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PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan Remove RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter
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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): Rubidium (82Rb)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Diagnostic
PIP number: EMEA-000488-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Radionuclide generator
Decision date: 18/05/2009, Last updated: 09/07/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dirucotide acetate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-000433-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/03/2009, Last updated: 18/05/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Ophthalmology
PIP number: Dexamethasone, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 23/03/2009, Last updated: 18/05/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Circadin, melatonin
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: Melatonin (Circadin), Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 24/03/2009, Last updated: 18/05/2009, 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): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: Perflubutane, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Lyophilisate for suspension for injection
Decision date: 28/11/2008, Last updated: 29/01/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002344-PIP01-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): moxonidine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002275-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/07/2018, Last updated: 28/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): trandolapril
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002274-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/07/2018, Last updated: 28/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-002469-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/03/2019, Last updated: 24/06/2019, 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): 2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Psychiatry
PIP number: EMEA-002519-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 14/06/2019, 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): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP04-19, Route(s) of administration: Epidural use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP05-19, Route(s) of administration: Ocular use, Pharmaceutical form(s): Gel
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human IgGlA monoclonal Fab antibody
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002766-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 15/07/2020, Last updated: 16/06/2021, 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): Reparixin
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001693-PIP02-20, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Tablet, Solution for infusion
Decision date: 07/05/2021, Last updated: 11/02/2022, 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