PSUSA/00010190/201506 - periodic safety update report single assessment
alanine
arginine
aspartic acid
cysteine
glucose anhydrous
glutamic acid
glycine
histidine
isoleucine
leucine
lysine
methionine
ornithine
phenylalanine
proline
serine
sodium chloride
sodium glycerophosphate hydrated
soya bean oil
taurine
threonine
tryptophan
tyrosine
valine
potassium acetate
calcium chloride dihydrate
magnesium acetate tetrahydrate
olive oil
Procedure number: PSUSA/00010190/201506
Regulatory outcome: Maintenance
Last updated:
PSUSAHuman
PSUSA/00010190/201512 - periodic safety update report single assessment
alanine
arginine
aspartic acid
cysteine
glucose anhydrous
glutamic acid
glycine
histidine
isoleucine
leucine
lysine
methionine
ornithine
phenylalanine
proline
serine
sodium chloride
sodium glycerophosphate hydrated
soya bean oil
taurine
threonine
tryptophan
tyrosine
valine
potassium acetate
calcium chloride dihydrate
magnesium acetate tetrahydrate
olive oil
Procedure number: PSUSA/00010190/201512
Regulatory outcome: Maintenance
Last updated:
PSUSAHuman
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-002735-PIP03-20-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: P/0484/2021
Pharmaceutical form(s):
Solution for organ preservation
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002735-PIP01-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: P/0228/2021
Route(s) of administration: Intracoronary use
Pharmaceutical form(s):
Concentrate and solvent for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002067-PIP02-17 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Nutrition
PIP number: P/0133/2017
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Emulsion for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Milaxyn Plus - referral
praziquantel
pyrantel
febantel
Article 34
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralVeterinary
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