# Official Journal C 349/28 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 349 |
| | |
| English edition | Information and Notices | Volume 6128 September 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 349

English edition

Information and Notices

Volume 6128 September 2018

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 349/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2018/C 349/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 14 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 349/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2018/C 349/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

14

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.9.2018 | EN | Official Journal of the European Union | C 349/1 |
| --- | --- | --- | --- |

28.9.2018

EN

Official Journal of the European Union

C 349/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018

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

(2018/C 349/01)

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 23.8.2018 | Duzallo | allopurinol/lesinurad | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | Film-coated tablet | M04AA51 | 27.8.2018 |
| 23.8.2018 | Kymriah | tisagenlecleucel | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1297 | Dispersion for infusion | Pending | 27.8.2018 |
| 23.8.2018 | Mepsevii | vestronidase alfa | Ultragenyx Germany GmbH
  Friedrichstraße 191, 10117 Berlin, Deutschland | EU/1/18/1301 | Concentrate for solution for infusion | A16AB18 | 27.8.2018 |
| 23.8.2018 | Vyxeos | daunorubicin/cytarabine | Jazz Pharmaceuticals Ireland Ltd
  5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland | EU/1/18/1308 | Powder for concentrate for solution for infusion | L01XY01 | 27.8.2018 |
| 23.8.2018 | Yescarta | axicabtagene ciloleucel | Kite Pharma EU B.V.
  Science Park 408, 1098 XH Amsterdam, Nederland | EU/1/18/1299 | Dispersion for infusion | L01X | 27.8.2018 |
| 27.8.2018 | Onpattro | patisiran | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/18/1320 | Concentrate for solution for infusion | Pending | 29.8.2018 |
| 27.8.2018 | Ulipristal Acetate Gedeon Richter | Ulipristal Acetate | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/18/1309 | Tablet | G03XB02 | 29.8.2018 |
| 31.8.2018 | Cablivi | caplacizumab | Ablynx N.V.
  Technologiepark 21, 9052 Zwijnaarde, België | EU/1/18/1305 | Powder and solvent for solution for injection | B01AX07 | 4.9.2018 |
| 31.8.2018 | Nerlynx | neratinib | Puma Biotechnology, Ltd
  11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom | EU/1/18/1311 | Film-coated tablet | L01XE45 | 4.9.2018 |
| 31.8.2018 | VEYVONDI | vonicog alfa | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/18/1298 | Powder and solvent for solution for injection | B02BD10 | 4.9.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

23.8.2018

Duzallo

allopurinol/lesinurad

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

Film-coated tablet

M04AA51

27.8.2018

23.8.2018

Kymriah

tisagenlecleucel

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/18/1297

Dispersion for infusion

Pending

27.8.2018

23.8.2018

Mepsevii

vestronidase alfa

Ultragenyx Germany GmbH

Friedrichstraße 191, 10117 Berlin, Deutschland

EU/1/18/1301

Concentrate for solution for infusion

A16AB18

27.8.2018

23.8.2018

Vyxeos

daunorubicin/cytarabine

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/18/1308

Powder for concentrate for solution for infusion

L01XY01

27.8.2018

23.8.2018

Yescarta

axicabtagene ciloleucel

Kite Pharma EU B.V.

Science Park 408, 1098 XH Amsterdam, Nederland

EU/1/18/1299

Dispersion for infusion

L01X

27.8.2018

27.8.2018

Onpattro

patisiran

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

Concentrate for solution for infusion

Pending

29.8.2018

27.8.2018

Ulipristal Acetate Gedeon Richter

Ulipristal Acetate

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/18/1309

Tablet

G03XB02

29.8.2018

31.8.2018

Cablivi

caplacizumab

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

Powder and solvent for solution for injection

B01AX07

4.9.2018

31.8.2018

Nerlynx

neratinib

Puma Biotechnology, Ltd

11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom

EU/1/18/1311

Film-coated tablet

L01XE45

4.9.2018

31.8.2018

VEYVONDI

vonicog alfa

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

Powder and solvent for solution for injection

B02BD10

4.9.2018

| — | Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.8.2018 | Avonex | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/97/033 | 6.8.2018 |
| 2.8.2018 | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/818 | 6.8.2018 |
| 2.8.2018 | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/99/100 | 6.8.2018 |
| 2.8.2018 | Conbriza | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/09/511 | 6.8.2018 |
| 2.8.2018 | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 6.8.2018 |
| 2.8.2018 | DUAVIVE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/14/960 | 6.8.2018 |
| 2.8.2018 | Fampyra | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/11/699 | 6.8.2018 |
| 2.8.2018 | Insulin lispro Sanofi | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1203 | 6.8.2018 |
| 2.8.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 6.8.2018 |
| 2.8.2018 | Kyntheum | Leo Pharma A/S
  Industriparken 55, 2750 Ballerup, Danmark | EU/1/16/1155 | 6.8.2018 |
| 2.8.2018 | Onglyza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/09/545 | 6.8.2018 |
| 2.8.2018 | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 6.8.2018 |
| 2.8.2018 | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/01/171 | 6.8.2018 |
| 2.8.2018 | ReFacto AF | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/99/103 | 6.8.2018 |
| 2.8.2018 | Siklos | Addmedica
  37 rue de Caumartin, 75009 Paris, France | EU/1/07/397 | 6.8.2018 |
| 2.8.2018 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/09/605 | 6.8.2018 |
| 2.8.2018 | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 6.8.2018 |
| 2.8.2018 | Tysabri | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/06/346 | 6.8.2018 |
| 2.8.2018 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 6.8.2018 |
| 3.8.2018 | Accofil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | 7.8.2018 |
| 3.8.2018 | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/963 | 7.8.2018 |
| 3.8.2018 | Crixivan | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/96/024 | 7.8.2018 |
| 3.8.2018 | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/964 | 7.8.2018 |
| 3.8.2018 | Duloxetine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1010 | 7.8.2018 |
| 3.8.2018 | Inlyta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/777 | 7.8.2018 |
| 3.8.2018 | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/06/378 | 7.8.2018 |
| 3.8.2018 | Memantine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/880 | 7.8.2018 |
| 3.8.2018 | Numient | Amneal Pharma Europe Ltd
  70 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/15/1044 | 7.8.2018 |
| 3.8.2018 | Ribavirin Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/10/634 | 7.8.2018 |
| 3.8.2018 | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/14/961 | 7.8.2018 |
| 3.8.2018 | Vyndaqel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/11/717 | 7.8.2018 |
| 6.8.2018 | GONAL-f | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/95/001 | 8.8.2018 |
| 8.8.2018 | Bortezomib Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1114 | 10.8.2018 |
| 8.8.2018 | Brinavess | Correvio
  15 rue du Bicentenaire, 92800 Puteaux, France | EU/1/10/645 | 10.8.2018 |
| 8.8.2018 | CANCIDAS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/01/196 | 10.8.2018 |
| 8.8.2018 | Cubicin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/328 | 10.8.2018 |
| 8.8.2018 | Januvia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/383 | 10.8.2018 |
| 8.8.2018 | Lymphoseek | Norgine B.V.
  Hogehilweg 7, 1101 CA Amsterdam, Nederland | EU/1/14/955 | 10.8.2018 |
| 8.8.2018 | Sivextro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/991 | 10.8.2018 |
| 8.8.2018 | Tesavel | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/435 | 10.8.2018 |
| 8.8.2018 | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 10.8.2018 |
| 8.8.2018 | Torisel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/424 | 10.8.2018 |
| 13.8.2018 | Ivabradine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1144 | 15.8.2018 |
| 13.8.2018 | Komboglyze | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/731 | 15.8.2018 |
| 13.8.2018 | Orbactiv | Rempex London Ltd
  115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom | EU/1/15/989 | 15.8.2018 |
| 13.8.2018 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 15.8.2018 |
| 20.8.2018 | Cholib | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/13/866 | 22.8.2018 |
| 20.8.2018 | Lenvima | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/15/1002 | 22.8.2018 |
| 20.8.2018 | Luveris | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/155 | 22.8.2018 |
| 20.8.2018 | Pergoveris | Merck Europe B.V.
  Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland | EU/1/07/396 | 22.8.2018 |
| 20.8.2018 | Xelevia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/382 | 22.8.2018 |
| 23.8.2018 | Abilify | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/04/276 | 28.8.2018 |
| 23.8.2018 | Aranesp | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185 | 27.8.2018 |
| 23.8.2018 | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland | EU/1/02/206 | 27.8.2018 |
| 23.8.2018 | Beromun | BELPHARMA s.a.
  2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg | EU/1/99/097 | 27.8.2018 |
| 23.8.2018 | Biktarvy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/18/1289 | 27.8.2018 |
| 23.8.2018 | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 27.8.2018 |
| 23.8.2018 | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 27.8.2018 |
| 23.8.2018 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 27.8.2018 |
| 23.8.2018 | Evicel | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, 1831 Diegem, België | EU/1/08/473 | 27.8.2018 |
| 23.8.2018 | Firazyr | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/08/461 | 27.8.2018 |
| 23.8.2018 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 27.8.2018 |
| 23.8.2018 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 27.8.2018 |
| 23.8.2018 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 28.8.2018 |
| 23.8.2018 | Lemtrada | Sanofi Belgium
  Leonardo Da Vincilaan 19, B-1831 Diegem, België | EU/1/13/869 | 28.8.2018 |
| 23.8.2018 | LIFMIOR | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1165 | 28.8.2018 |
| 23.8.2018 | Nivestim | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/10/631 | 27.8.2018 |
| 23.8.2018 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 27.8.2018 |
| 23.8.2018 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 28.8.2018 |
| 23.8.2018 | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 27.8.2018 |
| 23.8.2018 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 28.8.2018 |
| 23.8.2018 | Ristaben | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/621 | 28.8.2018 |
| 23.8.2018 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 27.8.2018 |
| 23.8.2018 | Somavert | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/02/240 | 27.8.2018 |
| 23.8.2018 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 27.8.2018 |
| 23.8.2018 | Steglujan | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1266 | 27.8.2018 |
| 23.8.2018 | Strimvelis | Orchard Therapeutics (Netherlands) B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | EU/1/16/1097 | 27.8.2018 |
| 23.8.2018 | Temodal | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/98/096 | 28.8.2018 |
| 23.8.2018 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 27.8.2018 |
| 23.8.2018 | Xagrid | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/04/295 | 25.8.2018 |
| 23.8.2018 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 27.8.2018 |
| 27.8.2018 | ABILIFY MAINTENA | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/13/882 | 29.8.2018 |
| 27.8.2018 | BYDUREON | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/696 | 29.8.2018 |
| 27.8.2018 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 29.8.2018 |
| 27.8.2018 | Coagadex | Bio Products Laboratory Ltd
  Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom | EU/1/16/1087 | 29.8.2018 |
| 27.8.2018 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 29.8.2018 |
| 27.8.2018 | Filgrastim Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/08/496 | 29.8.2018 |
| 27.8.2018 | Fulvestrant Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1253 | 29.8.2018 |
| 27.8.2018 | Lojuxta | Amryt Pharmaceuticals DAC
  90 Harcourt Street, Dublin 2, Ireland | EU/1/13/851 | 29.8.2018 |
| 27.8.2018 | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 29.8.2018 |
| 27.8.2018 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 29.8.2018 |
| 27.8.2018 | Rasilez HCT | Noden Pharma DAC
  D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland | EU/1/08/491 | 29.8.2018 |
| 27.8.2018 | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 29.8.2018 |
| 27.8.2018 | Varuby | TESARO U.K. Limited
  55 Baker Street, London W1U 7EU, United Kingdom | EU/1/17/1180 | 29.8.2018 |
| 27.8.2018 | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/09/529 | 29.8.2018 |
| 27.8.2018 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 29.8.2018 |
| 27.8.2018 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 29.8.2018 |
| 27.8.2018 | Zarzio | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/08/495 | 29.8.2018 |
| 28.8.2018 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 30.8.2018 |
| 28.8.2018 | Steglatro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1267 | 30.8.2018 |
| 31.8.2018 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, 58638 Iserlohn, Deutschland | EU/1/07/412 | 4.9.2018 |
| 31.8.2018 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 4.9.2018 |
| 31.8.2018 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/07/410 | 4.9.2018 |
| 31.8.2018 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 4.9.2018 |
| 31.8.2018 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | 4.9.2018 |
| 31.8.2018 | Epoetin alfa Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.9.2018 |
| 31.8.2018 | Spinraza | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/17/1188 | 4.9.2018 |
| 31.8.2018 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 4.9.2018 |
| 31.8.2018 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 4.9.2018 |
| 31.8.2018 | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 4.9.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.8.2018

Avonex

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/97/033

6.8.2018

2.8.2018

Bosulif

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/13/818

6.8.2018

2.8.2018

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/99/100

6.8.2018

2.8.2018

Conbriza

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/09/511

6.8.2018

2.8.2018

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

6.8.2018

2.8.2018

DUAVIVE

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/14/960

6.8.2018

2.8.2018

Fampyra

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/11/699

6.8.2018

2.8.2018

Insulin lispro Sanofi

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1203

6.8.2018

2.8.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

6.8.2018

2.8.2018

Kyntheum

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

6.8.2018

2.8.2018

Onglyza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/545

6.8.2018

2.8.2018

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

6.8.2018

2.8.2018

Rapamune

Pfizer Limited

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

EU/1/01/171

6.8.2018

2.8.2018

ReFacto AF

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/99/103

6.8.2018

2.8.2018

Siklos

Addmedica

37 rue de Caumartin, 75009 Paris, France

EU/1/07/397

6.8.2018

2.8.2018

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/09/605

6.8.2018

2.8.2018

Tepadina

ADIENNE S.r.l.

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

EU/1/10/622

6.8.2018

2.8.2018

Tysabri

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

6.8.2018

2.8.2018

Zoledronic acid Accord

Accord Healthcare Limited

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

EU/1/13/834

6.8.2018

3.8.2018

Accofil

Accord Healthcare Limited

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

EU/1/14/946

7.8.2018

3.8.2018

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

7.8.2018

3.8.2018

Crixivan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/96/024

7.8.2018

3.8.2018

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

7.8.2018

3.8.2018

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1010

7.8.2018

3.8.2018

Inlyta

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/12/777

7.8.2018

3.8.2018

Inovelon

Eisai Limited

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

EU/1/06/378

7.8.2018

3.8.2018

Memantine Accord

Accord Healthcare Limited

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

EU/1/13/880

7.8.2018

3.8.2018

Numient

Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/15/1044

7.8.2018

3.8.2018

Ribavirin Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/10/634

7.8.2018

3.8.2018

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

7.8.2018

3.8.2018

Vyndaqel

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/11/717

7.8.2018

6.8.2018

GONAL-f

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/95/001

8.8.2018

8.8.2018

Bortezomib Hospira

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/16/1114

10.8.2018

8.8.2018

Brinavess

Correvio

15 rue du Bicentenaire, 92800 Puteaux, France

EU/1/10/645

10.8.2018

8.8.2018

CANCIDAS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/196

10.8.2018

8.8.2018

Cubicin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

10.8.2018

8.8.2018

Januvia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

10.8.2018

8.8.2018

Lymphoseek

Norgine B.V.

Hogehilweg 7, 1101 CA Amsterdam, Nederland

EU/1/14/955

10.8.2018

8.8.2018

Sivextro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

10.8.2018

8.8.2018

Tesavel

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/435

10.8.2018

8.8.2018

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

10.8.2018

8.8.2018

Torisel

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/07/424

10.8.2018

13.8.2018

Ivabradine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1144

15.8.2018

13.8.2018

Komboglyze

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/731

15.8.2018

13.8.2018

Orbactiv

Rempex London Ltd

115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom

EU/1/15/989

15.8.2018

13.8.2018

Xyrem

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/05/312

15.8.2018

20.8.2018

Cholib

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/13/866

22.8.2018

20.8.2018

Lenvima

Eisai Europe Limited

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

EU/1/15/1002

22.8.2018

20.8.2018

Luveris

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/155

22.8.2018

20.8.2018

Pergoveris

Merck Europe B.V.

Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland

EU/1/07/396

22.8.2018

20.8.2018

Xelevia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/382

22.8.2018

23.8.2018

Abilify

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/04/276

28.8.2018

23.8.2018

Aranesp

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185

27.8.2018

23.8.2018

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

EU/1/02/206

27.8.2018

23.8.2018

Beromun

BELPHARMA s.a.

2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg

EU/1/99/097

27.8.2018

23.8.2018

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

27.8.2018

23.8.2018

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

27.8.2018

23.8.2018

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

27.8.2018

23.8.2018

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

27.8.2018

23.8.2018

Evicel

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, 1831 Diegem, België

EU/1/08/473

27.8.2018

23.8.2018

Firazyr

Shire Pharmaceuticals Ireland Limited

Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

EU/1/08/461

27.8.2018

23.8.2018

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

27.8.2018

23.8.2018

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

27.8.2018

23.8.2018

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

28.8.2018

23.8.2018

Lemtrada

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

28.8.2018

23.8.2018

LIFMIOR

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/16/1165

28.8.2018

23.8.2018

Nivestim

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/10/631

27.8.2018

23.8.2018

Opsumit

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/13/893

27.8.2018

23.8.2018

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

28.8.2018

23.8.2018

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

27.8.2018

23.8.2018

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

28.8.2018

23.8.2018

Ristaben

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/621

28.8.2018

23.8.2018

RoActemra

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/08/492

27.8.2018

23.8.2018

Somavert

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/02/240

27.8.2018

23.8.2018

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

27.8.2018

23.8.2018

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

27.8.2018

23.8.2018

Strimvelis

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/16/1097

27.8.2018

23.8.2018

Temodal

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/98/096

28.8.2018

23.8.2018

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

27.8.2018

23.8.2018

Xagrid

Shire Pharmaceuticals Ireland Limited

Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

EU/1/04/295

25.8.2018

23.8.2018

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

27.8.2018

27.8.2018

ABILIFY MAINTENA

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/13/882

29.8.2018

27.8.2018

BYDUREON

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

29.8.2018

27.8.2018

Cinryze

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

29.8.2018

27.8.2018

Coagadex

Bio Products Laboratory Ltd

Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom

EU/1/16/1087

29.8.2018

27.8.2018

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

29.8.2018

27.8.2018

Filgrastim Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/08/496

29.8.2018

27.8.2018

Fulvestrant Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1253

29.8.2018

27.8.2018

Lojuxta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/13/851

29.8.2018

27.8.2018

Mekinist

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/931

29.8.2018

27.8.2018

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

29.8.2018

27.8.2018

Rasilez HCT

Noden Pharma DAC

D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland

EU/1/08/491

29.8.2018

27.8.2018

Tafinlar

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/13/865

29.8.2018

27.8.2018

Varuby

TESARO U.K. Limited

55 Baker Street, London W1U 7EU, United Kingdom

EU/1/17/1180

29.8.2018

27.8.2018

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

29.8.2018

27.8.2018

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

29.8.2018

27.8.2018

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

29.8.2018

27.8.2018

Zarzio

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/08/495

29.8.2018

28.8.2018

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

30.8.2018

28.8.2018

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

30.8.2018

31.8.2018

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, 58638 Iserlohn, Deutschland

EU/1/07/412

4.9.2018

31.8.2018

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

4.9.2018

31.8.2018

Binocrit

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/07/410

4.9.2018

31.8.2018

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

4.9.2018

31.8.2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

4.9.2018

31.8.2018

Epoetin alfa Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/07/411

4.9.2018

31.8.2018

Spinraza

Biogen Idec Limited

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

EU/1/17/1188

4.9.2018

31.8.2018

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

4.9.2018

31.8.2018

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

4.9.2018

31.8.2018

XALKORI

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/12/793

4.9.2018

| — | Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.8.2018 | Intanza | Sanofi Pasteur Europe
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/505 | 7.8.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.8.2018

Intanza

Sanofi Pasteur Europe

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/505

7.8.2018

| — | Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.8.2018 | Cortacare | Hydrocortisone aceponate | Ecuphar NV
  Legeweg 157-i, 8020 Oostkamp, België | EU/2/18/230 | Cutaneous spray, solution | QD07AC16 | 29.8.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

27.8.2018

Cortacare

Hydrocortisone aceponate

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/18/230

Cutaneous spray, solution

QD07AC16

29.8.2018

| — | Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.8.2018 | Cerenia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/062 | 7.8.2018 |
| 3.8.2018 | LETIFEND | Laboratorios LETI, S.L.unipersonal
  C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España | EU/2/16/195 | 7.8.2018 |
| 3.8.2018 | Novem | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/04/042 | 7.8.2018 |
| 3.8.2018 | Onsior | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/08/089 | 7.8.2018 |
| 9.8.2018 | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/09/097 | 14.8.2018 |
| 9.8.2018 | Nobivac LeuFel | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/17/217 | 14.8.2018 |
| 20.8.2018 | BTVPUR | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/113 | 22.8.2018 |
| 20.8.2018 | CLYNAV | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/16/197 | 22.8.2018 |
| 20.8.2018 | Leucogen | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/09/096 | 22.8.2018 |
| 27.8.2018 | Prac-Tic | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/06/066 | 29.8.2018 |
| 27.8.2018 | Vectra 3D | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/13/156 | 29.8.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.8.2018

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

7.8.2018

3.8.2018

LETIFEND

Laboratorios LETI, S.L.unipersonal

C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España

EU/2/16/195

7.8.2018

3.8.2018

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

7.8.2018

3.8.2018

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

7.8.2018

9.8.2018

Leucofeligen FeLV/RCP

Virbac

1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France

EU/2/09/097

14.8.2018

9.8.2018

Nobivac LeuFel

Virbac

1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France

EU/2/17/217

14.8.2018

20.8.2018

BTVPUR

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/113

22.8.2018

20.8.2018

CLYNAV

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

22.8.2018

20.8.2018

Leucogen

Virbac

1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France

EU/2/09/096

22.8.2018

27.8.2018

Prac-Tic

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/06/066

29.8.2018

27.8.2018

Vectra 3D

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/13/156

29.8.2018

| — | Withdrawal of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 20.8.2018 | Gripovac 3 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/09/102 | 22.8.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

20.8.2018

Gripovac 3

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/09/102

22.8.2018

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

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

---

| 28.9.2018 | EN | Official Journal of the European Union | C 349/14 |
| --- | --- | --- | --- |

28.9.2018

EN

Official Journal of the European Union

C 349/14

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018

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

(2018/C 349/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 2.8.2018 | Scandonest and associated names | mepivacaine | See Annex | See Annex | 3.8.2018 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

2.8.2018

Scandonest and associated names

mepivacaine

See Annex

See Annex

3.8.2018

---

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

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

---

ANNEX

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Septodont GmbH
  Felix-Wankel-Str. 9
  53859 Niederkassel-Mondorf
  Germany | SCANDONEST 3 % OHNE VASOKONSTRIKTOR — ZYLINDERAMPULLEN | 3 % | Solution for injection | Dental use | 30 mg/ml |
| Belgium | Septodont NV-SA
  87 Avenue de la Constitution
  B-1083 Bruxelles
  Belgium | SCANDONEST 3 % SANS VASOCONSTRICTEUR | 3 % | Solution for injection | Dental use | 30 mg/ml |
| Bulgaria | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Solution for injection | Dental use | 30 mg/ml |
| Croatia | Apolonia d.o.o.
  Dubrova 308
  52220 Labin
  Croatia | SCANDONEST 30 mg/ml otopina za injekciju | 30 mg/ml | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Denmark | Spécialités Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Estonia | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Solution for injection in cartridge | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Finland | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Solution for injection | Dental use | 30 mg/ml |
| France | Laboratoires Septodont
  58, rue du Pont de Créteil
  94107 Saint-Maur-des-Fossés Cedex
  France | SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE | 30 mg/ml | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Germany | Septodont GmbH
  Felix-Wankel-Str. 9
  53859 Niederkassel-Mondorf
  Germany | SCANDONEST 3 % OHNE VASOKONSTRIKTOR | 3 % | Solution for injection | Dental use
  Perineural use | 30 mg/ml |
| Greece | John Tsaprazis SA
  157 Michalakopoulou Str.
  11527, Athens
  Greece | SCANDONEST 3 % | 3 % | Solution for injection | Periodontal use | 30 mg/ml |
| Hungary | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Ireland | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 3 % W/V SOLUTION FOR INJECTION | 3 % | Solution for injection | Dental use | 30 mg/ml |
| Italy | Laboratoires Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 3 % without vasoconstrictor | Solution for injection | Dental use | 30 mg/ml |
| Latvia | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML ŠĶĪDUMS INJEKCIJĀM KĀRTRIDŽĀ | 30 mg/ml | Solution for injection in cartridge | Perineural use
  Submucosal use | 30 mg/ml |
| Lithuania | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise | 30 mg/ml | Solution for injection in cartridge | Infiltration
  Perineural use | 30 mg/ml |
| Luxembourg | Septodont NV-SA
  Grondwetlaan
  87 Avenue de la Constitution
  B-1083 Brussel
  Belgium | SCANDONEST 3 % SANS VASOCONSTRICTEUR | 3 % | Solution for injection | Dental use | 30 mg/ml |
| Malta | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Solution for injection | Dental use
  Perineural use
  Submucosal use
  Infiltration | 30 mg/ml |
| Netherlands | Septodont NV-SA
  Grondwetlaan
  87 Avenue de la Constitution
  B-1083 Brussel
  Belgium | SCANDONEST 3 % ZONDER VASOCONSTRICTOR | 3 % | Solution for injection | Perineural use | 30 mg/ml |
| Norway | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST PLAIN 30 MG/ML | 30 mg/ml | Solution for injection | Dental use | 30 mg/ml |
| Poland | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 mg/ml | 30 mg/ml | Solution for injection | Infiltration
  Perineural use | 30 mg/ml |
| Portugal | Septodont, S.A.S.
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Solution for injection | Gingival use | 30 mg/ml |
| Romania | Laboratoires Septodont
  58, rue du Pont de Créteil
  94107 Saint-Maur-des-Fossés Cedex
  France | SCANDONEST 3 % PLAIN, SOLUŢIE INJECTABILĂ | 3 % | Solution for injection | Dental use | 30 mg/ml |
| Slovakia | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 3 % | 3 % | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |
| Slovenia | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDICAINE 30 MG/ML RAZTOPINA ZA INJICIRANJE | 30 mg/ml | Solution for injection | Dental use | 30 mg/ml |
| Spain | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE | 30 mg/ml | Solution for injection | Perineural use
  Infiltration | 30 mg/ml |
| Sweden | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | Scandonest | 30 mg/ml | Solution for injection | Dental use | 30 mg/ml |
| United Kingdom | Septodont Ltd
  Unit R & S
  Orchard Business Centre
  St Barnabas Close
  Allington Maidstone
  Kent ME16 OJZ
  England | SCANDONEST 3 % PLAIN
  BIOCAINE 3 % PLAIN | 3 % | Solution for injection | Dental use
  Perineural use
  Submucosal use | 30 mg/ml |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Septodont GmbH

Felix-Wankel-Str. 9

53859 Niederkassel-Mondorf

Germany

SCANDONEST 3 % OHNE VASOKONSTRIKTOR — ZYLINDERAMPULLEN

3 %

Solution for injection

Dental use

30 mg/ml

Belgium

Septodont NV-SA

87 Avenue de la Constitution

B-1083 Bruxelles

Belgium

SCANDONEST 3 % SANS VASOCONSTRICTEUR

3 %

Solution for injection

Dental use

30 mg/ml

Bulgaria

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Solution for injection

Dental use

30 mg/ml

Croatia

Apolonia d.o.o.

Dubrova 308

52220 Labin

Croatia

SCANDONEST 30 mg/ml otopina za injekciju

30 mg/ml

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

Denmark

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

Estonia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Solution for injection in cartridge

Dental use

Perineural use

Submucosal use

30 mg/ml

Finland

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Solution for injection

Dental use

30 mg/ml

France

Laboratoires Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des-Fossés Cedex

France

SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE

30 mg/ml

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

Germany

Septodont GmbH

Felix-Wankel-Str. 9

53859 Niederkassel-Mondorf

Germany

SCANDONEST 3 % OHNE VASOKONSTRIKTOR

3 %

Solution for injection

Dental use

Perineural use

30 mg/ml

Greece

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

SCANDONEST 3 %

3 %

Solution for injection

Periodontal use

30 mg/ml

Hungary

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

Ireland

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 3 % W/V SOLUTION FOR INJECTION

3 %

Solution for injection

Dental use

30 mg/ml

Italy

Laboratoires Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

3 % without vasoconstrictor

Solution for injection

Dental use

30 mg/ml

Latvia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML ŠĶĪDUMS INJEKCIJĀM KĀRTRIDŽĀ

30 mg/ml

Solution for injection in cartridge

Perineural use

Submucosal use

30 mg/ml

Lithuania

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise

30 mg/ml

Solution for injection in cartridge

Infiltration

Perineural use

30 mg/ml

Luxembourg

Septodont NV-SA

Grondwetlaan

87 Avenue de la Constitution

B-1083 Brussel

Belgium

SCANDONEST 3 % SANS VASOCONSTRICTEUR

3 %

Solution for injection

Dental use

30 mg/ml

Malta

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Solution for injection

Dental use

Perineural use

Submucosal use

Infiltration

30 mg/ml

Netherlands

Septodont NV-SA

Grondwetlaan

87 Avenue de la Constitution

B-1083 Brussel

Belgium

SCANDONEST 3 % ZONDER VASOCONSTRICTOR

3 %

Solution for injection

Perineural use

30 mg/ml

Norway

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST PLAIN 30 MG/ML

30 mg/ml

Solution for injection

Dental use

30 mg/ml

Poland

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 mg/ml

30 mg/ml

Solution for injection

Infiltration

Perineural use

30 mg/ml

Portugal

Septodont, S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Solution for injection

Gingival use

30 mg/ml

Romania

Laboratoires Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des-Fossés Cedex

France

SCANDONEST 3 % PLAIN, SOLUŢIE INJECTABILĂ

3 %

Solution for injection

Dental use

30 mg/ml

Slovakia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 3 %

3 %

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

Slovenia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDICAINE 30 MG/ML RAZTOPINA ZA INJICIRANJE

30 mg/ml

Solution for injection

Dental use

30 mg/ml

Spain

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE

30 mg/ml

Solution for injection

Perineural use

Infiltration

30 mg/ml

Sweden

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Scandonest

30 mg/ml

Solution for injection

Dental use

30 mg/ml

United Kingdom

Septodont Ltd

Unit R & S

Orchard Business Centre

St Barnabas Close

Allington Maidstone

Kent ME16 OJZ

England

SCANDONEST 3 % PLAIN

BIOCAINE 3 % PLAIN

3 %

Solution for injection

Dental use

Perineural use

Submucosal use

30 mg/ml

---