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1714 results
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Paediatric investigation plans Remove Paediatric investigation plans filter
PIP decision type
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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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): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, 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): Risperidone
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001034-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/07/2011, Last updated: 09/08/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alnus glutinosa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000906-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 03/12/2010, Last updated: 11/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001042-PIP02-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): grass pollen, cereal pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000964-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 25/01/2011, 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): rye pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000943-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): grass pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000954-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides farinae, Dermatophagoides pteronyssinus
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000866-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/01/2011, Last updated: 07/02/2011, 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): mugwort pollen, grass pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000929-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, 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): Entospletinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002058-PIP01-16, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
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): 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): 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): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000934-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 26/01/2011, 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): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000841-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Proteinase, metallo- (synthetic nociceptin receptor-binding) 1290102-81-6 (AGN214868)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-001200-PIP01-11, Route(s) of administration: Intradermal use, Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 26/02/2013, Last updated: 23/04/2013, 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