MHRA-102444-PIP01-26

Key Facts

Active Substance
Active Substance:
  • MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
Invented Name
  • Omjjara
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • OJJAARA
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Ojjara
  • Omjjaara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara 100mg Film coated tablet PLGB 19494/0318
  • Omjjara 150mg Film coated tablet PLGB 19494/0322
  • Omjjara 200mg Film coated tablet PLGB 19494/0323
PIP Number MHRA-102444-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Other: Congenital, familial and genetic disorders, neoplasms benign, malignant and unspecified (including cysts and polyps)
Conditions / Indications
Conditions / Indications:
  • Treatment of myelodysplastic syndrome
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE.pdf
Published Date 04/09/2026