# Official Journal C 509I/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 509I |
| | |
| English edition | Information and Notices | Volume 6417 December 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 509I

English edition

Information and Notices

Volume 6417 December 2021

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 509 I/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products on 17 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 509 I/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products on 17 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

| 17.12.2021 | EN | Official Journal of the European Union | CI 509/1 |
| --- | --- | --- | --- |

17.12.2021

EN

Official Journal of the European Union

CI 509/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products on 17 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 509 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 17.12.2021 | Xevudy | sotrovimab | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/21/1562 | Concentrate for solution for infusion | Pending | 17.12.2021 |

—

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

17.12.2021

Xevudy

sotrovimab

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

Concentrate for solution for infusion

Pending

17.12.2021

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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