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45 results
Medicine
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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
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
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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): 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 -
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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): 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): 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): Recombinant Hepatitis B vaccine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Vaccines
PIP number: EMEA-002157-PIP01-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 10/09/2019, Last updated: 23/03/2020, 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): Bilastine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Dermatology; Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-000347-PIP05-20, Route(s) of administration: Oral use, Intramuscular use, Intravenous use, Pharmaceutical form(s): Oral solution, Orodispersible tablet, Solution for injection, Tablet
Decision date: 17/06/2020, Last updated: 04/03/2021, 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