# Il-Ġurnal Uffiċjali C 208/30 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 208 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 6030 ta' Ġunju 2017 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 208

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 6030 ta' Ġunju 2017

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2017/C 208/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2017/C 208/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 10 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2017/C 208/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

2017/C 208/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

10

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MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 30.6.2017 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 208/1 |
| --- | --- | --- | --- |

30.6.2017

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 208/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))

(2017/C 208/01)

| — | Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.5.2017 | Dinutuximab beta Apeiron | Dinutuksimab beta | APEIRON Biologics AG
  Campus Vienna Biocenter 5, A-1030 Wien, Österreich | EU/1/17/1191 | Konċentrat għal soluzzjoni għal infużjoni | L01XC | 11.5.2017 |
| 22.5.2017 | Axumin | fluciclovine (18F) | Blue Earth Diagnostics Ltd
  215 Euston Road, London NW1 2BE, United Kingdom | EU/1/17/1186 | Soluzzjoni għall-injezzjoni | V09IX12 | 24.5.2017 |
| 22.5.2017 | Fampyra | fampridine | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/11/699 | Pillola li terħi l-mediċina bil-mod | N07XX07 | 24.5.2017 |
| 22.5.2017 | Ivabradine Accord | ivabradine | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/17/1190 | Pillola miksija b’rita | C01EB17 | 24.5.2017 |
| 24.5.2017 | Trumenba | B grupės meningokokų vakcina (rekombinacinė, adsorbuota) | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1187 | Suspensjoni għall-injezzjoni | J07AH09 | 30.5.2017 |
| 30.5.2017 | Brineura | cerliponase alfa | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/17/1192 | Soluzzjoni għal infużjoni | A16AB | 1.6.2017 |
| 30.5.2017 | Spinraza | nusinersen | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/17/1188 | Soluzzjoni għall-injezzjoni | Pending | 1.6.2017 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta’ notifika

8.5.2017

Dinutuximab beta Apeiron

Dinutuksimab beta

APEIRON Biologics AG

Campus Vienna Biocenter 5, A-1030 Wien, Österreich

EU/1/17/1191

Konċentrat għal soluzzjoni għal infużjoni

L01XC

11.5.2017

22.5.2017

Axumin

fluciclovine (18F)

Blue Earth Diagnostics Ltd

215 Euston Road, London NW1 2BE, United Kingdom

EU/1/17/1186

Soluzzjoni għall-injezzjoni

V09IX12

24.5.2017

22.5.2017

Fampyra

fampridine

Biogen Idec Limited

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

EU/1/11/699

Pillola li terħi l-mediċina bil-mod

N07XX07

24.5.2017

22.5.2017

Ivabradine Accord

ivabradine

Accord Healthcare Limited

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

EU/1/17/1190

Pillola miksija b’rita

C01EB17

24.5.2017

24.5.2017

Trumenba

B grupės meningokokų vakcina (rekombinacinė, adsorbuota)

Pfizer Limited

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

EU/1/17/1187

Suspensjoni għall-injezzjoni

J07AH09

30.5.2017

30.5.2017

Brineura

cerliponase alfa

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

Soluzzjoni għal infużjoni

A16AB

1.6.2017

30.5.2017

Spinraza

nusinersen

Biogen Idec Limited

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

EU/1/17/1188

Soluzzjoni għall-injezzjoni

Pending

1.6.2017

| — | Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 2.5.2017 | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 4.5.2017 |
| 2.5.2017 | Emtricitabine/Tenofovir disoproxil Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 4.5.2017 |
| 2.5.2017 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 4.5.2017 |
| 2.5.2017 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 4.5.2017 |
| 2.5.2017 | Xenical | CHEPLAPHARM Arzneimittel GmbH
  Ziegelhof 24, 17489 Greifswald, Deutschland | EU/1/98/071 | 4.5.2017 |
| 4.5.2017 | Ebymect | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1051 | 8.5.2017 |
| 4.5.2017 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 8.5.2017 |
| 4.5.2017 | Qutenza | Grünenthal GmbH
  Zieglerstrasse 6, D-52078, Aachen, Deutschland | EU/1/09/524 | 8.5.2017 |
| 8.5.2017 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | 11.5.2017 |
| 8.5.2017 | Glivec | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/198 | 11.5.2017 |
| 8.5.2017 | Ivabradine Anpharm | ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
  ul. Annopol 6B, 03–236 Warszawa, Polska | EU/1/15/1041 | 11.5.2017 |
| 8.5.2017 | Pergoveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/07/396 | 11.5.2017 |
| 8.5.2017 | Rasagiline Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1090 | 11.5.2017 |
| 8.5.2017 | Simbrinza | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | 11.5.2017 |
| 8.5.2017 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 11.5.2017 |
| 16.5.2017 | Azarga | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/08/482 | 18.5.2017 |
| 16.5.2017 | DuoTrav | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/06/338 | 18.5.2017 |
| 16.5.2017 | Emadine | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/98/095 | 18.5.2017 |
| 16.5.2017 | Feraccru | Shield TX (UK) Limited
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | 18.5.2017 |
| 16.5.2017 | Lysodren | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/04/273 | 18.5.2017 |
| 16.5.2017 | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 18.5.2017 |
| 16.5.2017 | Marixino | Consilient Health Ltd
  5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | EU/1/13/820 | 18.5.2017 |
| 16.5.2017 | Nevanac | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/07/433 | 18.5.2017 |
| 16.5.2017 | Obizur | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/15/1035 | 18.5.2017 |
| 16.5.2017 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 18.5.2017 |
| 18.5.2017 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 23.5.2017 |
| 18.5.2017 | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/745 | 23.5.2017 |
| 18.5.2017 | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 23.5.2017 |
| 18.5.2017 | Fampyra | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/11/699 | 23.5.2017 |
| 18.5.2017 | Ratiograstim | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/444 | 23.5.2017 |
| 18.5.2017 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/95/002 | 23.5.2017 |
| 18.5.2017 | Zalasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415 | 22.5.2017 |
| 18.5.2017 | Zelboraf | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/12/751 | 23.5.2017 |
| 22.5.2017 | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 24.5.2017 |
| 22.5.2017 | Clopidogrel BGR | Laboratoires BIOGARAN
  15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France | EU/1/09/558 | 24.5.2017 |
| 22.5.2017 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 24.5.2017 |
| 22.5.2017 | Faslodex | AstraZeneca UK Limited
  Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom | EU/1/03/269 | 24.5.2017 |
| 22.5.2017 | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 24.5.2017 |
| 22.5.2017 | IntronA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/127 | 24.5.2017 |
| 22.5.2017 | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 24.5.2017 |
| 22.5.2017 | Rasilez | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/405 | 24.5.2017 |
| 22.5.2017 | Respreeza | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/15/1006 | 24.5.2017 |
| 22.5.2017 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/09/595 | 24.5.2017 |
| 22.5.2017 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 24.5.2017 |
| 22.5.2017 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 24.5.2017 |
| 22.5.2017 | Zeffix | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/114 | 24.5.2017 |
| 22.5.2017 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/771 | 24.5.2017 |
| 22.5.2017 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 24.5.2017 |
| 24.5.2017 | Aerius | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/160 | 30.5.2017 |
| 24.5.2017 | Azomyr | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/157 | 30.5.2017 |
| 24.5.2017 | Busilvex | Pierre Fabre Médicament
  45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France | EU/1/03/254 | 30.5.2017 |
| 24.5.2017 | Cotellic | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | 31.5.2017 |
| 24.5.2017 | Desloratadine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 30.5.2017 |
| 24.5.2017 | Ecalta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/416 | 30.5.2017 |
| 24.5.2017 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 30.5.2017 |
| 24.5.2017 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/00/170 | 30.5.2017 |
| 24.5.2017 | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/99/108 | 30.5.2017 |
| 24.5.2017 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 30.5.2017 |
| 24.5.2017 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 30.5.2017 |
| 24.5.2017 | Kaletra | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/01/172 | 30.5.2017 |
| 24.5.2017 | Memantine LEK | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/13/826 | 31.5.2017 |
| 24.5.2017 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 30.5.2017 |
| 24.5.2017 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 30.5.2017 |
| 24.5.2017 | NovoThirteen | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/775 | 30.6.2017 |
| 24.5.2017 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 30.5.2017 |
| 24.5.2017 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 30.5.2017 |
| 24.5.2017 | Zoledronic acid Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/12/786 | 30.5.2017 |
| 31.5.2017 | Azopt | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/00/129 | 2.6.2017 |
| 31.5.2017 | Benepali | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | 2.6.2017 |
| 31.5.2017 | Chenodeoxycholic acid Leadiant | Leadiant GmbH
  Liebherrstr. 22, 80538 München, Deutschland | EU/1/16/1110 | 2.6.2017 |
| 31.5.2017 | Clopidogrel Apotex | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/09/568 | 2.6.2017 |
| 31.5.2017 | Elocta | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/15/1046 | 2.6.2017 |
| 31.5.2017 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 2.6.2017 |
| 31.5.2017 | Lopinavir/Ritonavir Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1067 | 2.6.2017 |
| 31.5.2017 | Odomzo | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/15/1030 | 2.6.2017 |
| 31.5.2017 | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 2.6.2017 |
| 31.5.2017 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 2.6.2017 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

2.5.2017

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

4.5.2017

2.5.2017

Emtricitabine/Tenofovir disoproxil Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

4.5.2017

2.5.2017

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

4.5.2017

2.5.2017

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

4.5.2017

2.5.2017

Xenical

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/98/071

4.5.2017

4.5.2017

Ebymect

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1051

8.5.2017

4.5.2017

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

8.5.2017

4.5.2017

Qutenza

Grünenthal GmbH

Zieglerstrasse 6, D-52078, Aachen, Deutschland

EU/1/09/524

8.5.2017

8.5.2017

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

11.5.2017

8.5.2017

Glivec

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/198

11.5.2017

8.5.2017

Ivabradine Anpharm

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B, 03–236 Warszawa, Polska

EU/1/15/1041

11.5.2017

8.5.2017

Pergoveris

Merck Serono Europe Limited

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

EU/1/07/396

11.5.2017

8.5.2017

Rasagiline Mylan

Mylan S.A.S

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

EU/1/16/1090

11.5.2017

8.5.2017

Simbrinza

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/14/933

11.5.2017

8.5.2017

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

11.5.2017

16.5.2017

Azarga

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/08/482

18.5.2017

16.5.2017

DuoTrav

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/06/338

18.5.2017

16.5.2017

Emadine

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/98/095

18.5.2017

16.5.2017

Feraccru

Shield TX (UK) Limited

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

18.5.2017

16.5.2017

Lysodren

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/04/273

18.5.2017

16.5.2017

Mabthera

Roche Registration Limited

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

EU/1/98/067

18.5.2017

16.5.2017

Marixino

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

18.5.2017

16.5.2017

Nevanac

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/07/433

18.5.2017

16.5.2017

Obizur

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/15/1035

18.5.2017

16.5.2017

Tygacil

Pfizer Limited

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

EU/1/06/336

18.5.2017

18.5.2017

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

23.5.2017

18.5.2017

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

23.5.2017

18.5.2017

Desloratadine ratiopharm

ratiopharm GmbH

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

EU/1/11/746

23.5.2017

18.5.2017

Fampyra

Biogen Idec Limited

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

EU/1/11/699

23.5.2017

18.5.2017

Ratiograstim

ratiopharm GmbH

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

EU/1/08/444

23.5.2017

18.5.2017

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/95/002

23.5.2017

18.5.2017

Zalasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

22.5.2017

18.5.2017

Zelboraf

Roche Registration Limited

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

EU/1/12/751

23.5.2017

22.5.2017

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

24.5.2017

22.5.2017

Clopidogrel BGR

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

24.5.2017

22.5.2017

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

24.5.2017

22.5.2017

Faslodex

AstraZeneca UK Limited

Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom

EU/1/03/269

24.5.2017

22.5.2017

Inlyta

Pfizer Limited

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

EU/1/12/777

24.5.2017

22.5.2017

IntronA

Merck Sharp & Dohme Limited

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

EU/1/99/127

24.5.2017

22.5.2017

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

24.5.2017

22.5.2017

Rasilez

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/405

24.5.2017

22.5.2017

Respreeza

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/15/1006

24.5.2017

22.5.2017

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/09/595

24.5.2017

22.5.2017

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

24.5.2017

22.5.2017

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

24.5.2017

22.5.2017

Zeffix

Glaxo Group Ltd

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

EU/1/99/114

24.5.2017

22.5.2017

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

24.5.2017

22.5.2017

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

24.5.2017

24.5.2017

Aerius

Merck Sharp & Dohme Limited

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

EU/1/00/160

30.5.2017

24.5.2017

Azomyr

Merck Sharp & Dohme Limited

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

EU/1/00/157

30.5.2017

24.5.2017

Busilvex

Pierre Fabre Médicament

45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France

EU/1/03/254

30.5.2017

24.5.2017

Cotellic

Roche Registration Limited

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

EU/1/15/1048

31.5.2017

24.5.2017

Desloratadine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

30.5.2017

24.5.2017

Ecalta

Pfizer Limited

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

EU/1/07/416

30.5.2017

24.5.2017

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

30.5.2017

24.5.2017

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/00/170

30.5.2017

24.5.2017

Ferriprox

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/99/108

30.5.2017

24.5.2017

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

30.5.2017

24.5.2017

Imnovid

Celgene Europe Limited

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

EU/1/13/850

30.5.2017

24.5.2017

Kaletra

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/01/172

30.5.2017

24.5.2017

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

31.5.2017

24.5.2017

Mirvaso

Galderma International

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

EU/1/13/904

30.5.2017

24.5.2017

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

30.5.2017

24.5.2017

NovoThirteen

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/775

30.6.2017

24.5.2017

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

30.5.2017

24.5.2017

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

30.5.2017

24.5.2017

Zoledronic acid Mylan

Mylan S.A.S

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

EU/1/12/786

30.5.2017

31.5.2017

Azopt

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/00/129

2.6.2017

31.5.2017

Benepali

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

2.6.2017

31.5.2017

Chenodeoxycholic acid Leadiant

Leadiant GmbH

Liebherrstr. 22, 80538 München, Deutschland

EU/1/16/1110

2.6.2017

31.5.2017

Clopidogrel Apotex

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/09/568

2.6.2017

31.5.2017

Elocta

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/15/1046

2.6.2017

31.5.2017

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

2.6.2017

31.5.2017

Lopinavir/Ritonavir Mylan

Mylan S.A.S

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

EU/1/15/1067

2.6.2017

31.5.2017

Odomzo

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/15/1030

2.6.2017

31.5.2017

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/10/640

2.6.2017

31.5.2017

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

2.6.2017

| — | Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.5.2017 | Zeleris | florfenicol/meloxicam | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | EU/2/17/210 | Soluzzjoni għall-injezzjoni | QJ01BA99 | 17.5.2017 |
| 17.5.2017 | RESPIPORC FLUpan H1N1 | Vaċċin influwenza Porċini (inattivat) | IDT Biologika GmbH
  Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/17/209 | Suspensjoni għall-injezzjoni | QI09AA03 | 19.5.2017 |
| 24.5.2017 | Ingelvac PCV FLEX | Vaċċin taċ-ċirkovirus tal-majjali (inattivat) | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/17/208 | Suspensjoni għall-injezzjoni | QI09AA07 | 30.5.2017 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta’ notifika

15.5.2017

Zeleris

florfenicol/meloxicam

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

EU/2/17/210

Soluzzjoni għall-injezzjoni

QJ01BA99

17.5.2017

17.5.2017

RESPIPORC FLUpan H1N1

Vaċċin influwenza Porċini (inattivat)

IDT Biologika GmbH

Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland

EU/2/17/209

Suspensjoni għall-injezzjoni

QI09AA03

19.5.2017

24.5.2017

Ingelvac PCV FLEX

Vaċċin taċ-ċirkovirus tal-majjali (inattivat)

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/17/208

Suspensjoni għall-injezzjoni

QI09AA07

30.5.2017

| — | Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 5.5.2017 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/118 | 9.5.2017 |
| 5.5.2017 | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 9.5.2017 |
| 5.5.2017 | Versican Plus Pi/L4R | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/173 | 9.5.2017 |
| 15.5.2017 | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/14/177 | 17.5.2017 |
| 15.5.2017 | Novem | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/04/042 | 17.5.2017 |
| 15.5.2017 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/140 | 17.5.2017 |
| 15.5.2017 | Zactran | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/08/082 | 17.5.2017 |
| 17.5.2017 | Suprelorin | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | EU/2/07/072 | 19.5.2017 |
| 17.5.2017 | Suvaxyn Circo + MH RTU | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/190 | 22.5.2017 |
| 24.5.2017 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/137 | 30.5.2017 |
| 24.5.2017 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 30.5.2017 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

5.5.2017

Activyl

Intervet International B.V.

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

EU/2/10/118

9.5.2017

5.5.2017

Kexxtone

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/12/145

9.5.2017

5.5.2017

Versican Plus Pi/L4R

Zoetis Belgium S.A.

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

EU/2/14/173

9.5.2017

15.5.2017

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/14/177

17.5.2017

15.5.2017

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

17.5.2017

15.5.2017

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

17.5.2017

15.5.2017

Zactran

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/082

17.5.2017

17.5.2017

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

19.5.2017

17.5.2017

Suvaxyn Circo + MH RTU

Zoetis Belgium S.A.

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

EU/2/15/190

22.5.2017

24.5.2017

Activyl Tick Plus

Intervet International B.V.

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

EU/2/11/137

30.5.2017

24.5.2017

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

30.5.2017

Kull min jixtieq jikkonsulta r-rapport ta’ evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  ĠU L 136, 30.4.2004, p. 1.

---

| 30.6.2017 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 208/10 |
| --- | --- | --- | --- |

30.6.2017

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 208/10

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2017 sal-31 ta’ Mejju 2017

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE (1) jew l-Artikolu 38 tad-Direttiva 2001/82/KE (2))

(2017/C 208/02)

| — | Ħruġ, manteniment jew modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq |
| --- | --- |

—

Ħruġ, manteniment jew modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- |
| 5.5.2017 | Saroten and associated names | amitriptyline | Ara l-Anness | Ara l-Anness | 10.5.2017 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta’ notifika

5.5.2017

Saroten and associated names

amitriptyline

Ara l-Anness

Ara l-Anness

10.5.2017

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS

Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodott mediċinali, mnejn jingħata, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Istati Membri

| Stat Membru EU/EEA | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten | 10 mg | Pillola miksija b’rita | Użu orali | |
| L-Awstrija | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten | 25 mg | Pillola miksija b’rita | Użu orali | |
| L-Awstrija | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten Retard | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| L-Awstrija | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten Retard | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Il-Belġju | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 10 mg | Pillola miksija b’rita | Użu orali | |
| Il-Belġju | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 25 mg | Pillola miksija b’rita | Użu orali | |
| Il-Belġju | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Il-Belġju | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Ċipru | C. G. Papaloisou Ltd.
  Office address:
  35 Kilkis Avenue
  2234 Latsia
  Cyprus
  Mail address:
  P.O. Box 1711
  2261 Latsia
  Cyprus | Saroten Retard | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Ċipru | C. G. Papaloisou Ltd.
  Office address:
  35 Kilkis Avenue
  2234 Latsia
  Cyprus
  Mail address:
  P.O. Box 1711
  2261 Latsia
  Cyprus | Saroten Retard | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Id-Danimarka | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 10 mg | Pillola miksija b’rita | Użu orali | |
| Id-Danimarka | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 25 mg | Pillola miksija b’rita | Użu orali | |
| Id-Danimarka | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Id-Danimarka | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| L-Estonja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Il-Ġermanja | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten Tabs | 50 mg | Pillola miksija b’rita | Użu orali | |
| Il-Ġermanja | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten retard Tabs | 75 mg | Pillola li terħi il-mediċina b’mod modifikat | Użu orali | |
| Il-Ġermanja | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten 2 ml | 50 mg/2 ml | Soluzzjoni għall-injezzjoni | Użu għal ġol-muskoli
  użu għal ġol-vini | 25 mg/ml |
| Il-Greċja | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 25 mg | Kapsula li terħi il-mediċina b’mod modifikat, iebsa | Użu orali | |
| Il-Greċja | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 75 mg | Kapsula li terħi il-mediċina b’mod modifikat, iebsa | Użu orali | |
| Il-Greċja | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 25 mg | Pillola miksija | Użu orali | |
| Il-Greċja | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 10 mg | Pillola miksija | Użu orali | |
| Il-Lussemburgu | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 10 mg | Pillola miksija b’rita | Użu orali | |
| Il-Lussemburgu | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 25 mg | Pillola miksija b’rita | Użu orali | |
| Il-Lussemburgu | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| Il-Lussemburgu | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| L-Olanda | Lundbeck B.V.
  Gebouw Jupiter Herikerbergweg 100
  Postbus 12021
  1100 AA Amsterdam
  The Netherlands | Sarotex Retard 25 | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| L-Olanda | Lundbeck B.V.
  Gebouw Jupiter Herikerbergweg 100
  Postbus 12021
  1100 AA Amsterdam
  The Netherlands | Sarotex Retard 50 | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| In-Norveġja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex | 10 mg | Pillola miksija b’rita | Użu orali | |
| In-Norveġja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex | 25 mg | Pillola miksija b’rita | Użu orali | |
| In-Norveġja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex Retard | 25 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| In-Norveġja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex Retard | 50 mg | Kapsula li terħi l-mediċina bil-mod, iebsa | Użu orali | |
| L-Iżvezja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 10 mg | Pillola miksija b’rita | Użu orali | |
| L-Iżvezja | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 25 mg | Pillola miksija b’rita | Użu orali | |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut (Konċentrat)

L-Awstrija

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten

10 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten

25 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten Retard

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Awstrija

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten Retard

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Belġju

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

10 mg

Pillola miksija b’rita

Użu orali

Il-Belġju

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

25 mg

Pillola miksija b’rita

Użu orali

Il-Belġju

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Belġju

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ċipru

C. G. Papaloisou Ltd.

Office address:

35 Kilkis Avenue

2234 Latsia

Cyprus

Mail address:

P.O. Box 1711

2261 Latsia

Cyprus

Saroten Retard

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ċipru

C. G. Papaloisou Ltd.

Office address:

35 Kilkis Avenue

2234 Latsia

Cyprus

Mail address:

P.O. Box 1711

2261 Latsia

Cyprus

Saroten Retard

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Id-Danimarka

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

10 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Id-Danimarka

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Estonja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten Tabs

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten retard Tabs

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Ġermanja

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten 2 ml

50 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

użu għal ġol-vini

25 mg/ml

Il-Greċja

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

25 mg

Kapsula li terħi il-mediċina b’mod modifikat, iebsa

Użu orali

Il-Greċja

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

75 mg

Kapsula li terħi il-mediċina b’mod modifikat, iebsa

Użu orali

Il-Greċja

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

25 mg

Pillola miksija

Użu orali

Il-Greċja

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

10 mg

Pillola miksija

Użu orali

Il-Lussemburgu

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

10 mg

Pillola miksija b’rita

Użu orali

Il-Lussemburgu

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

25 mg

Pillola miksija b’rita

Użu orali

Il-Lussemburgu

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Lussemburgu

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Olanda

Lundbeck B.V.

Gebouw Jupiter Herikerbergweg 100

Postbus 12021

1100 AA Amsterdam

The Netherlands

Sarotex Retard 25

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Olanda

Lundbeck B.V.

Gebouw Jupiter Herikerbergweg 100

Postbus 12021

1100 AA Amsterdam

The Netherlands

Sarotex Retard 50

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

In-Norveġja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex

10 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex

25 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex Retard

25 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

In-Norveġja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex Retard

50 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Iżvezja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

10 mg

Pillola miksija b’rita

Użu orali

L-Iżvezja

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

25 mg

Pillola miksija b’rita

Użu orali

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