# Službeni list C 439/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 439 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 58.30. prosinca 2015. |

ISSN 1977-1088

Službeni list

Europske unije

C 439

Hrvatsko izdanje

Informacije i objave

Svezak 58.30. prosinca 2015.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2015/C 439/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2015/C 439/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 12 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2015/C 439/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.(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

2015/C 439/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

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

12

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.12.2015 | HR | Službeni list Europske unije | C 439/1 |
| --- | --- | --- | --- |

30.12.2015

HR

Službeni list Europske unije

C 439/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.

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

(2015/C 439/01)

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

| Datum odluke | Naziv lijeka | INN (međunarodni 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.11.2015. | Edistride | dapagliflozina | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1052 | Filmom obložena tableta | A10BX09 | 12.11.2015. |
| 11.11.2015. | Obizur | Susoktokog alfa | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | EU/1/15/1035 | Prašak i otapalo za otopinu za injekciju | B02BD14 | 13.11.2015. |
| 16.11.2015. | Aripiprazole Accord | aripiprazol | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1045 | Tableta | N05AX12 | 19.11.2015. |
| 16.11.2015. | Ebymect | dapagliflozina/metformin | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1051 | Filmom obložena tableta | A10BD15 | 18.11.2015. |
| 16.11.2015. | Votubia | Everolimus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | Tableta | L01XE10 | 23.11.2015. |
| 19.11.2015. | Cinacalcet Mylan | sinakalcet | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1054 | Filmom obložena tableta | H05BX01 | 23.11.2015. |
| 19.11.2015. | Elocta | efmoroktokog alfa (efmoroctocog alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/15/1046 | Prašak i otapalo za otopinu za injekciju | Pending | 23.11.2015. |
| 19.11.2015. | Entresto | sakubitril/valsartan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | Filmom obložena tableta | C09DX04 | 23.11.2015. |
| 19.11.2015. | Genvoya | elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | Filmom obložena tableta | J05AR18 | 23.11.2015. |
| 19.11.2015. | IONSYS | fentanil | Incline Therapeutics Europe Ltd
  21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom | EU/1/15/1050 | Transdermalni sustav | N02AB03 | 23.11.2015. |
| 19.11.2015. | Kyprolis | karfilzomib | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | Prašak za otopinu za infuziju | L01XX45 | 23.11.2015. |
| 19.11.2015. | Numient | levodope/karbidope | Impax Laboratories (Netherlands) BV
  WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland | EU/1/15/1044 | Kapsula s prilagođenim oslobađanjem, tvrda | N04BA02 | 23.11.2015. |
| 19.11.2015. | Orkambi | Lumakaftor/ivakaftor | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | Filmom obložena tableta | R07AX30 | 24.11.2015. |
| 20.11.2015. | Cotellic | kobimetinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | Filmom obložena tableta | Pending | 24.11.2015. |
| 20.11.2015. | Kolbam | Kolatna kiselina | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | EU/1/13/895 | Kapsula, tvrda | A05AA03 | 24.11.2015. |
| 20.11.2015. | Pemetrexed Hospira | pemetreksed | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/15/1057 | Prašak za koncentrat za otopinu za infuziju | L01BA04 | 24.11.2015. |
| 20.11.2015. | Praxbind | idarucizumab | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | Prašak i otapalo za otopinu za injekciju/infuziju | V03AB | 24.11.2015. |
| 23.11.2015. | Blincyto | blinatumomab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | Prašak za koncentrat za otopinu za infuziju | L01XC19 | 25.11.2015. |
| 27.11.2015. | Pemetrexed medac | Pemetreksed | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/15/1038 | Prašak za koncentrat za otopinu za infuziju | L01BA04 | 1.12.2015. |
| 27.11.2015. | Ravicti | Glicerolfenilbutirat | Horizon Therapeutics Limited
  90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom | EU/1/15/1062 | Oralna tekućina | A16AX09 | 1.12.2015. |

Datum odluke

Naziv lijeka

INN (međunarodni 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

9.11.2015.

Edistride

dapagliflozina

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1052

Filmom obložena tableta

A10BX09

12.11.2015.

11.11.2015.

Obizur

Susoktokog alfa

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

EU/1/15/1035

Prašak i otapalo za otopinu za injekciju

B02BD14

13.11.2015.

16.11.2015.

Aripiprazole Accord

aripiprazol

Accord Healthcare Limited

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

EU/1/15/1045

Tableta

N05AX12

19.11.2015.

16.11.2015.

Ebymect

dapagliflozina/metformin

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1051

Filmom obložena tableta

A10BD15

18.11.2015.

16.11.2015.

Votubia

Everolimus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

Tableta

L01XE10

23.11.2015.

19.11.2015.

Cinacalcet Mylan

sinakalcet

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/15/1054

Filmom obložena tableta

H05BX01

23.11.2015.

19.11.2015.

Elocta

efmoroktokog alfa (efmoroctocog alfa)

Biogen Idec Limited

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

EU/1/15/1046

Prašak i otapalo za otopinu za injekciju

Pending

23.11.2015.

19.11.2015.

Entresto

sakubitril/valsartan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

Filmom obložena tableta

C09DX04

23.11.2015.

19.11.2015.

Genvoya

elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

Filmom obložena tableta

J05AR18

23.11.2015.

19.11.2015.

IONSYS

fentanil

Incline Therapeutics Europe Ltd

21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom

EU/1/15/1050

Transdermalni sustav

N02AB03

23.11.2015.

19.11.2015.

Kyprolis

karfilzomib

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

Prašak za otopinu za infuziju

L01XX45

23.11.2015.

19.11.2015.

Numient

levodope/karbidope

Impax Laboratories (Netherlands) BV

WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland

EU/1/15/1044

Kapsula s prilagođenim oslobađanjem, tvrda

N04BA02

23.11.2015.

19.11.2015.

Orkambi

Lumakaftor/ivakaftor

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

Filmom obložena tableta

R07AX30

24.11.2015.

20.11.2015.

Cotellic

kobimetinib

Roche Registration Limited

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

EU/1/15/1048

Filmom obložena tableta

Pending

24.11.2015.

20.11.2015.

Kolbam

Kolatna kiselina

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

EU/1/13/895

Kapsula, tvrda

A05AA03

24.11.2015.

20.11.2015.

Pemetrexed Hospira

pemetreksed

Hospira UK Limited

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

EU/1/15/1057

Prašak za koncentrat za otopinu za infuziju

L01BA04

24.11.2015.

20.11.2015.

Praxbind

idarucizumab

Boehringer Ingelheim International GmbH

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

EU/1/15/1056

Prašak i otapalo za otopinu za injekciju/infuziju

V03AB

24.11.2015.

23.11.2015.

Blincyto

blinatumomab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

Prašak za koncentrat za otopinu za infuziju

L01XC19

25.11.2015.

27.11.2015.

Pemetrexed medac

Pemetreksed

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/15/1038

Prašak za koncentrat za otopinu za infuziju

L01BA04

1.12.2015.

27.11.2015.

Ravicti

Glicerolfenilbutirat

Horizon Therapeutics Limited

90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom

EU/1/15/1062

Oralna tekućina

A16AX09

1.12.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 3.11.2015. | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/718 | 5.11.2015. |
| 3.11.2015. | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 5.11.2015. |
| 6.11.2015. | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 10.11.2015. |
| 6.11.2015. | Vedrop | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/09/533 | 10.11.2015. |
| 10.11.2015. | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 12.11.2015. |
| 11.11.2015. | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185 | 13.11.2015. |
| 11.11.2015. | Comtan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/081 | 13.11.2015. |
| 11.11.2015. | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 13.11.2015. |
| 11.11.2015. | Revestive | NPS Pharma Holdings Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 13.11.2015. |
| 11.11.2015. | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 13.11.2015. |
| 16.11.2015. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 18.11.2015. |
| 16.11.2015. | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 19.11.2015. |
| 16.11.2015. | Suboxone | Indivior UK Limited
  103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom | EU/1/06/359 | 18.11.2015. |
| 19.11.2015. | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 23.11.2015. |
| 19.11.2015. | Alimta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/290 | 23.11.2015. |
| 19.11.2015. | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/02/246 | 23.11.2015. |
| 19.11.2015. | Colobreathe | Forest Laboratories UK Ltd.
  Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom | EU/1/11/747 | 23.11.2015. |
| 19.11.2015. | Cosentyx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/980 | 23.11.2015. |
| 19.11.2015. | Cubicin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/328 | 23.11.2015. |
| 19.11.2015. | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/06/379 | 23.11.2015. |
| 19.11.2015. | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 23.11.2015. |
| 19.11.2015. | Exelon | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/066 | 23.11.2015. |
| 19.11.2015. | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 23.11.2015. |
| 19.11.2015. | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 23.11.2015. |
| 19.11.2015. | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 23.11.2015. |
| 19.11.2015. | Ifirmacombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 23.11.2015. |
| 19.11.2015. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 23.11.2015. |
| 19.11.2015. | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 23.11.2015. |
| 19.11.2015. | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/11/676 | 23.11.2015. |
| 19.11.2015. | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 23.11.2015. |
| 19.11.2015. | Lamivudine/Zidovudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/663 | 23.11.2015. |
| 19.11.2015. | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/05/325 | 24.11.2015. |
| 19.11.2015. | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 23.11.2015. |
| 19.11.2015. | NovoNorm | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/98/076 | 23.11.2015. |
| 19.11.2015. | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 23.11.2015. |
| 19.11.2015. | Prandin | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/162 | 23.11.2015. |
| 19.11.2015. | Prometax | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/092 | 23.11.2015. |
| 19.11.2015. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 23.11.2015. |
| 19.11.2015. | Simulect | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/084 | 23.11.2015. |
| 19.11.2015. | Teysuno | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/11/669 | 23.11.2015. |
| 19.11.2015. | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 23.11.2015. |
| 19.11.2015. | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 23.11.2015. |
| 19.11.2015. | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/08/499 | 23.11.2015. |
| 19.11.2015. | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212 | 23.11.2015. |
| 19.11.2015. | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 23.11.2015. |
| 19.11.2015. | Xenical | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/071 | 23.11.2015. |
| 20.11.2015. | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 24.11.2015. |
| 20.11.2015. | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 25.11.2015. |
| 23.11.2015. | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 25.11.2015. |
| 23.11.2015. | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 25.11.2015. |
| 23.11.2015. | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 25.11.2015. |
| 23.11.2015. | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 25.11.2015. |
| 23.11.2015. | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 25.11.2015. |
| 27.11.2015. | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 1.12.2015. |
| 27.11.2015. | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 1.12.2015. |
| 27.11.2015. | Pandemic influenza vaccine H5N1 BAXTER | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/09/571 | 1.12.2015. |
| 27.11.2015. | Quinsair | Raptor Pharmaceuticals Europe BV
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/14/973 | 1.12.2015. |
| 27.11.2015. | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/01/171 | 2.12.2015. |
| 27.11.2015. | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 1.12.2015. |
| 27.11.2015. | Rivastigmine HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/09/589 | 30.11.2015. |
| 27.11.2015. | Rivastigmine Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/09/599 | 2.12.2015. |
| 27.11.2015. | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 1.12.2015. |
| 30.11.2015. | Celvapan | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/08/506 | 2.12.2015. |
| 30.11.2015. | Rivastigmine 1 A Pharma | 1 A Pharma GmbH
  Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | EU/1/09/585 | 2.12.2015. |
| 30.11.2015. | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/12/752 | 2.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.11.2015.

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/718

5.11.2015.

3.11.2015.

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

5.11.2015.

6.11.2015.

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

10.11.2015.

6.11.2015.

Vedrop

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/09/533

10.11.2015.

10.11.2015.

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

12.11.2015.

11.11.2015.

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

13.11.2015.

11.11.2015.

Comtan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/081

13.11.2015.

11.11.2015.

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

13.11.2015.

11.11.2015.

Revestive

NPS Pharma Holdings Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

13.11.2015.

11.11.2015.

Ristfor

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620

13.11.2015.

16.11.2015.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

18.11.2015.

16.11.2015.

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

19.11.2015.

16.11.2015.

Suboxone

Indivior UK Limited

103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom

EU/1/06/359

18.11.2015.

19.11.2015.

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

23.11.2015.

19.11.2015.

Alimta

Eli Lilly Nederland B.V.

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

EU/1/04/290

23.11.2015.

19.11.2015.

Carbaglu

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/02/246

23.11.2015.

19.11.2015.

Colobreathe

Forest Laboratories UK Ltd.

Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom

EU/1/11/747

23.11.2015.

19.11.2015.

Cosentyx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/980

23.11.2015.

19.11.2015.

Cubicin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/328

23.11.2015.

19.11.2015.

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/06/379

23.11.2015.

19.11.2015.

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

23.11.2015.

19.11.2015.

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/066

23.11.2015.

19.11.2015.

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

23.11.2015.

19.11.2015.

HALAVEN

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

23.11.2015.

19.11.2015.

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

23.11.2015.

19.11.2015.

Ifirmacombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

23.11.2015.

19.11.2015.

Imnovid

Celgene Europe Limited

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

EU/1/13/850

23.11.2015.

19.11.2015.

Isentress

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/436

23.11.2015.

19.11.2015.

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/11/676

23.11.2015.

19.11.2015.

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

23.11.2015.

19.11.2015.

Lamivudine/Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

23.11.2015.

19.11.2015.

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/05/325

24.11.2015.

19.11.2015.

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

23.11.2015.

19.11.2015.

NovoNorm

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/98/076

23.11.2015.

19.11.2015.

Optimark

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland

EU/1/07/398

23.11.2015.

19.11.2015.

Prandin

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/162

23.11.2015.

19.11.2015.

Prometax

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/092

23.11.2015.

19.11.2015.

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/462

23.11.2015.

19.11.2015.

Simulect

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/084

23.11.2015.

19.11.2015.

Teysuno

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/11/669

23.11.2015.

19.11.2015.

Thalidomide Celgene

Celgene Europe Limited

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

EU/1/08/443

23.11.2015.

19.11.2015.

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

23.11.2015.

19.11.2015.

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/08/499

23.11.2015.

19.11.2015.

Vfend

Pfizer Limited

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

EU/1/02/212

23.11.2015.

19.11.2015.

XALKORI

Pfizer Limited

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

EU/1/12/793

23.11.2015.

19.11.2015.

Xenical

Roche Registration Limited

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

EU/1/98/071

23.11.2015.

20.11.2015.

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

24.11.2015.

20.11.2015.

Volibris

Glaxo Group Ltd

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

EU/1/08/451

25.11.2015.

23.11.2015.

alli

Glaxo Group Ltd

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

EU/1/07/401

25.11.2015.

23.11.2015.

Bosulif

Pfizer Limited

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

EU/1/13/818

25.11.2015.

23.11.2015.

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

25.11.2015.

23.11.2015.

XALKORI

Pfizer Limited

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

EU/1/12/793

25.11.2015.

23.11.2015.

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

25.11.2015.

27.11.2015.

CellCept

Roche Registration Limited

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

EU/1/96/005

1.12.2015.

27.11.2015.

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

1.12.2015.

27.11.2015.

Pandemic influenza vaccine H5N1 BAXTER

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/09/571

1.12.2015.

27.11.2015.

Quinsair

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/14/973

1.12.2015.

27.11.2015.

Rapamune

Pfizer Limited

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

EU/1/01/171

2.12.2015.

27.11.2015.

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

1.12.2015.

27.11.2015.

Rivastigmine HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

30.11.2015.

27.11.2015.

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/09/599

2.12.2015.

27.11.2015.

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

1.12.2015.

30.11.2015.

Celvapan

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/08/506

2.12.2015.

30.11.2015.

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

EU/1/09/585

2.12.2015.

30.11.2015.

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/12/752

2.12.2015.

—   Povlačenje odobrenja za stavljanje u promet (članak 13. 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 |
| --- | --- | --- | --- | --- |
| 30.11.2015. | Nivolumab BMS | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1026 | 2.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

30.11.2015.

Nivolumab BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1026

2.12.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 20.11.2015. | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 24.11.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

20.11.2015.

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

24.11.2015.

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

| Datum odluke | Naziv lijeka | INN (međunarodni 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.11.2015. | Simparica | sarolaner | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | Tablete za žvakanje | QP53BX06 | 10.11.2015. |
| 6.11.2015. | Suvaxyn Circo + MH RTU | Cjepivo protiv cirkovirusne infekcije i enzootske upale pluća svinja (inaktivirano). | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/190 | Emulzija za injekciju | QI09AL | 10.11.2015. |
| 6.11.2015. | Zycortal | dezoksikorton | Dechra Limited
  Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom | EU/2/15/189 | Suspenzija za injekciju | QH02AA03 | 10.11.2015. |

Datum odluke

Naziv lijeka

INN (međunarodni 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

6.11.2015.

Simparica

sarolaner

Zoetis Belgium S.A.

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

EU/2/15/191

Tablete za žvakanje

QP53BX06

10.11.2015.

6.11.2015.

Suvaxyn Circo + MH RTU

Cjepivo protiv cirkovirusne infekcije i enzootske upale pluća svinja (inaktivirano).

Zoetis Belgium S.A.

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

EU/2/15/190

Emulzija za injekciju

QI09AL

10.11.2015.

6.11.2015.

Zycortal

dezoksikorton

Dechra Limited

Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom

EU/2/15/189

Suspenzija za injekciju

QH02AA03

10.11.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 6.11.2015. | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/10/114 | 10.11.2015. |
| 9.11.2015. | Nobivac Bb | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/02/034 | 11.11.2015. |
| 19.11.2015. | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | EU/2/09/101 | 23.11.2015. |
| 20.11.2015. | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/09/097 | 24.11.2015. |
| 27.11.2015. | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/09/096 | 1.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.11.2015.

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/10/114

10.11.2015.

9.11.2015.

Nobivac Bb

Intervet International B.V.

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

EU/2/02/034

11.11.2015.

19.11.2015.

Zolvix

Novartis Healthcare A/S

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

EU/2/09/101

23.11.2015.

20.11.2015.

Leucofeligen FeLV/RCP

Virbac

1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France

EU/2/09/097

24.11.2015.

27.11.2015.

Leucogen

Virbac

1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France

EU/2/09/096

1.12.2015.

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK – LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK – LONDON E14 4H

---

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

---

| 30.12.2015 | HR | Službeni list Europske unije | C 439/12 |
| --- | --- | --- | --- |

30.12.2015

HR

Službeni list Europske unije

C 439/12

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2015. do 30. studenoga 2015.

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

(2015/C 439/02)

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

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 27.11.2015. | Repaglinide | repaglinide | Nije primjenjivo | Nije primjenjivo | 30.11.2015. |
| 23.11.2015. | Orlistat | Orlistat | Nije primjenjivo | Nije primjenjivo | 24.11.2015. |
| 20.11.2015. | Rivastigmine | Rivastigmine | Nije primjenjivo | Nije primjenjivo | 24.11.2015. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

27.11.2015.

Repaglinide

repaglinide

Nije primjenjivo

Nije primjenjivo

30.11.2015.

23.11.2015.

Orlistat

Orlistat

Nije primjenjivo

Nije primjenjivo

24.11.2015.

20.11.2015.

Rivastigmine

Rivastigmine

Nije primjenjivo

Nije primjenjivo

24.11.2015.

---

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

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

---