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1339 results
Medicine
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W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Victrelis, Boceprevir (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000583-PIP01-09-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Capsule, hard
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Varuby, rolapitant (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001768-PIP02-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002468-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001015-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 09/06/2011, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002214-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001929-PIP01-16, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 19/12/2017, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 07/04/2014, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 24/04/2009, Last updated: 26/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Molidustat (sodium)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001546-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 27/10/2014, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fremanezumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001877-PIP03-17, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): meropenem trihydrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001731-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 12/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002398-PIP01-18, Route(s) of administration: Capsule, hard, Age-appropriate oral dosage form, Pharmaceutical form(s): Oral use
Decision date: 17/05/2019, Last updated: 12/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002218-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 07/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): captopril
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001544-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 08/08/2014, Last updated: 11/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Levothyroxine (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002259-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 16/03/2018, Last updated: 29/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Live, attenuated, chimeric dengue virus, serotype 1, live, attenuated dengue virus, serotype 2, live, attenuated, chimeric dengue virus, serotype 3, live attenuated, chimeric dengue virus, serotype 4
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001888-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 03/07/2017, Last updated: 29/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Norovirus GI.1 virus-like particle antigen, norovirus GII.4 virus-like particle antigen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001609-PIP01-14, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 05/06/2015, Last updated: 29/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001855-PIP01-15-M01, Route(s) of administration: Solution for injection, Pharmaceutical form(s): Subcutaneous use
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): Aciclovir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001066-PIP02-11-M03, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 04/12/2019, Last updated: 01/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Yamagata lineage)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001894-PIP01-15-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/11/2016, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001191-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Film-coated tablet
Decision date: 08/11/2019, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin) of strain A (H1N1), influenza virus surface antigens (haemagglutinin) of strain A (H3N2), influenza virus surface antigens (haemagglutinin) of strain B (Victoria lineage), influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002027-PIP02-17-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001732-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 04/11/2016, Last updated: 07/08/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002057-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 04/10/2017, Last updated: 27/06/2019, Compliance check: X