Ing dina Jumuah, regulator obat Uni Eropa ngetokake 'saran' ndhukung panggunaan darurat obat anti-coronavirus anyar sing dikembangake dening perusahaan farmasi multinasional Amerika. Merck kanthi kolaborasi karo Ridgeback Biotherapeutics, sanajan durung diwenehi wewenang dening panguwasa AS.
The Badan Obat Eropa (Ema) wis dianjurake nggunakake darurat saka MerckPil kanggo perawatan pasien COVID-19 sing rawan sacara klinis amarga kasus koronavirus anyar mundhak ing bawana Eropa.
Ing statement, EMA ujar obat sing diarani Lagevrio - uga dikenal minangka molnupiravir utawa MK 4482 - "bisa digunakake kanggo ngobati wong diwasa sing nandhang COVID-19 sing ora mbutuhake oksigen tambahan lan duwe risiko tambah nandhang COVID-19 sing abot."
Regulator EU ujar manawa perawatan kasebut kudu ditindakake sanalika sawise COVID-19 didiagnosis lan sajrone limang dina wiwit gejala kasebut. Obat kasebut kudu dijupuk kaping pindho dina sajrone limang dina.
The EMA kadhaptar efek sisih potensial saka pil, kalebu diare entheng utawa Moderate, mual, dizziness lan sirah. Pangobatan kasebut ora dianjurake kanggo wanita ngandhut.
Regulator kasebut ngumumake sadurunge dina Jumuah yen wis miwiti mriksa obat Pfizer Paxlovid kanggo COVID-19 kanthi tujuan sing padha "kanggo ndhukung panguwasa nasional" sing bisa mutusake panggunaan awal sadurunge otorisasi pemasaran amarga mundhake kasus lan tiwas ing Eropa.
Dina iki, Austria ngumumake bakal mlebu kunci nasional anyar wiwit Senin lan nggawe vaksinasi wajib, dene panguwasa kesehatan Jerman ujar manawa negara kasebut wis dadi "wabah gedhe."
Pfizer lan Merck wis njaluk persetujuan kanggo obat-obatan koronavirus saka Administrasi Pangan lan Narkoba AS, nanging ora jelas kapan bisa diwenehake.
APA sing kudu dijupuk saka ARTIKEL INI:
- The regulator announced earlier on Friday that it had begun reviewing Pfizer's medicine Paxlovid for COVID-19 with the same goal “to support national authorities” who may decide on its early use prior to marketing authorization in light of rising cases and deaths in Europe.
- In a statement, EMA said the drug called Lagevrio – also known as molnupiravir or MK 4482 – “can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.
- The European Medicines Agency (EMA) has recommended the emergency use of Merck's pill for the treatment for clinically vulnerable COVID-19 patients as new coronavirus cases spike across the European continent.