Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
JCOVDEN suspension for injection.
COVID-19 vaccine (Ad26.COV2-S [recombinant]).
| Pharmaceutical Form |
|---|
|
Suspension for injection (injection). Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4). |
This is a multi-dose vial which contains 5 doses of 0.5 mL.
One dose (0.5 mL) contains: Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein* (Ad26.COV2-S), not less than 8.92 log10 infectious units (Inf.U).
* Produced in the PER.C6 TetR Cell Line and by recombinant DNA technology.
The product contains genetically modified organisms (GMOs).
Excipients with known effect:
Each dose (0.5 mL) contains approximately 2 mg of ethanol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S) |
SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S) is a monovalent vaccine composed of a recombinant, replicationincompetent human adenovirus type 26 vector that encodes a SARS-CoV-2 full-length spike (S) glycoprotein in a stabilised conformation. Following administration, the S glycoprotein of SARSCoV-2 is transiently expressed, stimulating both neutralising and other functional S-specific antibodies, as well as cellular immune responses directed against the S antigen, which may contribute to protection against COVID-19. |
| List of Excipients |
|---|
|
10 vial pack: 2-hydroxypropyl-β-cyclodextrin (HBCD) 20 vial pack: 2-hydroxypropyl-β-cyclodextrin (HBCD) |
A 2.5 mL suspension in a multi-dose vial (type I glass) with a rubber stopper (chlorobutyl with fluoropolymer coated surface), aluminium crimp and blue plastic cap. Each vial contains 5 doses of 0.5 mL.
Pack sizes of 10 or 20 multi-dose vials.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/20/1525/001
EU/1/20/1525/002
Date of first authorisation: 11 March 2021
Date of latest renewal: 03 January 2022
| Drug | Countries | |
|---|---|---|
| JCOVDEN | Estonia, Spain, France, Japan, Netherlands, Poland, Tunisia, South Africa |
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