Omnitrope
somatropin
Turner Syndrome
Prader-Willi Syndrome
Dwarfism, Pituitary
Date of authorisation:
Revision: 22
Last updated:
MedicineHumanAuthorised
NutropinAq
somatropin
Turner Syndrome
Dwarfism, Pituitary
Date of authorisation:
Revision: 20
Last updated:
MedicineHumanAuthorised
EMEA-002395-PIP01-18 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0333/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Somatropin Biopartners
somatropin
Growth
Date of authorisation:
Revision: 3
Last updated:
MedicineHumanLapsed
EMEA-001204-PIP02-14 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0079/2015
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001496-PIP01-13 - 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/0300/2013
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Valtropin
somatropin
Turner Syndrome
Dwarfism, Pituitary
Date of authorisation:
Revision: 5
Last updated:
MedicineHumanWithdrawn
Somatropin - referral
somatropin
Article 107 procedures (prior to July 2012)
Associated names:
Genotropin
Humatrope
Maxomat
Norditropin
Saizen
Zomacton
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Norditropin - referral
somatropin
Article 13 referrals
Associated names:
Norditropin FlexPro
Norditropin NordiFlex
Norditropin SimpleXx
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Genotropin - referral
somatropin
Article 6(12) referrals (prior to January 2010)
Associated names:
Genotonorm
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman