# Official Journal C 467/30 D

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 467 |
| | |
| English edition | Information and Notices | Volume 5730 December 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 467

English edition

Information and Notices

Volume 5730 December 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 467/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 467/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 467/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014(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

2014/C 467/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.12.2014 | EN | Official Journal of the European Union | C 467/1 |
| --- | --- | --- | --- |

30.12.2014

EN

Official Journal of the European Union

C 467/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014

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

(2014/C 467/01)

—   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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.11.2014 | Harvoni | ledipasvir/sofosbuvir | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | Film-coated tablet | Pending | 18.11.2014 |
| 19.11.2014 | Brimica Genuair | aclidinium bromide/formoterol fumarate dihydrate | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/963 | Inhalation powder | R03AL05 | 21.11.2014 |
| 19.11.2014 | Budesonide/Formoterol Teva | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/948 | Inhalation powder | R03AK07 | 24.11.2014 |
| 19.11.2014 | Budesonide/Formoterol Teva Pharma B.V. | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/950 | Inhalation powder | R03AK07 | 21.11.2014 |
| 19.11.2014 | Duaklir Genuair | aclidinium bromide/formoterol fumarate dihydrate | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/964 | Inhalation powder | R03AL05 | 21.11.2014 |
| 19.11.2014 | Ketoconazole HRA | ketoconazole | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | Tablet | Pending | 21.11.2014 |
| 19.11.2014 | Lymphoseek | tilmanocept | Navidea Biopharmaceuticals Limited
  30 Upper High Street Thame, OX9 3EZ United Kingdom | EU/1/14/955 | Kit for radiopharmaceutical preparation | V09IA09 | 21.11.2014 |
| 19.11.2014 | REZOLSTA | DARUNAVIR/COBICISTAT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | Film-coated tablet | J05AR14 | 21.11.2014 |
| 19.11.2014 | Vylaer Spiromax | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/949 | Inhalation powder | R03AK07 | 24.11.2014 |
| 21.11.2014 | Tadalafil Mylan | tadalafil | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | Film-coated tablet | G04BE08 | 25.11.2014 |
| 21.11.2014 | Trulicity | dulaglutide | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/956 | Solution for injection | Pending | 25.11.2014 |
| 21.11.2014 | Vargatef | nintedanib | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | Capsule, soft | Pending | 25.11.2014 |

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

17.11.2014

Harvoni

ledipasvir/sofosbuvir

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

Film-coated tablet

Pending

18.11.2014

19.11.2014

Brimica Genuair

aclidinium bromide/formoterol fumarate dihydrate

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/963

Inhalation powder

R03AL05

21.11.2014

19.11.2014

Budesonide/Formoterol Teva

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/948

Inhalation powder

R03AK07

24.11.2014

19.11.2014

Budesonide/Formoterol Teva Pharma B.V.

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/950

Inhalation powder

R03AK07

21.11.2014

19.11.2014

Duaklir Genuair

aclidinium bromide/formoterol fumarate dihydrate

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/964

Inhalation powder

R03AL05

21.11.2014

19.11.2014

Ketoconazole HRA

ketoconazole

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

Tablet

Pending

21.11.2014

19.11.2014

Lymphoseek

tilmanocept

Navidea Biopharmaceuticals Limited

30 Upper High Street Thame, OX9 3EZ United Kingdom

EU/1/14/955

Kit for radiopharmaceutical preparation

V09IA09

21.11.2014

19.11.2014

REZOLSTA

DARUNAVIR/COBICISTAT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

Film-coated tablet

J05AR14

21.11.2014

19.11.2014

Vylaer Spiromax

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/949

Inhalation powder

R03AK07

24.11.2014

21.11.2014

Tadalafil Mylan

tadalafil

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/14/961

Film-coated tablet

G04BE08

25.11.2014

21.11.2014

Trulicity

dulaglutide

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/14/956

Solution for injection

Pending

25.11.2014

21.11.2014

Vargatef

nintedanib

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

Capsule, soft

Pending

25.11.2014

—   Modification 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 | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.11.2014 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 11.11.2014 |
| 7.11.2014 | Biograstim | AbZ-Pharma GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/450 | 11.11.2014 |
| 7.11.2014 | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 11.11.2014 |
| 7.11.2014 | Pioglitazone Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/722 | 11.11.2014 |
| 7.11.2014 | Prometax | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/092 | 11.11.2014 |
| 7.11.2014 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 12.11.2014 |
| 7.11.2014 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 11.11.2014 |
| 11.11.2014 | Glidipion | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/12/756 | 13.11.2014 |
| 11.11.2014 | Imatinib Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/808 | 13.11.2014 |
| 11.11.2014 | Irbesartan/Hydrochlorothiazide Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/583 | 14.11.2014 |
| 11.11.2014 | Lamivudine/Zidovudine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/663 | 13.11.2014 |
| 11.11.2014 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/824 | 13.11.2014 |
| 11.11.2014 | Pioglitazone Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/12/755 | 13.11.2014 |
| 13.11.2014 | Neulasta | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227 | 17.11.2014 |
| 13.11.2014 | NovoMix | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142 | 17.11.2014 |
| 13.11.2014 | Ribavirin Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/509 | 17.11.2014 |
| 13.11.2014 | Ribavirin Teva Pharma BV | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/527 | 17.11.2014 |
| 13.11.2014 | Trisenox | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/02/204 | 17.11.2014 |
| 13.11.2014 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 17.11.2014 |
| 17.11.2014 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 19.11.2014 |
| 17.11.2014 | Fendrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/04/299 | 19.11.2014 |
| 17.11.2014 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 19.11.2014 |
| 17.11.2014 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 20.11.2014 |
| 17.11.2014 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 19.11.2014 |
| 17.11.2014 | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 19.11.2014 |
| 17.11.2014 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 19.11.2014 |
| 17.11.2014 | Zometa | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/176 | 19.11.2014 |
| 19.11.2014 | Aldurazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/253 | 20.11.2014 |
| 19.11.2014 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | 21.11.2014 |
| 19.11.2014 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 21.11.2014 |
| 19.11.2014 | Bretaris Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/12/781 | 21.11.2014 |
| 19.11.2014 | DuoCover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 21.11.2014 |
| 19.11.2014 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 21.11.2014 |
| 19.11.2014 | Eklira Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/12/778 | 21.11.2014 |
| 19.11.2014 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 21.11.2014 |
| 19.11.2014 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 21.11.2014 |
| 19.11.2014 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 21.11.2014 |
| 19.11.2014 | Kalydeco | Vertex Pharmaceuticals (U.K.) Limited
  Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom | EU/1/12/782 | 21.11.2014 |
| 19.11.2014 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 21.11.2014 |
| 19.11.2014 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 21.11.2014 |
| 19.11.2014 | Neupro | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/05/331 | 21.11.2014 |
| 19.11.2014 | Renagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/123 | 21.11.2014 |
| 19.11.2014 | Signifor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/12/753 | 21.11.2014 |
| 19.11.2014 | Temozolomide HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/10/616 | 21.11.2014 |
| 19.11.2014 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH
  Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | EU/1/10/617 | 21.11.2014 |
| 19.11.2014 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 21.11.2014 |
| 19.11.2014 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/08/499 | 21.11.2014 |
| 19.11.2014 | Xaluprine | Nova Laboratories Limited
  Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | EU/1/11/727 | 21.11.2014 |
| 19.11.2014 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 21.11.2014 |
| 21.11.2014 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 25.11.2014 |
| 21.11.2014 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 25.11.2014 |
| 21.11.2014 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/611 | 25.11.2014 |
| 21.11.2014 | Firmagon | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, DK-2300 København S, Danmark | EU/1/08/504 | 25.11.2014 |
| 21.11.2014 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 25.11.2014 |
| 21.11.2014 | Nexavar | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/06/342 | 25.11.2014 |
| 21.11.2014 | Repaglinide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/530 | 25.11.2014 |
| 21.11.2014 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 25.11.2014 |
| 21.11.2014 | Tafinlar | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/865 | 25.11.2014 |
| 28.11.2014 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 2.12.2014 |
| 28.11.2014 | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 2.12.2014 |
| 28.11.2014 | Firdapse | BioMarin Europe Ltd
  164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/09/601 | 2.12.2014 |
| 28.11.2014 | Topotecan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/552 | 2.12.2014 |
| 28.11.2014 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 2.12.2014 |

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

7.11.2014

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

11.11.2014

7.11.2014

Biograstim

AbZ-Pharma GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/450

11.11.2014

7.11.2014

Inlyta

Pfizer Limited

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

EU/1/12/777

11.11.2014

7.11.2014

Pioglitazone Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/11/722

11.11.2014

7.11.2014

Prometax

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092

11.11.2014

7.11.2014

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

12.11.2014

7.11.2014

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

11.11.2014

11.11.2014

Glidipion

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/12/756

13.11.2014

11.11.2014

Imatinib Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/808

13.11.2014

11.11.2014

Irbesartan/Hydrochlorothiazide Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/583

14.11.2014

11.11.2014

Lamivudine/Zidovudine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/663

13.11.2014

11.11.2014

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/824

13.11.2014

11.11.2014

Pioglitazone Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/12/755

13.11.2014

13.11.2014

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

17.11.2014

13.11.2014

NovoMix

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142

17.11.2014

13.11.2014

Ribavirin Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/509

17.11.2014

13.11.2014

Ribavirin Teva Pharma BV

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/527

17.11.2014

13.11.2014

Trisenox

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/02/204

17.11.2014

13.11.2014

Tysabri

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

17.11.2014

17.11.2014

Avastin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300

19.11.2014

17.11.2014

Fendrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/04/299

19.11.2014

17.11.2014

Kivexa

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/298

19.11.2014

17.11.2014

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

20.11.2014

17.11.2014

Revatio

Pfizer Limited

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

EU/1/05/318

19.11.2014

17.11.2014

Tepadina

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

19.11.2014

17.11.2014

Tygacil

Pfizer Limited

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

EU/1/06/336

19.11.2014

17.11.2014

Zometa

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176

19.11.2014

19.11.2014

Aldurazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/253

20.11.2014

19.11.2014

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

21.11.2014

19.11.2014

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

21.11.2014

19.11.2014

Bretaris Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/781

21.11.2014

19.11.2014

DuoCover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

21.11.2014

19.11.2014

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

21.11.2014

19.11.2014

Eklira Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/778

21.11.2014

19.11.2014

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

21.11.2014

19.11.2014

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

21.11.2014

19.11.2014

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

21.11.2014

19.11.2014

Kalydeco

Vertex Pharmaceuticals (U.K.) Limited

Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom

EU/1/12/782

21.11.2014

19.11.2014

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

21.11.2014

19.11.2014

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

21.11.2014

19.11.2014

Neupro

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

21.11.2014

19.11.2014

Renagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123

21.11.2014

19.11.2014

Signifor

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/753

21.11.2014

19.11.2014

Temozolomide HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616

21.11.2014

19.11.2014

Temozolomide Sandoz

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/10/617

21.11.2014

19.11.2014

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

21.11.2014

19.11.2014

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/08/499

21.11.2014

19.11.2014

Xaluprine

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom

EU/1/11/727

21.11.2014

19.11.2014

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

21.11.2014

21.11.2014

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

25.11.2014

21.11.2014

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

25.11.2014

21.11.2014

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

25.11.2014

21.11.2014

Firmagon

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, DK-2300 København S, Danmark

EU/1/08/504

25.11.2014

21.11.2014

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

25.11.2014

21.11.2014

Nexavar

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/06/342

25.11.2014

21.11.2014

Repaglinide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/530

25.11.2014

21.11.2014

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

25.11.2014

21.11.2014

Tafinlar

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/865

25.11.2014

28.11.2014

Brinavess

Cardiome UK Limited

Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/10/645

2.12.2014

28.11.2014

Cetrotide

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/99/100

2.12.2014

28.11.2014

Firdapse

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/09/601

2.12.2014

28.11.2014

Topotecan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

2.12.2014

28.11.2014

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

2.12.2014

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| --- | --- | --- | --- | --- |
| 19.11.2014 | MACI | Aastrom Biosciences DK ApS
  Oliefabriksvej 45, 2770 Kastrup, Danmark | EU/1/13/847 | 24.11.2014 |

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

19.11.2014

MACI

Aastrom Biosciences DK ApS

Oliefabriksvej 45, 2770 Kastrup, Danmark

EU/1/13/847

24.11.2014

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.11.2014 | Porcilis PCV M Hyo | Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated) | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/175 | Emulsion for injection | QI09AL | 11.11.2014 |

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

7.11.2014

Porcilis PCV M Hyo

Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/14/175

Emulsion for injection

QI09AL

11.11.2014

—   Modification of a marketing authorisation (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 | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.11.2014 | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | EU/2/09/101 | 11.11.2014 |
| 7.11.2014 | Zulvac 8 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/105 | 12.11.2014 |
| 7.11.2014 | Zulvac 8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/104 | 12.11.2014 |
| 28.11.2014 | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 2.12.2014 |
| 28.11.2014 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 2.12.2014 |

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

7.11.2014

Zolvix

Novartis Healthcare A/S

Edvard Thomsens Vej 14, DK-2300 København S, Danmark

EU/2/09/101

11.11.2014

7.11.2014

Zulvac 8 Bovis

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/105

12.11.2014

7.11.2014

Zulvac 8 Ovis

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/104

12.11.2014

28.11.2014

ProZinc

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

2.12.2014

28.11.2014

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

2.12.2014

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

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

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

---

| 30.12.2014 | EN | Official Journal of the European Union | C 467/11 |
| --- | --- | --- | --- |

30.12.2014

EN

Official Journal of the European Union

C 467/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2014/C 467/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.11.2014 | EMLA cream and associated names | See Annex I | See Annex I | See Annex I | 1.12.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

28.11.2014

EMLA cream and associated names

See Annex I

See Annex I

See Annex I

1.12.2014

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, and marketing authorisation holders in the Member States

| Member State
  in EEA | Marketing authorisation holder | (Invented) Name | INN | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH
  Schwarzenbergplatz 7
  A-1037 Wien
  Austria | Emla 5 % — Creme | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Ukkel
  Belgium | Emla 25 mg/25 mg crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Cyprus | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla Cream 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Czech Republic | AstraZeneca UK Limited
  2 Kingdom Street
  W2 6BD London
  United Kingdom | Emla krém 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Finland | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| France | ASTRAZENECA
  1, place Renault
  92844 Rueil Malmaison Cedex FRANCE | EMLA 5 POUR CENT, crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Germany | AstraZeneca GmbH
  Tinsdaler Weg 183
  22876 Wedel
  Germany | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Greece | AstraZeneca S.A.
  4, Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens
  Greece | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | EMLA 5 % w/w Cream | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via Francesco Sforza — Basiglio (Milano) 20080
  Italy | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Latvia | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla 5 % krēms | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Luxembourg | NV AstraZeneca SA
  Rue Egide Van Ophem 110
  1180 Bruxelles
  Belgium | Emla 25 mg/25 mg crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Malta | AstraZeneca AB, Gartunavagen
  S-151 85 Sodertalje
  Sweden | EMLA 5 % w/w Cream | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Norway | AstraZeneca AS
  Postboks 6050 Etterstad
  0601 OSLO
  Norway | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Poland | AstraZeneca AB
  Sodertalje 151 85 Gartunavagen
  Sweden | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Portugal | AstraZeneca Produtos
  Farmacêuticos, Lda.
  Rua Humberto Madeira 7
  — Queluz de Baixo
  Barcarena 2730-097
  Portugal | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Spain | ASTRAZENECA FARMACEUTICA SPAIN, S.A.
  Serrano Galvache 56
  Edificio Roble
  28033 Madrid
  Spain | EMLA 25 mg/g + 25 mg/g crema | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| The Netherlands | AstraZeneca B.V.
  Louis Pasteurlaan 5
  2719 EE ZOETERMEER
  The Netherlands | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream; hydrophilic | cutaneous use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Emla Cream 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |

Member State

in EEA

Marketing authorisation holder

(Invented) Name

INN

Strength

Pharmaceutical form

Route of administration

Austria

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Emla 5 % — Creme

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Ukkel

Belgium

Emla 25 mg/25 mg crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Cyprus

AstraZeneca AB

151 85 Södertälje

Sweden

Emla Cream 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Czech Republic

AstraZeneca UK Limited

2 Kingdom Street

W2 6BD London

United Kingdom

Emla krém 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Finland

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

France

ASTRAZENECA

1, place Renault

92844 Rueil Malmaison Cedex FRANCE

EMLA 5 POUR CENT, crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Germany

AstraZeneca GmbH

Tinsdaler Weg 183

22876 Wedel

Germany

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Greece

AstraZeneca S.A.

4, Theotokopoulou & Astronafton str

151 25 Maroussi

Athens

Greece

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

EMLA 5 % w/w Cream

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza — Basiglio (Milano) 20080

Italy

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Latvia

AstraZeneca AB

151 85 Södertälje

Sweden

Emla 5 % krēms

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Luxembourg

NV AstraZeneca SA

Rue Egide Van Ophem 110

1180 Bruxelles

Belgium

Emla 25 mg/25 mg crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Malta

AstraZeneca AB, Gartunavagen

S-151 85 Sodertalje

Sweden

EMLA 5 % w/w Cream

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Norway

AstraZeneca AS

Postboks 6050 Etterstad

0601 OSLO

Norway

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Poland

AstraZeneca AB

Sodertalje 151 85 Gartunavagen

Sweden

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Portugal

AstraZeneca Produtos

Farmacêuticos, Lda.

Rua Humberto Madeira 7

— Queluz de Baixo

Barcarena 2730-097

Portugal

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Spain

ASTRAZENECA FARMACEUTICA SPAIN, S.A.

Serrano Galvache 56

Edificio Roble

28033 Madrid

Spain

EMLA 25 mg/g + 25 mg/g crema

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

The Netherlands

AstraZeneca B.V.

Louis Pasteurlaan 5

2719 EE ZOETERMEER

The Netherlands

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream; hydrophilic

cutaneous use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Emla Cream 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

---