EVUSHELD 100 MGML SOLUTION FOR INJECTION
Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Summary of Product characteristics
(SPC)
24-05-2023
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Active ingredient:
Tixagevimab; Cilgavimab
Available from:
ASTRAZENECA SDN. BHD.
INN (International Name):
Tixagevimab; Cilgavimab
Units in package:
1.5 ml
Manufactured by:
ASTRAZENECA AB
Summary of Product characteristics
ASTRAZENECA SDN BHD
Nucleus Tower, Level 12
No. 10, Jalan PJU 7/6, Mutiara Damansara
47800 Petaling Jaya, Selangor, Malaysia
Company Regn No. 69730-X
18 JULY 2022
DEAR HEALTHCARE PROFESSIONAL,
CONDITIONAL REGISTRATION OF EVUSHELD 100MG/ML SOLUTION FOR INJECTION
WITH
EXEMPTIONS FROM MALAYSIA SPECIFIC LABELLING REQUIREMENTS
With regards to the matter above, AstraZeneca would like to inform
that the approval in Malaysia is
supported by common pack product label and carton to facilitate supply
during pandemic period. In
order to make the artwork acceptable to multiple countries around the
world during the pandemic the
artwork is exempted from a number of country specific labelling
requirements. There will not be
country-specific packs for Malaysia until the commercial supply stage
which currently has yet to be
determined.
3. Enclosed are the additional Malaysian local labelling information
for your reference which will not be
included in the artwork during the pandemic period.
IMMEDIATE LABEL
PRODUCT INFORMATION
DETAILS
Product Name
EVUSHELD 100MG/ML SOLUTION FOR INJECTION
OUTER CARTON
PRODUCT INFORMATION
DETAILS
Batch releaser
AstraZeneca AB
Gärtunavägen,
Södertälje, 151 85,
Sweden
Local Registration Number (MAL
Number)
MAL22056042ACRZ
Product
Registration
Holder
(PRH)
AstraZeneca Sdn Bhd (69730-X)
Level 11 & 12, The Bousteador, No. 10, Jalan PJU 7/6,
Mutiara Damansara, 47800 Petaling Jaya, Selangor,
Malaysia.
Others
Keep medicine out of reach of children/Jauhi Ubat dari Kanak-
kanak
Controlled Medicine
PACKAGE INSERT
ASTRAZENECA SDN BHD
The Bousteador, Level 12
No. 10, Jalan PJU 7/6, Mutiara Damansa
47800 Petaling Jaya, Selangor, Malaysia
T: +60 3 7624 3888
F: +60 3 7624 3999
astrazeneca.com
ASTRAZENECA SDN BHD
The Bousteador, Level 12
No. 10, Jalan PJU 7/6, Mutiara Damansara
47800 Petaling Jaya, Selangor, Malaysia
Company Regn No. 69730-X
A blank package insert with/without the wordings ‘THIS AREA IS
INTENTIONALLY LEFT BLANK’ will be
included in the carton.
For approved prescribing information, please refe
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