# Službeni list C 467/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 467 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 57.30. prosinca 2014. |

ISSN 1977-1088

Službeni list

Europske unije

C 467

Hrvatsko izdanje

Informacije i objave

Svezak 57.30. prosinca 2014.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2014/C 467/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2014/C 467/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC) | 11 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2014/C 467/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2014/C 467/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC)

11

| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.12.2014 | HR | Službeni list Europske unije | C 467/1 |
| --- | --- | --- | --- |

30.12.2014

HR

Službeni list Europske unije

C 467/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2014/C 467/01)

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.11.2014. | Harvoni | ledipasvir/sofosbuvir | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | Filmom obložena tableta | Pending | 18.11.2014. |
| 19.11.2014. | Brimica Genuair | aklidinijeva bromide/formoterol fumarat dihidrat | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/963 | Prašak inhalata | R03AL05 | 21.11.2014. |
| 19.11.2014. | Budesonide/Formoterol Teva | budezonid/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/948 | Prašak inhalata | R03AK07 | 24.11.2014. |
| 19.11.2014. | Budesonide/Formoterol Teva Pharma B.V. | budezonid/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/950 | Prašak inhalata | R03AK07 | 21.11.2014. |
| 19.11.2014. | Duaklir Genuair | aklidinijeva bromide/formoterol fumarat dihidrat | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/964 | Prašak inhalata | R03AL05 | 21.11.2014. |
| 19.11.2014. | Ketoconazole HRA | ketokonazol | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | Tableta | 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 | Set za pripravu radiofarmaceutika | V09IA09 | 21.11.2014. |
| 19.11.2014. | REZOLSTA | DARUNAVIR/KOBICISTAT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | Filmom obložena tableta | J05AR14 | 21.11.2014. |
| 19.11.2014. | Vylaer Spiromax | budezonid/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/949 | Prašak inhalata | 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 | Filmom obložena tableta | G04BE08 | 25.11.2014. |
| 21.11.2014. | Trulicity | dulaglutid | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/956 | Otopina za injekciju | 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 | Kapsula, meka | Pending | 25.11.2014. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

17.11.2014.

Harvoni

ledipasvir/sofosbuvir

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

Filmom obložena tableta

Pending

18.11.2014.

19.11.2014.

Brimica Genuair

aklidinijeva bromide/formoterol fumarat dihidrat

Almirall, S.A.

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

EU/1/14/963

Prašak inhalata

R03AL05

21.11.2014.

19.11.2014.

Budesonide/Formoterol Teva

budezonid/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/948

Prašak inhalata

R03AK07

24.11.2014.

19.11.2014.

Budesonide/Formoterol Teva Pharma B.V.

budezonid/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/950

Prašak inhalata

R03AK07

21.11.2014.

19.11.2014.

Duaklir Genuair

aklidinijeva bromide/formoterol fumarat dihidrat

Almirall, S.A.

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

EU/1/14/964

Prašak inhalata

R03AL05

21.11.2014.

19.11.2014.

Ketoconazole HRA

ketokonazol

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

Tableta

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

Set za pripravu radiofarmaceutika

V09IA09

21.11.2014.

19.11.2014.

REZOLSTA

DARUNAVIR/KOBICISTAT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

Filmom obložena tableta

J05AR14

21.11.2014.

19.11.2014.

Vylaer Spiromax

budezonid/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/949

Prašak inhalata

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

Filmom obložena tableta

G04BE08

25.11.2014.

21.11.2014.

Trulicity

dulaglutid

Eli Lilly Nederland B.V.

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

EU/1/14/956

Otopina za injekciju

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

Kapsula, meka

Pending

25.11.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

—   Obustava odobrenja za stavljanje u promet (članak 20 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 19.11.2014. | MACI | Aastrom Biosciences DK ApS
  Oliefabriksvej 45, 2770 Kastrup, Danmark | EU/1/13/847 | 24.11.2014. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

19.11.2014.

MACI

Aastrom Biosciences DK ApS

Oliefabriksvej 45, 2770 Kastrup, Danmark

EU/1/13/847

24.11.2014.

—   Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (2)): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.11.2014. | Porcilis PCV M Hyo | Cjepivo protiv svinjskog cirkovirusa i bakterije Mycoplasma hyopneumoniae (inaktivirano) | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/175 | Emulzija za injekciju | QI09AL | 11.11.2014. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

7.11.2014.

Porcilis PCV M Hyo

Cjepivo protiv svinjskog cirkovirusa i bakterije Mycoplasma hyopneumoniae (inaktivirano)

Intervet International B.V.

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

EU/2/14/175

Emulzija za injekciju

QI09AL

11.11.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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)  SL L 136, 30.4.2004, str. 1.

(2)  SL L 136, 30.4.2004, str. 1.

---

| 30.12.2014 | HR | Službeni list Europske unije | C 467/11 |
| --- | --- | --- | --- |

30.12.2014

HR

Službeni list Europske unije

C 467/11

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenog 2014. do 30. studenog 2014.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC (1) ili člankom 38. Direktive 2001/82/EC (2))

(2014/C 467/02)

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 28.11.2014. | EMLA cream and associated names | Vidi Prilog I. | Vidi Prilog I. | Vidi Prilog I. | 1.12.2014. |

Datum odluke

Naziv(i) lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

28.11.2014.

EMLA cream and associated names

Vidi Prilog I.

Vidi Prilog I.

Vidi Prilog I.

1.12.2014.

---

(1)  SL L 311, 28.11.2001, str. 67.

(2)  SL L 311, 28.11.2001, str. 1.

---

PRILOG I.

Popis naziva, farmaceutskih oblika, jačina lijeka, puteva primjene, nositelja odobrenja u državama članicama

| Država članica
  EGP | Nositelj odobrenja | (Zaštićeno) ime | INN | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | AstraZeneca Österreich GmbH
  Schwarzenbergplatz 7
  A-1037 Wien
  Austria | Emla 5 % – Creme | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Belgija | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Ukkel
  Belgium | Emla 25 mg/25 mg crème | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Cipar | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla Cream 5 % | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Češka Republika | AstraZeneca UK Limited
  2 Kingdom Street
  W2 6BD London
  United Kingdom | Emla krém 5 % | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Danska | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Finska | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Francuska | ASTRAZENECA
  1, place Renault
  92844 Rueil Malmaison Cedex FRANCE | EMLA 5 POUR CENT, crème | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Njemačka | AstraZeneca GmbH
  Tinsdaler Weg 183
  22876 Wedel
  Germany | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Grčka | AstraZeneca S.A.
  4, Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens
  Greece | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Island | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Irska | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | EMLA 5 % w/w Cream | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Italija | AstraZeneca S.p.A.
  Palazzo Volta
  Via Francesco Sforza – Basiglio (Milano) 20080
  Italy | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Latvija | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla 5 % krēms | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Luksemburg | NV AstraZeneca SA
  Rue Egide Van Ophem 110
  1180 Bruxelles
  Belgium | Emla 25 mg/25 mg crème | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Malta | AstraZeneca AB, Gartunavagen
  S-151 85 Sodertalje
  Sweden | EMLA 5 % w/w Cream | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Norveška | AstraZeneca AS
  Postboks 6050 Etterstad
  0601 Oslo
  Norway | Emla | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Poljska | AstraZeneca AB
  Sodertalje 151 85 Gartunavagen
  Sweden | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Portugal | AstraZeneca Produtos
  Farmacêuticos, Lda.
  Rua Humberto Madeira 7 –
  Queluz de Baixo
  Barcarena 2730-097
  Portugal | Emla | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Španjolska | ASTRAZENECA FARMACEUTICA SPAIN, S.A.
  Serrano Galvache 56
  Edificio Roble
  28033 Madrid
  Spain | EMLA 25 mg/g + 25 mg/g crema | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Švedska | AstraZeneca AB
  151 85 Södertälje
  Sweden | EMLA | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |
| Nizozemska | AstraZeneca B.V.
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Emla | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema; hidrofilna | Za kožu |
| Velika Britanija | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Emla Cream 5 % | lidokain
  prilokain | 25 mg/g
  25 mg/g | krema | Za kožu |

Država članica

EGP

Nositelj odobrenja

(Zaštićeno) ime

INN

Jačina

Farmaceutski oblik

Put primjene

Austrija

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Emla 5 % – Creme

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Belgija

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Ukkel

Belgium

Emla 25 mg/25 mg crème

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Cipar

AstraZeneca AB

151 85 Södertälje

Sweden

Emla Cream 5 %

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Češka Republika

AstraZeneca UK Limited

2 Kingdom Street

W2 6BD London

United Kingdom

Emla krém 5 %

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Danska

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Finska

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Francuska

ASTRAZENECA

1, place Renault

92844 Rueil Malmaison Cedex FRANCE

EMLA 5 POUR CENT, crème

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Njemačka

AstraZeneca GmbH

Tinsdaler Weg 183

22876 Wedel

Germany

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Grčka

AstraZeneca S.A.

4, Theotokopoulou & Astronafton str

151 25 Maroussi

Athens

Greece

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Island

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Irska

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

EMLA 5 % w/w Cream

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Italija

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza – Basiglio (Milano) 20080

Italy

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Latvija

AstraZeneca AB

151 85 Södertälje

Sweden

Emla 5 % krēms

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Luksemburg

NV AstraZeneca SA

Rue Egide Van Ophem 110

1180 Bruxelles

Belgium

Emla 25 mg/25 mg crème

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Malta

AstraZeneca AB, Gartunavagen

S-151 85 Sodertalje

Sweden

EMLA 5 % w/w Cream

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Norveška

AstraZeneca AS

Postboks 6050 Etterstad

0601 Oslo

Norway

Emla

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Poljska

AstraZeneca AB

Sodertalje 151 85 Gartunavagen

Sweden

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Portugal

AstraZeneca Produtos

Farmacêuticos, Lda.

Rua Humberto Madeira 7 –

Queluz de Baixo

Barcarena 2730-097

Portugal

Emla

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Španjolska

ASTRAZENECA FARMACEUTICA SPAIN, S.A.

Serrano Galvache 56

Edificio Roble

28033 Madrid

Spain

EMLA 25 mg/g + 25 mg/g crema

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Švedska

AstraZeneca AB

151 85 Södertälje

Sweden

EMLA

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

Nizozemska

AstraZeneca B.V.

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Emla

lidokain

prilokain

25 mg/g

25 mg/g

krema; hidrofilna

Za kožu

Velika Britanija

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Emla Cream 5 %

lidokain

prilokain

25 mg/g

25 mg/g

krema

Za kožu

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