Cotellic
Active substance: cobimetinib
cobimetinib hemifumarate
Centralised EU authorisationActive
Marketing holder: Roche Registration GmbH
Verified 2026-10-09 · EMA
Analogues in other countries- Source: EMA
- Countries with the substance registered: 2
Composition
- cobimetinib hemifumarate
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| US 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a12091-b677-710f-9a29-a80696f378bf;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- EMEA/H/C/003960
- Registration status
- Active
- ATC code
- L01XE38
Sources
- product · EMA · EMEA/H/C/003960 · Verified 2026-10-09
- registration_status · EMA · EMEA/H/C/003960 · Verified 2026-10-09
- ingredients.0 · EMA · EMEA/H/C/003960 · Verified 2026-10-09