Exubera (insulin human)
- Region
- 🇪🇺 EU
- Active substance
- insulin human
- Company
- Pfizer Limited
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus
- EU approval
- Tue 24 Jan 2006
- Application
- EMEA/H/C/000588
- ATC
- A10AF01
- Official record
- www.ema.europa.eu
Indication
EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Insuman Authorised · Sanofi-aventis Deutschland GmbH
- 🇪🇺 Insulin Human Rechon Application withdrawn · Rechon Life Science AB
- 🇪🇺 Actraphane Authorised · Novo Nordisk A/S
- 🇪🇺 Mixtard Authorised · Novo Nordisk A/S
- 🇪🇺 Inpremzia Withdrawn · Baxter Holding B.V.
- 🇪🇺 Insulatard Authorised · Novo Nordisk A/S
- 🇪🇺 Protaphane Authorised · Novo Nordisk A/S
- 🇪🇺 Insulin Human Winthrop Withdrawn · sanofi-aventis Deutschland GmbH
- 🇪🇺 Solumarv Refused · Marvel Lifesciences Ltd
- 🇪🇺 Combimarv Application withdrawn · Marvel Life Sciences Ltd.
- 🇪🇺 Solumarv Application withdrawn · Marvel Life Sciences Ltd.
- 🇪🇺 Isomarv medium Application withdrawn · Marvel Life Sciences Ltd.
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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.