EMEA-003125-PIP02-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0023/2023
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA/H/N/PSR/S/0017 - periodic safety update report single assessment
alanine
arginine
aspartic acid
cysteine
glucose
glutamic acid
glycine
histidine
isoleucine
leucine
lysine monohydrate
methionine
ornithine hydrochloride
phenylalanine
proline
serine
taurine
threonine
tryptophan
tyrosine
valine
calcium chloride
magnesium acetate
potassium acetate
sodium chloride
sodium glycerophosphate
olive oil
Soybean oil
Procedure number: EMEA/H/N/PSR/S/0017
Regulatory outcome: Variation
Last updated:
PSUSAHuman
EMEA-003125-PIP01-21 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0057/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman