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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage), Split influenza virus, inactivated (B/Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001254-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/05/2017, Last updated: 02/03/2018, Compliance check: V, 23/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trifarotene
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001492-PIP01-13-M01, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus type A, H1N1, influenza virus type A, H3N2, influenza virus type B, Yamagata lineage, influenza virus type B, Victoria lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001051-PIP01-10-M03, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray
Decision date: 12/10/2012, Last updated: 26/11/2012, Compliance check: V, 14/06/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Levamisole (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001885-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 08/07/2016, Last updated: 21/12/2016, Compliance check: V, 22/07/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): vigabatrin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000717-PIP02-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Soluble tablet
Decision date: 16/03/2017, Last updated: 02/03/2018, Compliance check: V, 21/07/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human nerve growth factor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP01-14-M01, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 12/10/2016, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Valganciclovir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000726-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
Decision date: 06/09/2013, Last updated: 08/10/2013, Compliance check: V, 11/10/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): House dust mites allergen extracts
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000319-PIP01-08-M03, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Sublingual tablet
Decision date: 06/03/2015, Last updated: 27/07/2015, Compliance check: V, 19/06/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001039-PIP01-10-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 15/12/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pandemrix, Split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000725-PIP01-09-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 29/09/2011, Last updated: 17/10/2011, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagulation Factor VIIa (Recombinant)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001203-PIP02-14-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/08/2017, Last updated: 16/09/2021, Compliance check: V, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001782-PIP01-15-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/07/2018, Last updated: 16/09/2021, Compliance check: V, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001244-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 12/09/2018, Last updated: 16/09/2021, Compliance check: V, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lubiprostone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000245-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 28/02/2020 -
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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): Sodium thiosulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002147-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): octenidine dihydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001514-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Lozenge
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Terbinafine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001259-PIP02-13-M02, Route(s) of administration: Topical use, Pharmaceutical form(s): Medicated nail lacquer
Decision date: 17/06/2019, Last updated: 21/09/2021, Compliance check: V, 26/07/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001157-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 12/09/2018, Last updated: 21/09/2021, Compliance check: V, 23/08/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate, formoterol fumarate dihydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000548-PIP01-09-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Pressurised inhalation, solution
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000055-PIP01-07-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant granules, Gastro-resistant tablet
Decision date: 03/12/2018, Last updated: 21/09/2021, Compliance check: V, 01/02/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): sebelipase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001331-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 21/09/2021, Compliance check: V, 01/03/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sutent, sunitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000342-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: V, 29/06/2018