: EMEA-002247-PIP02-17, Route(s) of administration: Oral use, Naso-gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
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): genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-002472-PIP02-19, Route(s) of administration: Topical use, Pharmaceutical form(s): Gel
Decision date: 08/07/2019, Last updated: 13/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): relugolix, estradiol, norethisterone acetate
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002428-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: X