# Official Journal C 429I/2022

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 429I |
| | |
| English edition | Information and Notices | Volume 6511 November 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 429I

English edition

Information and Notices

Volume 6511 November 2022

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 429 I/01 | 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
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 429 I/01

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
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council

1

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 11.11.2022 | EN | Official Journal of the European Union | CI 429/1 |
| --- | --- | --- | --- |

11.11.2022

EN

Official Journal of the European Union

CI 429/1

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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 |

—

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 |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 4, 7.1.2019, p. 43.

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