Kinpeygo (budesonide)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- budesonide
- Company
- Stada Arzneimittel AG
- Status
- Authorised
- Therapeutic area
- Glomerulonephritis, IGA
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 15 Jul 2022
- Designations
- Orphan
- Application
- EMEA/H/C/005653
- ATC
- A07EA06
- Official record
- www.ema.europa.eu
Indication
Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) Authorised · Teva Pharma B.V.
- 🇪🇺 DuoResp Spiromax Authorised · Teva Pharma B.V.
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- 🇪🇺 Budesonide/Formoterol Teva Pharma B.V. Withdrawn · Teva Pharma B.V.
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- 🇪🇺 Vylaer Spiromax Withdrawn · Teva Pharma B.V.
- 🇪🇺 Labazenit Refused · Laboratoires SMB S.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.