MFDS — authorised 4 September 2014
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: likely_approved
🇰🇷 Keytruda in South Korea
MFDS authorised Keytruda on 4 September 2014
Marketing authorisations
MFDS — authorised 28 April 2020
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: likely_approved
MFDS — authorised 21 November 2025
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: likely_approved
Keytruda in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in South Korea
Frequently asked questions
Is Keytruda approved in South Korea?
Yes. MFDS authorised it on 4 September 2014; MFDS authorised it on 28 April 2020; MFDS authorised it on 21 November 2025.
Who is the marketing authorisation holder for Keytruda in South Korea?
MERCK SHARP DOHME holds the South Korean marketing authorisation.