4 results
Keyword Plenvu Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): sodium sulfate, sodium chloride, sodium ascorbate, potassium chloride (NER1006), ascorbic acid, Polyethylene glycol 3350
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001705-PIP02-15-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 01/12/2020, Last updated: 27/09/2021, Compliance check: XInvented name Plenvu Active substance sodium sulfate … chloride / potassium chloride (Plenvu), (EMEA-001705-PIP02-15-M03 … chloride / potassium chloride (Plenvu), (EMEA-001705-PIP02-15-M03 … -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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News: Annual report 2020 published
Last updated: 14/06/2021