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PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
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Opinion/decision on a Paediatric investigation plan (PIP): Alirocumab
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-001169-PIP02-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2014, Last updated: 12/05/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tapentadol (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000494-PIP01-08-M09, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection/infusion
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bisoprolol fumarate, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Bisoprolol fumarate / acetylsalicylic acid, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule
Decision date: 24/03/2009, Last updated: 18/05/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): abaloparatide
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-001667-PIP01-14, Route(s) of administration: Subcutaneous use, Transdermal use, Pharmaceutical form(s): Solution for injection, Transdermal system
Decision date: 24/11/2014, Last updated: 17/02/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule
Decision date: 20/04/2009, Last updated: 10/06/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Selepressin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000506-PIP01-08-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/10/2016, Last updated: 24/11/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, losartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001380-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, pseudoephedrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002102-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 30/06/2017, Last updated: 24/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan
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): 17-allylamino-17-demethoxygeldanamycin hydroquinone, hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000435-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion
Decision date: 04/03/2009, Last updated: 18/05/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001269-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/08/2014, Last updated: 22/08/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Icosapent ethyl
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001300-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 28/09/2012, Last updated: 17/10/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydroxypropanimidamide
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-001824-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine camsylate, Losartan potassium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000886-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/09/2010, Last updated: 29/10/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, alder pollen, birch pollen, hazel pollen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000662-PIP02-09-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/01/2014, Last updated: 20/02/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001797-PIP01-15-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/01/2018, Last updated: 19/04/2018, Compliance check: V, 21/09/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Hydromorphone (hydrochloride), naloxone (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001762-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release capsule, Capsule, hard
Decision date: 02/10/2015, Last updated: 17/12/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Protelos, strontium ranelate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: Strontium ranelate, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 02/03/2010, Last updated: 19/04/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Acalabrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001796-PIP03-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form, Age-appropriate oral solid dosage form
Decision date: 15/03/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): lidocaine hydrochloride, Phenylephrine hydrochloride, Tropicamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000991-PIP01-10, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 26/10/2010, Last updated: 25/11/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Surotomycin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001226-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fostemsavir (tromethamine)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001687-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 15/07/2020, Last updated: 29/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Maci, Matrix applied characterised autologous cultured chondrocytes
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000979-PIP01-10-M02, Route(s) of administration: Implant use, Pharmaceutical form(s): Implant
Decision date: 30/01/2018, Last updated: 18/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): benralizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001214-PIP02-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X