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Medicine
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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): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen (updated)
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: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae (updated)
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: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae (updated)
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: 12/02/2021, 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 (updated)
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: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen (updated)
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: 12/02/2021, 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 (updated)
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: 12/02/2021, 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): 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): 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): 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): 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: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revolade, Eltrombopag
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000170-PIP02-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Film-coated tablet
Decision date: 22/03/2019, Last updated: 20/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride, ketorolac trometamol (OMS302)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001256-PIP02-12-M02, Route(s) of administration: Intraocular use, Ocular use, Pharmaceutical form(s): Concentrate for solution for injection, Irrigation solution
Decision date: 07/12/2018, Last updated: 19/02/2019, 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: Dermatology
PIP number: EMEA-001071-PIP03-14-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/12/2018, Last updated: 18/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): levofloxacin, dexamethasone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002375-PIP01-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution in single-dose container
Decision date: 12/09/2018, Last updated: 12/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000774-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 23/08/2018, Last updated: 05/02/2019, 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): Trobalt, retigabine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-000116-PIP01-07-M09, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet, Powder for solution for injection, Powder for solution for infusion, Chewable tablet
Decision date: 12/09/2018, Last updated: 30/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zydelig, Idelalisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001350-PIP02-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate dispersible tablet
Decision date: 09/11/2018, Last updated: 28/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri, pixantrone dimaleate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000713-PIP02-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 20/07/2018, Last updated: 28/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenuric, febuxostat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001417-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/07/2018, Last updated: 22/11/2018, Compliance check: X