JCOVDEN Suspension for injection Ref.[11085] Active ingredients: SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S)

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

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).

Qualitative and quantitative composition

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)
Citric acid monohydrate
Ethanol
Hydrochloric acid
Polysorbate-80
Sodium chloride
Sodium hydroxide
Trisodium citrate dihydrate
Water for injections

20 vial pack:

2-hydroxypropyl-β-cyclodextrin (HBCD)
Citric acid monohydrate
Ethanol
Hydrochloric acid
Polysorbate-80
Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/20/1525/001
EU/1/20/1525/002

Date of first authorisation: 11 March 2021
Date of latest renewal: 03 January 2022

Drugs

Drug Countries
JCOVDEN Estonia, Spain, France, Japan, Netherlands, Poland, Tunisia, South Africa

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