Pajjiż: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tozinameran
PFIZER (MALAYSIA) SDN. BHD.
Tozinameran
10 Vials
BioNTech Manufacturing GmbH
_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 10 MCG CONCENTRATE FOR DISPERSIONFOR INJECTION COVID-19 mRNA Vaccine (10 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 virus. COMIRNATY 10mcg Concentrate for Dispersion for Injection is given to children aged 5 to 11 years (i.e. 5 to less than 12 years of age). 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 your child COVID-19. BEFORE YOU USE COMIRNATY - _When you must not use it_ DO NOT TAKE COMIRNATY If your child is allergic to active substance or any of the other ingredients of COMIRNATY. _Pregnancy and lactation_ If your child is pregnant, tell your doctor, nurse or pharmacist before your child receives 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 10 mcg Concentrate for Dispersion for Injection should be used only for children Aqra d-dokument sħiħ
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: 603.22816000 Fax: 603.22816388 17 July 2023 Dear Healthcare Professionals, CONDITIONAL REGISTRATION OF COMIRNATY 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 10 mcg Concentrate for Dispersion for Injection REGISTRATION NUMBER MAL22016037AZ _ _ STRENGTH OF ACTIVE INGREDIENTS 10 MCG/DOSE (children 5 to 11 years) PACK SIZE 10 multidose vials with 1.3mL filling (After dilution, each vial contains 10 DOSES OF 0.2 ML ) 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 4. Pfizer Malaysia will submit label update to the National Pharmaceutical Regulatory Authority (NPRA) if there are any label updates in the future. Thank you. Yours since Aqra d-dokument sħiħ