# C_2018433EN.01000101.xml

| 30.11.2018 | EN | Official Journal of the European Union | C 433/1 |
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30.11.2018

EN

Official Journal of the European Union

C 433/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 30 September 2018

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

(2018/C 433/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.7.2018 | Carmustine Obvius | carmustine | Obvius Investment B.V.
  De Cuserstraat 93, 1081 CN Amsterdam, Nederland | EU/1/18/1278 | Powder and solvent for concentrate for solution for infusion | L01AD01 | 23.7.2018 |

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

19.7.2018

Carmustine Obvius

carmustine

Obvius Investment B.V.

De Cuserstraat 93, 1081 CN Amsterdam, Nederland

EU/1/18/1278

Powder and solvent for concentrate for solution for infusion

L01AD01

23.7.2018

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 20.9.2018 | Dexxience | Portola Pharma UK Limited
  209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1W 1AW, United Kingdom | — | 16.10.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

20.9.2018

Dexxience

Portola Pharma UK Limited

209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1W 1AW, United Kingdom

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16.10.2018

| — | Modification 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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Modification 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 | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 30.1.2018 | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 1.2.2018 |
| 8.5.2018 | Riluzole Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/12/768 | 15.5.2018 |
| 19.7.2018 | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 23.7.2018 |
| 26.7.2018 | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 30.7.2018 |
| 26.7.2018 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/08/448 | 30.7.2018 |
| 26.7.2018 | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/16/1152 | 30.9.2018 |
| 26.7.2018 | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 30.7.2018 |
| 30.7.2018 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 9.8.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

30.1.2018

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

1.2.2018

8.5.2018

Riluzole Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

15.5.2018

19.7.2018

Taxespira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/15/1017

23.7.2018

26.7.2018

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

30.7.2018

26.7.2018

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/08/448

30.7.2018

26.7.2018

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/16/1152

30.9.2018

26.7.2018

Xeljanz

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/17/1178

30.7.2018

30.7.2018

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

9.8.2018

| — | Issuing of a marketing authorization (Article 38 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 38 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.2.2018 | Oxybee | oxalic acid dihydrate | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/17/216 | Powder and solution for bee-hive dispersion | QP53AG03 | 5.2.2018 |

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

1.2.2018

Oxybee

oxalic acid dihydrate

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/17/216

Powder and solution for bee-hive dispersion

QP53AG03

5.2.2018

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 |
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| 30 Churchill Place |
| Canary Wharf |
| London |
| E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London

E14 5EU

United Kingdom

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(1)  OJ L 136, 30.4.2004, p. 1.

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