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
Vimizim
elosulfase alfa
Mucopolysaccharidosis IV
Date of authorisation:
Revision: 13
Last updated:
MedicineHumanAuthorised
EMEA-000973-PIP01-10-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0055/2015
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
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
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: P/191/2009
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Solution for infusion
Decision date:
Last updated:
Compliance check: ✔
PIPHuman