Vijoice
alpelisib
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Comirnaty
COVID-19 mRNA vaccine
tozinameran
riltozinameran and tozinameran
famtozinameran and tozinameran
raxtozinameran
COVID-19 virus infection
Date of authorisation:
Revision: 46
Last updated:
MedicineHumanAuthorised
Piqray
alpelisib
Breast Neoplasms
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
EMEA-002016-PIP03-19-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: P/0412/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Granules
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002861-PIP02-20-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0466/2022
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Concentrate for dispersion for injection
Dispersion for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002016-PIP04-20 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0122/2021
Route(s) of administration: All routes of administration
Pharmaceutical form(s):
All pharmaceutical forms
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Comirnaty / Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare professional communication (DHPC)
Active substance: Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)
DHPC type:
Safety signal
Last updated:
DHPCHuman
EMEA-002016-PIP02-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0079/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman