41 results
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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): Avacopan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002023-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Decision date: 04/11/2019, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000597-PIP02-10-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Polonged-release granules for oral suspension, Prolonged-release tablet
Decision date: 30/09/2019, Last updated: 26/03/2020, 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): 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): Chemically modified extract of trees pollen from birch and alder
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001012-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 25/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified house dust mites allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001011-PIP01-10-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/03/2019, Last updated: 25/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001017-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
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): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001016-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
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): Chemically modified house dust mites allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001014-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
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): Chemically modified extract of trees pollen from birch and alder
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001013-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
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): 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): 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): 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): 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): 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): Recombinant human glutamic acid decarboxylase (rhGAD65)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000609-PIP01-09-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000172-PIP01-07-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chlorhexidine gluconate, isopropyl alcohol
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000989-PIP01-10-M02, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Solution
Decision date: 11/08/2017, Last updated: 02/10/2017, 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): human fibrinogen, human thrombin
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001598-PIP01-13-M02, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant
Decision date: 07/10/2016, Last updated: 25/11/2016, 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): (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