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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): Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002155-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human Neutrophil Elastase Inhibitor (CHF6333)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002196-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
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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, -gynacology-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): Akynzeo, Fosnetupitant, Palonosetron
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Other
PIP number: EMEA-001198-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 21/12/2016, Last updated: 31/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Terguride (hydrogenmaleate)
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-002015-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, 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): Levomilnacipran
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-001724-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release capsule, Capsule, hard
Decision date: 05/06/2015, Last updated: 02/09/2015, 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): (R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl)phenoxy]butanoic acid
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-001573-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/09/2014, Last updated: 14/11/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Acotiamide
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001461-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 05/09/2013, Last updated: 08/10/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Esketamine
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-001428-PIP01-13, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, Solution
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tivantinib
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: EMEA-001284-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 24/07/2012, Last updated: 22/08/2012, 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): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir
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-001066-PIP01-10, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor, recombinant human albumin fusion protein
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: P/36/2011, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/01/2011, Last updated: 24/02/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 4-Hydroxy-n-(2-hydroxyethyl)-butyramide
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-000764-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 23/11/2010, Last updated: 20/12/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): sodium sulfate, potassium sulfate, magnesium sulfate heptahydrate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: P/116/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 07/07/2010, Last updated: 29/07/2010, 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): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen, alder pollen, hazel pollen
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder and hazel pollen, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection (multidose vial)
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection (multidose vial)
Decision date: 30/10/2009, Last updated: 07/12/2009, 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: Chloroprocaine hydrochloride, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: X