# Official Journal C 458I/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 458I |
| | |
| English edition | Information and Notices | Volume 6413 November 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 458I

English edition

Information and Notices

Volume 6413 November 2021

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 458 I/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products on 12 November 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 458 I/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products on 12 November 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

| 13.11.2021 | EN | Official Journal of the European Union | CI 458/1 |
| --- | --- | --- | --- |

13.11.2021

EN

Official Journal of the European Union

CI 458/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products on 12 November 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 458 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2021 | Regkirona | regdanvimab | Celltrion Healthcare Hungary Kft. |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

—

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

12.11.2021

Regkirona

regdanvimab

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/21/1597

Concentrate for solution for infusion

Pending

12.11.2021

12.11.2021

Ronapreve

casirivimab / imdevimab

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/21/1601

Solution for injection / infusion

Pending

12.11.2021

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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