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254 results
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Referral: Zinbryta
associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018 -
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Referral: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitekta, elvitegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000968-PIP02-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 07/10/2016, Last updated: 24/11/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olysio, simeprevir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000625-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fexeric, ferric citrate coordination complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001213-PIP02-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 15/06/2016, Last updated: 07/03/2019, 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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Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Incivo, telaprevir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000196-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet
Decision date: 12/04/2017, Last updated: 29/05/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vibativ, Telavancin (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000239-PIP01-08-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): BindRen, colestilan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000878-PIP02-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Film-coated tablet
Decision date: 01/09/2011, Last updated: 29/01/2015, Compliance check: X -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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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): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 31/01/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002066-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Capsule, soft
Decision date: 14/04/2021, Last updated: 12/01/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluenz, Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
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-000249-PIP01-10, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 03/01/2011, Last updated: 07/02/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib
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-002066-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cinryze, C1 inhibitor (human)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000568-PIP01-09-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: V, 26/02/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Recarbrio, relebactam (MK-7655A), cilastatin sodium, imipenem monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001809-PIP01-15-M02, Route(s) of administration: Parenteral use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 24/07/2020, Last updated: 29/06/2021, Compliance check: X -
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Withdrawn application: Tookad
padeliporfin, date of withdrawal: 14/12/2021, Post-authorisation, Last updated: 28/01/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Exjade, deferasirox
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001103-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet, Granules
Decision date: 30/06/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002311-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 16/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
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-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X