# Official Journal C 516/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 516 |
| | |
| English edition | Information and Notices | Volume 6421 December 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 516

English edition

Information and Notices

Volume 6421 December 2021

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 516/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products on 20 December 2021
  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 516/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products on 20 December 2021
  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 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

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 21.12.2021 | EN | Official Journal of the European Union | C 516/1 |
| --- | --- | --- | --- |

21.12.2021

EN

Official Journal of the European Union

C 516/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products on 20 December 2021

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

(2021/C 516/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 20.12.2021 | Nuvaxovid | COVID-19 Vaccine (recombinant, adjuvanted) | Novavax CZ, a.s. |
| Bohumil 138, 281 63 Jevany, Česká republika |

—

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

20.12.2021

Nuvaxovid

COVID-19 Vaccine (recombinant, adjuvanted)

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

dispersion for injection

J07BX03

20.12.2021

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.

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