EMEA-002067-PIP02-17 - paediatric investigation plan

Medium-chain triglycerides

olive oil

Fish oil

acetyl-cysteine

alanine

histidine

Isoleucin

leucine

Lysine acetate

methionine

phenylalanine

proline

tryptophan

tyrosine

valine

glucose

calcium chloride

potassium chloride

sodium acetate

Zinc sulfate

Malic acid

arginine

glycine

serine

threonine

sodium glycerophosphate

soya bean oil

magnesium sulfate

Key facts

• Active Substance:
  • Medium-chain triglycerides
  • olive oil
  • Fish oil
  • acetyl-cysteine
  • alanine
  • histidine
  • Isoleucin
  • leucine
  • Lysine acetate
  • methionine
  • phenylalanine
  • proline
  • tryptophan
  • tyrosine
  • valine
  • glucose
  • calcium chloride
  • potassium chloride
  • sodium acetate
  • Zinc sulfate
  • Malic acid
  • arginine
  • glycine
  • serine
  • threonine
  • sodium glycerophosphate
  • soya bean oil
  • magnesium sulfate
• Therapeutic area:
  Nutrition
• Decision number:
  P/0133/2017
• PIP number:
  EMEA-002067-PIP02-17
• Pharmaceutical form(s):
  Emulsion for infusion
• Condition(s) / indication(s):
  Parenteral nutrition
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/06/2017

Decision

P/0133/2017: EMA decision of 7 June 2017 on the granting of a product specific waiver for soybean oil/medium-chain triglycerides/olive oil/fish oil/acetyl-cysteine/alanine/arginine/glycine/histidine/isoleucin/leucine/lys...

AdoptedReference Number: EMA/312725/2017