# Official Journal C 218/2019

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 218 |
| | |
| English edition | Information and Notices | Volume 6228 June 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 218

English edition

Information and Notices

Volume 6228 June 2019

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 218/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2019/C 218/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019  (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 218/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019  (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

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2019/C 218/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019  (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)

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.6.2019 | EN | Official Journal of the European Union | C 218/1 |
| --- | --- | --- | --- |

28.6.2019

EN

Official Journal of the European Union

C 218/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019

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

(2019/C 218/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.5.2019 | Palynziq | pegvaliase | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/19/1362 | Solution for injection | A16AB19 | 8.5.2019 |
| 3.5.2019 | Waylivra | volanesorsen | Akcea Therapeutics Ireland Limited
  Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland | EU/1/19/1360 | Solution for injection | Pending | 8.5.2019 |
| 6.5.2019 | Lorviqua | lorlatinib | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1355 | Film-coated tablet | L01XE44 | 8.5.2019 |
| 6.5.2019 | Pazenir | paclitaxel | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/18/1317 | Powder for dispersion for infusion | L01CD01 | 8.5.2019 |
| 29.5.2019 | Zynteglo | autologous CD34+ cells encoding βΑ-T87Q-globin gene | bluebird bio (Netherlands) B.V.
  Stadsplateau 7, 3521 AZ Utrecht, Nederland | EU/1/19/1367 | Dispersion for infusion | Pending | 4.6.2019 |

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

3.5.2019

Palynziq

pegvaliase

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

Solution for injection

A16AB19

8.5.2019

3.5.2019

Waylivra

volanesorsen

Akcea Therapeutics Ireland Limited

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/19/1360

Solution for injection

Pending

8.5.2019

6.5.2019

Lorviqua

lorlatinib

Pfizer Europe MA EEIG

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

EU/1/19/1355

Film-coated tablet

L01XE44

8.5.2019

6.5.2019

Pazenir

paclitaxel

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/18/1317

Powder for dispersion for infusion

L01CD01

8.5.2019

29.5.2019

Zynteglo

autologous CD34+ cells encoding βΑ-T87Q-globin gene

bluebird bio (Netherlands) B.V.

Stadsplateau 7, 3521 AZ Utrecht, Nederland

EU/1/19/1367

Dispersion for infusion

Pending

4.6.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 3.5.2019 | Clopidogrel Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 8.5.2019 |
| 3.5.2019 | Episalvan | Amryt AG
  Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland | EU/1/15/1069 | 8.5.2019 |
| 3.5.2019 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 8.5.2019 |
| 3.5.2019 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/12/806 | 8.5.2019 |
| 3.5.2019 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 8.5.2019 |
| 3.5.2019 | Yondelis | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 8.5.2019 |
| 6.5.2019 | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 9.5.2019 |
| 6.5.2019 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 8.5.2019 |
| 6.5.2019 | Ritonavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1242 | 9.5.2019 |
| 6.5.2019 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 8.5.2019 |
| 13.5.2019 | Ferriprox | Apotex B.V.
  Keizersgracht 311, 1016 EE, Amsterdam, Nederland | EU/1/99/108 | 15.5.2019 |
| 13.5.2019 | Imnovid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/13/850 | 15.5.2019 |
| 13.5.2019 | Mozobil | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/09/537 | 15.5.2019 |
| 13.5.2019 | Ozempic | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/17/1251 | 15.5.2019 |
| 13.5.2019 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 15.5.2019 |
| 13.5.2019 | Ratiograstim | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/08/444 | 15.5.2019 |
| 13.5.2019 | Revlimid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 15.5.2019 |
| 13.5.2019 | Tevagrastim | Teva GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/08/445 | 15.5.2019 |
| 16.5.2019 | Pemetrexed medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/15/1038 | 20.5.2019 |
| 16.5.2019 | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/672 | 20.5.2019 |
| 20.5.2019 | Bondronat | Atnahs Pharma Netherlands B.V.
  Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/96/012 | 22.5.2019 |
| 20.5.2019 | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 22.5.2019 |
| 20.5.2019 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 22.5.2019 |
| 20.5.2019 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, 4020 Linz, Österreich | EU/1/04/277 | 22.5.2019 |
| 22.5.2019 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 27.5.2019 |
| 22.5.2019 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1205 | 27.5.2019 |
| 22.5.2019 | Bonviva | Atnahs Pharma Netherlands B.V.
  Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/03/265 | 28.5.2019 |
| 22.5.2019 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 27.5.2019 |
| 22.5.2019 | Erbitux | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/04/281 | 27.5.2019 |
| 22.5.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 27.5.2019 |
| 22.5.2019 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 27.5.2019 |
| 27.5.2019 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1014 | 29.5.2019 |
| 27.5.2019 | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 29.5.2019 |
| 27.5.2019 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 29.5.2019 |
| 27.5.2019 | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 29.5.2019 |
| 27.5.2019 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 29.5.2019 |
| 27.5.2019 | Xermelo | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/17/1224 | 29.5.2019 |

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

3.5.2019

Clopidogrel Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

8.5.2019

3.5.2019

Episalvan

Amryt AG

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

8.5.2019

3.5.2019

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

8.5.2019

3.5.2019

Ryzodeg

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/806

8.5.2019

3.5.2019

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

8.5.2019

3.5.2019

Yondelis

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

8.5.2019

6.5.2019

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

9.5.2019

6.5.2019

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

8.5.2019

6.5.2019

Ritonavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1242

9.5.2019

6.5.2019

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

8.5.2019

13.5.2019

Ferriprox

Apotex B.V.

Keizersgracht 311, 1016 EE, Amsterdam, Nederland

EU/1/99/108

15.5.2019

13.5.2019

Imnovid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/13/850

15.5.2019

13.5.2019

Mozobil

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/537

15.5.2019

13.5.2019

Ozempic

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

15.5.2019

13.5.2019

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

15.5.2019

13.5.2019

Ratiograstim

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/444

15.5.2019

13.5.2019

Revlimid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/391

15.5.2019

13.5.2019

Tevagrastim

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445

15.5.2019

16.5.2019

Pemetrexed medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1038

20.5.2019

16.5.2019

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

20.5.2019

20.5.2019

Bondronat

Atnahs Pharma Netherlands B.V.

Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

EU/1/96/012

22.5.2019

20.5.2019

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

22.5.2019

20.5.2019

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

22.5.2019

20.5.2019

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, 4020 Linz, Österreich

EU/1/04/277

22.5.2019

22.5.2019

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

27.5.2019

22.5.2019

Blitzima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1205

27.5.2019

22.5.2019

Bonviva

Atnahs Pharma Netherlands B.V.

Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

EU/1/03/265

28.5.2019

22.5.2019

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

27.5.2019

22.5.2019

Erbitux

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/04/281

27.5.2019

22.5.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

27.5.2019

22.5.2019

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

27.5.2019

27.5.2019

Opdivo

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

29.5.2019

27.5.2019

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

29.5.2019

27.5.2019

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

29.5.2019

27.5.2019

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

29.5.2019

27.5.2019

Xeloda

Roche Registration GmbH

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

EU/1/00/163

29.5.2019

27.5.2019

Xermelo

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

29.5.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 13.5.2019 | Nonafact | Sanquin Plasma Products B.V.
  Plesmanlaan 125, 1066 CX Amsterdam, Nederland | EU/1/01/186 | 15.5.2019 |

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

13.5.2019

Nonafact

Sanquin Plasma Products B.V.

Plesmanlaan 125, 1066 CX Amsterdam, Nederland

EU/1/01/186

15.5.2019

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.5.2019 | Afoxolaner MERIAL | afoxolaner | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/19/240 | Chewable tablet | QP53BE01 | 22.5.2019 |
| 20.5.2019 | Baycox Iron | toltrazuril/gleptoferron | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/19/239 | Suspension for injection | QP51AJ51 | 22.5.2019 |

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

20.5.2019

Afoxolaner MERIAL

afoxolaner

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/19/240

Chewable tablet

QP53BE01

22.5.2019

20.5.2019

Baycox Iron

toltrazuril/gleptoferron

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/19/239

Suspension for injection

QP51AJ51

22.5.2019

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

—

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

| 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 |
| --- | --- | --- | --- | --- |
| 13.5.2019 | Horse Allo 20 | Centauri Biotech SL
  Calle Asunción SN - 1oIzq (Meicende — Arteixo), 15142 A Coruña, España | — | 15.5.2019 |

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

13.5.2019

Horse Allo 20

Centauri Biotech SL

Calle Asunción SN - 1oIzq (Meicende — Arteixo), 15142 A Coruña, España

—

15.5.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 13.5.2019 | Cortavance | VIRBAC S.A.
  1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/06/069 | 15.5.2019 |
| 27.5.2019 | Innovax-ND-IBD | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/17/213 | 29.5.2019 |
| 27.5.2019 | VEPURED | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/17/214 | 29.5.2019 |
| 29.5.2019 | Suvaxyn PCV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 4.6.2019 |
| 29.5.2019 | Versican Plus Pi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/173 | 4.6.2019 |

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

13.5.2019

Cortavance

VIRBAC S.A.

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

EU/2/06/069

15.5.2019

27.5.2019

Innovax-ND-IBD

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/213

29.5.2019

27.5.2019

VEPURED

Laboratorios Hipra, S.A.

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

EU/2/17/214

29.5.2019

29.5.2019

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

4.6.2019

29.5.2019

Versican Plus Pi/L4R

Zoetis Belgium S.A.

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

EU/2/14/173

4.6.2019

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

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

---

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 28.6.2019 | EN | Official Journal of the European Union | C 218/8 |
| --- | --- | --- | --- |

28.6.2019

EN

Official Journal of the European Union

C 218/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019

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

  )

(2019/C 218/02)

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 20.5.2019 | Closantel inj 50 mg | closantel | See Annex I | See Annex I | 21.5.2019 |
| 16.5.2019 | Syner-Kinase and associated names | urokinase | See Annex II | See Annex II | 17.5.2019 |
| 27.5.2019 | Septanest and associated names | articaine (hydrochloride)/adrenaline (tartrate) | See Annex III | See Annex III | 28.5.2019 |

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

20.5.2019

Closantel inj 50 mg

closantel

See Annex I

See Annex I

21.5.2019

16.5.2019

Syner-Kinase and associated names

urokinase

See Annex II

See Annex II

17.5.2019

27.5.2019

Septanest and associated names

articaine (hydrochloride)/adrenaline (tartrate)

See Annex III

See Annex III

28.5.2019

---

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

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

---

ANNEX I

List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Сантиола 50 mg/ml инжекционен разтвор за говеда и овце | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Bulgaria | Industrial Veterinaria, S.A
  Esmeralda 19
  Esplugues de Llobregat
  Barcelona 08950
  Spain | Роленол | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Croatia | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola, 50 mg/mL, otopina za injekciju, za goveda i ovce | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Czech Republic | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml injekční roztok pro skot a ovce | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Denmark | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola Vet | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Estonia | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| France | LILLY France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | FLUKIVER | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Hungary | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml oldatos injekció szarvasmarhák és juhok részére A.U.V. | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Ireland | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml solution for injection for cattle and sheep | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Latvia | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Lithuania | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml injekcinis tirpalas galvijams ir avims | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Romania | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Slovenia | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Spain | Laboratorios e Industrias Iven, S.A.
  Luis I, 56.
  Poligono Industrial Vallecas
  28031 Madrid
  Spain | Endoectiven | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Spain | CENAVISA, S.L.
  Cami Pedra Estela s/n
  Reus (Tarragona)
  43205
  Spain | TELCEN | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Spain | S.P. VETERINARIA, S.A.
  Ctra. Reus-Vinyols, KM.4,1
  Riudoms (Tarragona)
  43330
  Spain | ENDOEX 50 mg/ml SOLUCION INYECTABLE | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Spain | Industrial Veterinaria, S.A
  Esmeralda 19
  Esplugues de Llobregat
  Barcelona 08950
  Spain | ROLENOL | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| Sweden | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola vet. | Closantel | 50 mg/ml | solution for injection | cattle, sheep | sheep: subcutaneous |
| United Kingdom | KRKA d.d.
  Šmarješka cesta 6
  Novo mesto
  8501
  Slovenia | Santiola 50 mg/ml Solution for Injection for Cattle and Sheep | Closantel | 50 mg/ml | solution for injection | sheep | sheep: subcutaneous |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Bulgaria

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Сантиола 50 mg/ml инжекционен разтвор за говеда и овце

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Bulgaria

Industrial Veterinaria, S.A

Esmeralda 19

Esplugues de Llobregat

Barcelona 08950

Spain

Роленол

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Croatia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola, 50 mg/mL, otopina za injekciju, za goveda i ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Czech Republic

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml injekční roztok pro skot a ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Denmark

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola Vet

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Estonia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

France

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

FLUKIVER

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Hungary

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml oldatos injekció szarvasmarhák és juhok részére A.U.V.

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Ireland

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml solution for injection for cattle and sheep

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Latvia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Lithuania

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml injekcinis tirpalas galvijams ir avims

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Romania

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Slovenia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

Laboratorios e Industrias Iven, S.A.

Luis I, 56.

Poligono Industrial Vallecas

28031 Madrid

Spain

Endoectiven

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

CENAVISA, S.L.

Cami Pedra Estela s/n

Reus (Tarragona)

43205

Spain

TELCEN

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

S.P. VETERINARIA, S.A.

Ctra. Reus-Vinyols, KM.4,1

Riudoms (Tarragona)

43330

Spain

ENDOEX 50 mg/ml SOLUCION INYECTABLE

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

Industrial Veterinaria, S.A

Esmeralda 19

Esplugues de Llobregat

Barcelona 08950

Spain

ROLENOL

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Sweden

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola vet.

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

United Kingdom

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml Solution for Injection for Cattle and Sheep

Closantel

50 mg/ml

solution for injection

sheep

sheep: subcutaneous

---

ANNEX II

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| France | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 10,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| France | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 25,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| France | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 100,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| France | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 250,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| France | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 500,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Germany | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 10,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Germany | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 25,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Germany | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 100,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Germany | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 250,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Germany | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 500,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| The Netherlands | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Urokinase Devrimed 10.000 IE, poeder voor oplossing voor injectie/infusie | 10,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| The Netherlands | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Urokinase Devrimed 25.000 IE, poeder voor oplossing voor injectie/infusie | 25,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| The Netherlands | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Urokinase Devrimed 100.000 IE, poeder voor oplossing voor injectie/infusie | 100,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| The Netherlands | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Urokinase Devrimed 250.000 IE, poeder voor oplossing voor injectie/infusie | 250,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| The Netherlands | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Urokinase Devrimed 500.000 IE, poeder voor oplossing voor injectie/infusie | 500,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Spain | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 10,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Spain | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 25,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Spain | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 100,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Spain | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 250,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| Spain | | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | Syner-KINASE | 500,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| United Kingdom | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | | Syner-KINASE | 10,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| United Kingdom | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | | Syner-KINASE | 25,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| United Kingdom | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | | Syner-KINASE | 100,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| United Kingdom | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | | Syner-KINASE | 250,000 IU | Powder for solution for injection/infusion | Intravenous Use |
| United Kingdom | Syner-Medica Ltd
  Syner-Med House,
  120 High Street,
  Purley, Surrey,
  CR8 2AD,
  United Kingdom | | Syner-KINASE | 500,000 IU | Powder for solution for injection/infusion | Intravenous Use |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 10.000 IE, poeder voor oplossing voor injectie/infusie

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 25.000 IE, poeder voor oplossing voor injectie/infusie

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 100.000 IE, poeder voor oplossing voor injectie/infusie

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 250.000 IE, poeder voor oplossing voor injectie/infusie

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 500.000 IE, poeder voor oplossing voor injectie/infusie

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

---

ANNEX III

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 |
| D - 53859 Niederkassel-Mondorf |
| Germany |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Septodont GmbH

Felix-Wankel-Str. 9

D - 53859 Niederkassel-Mondorf

Germany

Septanest mit Epinephrin 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Austria

| Septodont GmbH |
| --- |
| Felix-Wankel-Str. 9 |
| D - 53859 Niederkassel-Mondorf |
| Germany |

Septodont GmbH

Felix-Wankel-Str. 9

D - 53859 Niederkassel-Mondorf

Germany

Septanest mit Epinephrin 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Belgium

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Normal

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Belgium

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Special

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Bulgaria

| Laboratories Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-des- Fossés Cedex |
| France |

Laboratories Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des- Fossés Cedex

France

Септанест с Адреналин 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Bulgaria

| Laboratories Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-des- Fossés Cedex |
| France |

Laboratories Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des- Fossés Cedex

France

Септанест с Адреналин 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Croatia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Croatia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Cyprus

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Cyprus

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Czech Republic

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des- Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des- Fossés

France

Septanest s adrenalinem 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Czech Republic

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des- Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des- Fossés

France

Septanest s adrenalinem 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Denmark

| Spécialités Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Denmark

| Spécialités Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Estonia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Estonia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Finland

| Specialites Septodont. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Specialites Septodont.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 5 microg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 5 microg/ml

Finland

| Specialites Septodont. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Specialites Septodont.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine Forte

40 mg/ml + 10 microg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 10 microg/ml

France

| Septodont SAS |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-Des-Fossés Cedex |
| France |

Septodont SAS

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septanest 40 mg/ml Adrenalinée au 1/200 000 , solution injectable à usage dentaire

40 mg/ml + 0,005 mg/ml

Solution for injection

Local or regional injection intra-oral

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

adrénaline (tartrate d’): non précisé

France

| Septodont S.A.S. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/200 000 , solution injectable

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use in the oral cavity

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

adrénaline (tartrate d’): non précisé

France

| Septodont SAS |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-Des-Fossés Cedex |
| France |

Septodont SAS

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septanest 40 mg/ml Adrenalinée au 1/100 000 , solution injectable à usage dentaire

40 mg/ml + 0,01 mg/ml

Solution for injection

Local or regional injection intra-oral

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

adrénaline (tartrate d’): non précisé

France

| Septodont S.A.S. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/100 000 , solution injectable

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use in the oral cavity

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

adrénaline (tartrate d’): non précisé

Germany

| Septodont GmbH |
| --- |
| Felix-Wankel-Str. 9 |
| D-53859 Niederkassel |
| Germany |

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Epinephrin 1:200 000 - 40 mg/ml + 0,005 mg/ml Injektionslösung

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Germany

| Septodont GmbH |
| --- |
| Felix-Wankel-Str. 9 |
| D-53859 Niederkassel |
| Germany |

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Adrenalin 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Germany

| Septodont GmbH |
| --- |
| Felix-Wankel-Str. 9 |
| D-53859 Niederkassel |
| Germany |

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Epinephrin 1:100 000 - 40 mg/ml + 0,01 mg/ml Injektionslösung

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Germany

| Septodont GmbH |
| --- |
| Felix-Wankel-Str. 9 |
| D-53859 Niederkassel |
| Germany |

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Adrenalin 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Greece

| John Tsaprazis SA |
| --- |
| 157 Michalakopoulou Str. |
| 11527, Athens |
| Greece |

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

Septanest Ενέσιμο διάλυμα 4 % + 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration

Periodontal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Greece

| John Tsaprazis SA |
| --- |
| 157 Michalakopoulou Str. |
| 11527, Athens |
| Greece |

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

Septanest Ενέσιμο διάλυμα 4 % + 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration

Periodontal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Hungary

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Italy

| Spécialités Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Spécialités Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Italy

| Spécialités Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Spécialités Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Latvia

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| Francija |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

Francija

Septanest 40 mg/5 mikrogrami/ml šķīdums injekcijām kārtridžā

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Latvia

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| Francija |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

Francija

Septanest Forte 40 mg/10 mikrogrami/ml šķīdums injekcijām kārtridžā

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Lithuania

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Lithuania

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Luxembourg

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest-N 1*200.000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Luxembourg

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Adrenaline 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Malta

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest with adrenaline 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Malta

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest with adrenaline 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Netherlands

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest N

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Netherlands

| Septodont Nv-Sa |
| --- |
| 87 Avenue de la Constitution |
| B-1083 Brussel |
| Belgium |

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest SP

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Norway

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-Des-Fossés Cedex |
| France |

Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septocaine

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Norway

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94107 Saint-Maur-Des-Fossés Cedex |
| France |

Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septocaine Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Poland

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Z Adrenaliną 1: 200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Poland

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Z Adrenaliną 1: 100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Portugal

| Septodont S.A.S. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest 1/200 000

68 mg/1.7 ml + 0.015 mg/1.7 ml

Solução injetável

Via bucal

Articaína, cloridrato 40 mg/ml

Adrenalina, tartarato 0,0091 mg/ml

Portugal

| Septodont S.A.S. |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest 1/100 000

68 mg/1.7 ml + 0.031 mg/1.7 ml

Solução injetável

Via bucal

Articaína, cloridrato 40 mg/ml

Adrenalina, tartarato 0,0182 mg/ml

Romania

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Cu Adrenalină 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Romania

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Cu Adrenalină 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Slovak Republic

| Septodont |
| --- |
| 58, rue du Pont de Créteil, |
| 94100 Saint-Maur-Des-Fossés, |
| France |

Septodont

58, rue du Pont de Créteil,

94100 Saint-Maur-Des-Fossés,

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Slovak Republic

| Septodont |
| --- |
| 58, rue du Pont de Créteil, |
| 94100 Saint-Maur-Des-Fossés, |
| France |

Septodont

58, rue du Pont de Créteil,

94100 Saint-Maur-Des-Fossés,

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Slovenia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanestepi 40 mg/0,005 mg v 1 ml raztopina za injiciranje

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Slovenia

| Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanestepi 40 mg/0,01 mg v 1 ml raztopina za injiciranje

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Spain

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest con adrenalina 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline bitartrate 0,005 mg/ml

Spain

| Septodont |
| --- |
| 58 rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest con adrenalina 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline bitartrate 0,01 mg/ml

Sweden

| Specialites Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Specialites Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Sweden

| Specialites Septodont |
| --- |
| 58, rue du Pont de Créteil |
| 94100 Saint-Maur-des-Fossés |
| France |

Specialites Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

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