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Document 52022XC1111(05)

Summary of European Union decisions on marketing authorisations in respect of medicinal products of 10 November 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 136, 30.4.2004, p. 1.) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 4, 7.1.2019, p. 43.)) 2022/C 429 I/01

OJ C 429I, 11.11.2022, p. 1–1 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

11.11.2022   

EN

Official Journal of the European Union

CI 429/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products of 10 November 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2022/C 429 I/01)

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

10.11.2022

VidPrevtyn Beta

COVID-19 vaccine (recombinant, adjuvanted)

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/21/1580

Solution and emulsion for emulsion for injection

J07BX03

10.11.2022

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 4, 7.1.2019, p. 43.

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