The caseload stands at 2,009,434 as the death toll remains unchanged at 29,314
Paxlovid, which combines nirmatrelvir and ritonavir in a tablet, will require a prescription, it said in a statement.
The treatment was nearly 90% effective in preventing hospitalisations and deaths, and data suggested it retains its effectiveness against the omicron variant, Pfizer has said.
Late last year, COFEPRIS had approved a similar treatment by Eli Lilly and Co.