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1020 results
Medicine
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, irbesartan, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002167-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veliparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
PIP number: EMEA-000499-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP04-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lifitegrast
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001979-PIP01-16, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 05/10/2016, Last updated: 18/12/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002163-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fluticasone propionate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002140-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Litoxetine (benzoate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002151-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fluticasone propionate, salmeterol xinafoate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002177-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002084-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002092-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Methacholine chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic
PIP number: EMEA-002120-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pexastimogene devacirepvec
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002124-PIP01-17, Route(s) of administration: Intratumoral use, Pharmaceutical form(s): Suspension for injection
Decision date: 14/07/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002132-PIP01-17, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): DaxibotulinumtoxinA
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002149-PIP01-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH(YGRKKRRQRRRKLSSIESDV)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002108-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 5, 7-dihydroxy-2-[3-hydroxy-4-methoxy-2-(2-methyl-2-propenyl) phenyl]-6, 8-bis (2-methyl-2-propenyl)-4H-chromen-4-one
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002148-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 11/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant humanized anti-alpha-synuclein IgG1 monoclonal antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002137-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tagrisso, Osimertinib (as mesilate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002125-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000828-PIP05-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Laquinimod (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-000972-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/06/2017, Last updated: 26/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cimzia, Certolizumab pegol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001071-PIP02-12-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 26/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Miridesap
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002111-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 03/07/2017, Last updated: 25/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002136-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/07/2017, Last updated: 25/07/2017, Compliance check: X