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14 Ogos 2026, 3:20 am

Jangka hayat vaksin Convidecia dilanjut

PUTRAJAYA: Vaksin Covid-19 iaitu Convidecia (Trade Mark) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection dilanjut dari 15 bulan ke 18 bulan.

Kementerian Kesihatan (KKM) memaklumkan, Bahagian Regulatori Farmasi Negara (NPRA) meluluskan permohonan variasi daripada syarikat Solution Biologics Sdn. Bhd. berhubung pengemaskinian tempoh jangka hayat produk itu.

Pengarah Kanan Perkhidmatan Farmasi KKM, Norhaliza A Halim berkata, pelanjutan tempoh jangka hayat produk tersebut diberikan berdasarkan data stabiliti terkini yang dikemukakan oleh pihak pengilang.

Menurutnya, ia melibatkan produk Convidecia (MAL21066050AZ) yang dikilangkan di CanSino Biologics Inc, China dan Convidecia (MAL22126013ASZ) di Solution Biologics Sdn. Bhd., Malaysia bagi vial vaksin yang disimpan dalam suhu 2°C hingga 8°C.

“Kelulusan pelanjutan jangka hayat ini adalah secara retrospektif, bermaksud kelulusan ini juga terpakai kepada semua stok termasuk semua stok yang diterima sebelum variasi pelanjutan tempoh jangka hayat ini diluluskan,” katanya dalam kenyataan hari ini.

Jelasnya tarikh luput pada label vaksin mungkin menunjukkan produk berkenaan sudah luput, tetapi semakan tarikh luput yang terkini (selepas pelanjutan jangka hayat) boleh disemak melalui laman sesawang NPRA (https://npra.gov.my/index.php/en/consumers/information/vaccine-covid-19- update.html).

Katanya, KKM sentiasa komited untuk memastikan semua produk farmaseutikal termasuk vaksin Covid-19 yang dibekalkan di Malaysia telah dinilai dari aspek kualiti, keselamatan dan keberkesanan oleh NPRA- UTUSAN

Tags: KKM vaksin covid-19

Jangka hayat vaksin Convidecia dilanjut

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