# Official Journal C 116I/2023

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 116I |
| | |
| English edition | Information and Notices | Volume 6631 March 2023 |

ISSN 1977-091X

Official Journal

of the European Union

C 116I

English edition

Information and Notices

Volume 6631 March 2023

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2023/C 116 I/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 30 March 2023 to 30 March 2023
  (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

2023/C 116 I/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 30 March 2023 to 30 March 2023
  (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

| 31.3.2023 | EN | Official Journal of the European Union | CI 116/1 |
| --- | --- | --- | --- |

31.3.2023

EN

Official Journal of the European Union

CI 116/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 30 March 2023 to 30 March 2023

(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))

(2023/C 116 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 30.3.2023 | BIMERVAX | COVID-19 Vaccine (recombinant, adjuvanted) | Hipra Human Health, S.L.U. |
| Avda. la Selva, 135, 17170 Amer (Girona), España |

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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

30.3.2023

BIMERVAX

COVID-19 Vaccine (recombinant, adjuvanted)

Hipra Human Health, S.L.U.

Avda. la Selva, 135, 17170 Amer (Girona), España

EU/1/22/1709

Emulsion for injection

J07BN

30.3.2023

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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