EMEA-001809-PIP01-15-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0090/2023
Route(s) of administration: Parenteral use
Pharmaceutical form(s):
Powder for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Recarbrio
imipenem
cilastatin
relebactam
Gram-Negative Bacterial Infections
Date of authorisation:
Revision: 5
Last updated:
MedicineHumanAuthorised
Qsiva
phentermine
topiramate
Obesity
Date of refusal:
Last updated:
MedicineHumanRefused
Tienam - referral
imipenem
cilastatin
Article 30 referrals
Associated names:
Conet
Imipem
Primaxin
Tenacid
Zienam
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-000826-PIP01-09 - 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/223/2010
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman