Jorveza (budesonide)
OrphanAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- budesonide
- Company
- Dr. Falk Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Esophageal Diseases
- CHMP opinion
- Thu 09 Nov 2017
- EU approval
- Mon 08 Jan 2018
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/004655
- ATC
- A07EA06
- Official record
- www.ema.europa.eu
Indication
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇺🇸 Breztri Aerosphere Approved · Astrazeneca Ab
- 🇪🇺 Kinpeygo Authorised · Stada Arzneimittel AG
- 🇪🇺 GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) Authorised · Teva Pharma B.V.
- 🇪🇺 DuoResp Spiromax Authorised · Teva Pharma B.V.
- 🇪🇺 BiResp Spiromax Authorised · Teva Pharma B.V.
- 🇪🇺 Budesonide/Formoterol Teva Pharma B.V. Withdrawn · Teva Pharma B.V.
- 🇪🇺 Budesonide/Formoterol Teva Withdrawn · Teva Pharma B.V.
- 🇪🇺 Vylaer Spiromax Withdrawn · Teva Pharma B.V.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.