# Official Journal C 447I/2020

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 447I |
| | |
| English edition | Information and Notices | Volume 6324 December 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 447I

English edition

Information and Notices

Volume 6324 December 2020

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2020/C 447 I/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 21 December 2020 to 21 December 2020( OJ C 136, 30.4.2004 ) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2020/C 447 I/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 21 December 2020 to 21 December 2020( OJ C 136, 30.4.2004 )

( OJ C 136, 30.4.2004 )

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 24.12.2020 | EN | Official Journal of the European Union | CI 447/1 |
| --- | --- | --- | --- |

24.12.2020

EN

Official Journal of the European Union

CI 447/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 21 December 2020 to 21 December 2020

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

(2020/C 447 I/01)

| — | Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

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Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.12.2020 | Comirnaty | COVID-19 mRNA Vaccine (nucleoside modified) | BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland | EU/1/20/1528 | Concentrate for dispersion for injection | J07BX | 21.12.2020 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

21.12.2020

Comirnaty

COVID-19 mRNA Vaccine (nucleoside modified)

BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

Concentrate for dispersion for injection

J07BX

21.12.2020

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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