# Europos Sąjungos C 439/2015

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 439 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 58 tomas2015m. gruodžio 30d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 439

Leidimas lietuvių kalba

Informacija ir pranešimai

58 tomas2015m. gruodžio 30d.

---

| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2015/C 439/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |
| 2015/C 439/02 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį) | 12 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2015/C 439/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

2015/C 439/02

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

12

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 30.12.2015 | LT | Europos Sąjungos oficialusis leidinys | C 439/1 |
| --- | --- | --- | --- |

30.12.2015

LT

Europos Sąjungos oficialusis leidinys

C 439/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)

(2015/C 439/01)

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2015 11 9 | Edistride | dapagliflozinas | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/15/1052 | Plėvele dengta tabletė | A10BX09 | 2015 11 12 |
| 2015 11 11 | Obizur | Susoktokogas alfa | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | ES/1/15/1035 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD14 | 2015 11 13 |
| 2015 11 16 | Aripiprazole Accord | aripiprazolas | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/15/1045 | Tabletės | N05AX12 | 2015 11 19 |
| 2015 11 16 | Ebymect | dapagliflozinas/metformīna | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/15/1051 | Plėvele dengta tabletė | A10BD15 | 2015 11 18 |
| 2015 11 16 | Votubia | Everolimuzas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/11/710 | Tabletės | L01XE10 | 2015 11 23 |
| 2015 11 19 | Cinacalcet Mylan | cinakalcetas | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | ES/1/15/1054 | Plėvele dengta tabletė | H05BX01 | 2015 11 23 |
| 2015 11 19 | Elocta | efmoroktokogo alfa (efmoroctocogum alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | ES/1/15/1046 | Milteliai ir tirpiklis injekciniam tirpalui | Pending | 2015 11 23 |
| 2015 11 19 | Entresto | sakubitrilas/valsartanas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/15/1058 | Plėvele dengta tabletė | C09DX04 | 2015 11 23 |
| 2015 11 19 | Genvoya | elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/15/1061 | Plėvele dengta tabletė | J05AR18 | 2015 11 23 |
| 2015 11 19 | IONSYS | fentanilis | Incline Therapeutics Europe Ltd
  21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom | ES/1/15/1050 | Transderminė sistema | N02AB03 | 2015 11 23 |
| 2015 11 19 | Kyprolis | karfilzomibas | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | ES/1/15/1060 | Milteliai infuziniam tirpalui | L01XX45 | 2015 11 23 |
| 2015 11 19 | Numient | levodopos/karbidopos | Impax Laboratories (Netherlands) BV
  WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland | ES/1/15/1044 | Modifikuoto atpalaidavimo kietosios kapsulė | N04BA02 | 2015 11 23 |
| 2015 11 19 | Orkambi | Lumakaftoras/ivakaftoras | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | ES/1/15/1059 | Plėvele dengta tabletė | R07AX30 | 2015 11 24 |
| 2015 11 20 | Cotellic | kobimetinibas | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/15/1048 | Plėvele dengta tabletė | Pending | 2015 11 24 |
| 2015 11 20 | Kolbam | Cholio rūgštis | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | ES/1/13/895 | Kieta kapsulė | A05AA03 | 2015 11 24 |
| 2015 11 20 | Pemetrexed Hospira | Pemetreksedas | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | ES/1/15/1057 | Milteliai koncentratui infuziniam tirpalui | L01BA04 | 2015 11 24 |
| 2015 11 20 | Praxbind | idarucizumabas | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/15/1056 | Milteliai ir tirpiklis injekciniam/infuziniam tirpalui | V03AB | 2015 11 24 |
| 2015 11 23 | Blincyto | Blinatumomabas | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | ES/1/15/1047 | Milteliai koncentratui infuziniam tirpalui | L01XC19 | 2015 11 25 |
| 2015 11 27 | Pemetrexed medac | Pemetreksedas | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | ES/1/15/1038 | Milteliai koncentratui infuziniam tirpalui | L01BA04 | 2015 12 1 |
| 2015 11 27 | Ravicti | Glicerolio fenilbutiratas | Horizon Therapeutics Limited
  90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom | ES/1/15/1062 | Geriamasis skystis | A16AX09 | 2015 12 1 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2015 11 9

Edistride

dapagliflozinas

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/15/1052

Plėvele dengta tabletė

A10BX09

2015 11 12

2015 11 11

Obizur

Susoktokogas alfa

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

ES/1/15/1035

Milteliai ir tirpiklis injekciniam tirpalui

B02BD14

2015 11 13

2015 11 16

Aripiprazole Accord

aripiprazolas

Accord Healthcare Limited

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

ES/1/15/1045

Tabletės

N05AX12

2015 11 19

2015 11 16

Ebymect

dapagliflozinas/metformīna

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/15/1051

Plėvele dengta tabletė

A10BD15

2015 11 18

2015 11 16

Votubia

Everolimuzas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/11/710

Tabletės

L01XE10

2015 11 23

2015 11 19

Cinacalcet Mylan

cinakalcetas

Mylan S.A.S

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

ES/1/15/1054

Plėvele dengta tabletė

H05BX01

2015 11 23

2015 11 19

Elocta

efmoroktokogo alfa (efmoroctocogum alfa)

Biogen Idec Limited

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

ES/1/15/1046

Milteliai ir tirpiklis injekciniam tirpalui

Pending

2015 11 23

2015 11 19

Entresto

sakubitrilas/valsartanas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/15/1058

Plėvele dengta tabletė

C09DX04

2015 11 23

2015 11 19

Genvoya

elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/15/1061

Plėvele dengta tabletė

J05AR18

2015 11 23

2015 11 19

IONSYS

fentanilis

Incline Therapeutics Europe Ltd

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

ES/1/15/1050

Transderminė sistema

N02AB03

2015 11 23

2015 11 19

Kyprolis

karfilzomibas

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

ES/1/15/1060

Milteliai infuziniam tirpalui

L01XX45

2015 11 23

2015 11 19

Numient

levodopos/karbidopos

Impax Laboratories (Netherlands) BV

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

ES/1/15/1044

Modifikuoto atpalaidavimo kietosios kapsulė

N04BA02

2015 11 23

2015 11 19

Orkambi

Lumakaftoras/ivakaftoras

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

ES/1/15/1059

Plėvele dengta tabletė

R07AX30

2015 11 24

2015 11 20

Cotellic

kobimetinibas

Roche Registration Limited

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

ES/1/15/1048

Plėvele dengta tabletė

Pending

2015 11 24

2015 11 20

Kolbam

Cholio rūgštis

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

ES/1/13/895

Kieta kapsulė

A05AA03

2015 11 24

2015 11 20

Pemetrexed Hospira

Pemetreksedas

Hospira UK Limited

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

ES/1/15/1057

Milteliai koncentratui infuziniam tirpalui

L01BA04

2015 11 24

2015 11 20

Praxbind

idarucizumabas

Boehringer Ingelheim International GmbH

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

ES/1/15/1056

Milteliai ir tirpiklis injekciniam/infuziniam tirpalui

V03AB

2015 11 24

2015 11 23

Blincyto

Blinatumomabas

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

ES/1/15/1047

Milteliai koncentratui infuziniam tirpalui

L01XC19

2015 11 25

2015 11 27

Pemetrexed medac

Pemetreksedas

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

ES/1/15/1038

Milteliai koncentratui infuziniam tirpalui

L01BA04

2015 12 1

2015 11 27

Ravicti

Glicerolio fenilbutiratas

Horizon Therapeutics Limited

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

ES/1/15/1062

Geriamasis skystis

A16AX09

2015 12 1

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 11 3 | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | ES/1/11/718 | 2015 11 5 |
| 2015 11 3 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | ES/1/03/255 | 2015 11 5 |
| 2015 11 6 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/13/886 | 2015 11 10 |
| 2015 11 6 | Vedrop | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | ES/1/09/533 | 2015 11 10 |
| 2015 11 10 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | ES/1/02/226 | 2015 11 12 |
| 2015 11 11 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | ES/1/01/185 | 2015 11 13 |
| 2015 11 11 | Comtan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/98/081 | 2015 11 13 |
| 2015 11 11 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | ES/1/08/497 | 2015 11 13 |
| 2015 11 11 | Revestive | NPS Pharma Holdings Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/12/787 | 2015 11 13 |
| 2015 11 11 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/10/620 | 2015 11 13 |
| 2015 11 16 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/13/845 | 2015 11 18 |
| 2015 11 16 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | ES/1/12/782 | 2015 11 19 |
| 2015 11 16 | Suboxone | Indivior UK Limited
  103–105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom | ES/1/06/359 | 2015 11 18 |
| 2015 11 19 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/12/794 | 2015 11 23 |
| 2015 11 19 | Alimta | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/04/290 | 2015 11 23 |
| 2015 11 19 | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | ES/1/02/246 | 2015 11 23 |
| 2015 11 19 | Colobreathe | Forest Laboratories UK Ltd.
  Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom | ES/1/11/747 | 2015 11 23 |
| 2015 11 19 | Cosentyx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/14/980 | 2015 11 23 |
| 2015 11 19 | Cubicin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/05/328 | 2015 11 23 |
| 2015 11 19 | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | ES/1/06/379 | 2015 11 23 |
| 2015 11 19 | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/10/665 | 2015 11 23 |
| 2015 11 19 | Exelon | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/98/066 | 2015 11 23 |
| 2015 11 19 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/11/677 | 2015 11 23 |
| 2015 11 19 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | ES/1/11/678 | 2015 11 23 |
| 2015 11 19 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | ES/1/03/256 | 2015 11 23 |
| 2015 11 19 | Ifirmacombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/11/673 | 2015 11 23 |
| 2015 11 19 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | ES/1/13/850 | 2015 11 23 |
| 2015 11 19 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/07/436 | 2015 11 23 |
| 2015 11 19 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | ES/1/11/676 | 2015 11 23 |
| 2015 11 19 | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | ES/1/12/810 | 2015 11 23 |
| 2015 11 19 | Lamivudine/Zidovudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/10/663 | 2015 11 23 |
| 2015 11 19 | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | ES/1/05/325 | 2015 11 24 |
| 2015 11 19 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | ES/1/13/904 | 2015 11 23 |
| 2015 11 19 | NovoNorm | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | ES/1/98/076 | 2015 11 23 |
| 2015 11 19 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | ES/1/07/398 | 2015 11 23 |
| 2015 11 19 | Prandin | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | ES/1/00/162 | 2015 11 23 |
| 2015 11 19 | Prometax | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/98/092 | 2015 11 23 |
| 2015 11 19 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/08/462 | 2015 11 23 |
| 2015 11 19 | Simulect | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/98/084 | 2015 11 23 |
| 2015 11 19 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | ES/1/11/669 | 2015 11 23 |
| 2015 11 19 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | ES/1/08/443 | 2015 11 23 |
| 2015 11 19 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | ES/1/08/498 | 2015 11 23 |
| 2015 11 19 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | ES/1/08/499 | 2015 11 23 |
| 2015 11 19 | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/02/212 | 2015 11 23 |
| 2015 11 19 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/12/793 | 2015 11 23 |
| 2015 11 19 | Xenical | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/98/071 | 2015 11 23 |
| 2015 11 20 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/11/736 | 2015 11 24 |
| 2015 11 20 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/08/451 | 2015 11 25 |
| 2015 11 23 | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/07/401 | 2015 11 25 |
| 2015 11 23 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/13/818 | 2015 11 25 |
| 2015 11 23 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/11/677 | 2015 11 25 |
| 2015 11 23 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/12/793 | 2015 11 25 |
| 2015 11 23 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | ES/1/11/671 | 2015 11 25 |
| 2015 11 27 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/96/005 | 2015 12 1 |
| 2015 11 27 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | ES/1/13/839 | 2015 12 1 |
| 2015 11 27 | Pandemic influenza vaccine H5N1 BAXTER | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | ES/1/09/571 | 2015 12 1 |
| 2015 11 27 | Quinsair | Raptor Pharmaceuticals Europe BV
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | ES/1/14/973 | 2015 12 1 |
| 2015 11 27 | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/01/171 | 2015 12 2 |
| 2015 11 27 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/14/929 | 2015 12 1 |
| 2015 11 27 | Rivastigmine HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | ES/1/09/589 | 2015 11 30 |
| 2015 11 27 | Rivastigmine Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | ES/1/09/599 | 2015 12 2 |
| 2015 11 27 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | ES/1/13/846 | 2015 12 1 |
| 2015 11 30 | Celvapan | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | ES/1/08/506 | 2015 12 2 |
| 2015 11 30 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH
  Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | ES/1/09/585 | 2015 12 2 |
| 2015 11 30 | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | ES/1/12/752 | 2015 12 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 11 3

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

ES/1/11/718

2015 11 5

2015 11 3

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

ES/1/03/255

2015 11 5

2015 11 6

Relvar Ellipta

Glaxo Group Ltd

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

ES/1/13/886

2015 11 10

2015 11 6

Vedrop

Orphan Europe S.A.R.L.

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

ES/1/09/533

2015 11 10

2015 11 10

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

ES/1/02/226

2015 11 12

2015 11 11

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

ES/1/01/185

2015 11 13

2015 11 11

Comtan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/98/081

2015 11 13

2015 11 11

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

ES/1/08/497

2015 11 13

2015 11 11

Revestive

NPS Pharma Holdings Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/12/787

2015 11 13

2015 11 11

Ristfor

Merck Sharp & Dohme Limited

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

ES/1/10/620

2015 11 13

2015 11 16

Imatinib Accord

Accord Healthcare Limited

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

ES/1/13/845

2015 11 18

2015 11 16

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

ES/1/12/782

2015 11 19

2015 11 16

Suboxone

Indivior UK Limited

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

ES/1/06/359

2015 11 18

2015 11 19

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/12/794

2015 11 23

2015 11 19

Alimta

Eli Lilly Nederland B.V.

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

ES/1/04/290

2015 11 23

2015 11 19

Carbaglu

Orphan Europe S.A.R.L.

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

ES/1/02/246

2015 11 23

2015 11 19

Colobreathe

Forest Laboratories UK Ltd.

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

ES/1/11/747

2015 11 23

2015 11 19

Cosentyx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/14/980

2015 11 23

2015 11 19

Cubicin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/05/328

2015 11 23

2015 11 19

Cystadane

Orphan Europe S.A.R.L.

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

ES/1/06/379

2015 11 23

2015 11 19

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/10/665

2015 11 23

2015 11 19

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/98/066

2015 11 23

2015 11 19

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/11/677

2015 11 23

2015 11 19

HALAVEN

Eisai Europe Limited

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

ES/1/11/678

2015 11 23

2015 11 19

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

ES/1/03/256

2015 11 23

2015 11 19

Ifirmacombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/11/673

2015 11 23

2015 11 19

Imnovid

Celgene Europe Limited

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

ES/1/13/850

2015 11 23

2015 11 19

Isentress

Merck Sharp & Dohme Limited

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

ES/1/07/436

2015 11 23

2015 11 19

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

ES/1/11/676

2015 11 23

2015 11 19

Krystexxa

Crealta Pharmaceuticals Ireland Limited

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

ES/1/12/810

2015 11 23

2015 11 19

Lamivudine/Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/10/663

2015 11 23

2015 11 19

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

ES/1/05/325

2015 11 24

2015 11 19

Mirvaso

Galderma International

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

ES/1/13/904

2015 11 23

2015 11 19

NovoNorm

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

ES/1/98/076

2015 11 23

2015 11 19

Optimark

Mallinckrodt Deutschland GmbH

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

ES/1/07/398

2015 11 23

2015 11 19

Prandin

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

ES/1/00/162

2015 11 23

2015 11 19

Prometax

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/98/092

2015 11 23

2015 11 19

Ranexa

Menarini International Operations Luxembourg S.A.

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

ES/1/08/462

2015 11 23

2015 11 19

Simulect

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/98/084

2015 11 23

2015 11 19

Teysuno

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

ES/1/11/669

2015 11 23

2015 11 19

Thalidomide Celgene

Celgene Europe Limited

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

ES/1/08/443

2015 11 23

2015 11 19

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

ES/1/08/498

2015 11 23

2015 11 19

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

ES/1/08/499

2015 11 23

2015 11 19

Vfend

Pfizer Limited

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

ES/1/02/212

2015 11 23

2015 11 19

XALKORI

Pfizer Limited

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

ES/1/12/793

2015 11 23

2015 11 19

Xenical

Roche Registration Limited

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

ES/1/98/071

2015 11 23

2015 11 20

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/11/736

2015 11 24

2015 11 20

Volibris

Glaxo Group Ltd

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

ES/1/08/451

2015 11 25

2015 11 23

alli

Glaxo Group Ltd

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

ES/1/07/401

2015 11 25

2015 11 23

Bosulif

Pfizer Limited

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

ES/1/13/818

2015 11 25

2015 11 23

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/11/677

2015 11 25

2015 11 23

XALKORI

Pfizer Limited

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

ES/1/12/793

2015 11 25

2015 11 23

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

ES/1/11/671

2015 11 25

2015 11 27

CellCept

Roche Registration Limited

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

ES/1/96/005

2015 12 1

2015 11 27

Iclusig

ARIAD Pharma Ltd

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

ES/1/13/839

2015 12 1

2015 11 27

Pandemic influenza vaccine H5N1 BAXTER

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

ES/1/09/571

2015 12 1

2015 11 27

Quinsair

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

ES/1/14/973

2015 12 1

2015 11 27

Rapamune

Pfizer Limited

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

ES/1/01/171

2015 12 2

2015 11 27

Revinty Ellipta

Glaxo Group Ltd

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

ES/1/14/929

2015 12 1

2015 11 27

Rivastigmine HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

ES/1/09/589

2015 11 30

2015 11 27

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

ES/1/09/599

2015 12 2

2015 11 27

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

ES/1/13/846

2015 12 1

2015 11 30

Celvapan

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

ES/1/08/506

2015 12 2

2015 11 30

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

ES/1/09/585

2015 12 2

2015 11 30

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

ES/1/12/752

2015 12 2

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 11 30 | Nivolumab BMS | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/15/1026 | 2015 12 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 11 30

Nivolumab BMS

Bristol-Myers Squibb Pharma EEIG

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

ES/1/15/1026

2015 12 2

—   Rinkodaros leidimo sustabdymas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 20 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 11 20 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | ES/1/02/226 | 2015 11 24 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 11 20

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

ES/1/02/226

2015 11 24

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2015 11 6 | Simparica | sarolaneras | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/15/191 | Kramtomos tabletės | QP53BX06 | 2015 11 10 |
| 2015 11 6 | Suvaxyn Circo + MH RTU | Kiaulių cirkovirusas ir kiaulių enzootinės pneumonijos vakcina (inaktyvinta) | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/15/190 | Injekcinė emulsija | QI09AL | 2015 11 10 |
| 2015 11 6 | Zycortal | dezoksikortonas | Dechra Limited
  Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom | ES/2/15/189 | Injekcinė suspensija | QH02AA03 | 2015 11 10 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2015 11 6

Simparica

sarolaneras

Zoetis Belgium S.A.

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

ES/2/15/191

Kramtomos tabletės

QP53BX06

2015 11 10

2015 11 6

Suvaxyn Circo + MH RTU

Kiaulių cirkovirusas ir kiaulių enzootinės pneumonijos vakcina (inaktyvinta)

Zoetis Belgium S.A.

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

ES/2/15/190

Injekcinė emulsija

QI09AL

2015 11 10

2015 11 6

Zycortal

dezoksikortonas

Dechra Limited

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

ES/2/15/189

Injekcinė suspensija

QH02AA03

2015 11 10

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 11 6 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | ES/2/10/114 | 2015 11 10 |
| 2015 11 9 | Nobivac Bb | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | ES/2/02/034 | 2015 11 11 |
| 2015 11 19 | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | ES/2/09/101 | 2015 11 23 |
| 2015 11 20 | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | ES/2/09/097 | 2015 11 24 |
| 2015 11 27 | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | ES/2/09/096 | 2015 12 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 11 6

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

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

ES/2/10/114

2015 11 10

2015 11 9

Nobivac Bb

Intervet International B.V.

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

ES/2/02/034

2015 11 11

2015 11 19

Zolvix

Novartis Healthcare A/S

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

ES/2/09/101

2015 11 23

2015 11 20

Leucofeligen FeLV/RCP

Virbac

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

ES/2/09/097

2015 11 24

2015 11 27

Leucogen

Virbac

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

ES/2/09/096

2015 12 1

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

| 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)  OL L 136, 2004 4 30, p. 1.

---

| 30.12.2015 | LT | Europos Sąjungos oficialusis leidinys | C 439/12 |
| --- | --- | --- | --- |

30.12.2015

LT

Europos Sąjungos oficialusis leidinys

C 439/12

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. lapkričio 1 d. iki 2015 m. lapkričio 30 d.

(Sprendimai priimti pagal Direktyvos 2001/83/EB (1) 34 straipsnį arba Direktyvos 2001/82/EB (2) 38 straipsnį)

(2015/C 439/02)

—   Nacionalinio rinkodaros leidimo suteikimas, atnaujinimas arba pakeitimas

| Sprendimo data | Vaisto pavadinimas (-ai) | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas (-ai) | Susijusi valstybė narė | Pranešimo data |
| --- | --- | --- | --- | --- | --- |
| 2015 11 27 | Repaglinide | repaglinide | Netaikoma | Netaikoma | 2015 11 30 |
| 2015 11 23 | Orlistat | Orlistat | Netaikoma | Netaikoma | 2015 11 24 |
| 2015 11 20 | Rivastigmine | Rivastigmine | Netaikoma | Netaikoma | 2015 11 24 |

Sprendimo data

Vaisto pavadinimas (-ai)

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas (-ai)

Susijusi valstybė narė

Pranešimo data

2015 11 27

Repaglinide

repaglinide

Netaikoma

Netaikoma

2015 11 30

2015 11 23

Orlistat

Orlistat

Netaikoma

Netaikoma

2015 11 24

2015 11 20

Rivastigmine

Rivastigmine

Netaikoma

Netaikoma

2015 11 24

---

(1)  OL L 311, 2001 11 28, p. 67.

(2)  OL L 311, 2001 11 28, p. 1.

---