PIPS Key Facts
| Active Substance |
Active Substance:
- MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
|
Invented Name
|
- Omjjara
- Omjjara 100mg film-coated tablets (PLGB 19494/0318)
- Omjjara 150mg film-coated tablets (PLGB 19494/0322)
- Omjjara 200mg film-coated tablets (PLGB 19494/0323)
- Ojjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- OJJAARA
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
- Ojjara
- Omjjara
- Omjjara
- Omjjara
- Omjjara
|
| PIP Number |
MHRA-102219-PIP01-25 |
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Pharmaceutical form(s)
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Pharmaceutical form(s):
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Therapeutic area
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Therapeutic area:
- Other: hemato-inflammatory condition
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Conditions / Indications
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Conditions / Indications:
- Treatment of VEXAS syndrome in adults.
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Route(s) of administration
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Route(s) of administration:
- All routes of administration
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PIP applicant
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Decision Type
|
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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Compliance Check
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Compliance Check Decision Date
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Compliance Check Procedure Number
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