COMIRNATY Concentrate for Dispersion for Injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

BNT162b2

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BNT162b2

Unit dalam pakej:

195 Vials

Dikeluarkan oleh:

Pfizer Manufacturing Belgium NV

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DISCLAIMER: THIS PRODUCT IS APPROVED UNDER MALAYSIA CONDITIONAL
REGISTRATION FOR
PHARMACEUTICAL PRODUCTS DURING DISASTER GUIDELINE. THE ADMINISTRATION
OF THE
PRODUCT IS PURELY BASED ON INDIVIDUAL’S PREFERENCE.
COMIRNATY
®
CONCENTRATE FOR DISPERSION FOR
INJECTION
COVID-19 mRNA Vaccine (30 mcg)
1
WHAT IS IN THIS LEAFLET
1.
What COMIRNATY is used for
2.
How COMIRNATY works
3.
Before you use COMIRNATY
4.
How to use COMIRNATY
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
COMIRNATY
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT COMIRNATY IS USED FOR
COMIRNATY is a vaccine used for
preventing COVID-19 caused by
SARS-CoV-2.
COMIRNATY Concentrate for
Dispersion for Injection is given to
adults and adolescents from 12 years
of age and older.
HOW COMIRNATY WORKS
The vaccine causes the immune
system (the body’s natural defenses)
to produce antibodies and blood cells
that work against the virus, so giving
protection against COVID-19.
As COMIRNATY does not contain
the virus to produce immunity, it
cannot give you COVID-19.
BEFORE YOU USE COMIRNATY
-
_When you must not use it_
DO NOT TAKE COMIRNATY
If you are allergic to
the active
substance
or any of the other
ingredients of COMIRNATY.
_Pregnancy and lactation_
If you are pregnant or think you
may be pregnant, tell your doctor,
nurse or pharmacist before you
receive this vaccine.
Comirnaty can be used during
pregnancy. A large amount of
information from pregnant women
vaccinated with Comirnaty during
the second and third trimester have
not shown negative effects on the
pregnancy or the newborn baby.
While information on effects on
pregnancy or the newborn baby
after vaccination during the first
trimester is limited, no change to
the risk for miscarriage has been
seen.
Comirnaty can be given during
breast-feeding.
_Children_
COMIRNATY Concentrate for
Dispersion for Injection is not
recommended for children aged
under 12 years. There i

Ciri produk

Pfizer (Malaysia) Sdn Bhd 197801003134 (40131-T)
Level 10 & 11, Wisma Averis, Tower 2
Avenue 5, Bangsar South, No. 8 Jalan Kerinchi
59200 Kuala Lumpur, Malaysia
Tel: [phone] Fax: [phone]
03 Jan 2023
Dear Healthcare Professionals,
CONDITIONAL REGISTRATION OF COMIRNATY CONCENTRATE FOR DISPERSION FOR
INJECTION COVID-
19 MRNA VACCINE WITH EU LABEL ON PRODUCT CARTON
With regards to the matter above, Pfizer would like to inform that the
label on the product carton
is the label approved by European Medicines Agency (EMA). During
pandemic supply period, the approved
label by EMA will be used for stocks supply to the rest of world
including Malaysia. There will not be
country-specific packs for Malaysia until commercial supply stage
which has not been determined yet.
2.
The name and address for the Marketing Authorization Holder (MAH) in
EU information is
reflected on the product carton, BioNTech Manufacturing GmbH with the
address of An der Goldgrube
12, 55131 Mainz, Germany. The batch release site information will not
be reflected on the product label.
3.
Enclosed are product information approved in Malaysia for your
reference.
PRODUCT INFORMATION
Details
FULL NAME OF PRODUCT
COMIRNATY Concentrate for Dispersion for Injection
COVID-19 mRNA Vaccine (nucleoside modified)
REGISTRATION NUMBER
Pfizer Puurs Release Site: MAL21016022AZ
BNT Mainz Release Site: MAL21036039ASZ
STRENGTH OF ACTIVE
INGREDIENTS
30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid
nanoparticles)
MANUFACTURER AND BATCH
RELEASER (FOR MALAYSIA)
BATCH RELEASE SITE:
Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs, 2870, Belgium
BATCH RELEASE SITE:
BioNTech Manufacturing GmbH, Kupferbergterrasse 17-19, 55116 Mainz,
Germany
PRH NAME AND ADDRESS
Pfizer Malaysia Sdn. Bhd. Level 10 & 11, Wisma Averis (Tower 2),
Bangsar
South, No.8, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia
STORAGE CONDITION
Store in a freezer at -90°C to -60°C
PACK SIZE
195 vials (one purple cap vial contains 6 doses of 0.3 mL after
dilution)
4.
Pfizer Malaysia will subm