Teizeild (teplizumab)
PRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- teplizumab
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 1
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Thu 08 Jan 2026
- Designations
- PRIME, Additional monitoring
- Application
- EMEA/H/C/005496
- ATC
- A10XX01
- Official record
- www.ema.europa.eu
Indication
Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.
Regulatory milestones
Thu 08 Jan 2026🇪🇺 EU approval (EC decision)
Teizeild (teplizumab) approved in the EU
Marketing authorisation to Sanofi Winthrop Industrie; PRIME, Additional monitoring · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Teizeild (teplizumab): CHMP positive opinion
Sanofi Winthrop Industrie; PRIME, Additional monitoring · source
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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.