Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod... - paediatric investigation plan

alanine

arginine

aspartic acid

cysteine

cystine

glutamic acid

glycine

histidine

isoleucine

leucine

lysine monohydrate

methionine

ornithine hydrochloride

phenylalanine

proline

serine

taurine

threonine

tryptophan

tyrosine

valine

sodium chloride

potassium acetate

magnesium acetate tetrahydrate

calcium chloride

sodium glycerophosphate

glucose

soya bean oil

olive oil

Key facts

• Active Substance:
  • alanine
  • arginine
  • aspartic acid
  • cysteine
  • cystine
  • glutamic acid
  • glycine
  • histidine
  • isoleucine
  • leucine
  • lysine monohydrate
  • methionine
  • ornithine hydrochloride
  • phenylalanine
  • proline
  • serine
  • taurine
  • threonine
  • tryptophan
  • tyrosine
  • valine
  • sodium chloride
  • potassium acetate
  • magnesium acetate tetrahydrate
  • calcium chloride
  • sodium glycerophosphate
  • glucose
  • soya bean oil
  • olive oil
• Therapeutic area:
  Nutrition
• Decision number:
  P/191/2009
• PIP number:
  Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod...
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Parenteral nutrition
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/10/2009
• Compliance procedure number:
  EMEA-C-000112-PIP01-07-M01
• Compliance opinion date:
  16/10/2009
• Compliance outcome:
  Positive

Decision

P/191/2009: Modification of a PIP for alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, pr...

AdoptedReference Number: EMEA/610520/2009