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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tyverb, Lapatinib ditosilate monohydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000404-PIP02-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
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): valsartan, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000744-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Netarsudil, Latanoprost
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002175-PIP01-17, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Testosterone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Testosterone, Route(s) of administration: Transdermal use, Pharmaceutical form(s): Transdermal patch
Decision date: 11/08/2009, Last updated: 22/10/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Delafloxacin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001080-PIP01-10, Route(s) of administration: Intravenous use Oral Use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002024-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 31/01/2017, Last updated: 17/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001942-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/08/2016, Last updated: 28/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): telmisartan, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000045-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/02/2008, Last updated: 15/02/2008, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flibanserin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Flibanserin, Route(s) of administration: Oral, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/04/2008, Last updated: 16/05/2008, 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): Baclofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Psychiatry
PIP number: EMEA-001549-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2017, Last updated: 21/04/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veliparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
PIP number: EMEA-000499-PIP03-17, Route(s) of administration: Capsule, hard, Age-appropriate oral liquid dosage form, Tablet, Pharmaceutical form(s): Oral use
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Famotidine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Ibuprofen / Famotidine, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/10/2009, Last updated: 07/12/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001343-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxycodone (hydrochloride), naloxone (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001700-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 06/03/2015, Last updated: 06/07/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ciclosporin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001998-PIP01-16, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, emulsion
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpelisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002016-PIP02-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2017, Last updated: 21/04/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lasofoxifene tartrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Lasofoxifene tartrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/01/2008, Last updated: 16/01/2008, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Capmatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002203-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ertugliflozin, Metformin
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-001532-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001668-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral powder
Decision date: 24/11/2014, Last updated: 12/12/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine besilate, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001607-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/06/2014, Last updated: 22/07/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human plasma proteins
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Human plasma proteins, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/06/2009, Last updated: 11/08/2009, Compliance check: X