PENGEMASKINIAN TEMPOH JANGKA HAYAT VAKSIN COMIRNATY (ADULT DOSE) DARIPADA 12 BULAN KEPADA 15 BULAN

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1.1 MAKLUMAN PENGEMASKINIAN TEMPOH JANGKA HAYAT VAKSIN COMIRNATY (ADULT DOSE) DARIPADA 12 BULAN KEPADA 15 BULAN


 

1.1 MAKLUMAN PENGEMASKINIAN TEMPOH JANGKA HAYAT VAKSIN COMIRNATY (ADULT DOSE) DARIPADA 12 BULAN KEPADA 15 BULAN

 

Sukacita dimaklumkan bahawa pada 13 September 2022, NPRA telah meluluskan permohonan variasi daripada syarikat Pfizer (Malaysia) Sdn. Bhd, berhubung pengemaskinian tempoh jangka hayat produk untuk vaksin COMIRNATY seperti berikut:

1.    COMIRNATY Concentrate for Dispersion for Injection (MAL21016022AZ)

 

2.    COMIRNATY Concentrate for Dispersion for Injection (MAL21036039ASZ) 

Kategori

Deskripsi variasi yang diluluskan

MaVB-59

Memanjangkan tempoh penyimpanan vaksin dari 12 bulan ke 15 bulan apabila disimpan pada suhu -90°C hingga -60°C

 

Bersama ini dilampirkan senarai kelompok dengan tarikh luput baharu yang telah dikemaskini seperti di Lampiran A. Maklumat jangka hayat produk di sisip bungkusan juga telah dikemaskini dan boleh dimuat turun melalui laman sesawang NPRA.

 

Sekiranya terdapat sebarang pertanyaan lanjut, YBhg. Datuk/ Dato’/ Tuan/ Puan boleh menghubungi One-Stop-Centre di alamat This email address is being protected from spambots. You need JavaScript enabled to view it. atau di talian 03-7883 5400 (sambungan: 4435/4436/4437) atau 03-7801 8445/8446/8447/8449

 

 

Sekian, terima kasih.

 

Senarai vaksin COMIRNATY Concentrate for Dispersion for Injection  (MAL21016022AZ & MAL21036039ASZ) dengan Tarikh Luput Baru selepas Pelanjutan Jangka Hayat Vaksin ke 15 Bulan

 

Bil

No. Kelompok

Tarikh Mengilang

Tarikh Luput dari sijil Lot Release

Tarikh Luput Baru

(15 bulan)

1

EP2163

23-Dec-20

31-May-21

28-Feb-22

2

EP9605

13-Jan-21

30-Jun-21

31-Mac-22

3

ER7449

27-Jan-21

30-Jun-21

31-Mac-22

4

ET9096

12-Feb-21

31-Jul-21

30-Apr-22

5

ET3045

25-Feb-21

31-Jul-21

30-Apr-22

6

EX2405

4-Mar-21

31-Aug-21

31-May-22

7

EX6564

15-Mar-21

31-Aug-21

31-May-22

8

FA5715

31-Mar-21

31-Aug-21

31-May-22

9

EW0198

6-Apr-21

30-Sep-21

30-Jun-22

10

FC3558

6-Apr-21

30-Sep-21

30-Jun-22

11

FD0927

21-Apr-21

30-Sep-21

30-Jun-22

12

FD5996

30-Apr-21

30-Sep-21

30-Jun-22

13

FE2083

11-May-21

31-Oct-21

31-Jul-22

14

FE2625

11-May-21

31-Oct-21

31-Jul-22

15

EY0584

16-May-21

31-Oct-21

31-Jul-22

16

FE3064

20-May-21

31-Oct-21

31-Jul-22

17

FC5029

26-May-21

31-Oct-21

31-Jul-22

18

FF4222

2-Jun-21

31-Oct-21

31-Jul-22

19

FE3430

2-Jun-21

31-Oct-21

31-Jul-22

20

FE8163

2-Jun-21

31-Oct-21

31-Jul-22

21

FF0884

10-Jun-21

30-Nov-21

31-Aug-22

22

FF8871

10-Jun-21

30-Nov-21

31-Aug-22

23

FG1807

15-Jun-21

30-Nov-21

31-Aug-22

24

FG2872

15-Jun-21

30-Nov-21

31-Aug-22

25

FG4421

15-Jun-21

30-Nov-21

31-Aug-22

26

FG3716

30-Jun-21

30-Nov-21

31-Aug-22

27

FG2975

30-Jun-21

30-Nov-21

31-Aug-22

28

FG8643

1-Jul-21

30-Nov-21

31-Aug-22

29

FG9019

6-Jul-21

31-Dec-21

30-Sep-22

30

FH2528

16-Jul-21

31-Dec-21

30-Sep-22

31

FG7900

26-Jul-21

31-Dec-21

30-Sep-22

32

FG6272

2-Aug-21

31-Dec-21

30-Sep-22

33

FH3253

5-Aug-21

31-Jan-22

31-Oct-22

34

FH4763

9-Aug-21

31-Jan-22

31-Oct-22

35

FH8773

10-Aug-21

31-Jan-22

31-Oct-22

36

FK0112

11-Aug-21

31-Jan-22

31-Oct-22

37

FK5475

12-Aug-21

31-Jan-22

31-Oct-22

38

FJ5973

25-Aug-21

31-Jan-22

31-Oct-22

39

FH4750

25-Aug-21

31-Jan-22

31-Oct-22

40

FH4752

27-Aug-21

31-Jan-22

31-Oct-22

41

FK6858

27-Aug-21

31-Jan-22

31-Oct-22

42

FJ4188

27-Aug-21

30-Apr-22

31-Oct-22

43

FK9414

1-Sep-21

28-Feb-22

30-Nov-22

44

FL3650

3-Sep-21

31-May-22

30-Nov-22

45

FH3221

8-Sep-21

31-May-22

30-Nov-22

46

FL5324

9-Sep-21

31-May-22

30-Nov-22

47

FL7476

13-Sep-21

31-May-22

30-Nov-22

48

FL1940

15-Sep-21

31-May-22

30-Nov-22

49

FL1939

15-Sep-21

31-May-22

30-Nov-22

50

FK8888

16-Sep-21

31-May-22

30-Nov-22

51

FK0892

17-Sep-21

31-May-22

30-Nov-22

52

210961

21-Sep-21

31-May-22

30-Nov-22

53

FM3809

23-Sep-21

31-May-22

30-Nov-22

54

FK6268

29-Sep-21

31-May-22

30-Nov-22

55

FM3802

30-Sep-21

31-May-22

30-Nov-22

56

FL4210

18-Oct-21

30-Jun-22

31-Dec-22

57

FN1430

26-Oct-21

30-Jun-22

31-Dec-22

58

FM9090

3-Nov-21

31-Jul-22

31-Jan-23

59

34513TB

3-Nov-21

31-Jul-22

31-Jan-23

60

1K077A

4-Nov-21

31-Jul-22

31-Jan-23

61

1K077-1A

5-Nov-21

31-Jul-22

31-Jan-23

62

141044A

8-Nov-21

31-Jul-22

31-Jan-23

63

141044A

8-Nov-21

31-Jul-22

31-Jan-23

64

141045A

9-Nov-21

31-Jul-22

31-Jan-23

65

1K078A

10-Nov-21

31-Jul-22

31-Jan-23

66

35559TB

15-Nov-21

31-Jul-22

31-Jan-23

67

FM9281

17-Nov-21

31-Jul-22

31-Jan-23

68

FP8233

19-Nov-21

31-Jul-22

31-Jan-23

69

1F1053A

24-Nov-21

31-Jul-22

31-Jan-23

70

141054A

24-Nov-21

31-Jul-22

31-Jan-23

71

SDWE5

6-Dec-21

31-Aug-22

28-Feb-23

72

1F1060A

8-Dec-21

31-Aug-22

28-Feb-23

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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