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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): 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): Amlodipine besylate, valsartan, hydrochlorothiazide
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): 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): 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): 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): 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): 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): 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): Amlodipine (besylate), hydrochlorothiazide, Candesartan cilexetil
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): 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Freeze-dried culture of Lactobacillus casei subspecies rhamnosus Döderleini (Lcr35)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
PIP number: EMEA-001541-PIP01-13, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal capsule, Capsule, hard
Decision date: 16/06/2014, Last updated: 22/07/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Amlodipine (besylate), Candesartan cilexetil
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): 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): 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): 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): 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): (E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic
PIP number: EMEA-001060-PIP01-10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/03/2011, Last updated: 05/04/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): dimethyl fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001721-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant tablet
Decision date: 26/11/2015, Last updated: 22/12/2015, 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): (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 (besylate), valsartan
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): 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): 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