# C_2019218EN.01000801.xml

| 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

---