# C_2013093EN.01000801.xml

| 28.3.2013 | EN | Official Journal of the European Union | C 93/8 |
| --- | --- | --- | --- |

28.3.2013

EN

Official Journal of the European Union

C 93/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2013/C 93/02

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.2.2013 | Quixil | See Annex I | See Annex I | 22.2.2013 |
| 13.2.2013 | Calcitonin | See Annex II | See Annex II | 14.2.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.2.2013

Quixil

See Annex I

See Annex I

22.2.2013

13.2.2013

Calcitonin

See Annex II

See Annex II

14.2.2013

—   Refusal of a national marketing authorization

Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 12.2.2013 | Melosolute 40 mg/ml solution for injection for cattle, pigs and horses | See Annex III | See Annex III | 14.2.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

12.2.2013

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

See Annex III

See Annex III

14.2.2013

—   Suspension of a national marketing authorization

Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.2.2013 | Fenofibrato Pensa, Fenofibrato Ranbaxy | See Annex IV | See Annex IV | 22.2.2013 |
| 13.2.2013 | Calcitonin | See Annex II | See Annex II | 14.2.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.2.2013

Fenofibrato Pensa, Fenofibrato Ranbaxy

See Annex IV

See Annex IV

22.2.2013

13.2.2013

Calcitonin

See Annex II

See Annex II

14.2.2013

---

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

1

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

2

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Omrix Biopharmaceuticals S.A., |
| Chaussee de Waterloo 200, |
| B-1640 Rhode-St-Genese |
| Belgium |

Member State

(in EEA)

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Denmark

Omrix Biopharmaceuticals S.A.,

Chaussee de Waterloo 200,

B-1640 Rhode-St-Genese

Belgium

Quixil

Fibronectin, human: 30 mg

Human fibrinogen: 30 mg

Arginine hydrochloride 19 mg

Acidum tranexamicum 95 mg

Glycine 7,9 mg

Sodium chloride 7 mg

Solution for sealant

Intralesional use

France

| OMRIX Biopharmaceuticals S.A. |
| --- |
| Chaussée de Waterloo 200 |
| 1640 Rhode-St-Genèse |
| Belgium |

OMRIX Biopharmaceuticals S.A.

Chaussée de Waterloo 200

1640 Rhode-St-Genèse

Belgium

QUIXIL solution for sealant

1st Component (BAC)

Fibrinogen-Fibronectin 40-60 mg/ml

Tranexamic acid 85-105 mg/ml

2nd Component (Thrombin)

Thrombin 800-1 200 IU/ml

Calcium chloride 5,6-6,2 mg/ml

Solution for sealant

Epilesional use

Italy

| OMRIX Biopharmaceuticals S.A. |
| --- |
| Chaussée de Waterloo 200 |
| 1640 Rhode-St-Genèse |
| Belgium |

OMRIX Biopharmaceuticals S.A.

Chaussée de Waterloo 200

1640 Rhode-St-Genèse

Belgium

QUIXIL

Fibrinogen and Fibronectin: 40-60 mg/ml

Tranexamic acid: 85-105 mg/ml

Thrombin: 800-1 200 IU/ml

Calcium Chloride: 5,6-6,2 mg/ml

Solution for sealant

Epilesional use

United Kingdom

| Omrix Biopharmaceuticals S.A., |
| --- |
| Chaussee de Waterloo 200, |
| B-1640 Rhode-St-Genese |
| Belgium |

Omrix Biopharmaceuticals S.A.,

Chaussee de Waterloo 200,

B-1640 Rhode-St-Genese

Belgium

Quixil

Clottable protein conc: 50 mg/ml

Thrombin: 1 000 IU/ml

Calcium chloride: 5,9 mg/ml

Tranexamic acid: 95 mg/ml

Solution for sealant

Epilesional use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State in EEA | Marketing authorisaton holder | Product Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| A-1020 Wien, |
| Austria |

Member State in EEA

Marketing authorisaton holder

Product Name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A-1020 Wien,

Austria

Calcitonin ‘Novartis’ 100 I.E./ml - Lösung zur Injektion und Infusion

100 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| A-1020 Wien, |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A-1020 Wien,

Austria

Calcitonin ‘Novartis’ 50 I.E./ml - Lösung zur Injektion und Infusion

50 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| A-1020 Wien, |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A-1020 Wien,

Austria

Calcitonin ‘Novartis’ 100 I.E. - Nasalspray

100 IU/ml

nasal spray, solution

nasal use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| A-1020 Wien, Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A-1020 Wien, Austria

Calcitonin ‘Novartis’ 200 I.E. - Nasalspray

200 IU/ml

nasal spray, solution

nasal use

Austria

UCB Pharma GmbH Geiselbergstraße 17-19/2, 5.Stock 1110 Wien, Austria

Ucecal 100 I.E. - Nasalspray

100 IU/ml

nasal spray, solution

nasal use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma NV

Medialaan 40

1800 Vilvoorde

Belgium

Miacalcic

50 IU/0,5 ml

solution for injection/infusion

subcutaneous use, intramuscular use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma NV

Medialaan 40

1800 Vilvoorde

Belgium

Miacalcic

100 IU/2 ml

nasal spray, solution

nasal use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma NV

Medialaan 40

1800 Vilvoorde

Belgium

Miacalcic

200 IU/2 ml

nasal spray, solution

nasal use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma NV

Medialaan 40

1800 Vilvoorde

Belgium

Miacalcic

100 IE/1 ml

solution for injection

subcutaneous use, intramuscular use

Belgium

| Novartis Pharma NV |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma NV

Medialaan 40

1800 Vilvoorde

Belgium

Miacalcic

50 IU/0,5 ml

solution for injection

subcutaneous use, intramuscular use

Belgium

| Nycomed Belgium sca/cva |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

Nycomed Belgium sca/cva

Gentsesteenweg 615

1080 Brussels

Belgium

Steocalcin

100 IU

solution for injection

subcutaneous use, intramuscular use, intravenous use

Belgium

| Nycomed Belgium sca/cva |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

Nycomed Belgium sca/cva

Gentsesteenweg 615

1080 Brussels

Belgium

Steocalcin

100 IU

pre-filled syringe

subcutaneous use, intramuscular use, intravenous use

Belgium

| Nycomed Belgium sca/cva |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

Nycomed Belgium sca/cva

Gentsesteenweg 615

1080 Brussels

Belgium

Steocalcin

50 IU

pre-filled syringe

subcutaneous use, intramuscular use, intravenous use

Belgium

| Nycomed Belgium sca/cva |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

Nycomed Belgium sca/cva

Gentsesteenweg 615

1080 Brussels

Belgium

Steocalcin

50 IU

solution for injection

subcutaneous use, intramuscular use, intravenous use

Belgium

| Nycomed Belgium sca/cva |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

Nycomed Belgium sca/cva

Gentsesteenweg 615

1080 Brussels

Belgium

Steocalcin

100 IU

nasal spray, solution

nasal use

Bulgaria

Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany

Miacalcic Nasal

200 IU/dose

nasal spray, solution

nasal use

Bulgaria

Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany

Miacalcic

100 IU/ml

solution for injection

intramuscular use, subcutaneous use

Cyprus

Novartis Pharmaceuticals UK Ltd, Frimley, Camberley, Surrey GU16 7SR, UK

Miacalcic nasal spray 200iu

200 IU

nasal spray, solution

nasal use

Czech Republic

| Novartis s.r.o. |
| --- |
| Pharma, Gemini, Budova B |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Pharma, Gemini, Budova B

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

MIACALCIC 100 I.U.INJEKCE

100 IU/ml

solution for injection/infusion

intravenous use, intramuscular use, subcutaneous use

Czech Republic

| Novartis s.r.o. |
| --- |
| Pharma, Gemini, Budova B |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Pharma, Gemini, Budova B

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

MIACALCIC 50 I.U.INJEKCE

50 IU/ml

solution for injection/infusion

intravenous use, intramuscular use, subcutaneous use

Czech Republic

| Novartis s.r.o. |
| --- |
| Pharma, Gemini, Budova B |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Pharma, Gemini, Budova B

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

MIACALCIC NASAL 200

200 IU/dose

nasal spray, solution

nasal use

Czech Republic

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00 Brno Czech republic |

Medicom International s.r.o.

Páteřní 7

635 00 Brno Czech republic

TONOCALCIN 200 I.U.NOSNÍ SPREJ

200 IU/dose, 2 000 IU/ML

nasal spray, solution

nasal use

Denmark

Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 Østerbro, Denmark

Miacalcic

100 IU/ml

solution for injection/infusion

intramuscular use, intravenous use, subcutaneous use

Denmark

Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 Østerbro, Denmark

Miacalcic Nasal

200 IU/dose

nasal spray, solution

nasal use

Finland

| Novartis Finland Oy Metsänneidonkuja 10 |
| --- |
| 02130 Espoo |
| Finland |

Novartis Finland Oy Metsänneidonkuja 10

02130 Espoo

Finland

Miacalcic

100 IU/ml

solution for injection

intravenous use subcutaneous use, intramuscular use

Finland

| Novartis Finland Oy Metsänneidonkuja 10 |
| --- |
| 02130 Espoo |
| Finland |

Novartis Finland Oy Metsänneidonkuja 10

02130 Espoo

Finland

Miacalcic Nasal

200 IU/dose

nasal spray, solution

nasal use

France

| Zambon France |
| --- |
| 13 rue René Jacques |
| 92138 Issy les Moulineaux Cedex - France |

Zambon France

13 rue René Jacques

92138 Issy les Moulineaux Cedex - France

Cadens

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Zambon France |
| --- |
| 13 rue René Jacques |
| 92138 Issy les Moulineaux Cedex - France |

Zambon France

13 rue René Jacques

92138 Issy les Moulineaux Cedex - France

Cadens

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Cediat Mediffusion |
| --- |
| 11 bis rue du Colisée |
| 75008 Paris - France |

Cediat Mediffusion

11 bis rue du Colisée

75008 Paris - France

Calcitonine Cédiat

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Cediat Mediffusion |
| --- |
| 11 bis rue du Colisée |
| 75008 Paris - France |

Cediat Mediffusion

11 bis rue du Colisée

75008 Paris - France

Calcitonine Cédiat

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Laboratoire Pharmy II |
| --- |
| Strategy center |
| 26 rue des Gaudines |
| 78100 Saint Germain en Laye - France |

Laboratoire Pharmy II

Strategy center

26 rue des Gaudines

78100 Saint Germain en Laye - France

Calcitonine Pharmy II

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Laboratoire Pharmy II |
| --- |
| Strategy center |
| 26 rue des Gaudines |
| 78100 Saint Germain en Laye - France |

Laboratoire Pharmy II

Strategy center

26 rue des Gaudines

78100 Saint Germain en Laye - France

Calcitonine Pharmy II

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Laboratoire Sandoz |
| --- |
| 49 avenue Georges Pompidou |
| 92300 Levallois-Perret - France |

Laboratoire Sandoz

49 avenue Georges Pompidou

92300 Levallois-Perret - France

Calcitonine Sandoz

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Sanofi Aventis France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris - France |

Sanofi Aventis France

1-13 boulevard Romain Rolland

75014 Paris - France

Calsyn

50 IU/0,5 ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Sanofi Aventis France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris - France |

Sanofi Aventis France

1-13 boulevard Romain Rolland

75014 Paris - France

Calsyn

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Novartis Pharma SAS |
| --- |
| 2-4 rue Lionel Terray |
| 92500 Rueil-Malmaison - France |

Novartis Pharma SAS

2-4 rue Lionel Terray

92500 Rueil-Malmaison - France

Cibacalcine

0,25 mg

powder and solvent for solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Novartis Pharma SAS |
| --- |
| 2-4 rue Lionel Terray |
| 92500 Rueil-Malmaison - France |

Novartis Pharma SAS

2-4 rue Lionel Terray

92500 Rueil-Malmaison - France

Cibacalcine

0,50 mg

powder and solvent for solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Novartis Pharma SAS |
| --- |
| 2-4 rue Lionel Terray |
| 92500 Rueil-Malmaison - France |

Novartis Pharma SAS

2-4 rue Lionel Terray

92500 Rueil-Malmaison - France

Miacalcic

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

France

| Zambon France |
| --- |
| 13 rue René Jacques |
| 92138 Issy les Moulineaux Cedex - France |

Zambon France

13 rue René Jacques

92138 Issy les Moulineaux Cedex - France

Staporos

50 IU/ml

solution for injection in pre-filled syringe

intramuscular use, intravenous use, subcutaneous use

France

| Zambon France |
| --- |
| 13 rue René Jacques |
| 92138 Issy les Moulineaux Cedex - France |

Zambon France

13 rue René Jacques

92138 Issy les Moulineaux Cedex - France

Staporos

100 IU/ml

solution for injection in pre-filled syringe

intramuscular use, intravenous use, subcutaneous use

France

| Zambon France |
| --- |
| 13 rue René Jacques |
| 92138 Issy les Moulineaux Cedex - France |

Zambon France

13 rue René Jacques

92138 Issy les Moulineaux Cedex - France

Staporos

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Germany

Karil 100 I.E. Injektionslösung

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Germany

Karil 200 I.E. Nasenspray

200 IU/dose

nasal spray, solution

nasal use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-CT 100 I.E./0,1 ml Nasenspray

100 IU/dose

nasal spray, solution

nasal use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-CT 100 I.E./ml Ampullen

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-CT 50 I.E./ml Ampullen

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Calcihexal 100

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Calcihexal 50

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |
| Germany |

mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Germany

Ostostabil 100 I.E.

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |
| Germany |

mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Germany

Ostostabil 50 I.E.

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-ratiopharm 100 I.E. Ampullen

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-ratiopharm 50 I.E. Ampullen

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Calcitonin-ratiopharm Nasenspray

100 IU/dose

nasal spray, solution

nasal use

Germany

| Rotexmedica GmbH Arzneimittelwerk |
| --- |
| Bunsenstr. 4 |
| D-22946 Trittau |
| Germany |

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

D-22946 Trittau

Germany

Calcitonin 100 I.E.- Rotexmedica

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| Rotexmedica GmbH Arzneimittelwerk |
| --- |
| Bunsenstr. 4 |
| D-22946 Trittau |
| Germany |

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

D-22946 Trittau

Germany

Calcitonin 50 I.E.- Rotexmedica

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Calcitonin Sandoz 100 I.E./Sprühstoß Nasenspray

100 IU/dose

nasal spray, solution

nasal use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Calcitonin Stada 100 I.E. Injektionslösung

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Calcitonin Stada 50 I.E. Injektionslösung

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Germany

Osteos 100 I.E./ml

100 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Germany

Osteos 50 I.E./ml

50 IU/1 ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway |
| Metamorfosi Attikis 14451 |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway

Metamorfosi Attikis 14451

MIACALCIC

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway |
| Metamorfosi Attikis 14452 |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway

Metamorfosi Attikis 14452

MIACALCIC

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| RAFARM A.E.B.E. |
| --- |
| KORINTHOU 12, NEO PSYCHIKO 15451 |

RAFARM A.E.B.E.

KORINTHOU 12, NEO PSYCHIKO 15451

ALICITONIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| NOVENDIA PHARMACEUTICALS LTD |
| --- |
| HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION |

NOVENDIA PHARMACEUTICALS LTD

HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION

NYLEX

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| NOVENDIA PHARMACEUTICALS LTD |
| --- |
| HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION |

NOVENDIA PHARMACEUTICALS LTD

HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION

NYLEX

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| NOVENDIA PHARMACEUTICALS LTD |
| --- |
| HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION |

NOVENDIA PHARMACEUTICALS LTD

HERAKLEIOU AVENUE 425 AND OLYMPIAS 28, NEO HERAKELION

NYLEX

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| IASIS PHARMACEUTICALS |
| --- |
| FYLIS AVENUE 137, KAMATERO 13451 |

IASIS PHARMACEUTICALS

FYLIS AVENUE 137, KAMATERO 13451

CALCO

100 IU/1ML AMP

solution for injection

intramuscular use, subcutaneous use

Greece

| IASIS PHARMACEUTICALS |
| --- |
| FYLIS AVENUE 137, KAMATERO 13452 |

IASIS PHARMACEUTICALS

FYLIS AVENUE 137, KAMATERO 13452

CALCO

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| IASIS PHARMACEUTICALS |
| --- |
| FYLIS AVENUE 137, KAMATERO 13453 |

IASIS PHARMACEUTICALS

FYLIS AVENUE 137, KAMATERO 13453

CALCO

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| SYGGROU AVENUE 348, BUILDING A |
| KALITHEA 17674 |

SANOFI-AVENTIS AEBE

SYGGROU AVENUE 348, BUILDING A

KALITHEA 17674

CALSYNAR

100 IU/1ML AMP

solution for injection

intramuscular use, subcutaneous use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| SYGGROU AVENUE 348, BUILDING A |
| KALITHEA 17674 |

SANOFI-AVENTIS AEBE

SYGGROU AVENUE 348, BUILDING A

KALITHEA 17674

CALSYNAR

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| SYGGROU AVENUE 348, BUILDING A |
| KALITHEA 17674 |

SANOFI-AVENTIS AEBE

SYGGROU AVENUE 348, BUILDING A

KALITHEA 17674

CALSYNAR

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMANEL LTD |
| --- |
| MARATHONOS 106 |
| GERAKAS ATTIKIS 15344 |

PHARMANEL LTD

MARATHONOS 106

GERAKAS ATTIKIS 15344

TOSICALCIN

100 IU/1ML AMP

solution for injection

intramuscular use, subcutaneous use

Greece

| PHARMANEL LTD |
| --- |
| MARATHONOS 106 |
| GERAKAS ATTIKIS 15344 |

PHARMANEL LTD

MARATHONOS 106

GERAKAS ATTIKIS 15344

TOSICALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMANEL LTD |
| --- |
| MARATHONOS 106 |
| GERAKAS ATTIKIS 15344 |

PHARMANEL LTD

MARATHONOS 106

GERAKAS ATTIKIS 15344

TOSICALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| GENEPHARM SA |
| --- |
| 18TH KM MARATHONOS AVENUE |
| PALLINI ATTIKIS 15351 |

GENEPHARM SA

18TH KM MARATHONOS AVENUE

PALLINI ATTIKIS 15351

GENECALCIN

100 IU/1ML AMP

solution for injection

intramuscular use, subcutaneous use

Greece

| GENEPHARM SA |
| --- |
| 18TH KM MARATHONOS AVENUE |
| PALLINI ATTIKIS 15352 |

GENEPHARM SA

18TH KM MARATHONOS AVENUE

PALLINI ATTIKIS 15352

GENECALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| GENEPHARM SA |
| --- |
| 18TH KM MARATHONOS AVENUE |
| PALLINI ATTIKIS 15353 |

GENEPHARM SA

18TH KM MARATHONOS AVENUE

PALLINI ATTIKIS 15353

GENECALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES |
| --- |
| ACHAIAS AND TRIZOINIAS |
| NEA KIFISSIA 14564 |

FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA 14564

TONOCALCIN

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES |
| --- |
| ACHAIAS AND TRIZOINIAS |
| NEA KIFISSIA 14566 |

FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA 14566

TONOCALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARMEDIA SA |
| --- |
| ATHINAS 22 AND APOLLONOS |
| GERAKAS ATTIKIS 15344 |

FARMEDIA SA

ATHINAS 22 AND APOLLONOS

GERAKAS ATTIKIS 15344

OSTIFIX

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARMEDIA SA |
| --- |
| ATHINAS 22 AND APOLLONOS |
| GERAKAS ATTIKIS 15345 |

FARMEDIA SA

ATHINAS 22 AND APOLLONOS

GERAKAS ATTIKIS 15345

OSTIFIX

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ANFARM HELLAS |
| --- |
| PERIKLEOUS 53-57 |
| ATHENS |

ANFARM HELLAS

PERIKLEOUS 53-57

ATHENS

MIADENIL

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| ANFARM HELLAS |
| --- |
| PERIKLEOUS 53-57 |
| ATHENS |

ANFARM HELLAS

PERIKLEOUS 53-57

ATHENS

MIADENIL

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| BIOMEDICA-CHEMICA S.A |
| --- |
| G. LYRA 25, KIFISSIA |

BIOMEDICA-CHEMICA S.A

G. LYRA 25, KIFISSIA

NORCALCIN

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| BIOMEDICA-CHEMICA S.A |
| --- |
| G. LYRA 25, KIFISSIA |

BIOMEDICA-CHEMICA S.A

G. LYRA 25, KIFISSIA

NORCALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| BIOMEDICA-CHEMICA S.A |
| --- |
| G. LYRA 25, KIFISSIA |

BIOMEDICA-CHEMICA S.A

G. LYRA 25, KIFISSIA

NORCALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| NYCOMED HELLAS S.A. |
| --- |
| KIFISSIAS AVENUE 196, HALANDRI 15231 |

NYCOMED HELLAS S.A.

KIFISSIAS AVENUE 196, HALANDRI 15231

NEOSTESIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| NYCOMED HELLAS S.A. |
| --- |
| KIFISSIAS AVENUE 196, HALANDRI 15232 |

NYCOMED HELLAS S.A.

KIFISSIAS AVENUE 196, HALANDRI 15232

NEOSTESIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| KLEVA AFBEE |
| --- |
| PARNITHOS AVENUE 189, ACHARNES ATTIKIS 13675 |

KLEVA AFBEE

PARNITHOS AVENUE 189, ACHARNES ATTIKIS 13675

ALCITON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| KLEVA AFBEE |
| --- |
| PARNITHOS AVENUE 189, ACHARNES ATTIKIS 13676 |

KLEVA AFBEE

PARNITHOS AVENUE 189, ACHARNES ATTIKIS 13676

ALCITON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| RAFARM A.E.B.E. |
| --- |
| KORINTHOU 12, NEO PSYCHIKO 15451 |

RAFARM A.E.B.E.

KORINTHOU 12, NEO PSYCHIKO 15451

RAFACALCIN

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| RAFARM A.E.B.E. |
| --- |
| KORINTHOU 12, NEO PSYCHIKO 15452 |

RAFARM A.E.B.E.

KORINTHOU 12, NEO PSYCHIKO 15452

RAFACALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| RAFARM A.E.B.E. |
| --- |
| KORINTHOU 12, NEO PSYCHIKO 15453 |

RAFARM A.E.B.E.

KORINTHOU 12, NEO PSYCHIKO 15453

RAFACALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ELPEN SA PHARMACEUTICAL INDUSTRY |
| --- |
| MARATHONOS AVENUE 95 |
| PIKERMI ATTIKIS 19009 |

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI ATTIKIS 19009

TENDOLON

50 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| ELPEN SA PHARMACEUTICAL INDUSTRY |
| --- |
| MARATHONOS AVENUE 95 |
| PIKERMI ATTIKIS 19009 |

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI ATTIKIS 19009

TENDOLON

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| ELPEN SA PHARMACEUTICAL INDUSTRY |
| --- |
| MARATHONOS AVENUE 95 |
| PIKERMI ATTIKIS 19009 |

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI ATTIKIS 19009

TENDOLON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| ELPEN SA PHARMACEUTICAL INDUSTRY |
| --- |
| MARATHONOS AVENUE 95 |
| PIKERMI ATTIKIS 19009 |

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI ATTIKIS 19009

TENDOLON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ROTTAPHARM HELLAS |
| --- |
| ACHAIAS AND TRIZOINIAS |
| NEA KIFISSIA 14564 |

ROTTAPHARM HELLAS

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA 14564

LATONINA

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| ROTTAPHARM HELLAS |
| --- |
| ACHAIAS AND TRIZOINIAS |
| NEA KIFISSIA 14564 |

ROTTAPHARM HELLAS

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA 14564

LATONINA

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| AURORA PHARMACEUTICALS SA |
| --- |
| EVROU 4 AND MESSINIAS 2 |
| GERAKAS 15344 |

AURORA PHARMACEUTICALS SA

EVROU 4 AND MESSINIAS 2

GERAKAS 15344

CROCALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| AURORA PHARMACEUTICALS SA |
| --- |
| EVROU 4 AND MESSINIAS 2 |
| GERAKAS 15344 |

AURORA PHARMACEUTICALS SA

EVROU 4 AND MESSINIAS 2

GERAKAS 15344

CROCALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| VOCATE PHARMACEUTICALS SA |
| --- |
| GOUNARI 150, |
| GLYFADA 16674 |

VOCATE PHARMACEUTICALS SA

GOUNARI 150,

GLYFADA 16674

IRICALCIN

100 IU/1ML AMP

solution for injection

intramuscular use, subcutaneous use

Greece

| VOCATE PHARMACEUTICALS SA |
| --- |
| GOUNARI 150, |
| GLYFADA 16674 |

VOCATE PHARMACEUTICALS SA

GOUNARI 150,

GLYFADA 16674

IRICALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| VOCATE PHARMACEUTICALS SA |
| --- |
| GOUNARI 150, |
| GLYFADA 16674 |

VOCATE PHARMACEUTICALS SA

GOUNARI 150,

GLYFADA 16674

IRICALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ADEPHARM |
| --- |
| MARNI 54 |
| ATHENS |

ADEPHARM

MARNI 54

ATHENS

SALMOTEN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| BELKA HELLAS |
| --- |
| KAPODISTRIOU AND KORINTHOU 12 |
| NEO PSYCHIKO 15451 |

BELKA HELLAS

KAPODISTRIOU AND KORINTHOU 12

NEO PSYCHIKO 15451

VELKACALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| BELKA HELLAS |
| --- |
| KAPODISTRIOU AND KORINTHOU 12 |
| NEO PSYCHIKO 15451 |

BELKA HELLAS

KAPODISTRIOU AND KORINTHOU 12

NEO PSYCHIKO 15451

VELKACALCIN

100 IU/1ML AMP

solution for injection

intramuscular use

Greece

| BROS LTD |
| --- |
| AYGIS AND GALINIS 15 |
| KIFISSIA |

BROS LTD

AYGIS AND GALINIS 15

KIFISSIA

BROSIDON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| BROS LTD |
| --- |
| AYGIS AND GALINIS 15 |
| KIFISSIA |

BROS LTD

AYGIS AND GALINIS 15

KIFISSIA

BROSIDON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| BROS LTD |
| --- |
| AYGIS AND GALINIS 15 |
| KIFISSIA |

BROS LTD

AYGIS AND GALINIS 15

KIFISSIA

BROSIDON

100 IU/1ML AMP

solution for injection

intramuscular use

Greece

| EVAGGELOS KALOFOLIAS IAPHARM |
| --- |
| MENANDROU 54 |
| ATHENS 10431 |

EVAGGELOS KALOFOLIAS IAPHARM

MENANDROU 54

ATHENS 10431

ROTHRIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| EVAGGELOS KALOFOLIAS IAPHARM |
| --- |
| MENANDROU 54 |
| ATHENS 10431 |

EVAGGELOS KALOFOLIAS IAPHARM

MENANDROU 54

ATHENS 10431

ROTHRIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMATHEN ABEE |
| --- |
| DERVENAKION 6 |
| PALLINI ATTIKIS 15351 |

PHARMATHEN ABEE

DERVENAKION 6

PALLINI ATTIKIS 15351

CALCI-10

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMATHEN ABEE |
| --- |
| DERVENAKION 6 |
| PALLINI ATTIKIS 15351 |

PHARMATHEN ABEE

DERVENAKION 6

PALLINI ATTIKIS 15351

CALCI-10

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMANEL PHARMACEUTICALS SA |
| --- |
| MARATHONOS 106 |
| GERAKAS 15344 |

PHARMANEL PHARMACEUTICALS SA

MARATHONOS 106

GERAKAS 15344

AUROCALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMANEL PHARMACEUTICALS SA |
| --- |
| MARATHONOS 106 |
| GERAKAS 15344 |

PHARMANEL PHARMACEUTICALS SA

MARATHONOS 106

GERAKAS 15344

AUROCALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| VERISFIELD (UK) LTD, U.K. |
| --- |
| 41 Chalton street, |
| London, NW1 1JD, |
| United Kingdom |

VERISFIELD (UK) LTD, U.K.

41 Chalton street,

London, NW1 1JD,

United Kingdom

TRANSCALCIUM

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| VIVAX PHARMACEUTICALS LTD, DERVENAKION 38 |
| --- |
| GERAKAS 15344 |

VIVAX PHARMACEUTICALS LTD, DERVENAKION 38

GERAKAS 15344

CALCICONTROL

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| VIVAX PHARMACEUTICALS LTD, DERVENAKION 38 |
| --- |
| GERAKAS 15344 |

VIVAX PHARMACEUTICALS LTD, DERVENAKION 38

GERAKAS 15344

CALCICONTROL

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI ATTIKIS 144 52 |

HELP ABEE

VALAORITOU 10, METAMORFOSI ATTIKIS 144 52

MIOSER

100 IU/1ML AMP

solution for injection

intravenous use, intramuscular use, subcutaneous use

Greece

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI ATTIKIS 144 52 |

HELP ABEE

VALAORITOU 10, METAMORFOSI ATTIKIS 144 52

MOSER

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI ATTIKIS 144 52 |

HELP ABEE

VALAORITOU 10, METAMORFOSI ATTIKIS 144 52

MOSER

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| Vianex SA, Tatoiou street, |
| --- |
| 18th km Athens-Lamia National Road |
| 146 71 Nea Erythrea |
| Greece |

Vianex SA, Tatoiou street,

18th km Athens-Lamia National Road

146 71 Nea Erythrea

Greece

REDICALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| Vianex SA, Tatoiou street, |
| --- |
| 18th km Athens-Lamia National Road |
| 146 71 Nea Erythrea |
| Greece |

Vianex SA, Tatoiou street,

18th km Athens-Lamia National Road

146 71 Nea Erythrea

Greece

REDICALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| S.J.A. PHARM LTD |
| --- |
| ARKOLEON 11 |
| KATW PATISSIA |

S.J.A. PHARM LTD

ARKOLEON 11

KATW PATISSIA

ASSOCALS

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ARS MEDENDI KARANIKOLOPOULOS KARAMANLI |
| --- |
| VALAORITOU 7 |
| HALANDRI 15232 |

ARS MEDENDI KARANIKOLOPOULOS KARAMANLI

VALAORITOU 7

HALANDRI 15232

ARSIPOR

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| DOCTUM PHARMACEUTICALS |
| --- |
| 1ST KM PAIANIAS-MARKOPOULOU AVENUE |
| PAIANIA 19002 |

DOCTUM PHARMACEUTICALS

1ST KM PAIANIAS-MARKOPOULOU AVENUE

PAIANIA 19002

DOCTADRYLE

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| DOCTUM PHARMACEUTICALS |
| --- |
| 1ST KM PAIANIAS-MARKOPOULOU AVENUE |
| PAIANIA 19002 |

DOCTUM PHARMACEUTICALS

1ST KM PAIANIAS-MARKOPOULOU AVENUE

PAIANIA 19002

DOCTADRYLE

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| BIOSPRAY ABEE |
| --- |
| FAVIEROU STREET 39 |
| Athens 10438 |

BIOSPRAY ABEE

FAVIEROU STREET 39

Athens 10438

CALCITON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDITRINA LTD |
| --- |
| HERAKLEITOU 117 |
| HALANDRI 15238 |

MEDITRINA LTD

HERAKLEITOU 117

HALANDRI 15238

OSTOPLUS

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDITRINA LTD |
| --- |
| HERAKLEITOU 117 |
| HALANDRI 15238 |

MEDITRINA LTD

HERAKLEITOU 117

HALANDRI 15238

OSTOPLUS

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS |
| --- |
| 30TH KM ATHENS-LAVRION AVENUE |
| MARKOPOULO 19003 |

BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS

30TH KM ATHENS-LAVRION AVENUE

MARKOPOULO 19003

CALSAL

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS |
| --- |
| 30TH KM ATHENS-LAVRION AVENUE |
| MARKOPOULO 19003 |

BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS

30TH KM ATHENS-LAVRION AVENUE

MARKOPOULO 19003

CALSAL

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| LEOVAN M. LEON AND CO |
| --- |
| MENANDROU 54 |
| ATHENS 10432 |

LEOVAN M. LEON AND CO

MENANDROU 54

ATHENS 10432

OSIVAN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| LEOVAN M. LEON AND CO |
| --- |
| MENANDROU 54 |
| ATHENS 10432 |

LEOVAN M. LEON AND CO

MENANDROU 54

ATHENS 10432

OSIVAN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| MINERVA PHARMACEUTICALS SA |
| --- |
| KIFISSOU AVENUE 122 |
| PERISTERI 1231 |

MINERVA PHARMACEUTICALS SA

KIFISSOU AVENUE 122

PERISTERI 1231

NOPREMIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| REMEDINA ABEE |
| --- |
| GOUNARI 25 & AREOS |
| KAMATERO ATTIKIS 13451 |

REMEDINA ABEE

GOUNARI 25 & AREOS

KAMATERO ATTIKIS 13451

SAL-CAL

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| MED-ONE AFBEE |
| --- |
| AGIOU PETROU 30 AND EPAMEINONDA |
| ACHARNES 13675 |

MED-ONE AFBEE

AGIOU PETROU 30 AND EPAMEINONDA

ACHARNES 13675

LIXOCAM

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| MED-ONE AFBEE |
| --- |
| AGIOU PETROU 30 AND EPAMEINONDA |
| ACHARNES 13675 |

MED-ONE AFBEE

AGIOU PETROU 30 AND EPAMEINONDA

ACHARNES 13675

LIXOCAM

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| VOTANIA SA |
| --- |
| PEGASSOU 18 |
| PARADEISOS MAROUSSIOU 15125 |

VOTANIA SA

PEGASSOU 18

PARADEISOS MAROUSSIOU 15125

CALSATON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| VOTANIA SA |
| --- |
| PEGASSOU 18 |
| PARADEISOS MAROUSSIOU 15125 |

VOTANIA SA

PEGASSOU 18

PARADEISOS MAROUSSIOU 15125

CALSATON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ZWITTER PHARMACEUTICALS LTD |
| --- |
| PENTELIS AVENUE 34-36 |
| 15234 |

ZWITTER PHARMACEUTICALS LTD

PENTELIS AVENUE 34-36

15234

CALTEC

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| IAMATICA MON. LTD |
| --- |
| CHALANDRIOU 6A |
| AGIA PARASKEVI |

IAMATICA MON. LTD

CHALANDRIOU 6A

AGIA PARASKEVI

IAMACALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| FERAKON LTD |
| --- |
| MENANDROU 85 |
| ATHENS |

FERAKON LTD

MENANDROU 85

ATHENS

PLUSTON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| FERAKON LTD |
| --- |
| MENANDROU 85 |
| ATHENS |

FERAKON LTD

MENANDROU 85

ATHENS

PLUSTON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES |
| --- |
| ACHAIAS AND TRIZOINIAS |
| NEA KIFISSIA 14564 |

FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA 14564

ALFATON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| IASIS PHARMACEUTICALS |
| --- |
| FYLIS AVENUE 137, KAMATERO 13451 |

IASIS PHARMACEUTICALS

FYLIS AVENUE 137, KAMATERO 13451

OSANIT

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| IASIS PHARMACEUTICALS |
| --- |
| FYLIS AVENUE 137, KAMATERO 13451 |

IASIS PHARMACEUTICALS

FYLIS AVENUE 137, KAMATERO 13451

OSANIT

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| TARGET PHARMA LTD |
| --- |
| MENANDROU 54 |
| ATHENS 10431 |

TARGET PHARMA LTD

MENANDROU 54

ATHENS 10431

CALCITONIN/TARGET

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| TARGET PHARMA LTD |
| --- |
| MENANDROU 54 |
| ATHENS 10431 |

TARGET PHARMA LTD

MENANDROU 54

ATHENS 10431

CALCITONIN/TARGET

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| GABRIEL HEALTH PHARMACEUTICALS LTD |
| --- |
| GRIG. KOYSIDI 14 |
| ZOGRAFOU ATHENS 15772 |

GABRIEL HEALTH PHARMACEUTICALS LTD

GRIG. KOYSIDI 14

ZOGRAFOU ATHENS 15772

GALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| VIOFAR LTD |
| --- |
| ETHNIKIS ANTISTASEOS AND TRIFYLLIAS |
| ACHARNES 13671 |

VIOFAR LTD

ETHNIKIS ANTISTASEOS AND TRIFYLLIAS

ACHARNES 13671

SALMOCALCIN

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| VIOFAR LTD |
| --- |
| ETHNIKIS ANTISTASEOS AND TRIFYLLIAS |
| ACHARNES 13671 |

VIOFAR LTD

ETHNIKIS ANTISTASEOS AND TRIFYLLIAS

ACHARNES 13671

SALMOCALCIN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| PHARMEX S.A. |
| --- |
| KIFISSOU AVENUE 132 |
| PERISTERI 121 31 |
| ATHENS |

PHARMEX S.A.

KIFISSOU AVENUE 132

PERISTERI 121 31

ATHENS

CALCIPHAR

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| ALPHA GENERICS THERAPY AEBEF |
| --- |
| KORYTSAS 13 |
| KIFISSIA 14561 |

ALPHA GENERICS THERAPY AEBEF

KORYTSAS 13

KIFISSIA 14561

CALCITHERAPY

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| ALAPIS ABEE |
| --- |
| AYTOKRATOROS NIKOLAOU 2 |
| ATHENS 17671 |

ALAPIS ABEE

AYTOKRATOROS NIKOLAOU 2

ATHENS 17671

FARMICALCINE

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDIMAR SA MEDICINES COSMETICS |
| --- |
| KIFISSIAS 13 |
| THESSALONIKI 54655 |

MEDIMAR SA MEDICINES COSMETICS

KIFISSIAS 13

THESSALONIKI 54655

ZYOSTON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDIMAR SA MEDICINES COSMETICS |
| --- |
| KIFISSIAS 13 |
| THESSALONIKI 54655 |

MEDIMAR SA MEDICINES COSMETICS

KIFISSIAS 13

THESSALONIKI 54655

ZYOSTON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| A. HATZIANTONOGLOU-VELTIPHARM LTD |
| --- |
| DELIGIORGI 55-57 |
| ATHENS 10437 |

A. HATZIANTONOGLOU-VELTIPHARM LTD

DELIGIORGI 55-57

ATHENS 10437

CLARISPREN

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| SANUS OE KARANIKOLOPOULOS-KAKLAMANI |
| --- |
| VALAORITOU 7 |
| HALANDRI 15232 |

SANUS OE KARANIKOLOPOULOS-KAKLAMANI

VALAORITOU 7

HALANDRI 15232

CALOSTON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| SANUS OE KARANIKOLOPOULOS-KAKLAMANI |
| --- |
| VALAORITOU 7 |
| HALANDRI 15232 |

SANUS OE KARANIKOLOPOULOS-KAKLAMANI

VALAORITOU 7

HALANDRI 15232

CALOSTON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARMEDIA SA |
| --- |
| ATHINAS 22 AND APOLLONOS |
| GERAKAS ATTIKIS 15344 |

FARMEDIA SA

ATHINAS 22 AND APOLLONOS

GERAKAS ATTIKIS 15344

CALCIDERON

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| FARMEDIA SA |
| --- |
| ATHINAS 22 AND APOLLONOS |
| GERAKAS ATTIKIS 15344 |

FARMEDIA SA

ATHINAS 22 AND APOLLONOS

GERAKAS ATTIKIS 15344

CALCIDERON

200 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDARTE PHARMACEUTICALS ABE |
| --- |
| SPYROU VRETOU 10 |
| METAMORFOSI 14452 |

MEDARTE PHARMACEUTICALS ABE

SPYROU VRETOU 10

METAMORFOSI 14452

CALCYTONIL

100 IU/DOSE

nasal spray, solution

nasal use

Greece

| MEDHEL HELLAS PHARMACEUTICAL INDUSTRY |
| --- |
| 30TH KM ATHENS-LAVRION AVENUE |
| MARKOPOULO 19003 |

MEDHEL HELLAS PHARMACEUTICAL INDUSTRY

30TH KM ATHENS-LAVRION AVENUE

MARKOPOULO 19003

CALC-UP

200 IU/DOSE

nasal spray, solution

nasal use

Hungary

| Lisapharma S.p.A. |
| --- |
| Via Licinio 11, Erba(Como) |
| 22036 |
| Italy |

Lisapharma S.p.A.

Via Licinio 11, Erba(Como)

22036

Italy

CALCO 100 NE/ml injekció

100 IU/ml

solution for injection

subcutaneous use, intramuscular use, intravenous use

Hungary

| Lisapharma S.p.A. |
| --- |
| Via Licinio 11, Erba(Como) |
| 22036 |
| Italy |

Lisapharma S.p.A.

Via Licinio 11, Erba(Como)

22036

Italy

CALCO 50 NE/ml injekció

50 IU/ml

solution for injection

subcutaneous use, intramuscular use, intravenous use

Hungary

| Novartis Hungária Kft. |
| --- |
| Bartók Béla út 43-47. Budapest |
| 1114 |
| Hungary |

Novartis Hungária Kft.

Bartók Béla út 43-47. Budapest

1114

Hungary

MIACALCIC 50 NE/ml oldatos injekció és infúzió

50 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

Hungary

| Novartis Hungária Kft. |
| --- |
| Bartók Béla út 43-47. Budapest |
| 1114 |
| Hungary |

Novartis Hungária Kft.

Bartók Béla út 43-47. Budapest

1114

Hungary

MIACALCIC 200 NE oldatos orrspray

200 IU/metered dose

nasal spray, solution

nasal use

Hungary

| Novartis Hungária Kft. |
| --- |
| Bartók Béla út 43-47. Budapest |
| 1114 |
| Hungary |

Novartis Hungária Kft.

Bartók Béla út 43-47. Budapest

1114

Hungary

MIACALCIC 100 NE/ml oldatos injekció és infúzió

100 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

Hungary

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3., Ulm |
| 89070 |
| Germany |

Ratiopharm GmbH

Graf-Arco-Str. 3., Ulm

89070

Germany

CALCITONIN-ratiopharm 200 NE/adag oldatos orrspray

200 IU/metered dose

nasal spray, solution

nasal use

Iceland

Novartis Healthcare A/S, Lyngbyvej 172, DK-2100, København Ø, Denmark

Miacalcic

100 IU. Ml

solution for injection/infusion

intravenous use, intramuscular use, subcutaneous use

Iceland

Novartis Healthcare A/S, Lyngbyvej 172, DK-2100, København Ø, Denmark

Miacalcic Nasal

200 IU. Ml

nasal spray, solution

nasal use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Miacalcic

100 IU/ml

solution for injection/infusion

Subcutaneous use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Miacalcic

50 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Miacalcic

100 IU

nasal spray, solution

nasal use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Miacalcic

200 IU

nasal spray, solution

nasal use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Ostulex

200 IU in 1ml

nasal spray, solution

nasal use

Ireland

Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK

Miakaril

200 IU

nasal spray, solution

nasal use

Italy

NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 Origgio - VARESE

CALCITONINA SANDOZ

100 UI/ml

solution for injection and infusion

intravenous use, intramuscular use, subcutaneous use

Italy

NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 Origgio - VARESE

CALCITONINA SANDOZ

50 UI/ml

solution for injection and infusion

intravenous use, intramuscular use, subcutaneous use

Italy

ALFA WASSERMANN SPA via Enrico Fermi, 1 65020 Alanno -PESCARA

TONOCALCIN

100 UI/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Italy

ALFA WASSERMANN SPA via Enrico Fermi, 1 65020 Alanno -PESCARA

TONOCALCIN

50 UI/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Italy

| ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL |
| --- |
| del Mare 36 - 00040 Pomezia - Roma |

ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL

del Mare 36 - 00040 Pomezia - Roma

POROSTENINA

100 UI/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Italy

LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA Via Licinio, 11 22036 Erba - COMO

CALCO

50 UI/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Italy

LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA Via Licinio, 11 22036 Erba - COMO

CALCO

100 UI/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Luxembourg

| NOVARTIS PHARMA GMBH |
| --- |
| 25, ROONSTRASSE |
| D 90429 NUERNBERG |

NOVARTIS PHARMA GMBH

25, ROONSTRASSE

D 90429 NUERNBERG

Karil Nasenspray

200 UI/1d.

nasal spray, solution

nasal use

Malta

Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

Miacalcic Solution for Injection 100IU/ml

100 IU/ml

solution for injection

subcutaneous, intramuscular and intravenous use

Malta

Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

Miacalcic Nasal 200 Nasal Spray Solution 200 IU/dose

200 IU/dose

nasal spray, solution

nasal use

Norway

Novartis Norge AS, Postboks 4284 Nydalen 0401 Oslo, Norway

Miacalcic

100 IU/ml

solution for injection/infusion

intramuscular use, subcutaneous use

Norway

Novartis Norge AS, Postboks 4284 Nydalen 0401 Oslo, Norway

Miacalcic Nasal

200 IU/ml

nasal spray, solution

nasal use

Poland

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel, Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Calcistad 50

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

Poland

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel, Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Calcistad 100

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

Poland

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| Wincentego st. Pola 21 |
| 58-500, Jelenia Góra, Poland |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

Wincentego st. Pola 21

58-500, Jelenia Góra, Poland

Calcitonin 100 Jelfa

100 IU/ml

Injection

subcutaneous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Miacalcic

50 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Miacalcic

100 IU/ml

solution for injection

intramuscular use, intravenous use, subcutaneous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Miacalcic Nasal 200

200 IU/dose

nasal spray

nasal use

Poland

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi, 1 |
| 65020 - Alanno (Pescara) |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi, 1

65020 - Alanno (Pescara)

Italy

Tonocalcin

200 IU/dose

nasal spray, liquid

nasal use

Poland

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi, 1 |
| 65020 - Alanno (Pescara) |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi, 1

65020 - Alanno (Pescara)

Italy

Tonocalcin

100 IU/ml

solution for injection

intramuscular use, subcutaneous use

Portugal

| Sociedade de Produtos Farmacêuticos Wander, |
| --- |
| Lda. Rua do Centro Empresarial, |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Sociedade de Produtos Farmacêuticos Wander,

Lda. Rua do Centro Empresarial,

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Calcitonina Wander 200

200 IU/dose

nebuliser solution

nasal use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial, |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial,

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Miacalcic 200 Spray Nasal

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial, |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial,

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Osseocalcina 200

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Salcat

100 IU/dose

nasal spray, solution

nasal use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Salcat

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Grünenthal, S.A. |
| --- |
| Rua Alfredo da Silva, 16 |
| 2610-016 Amadora |
| Portugal |

Grünenthal, S.A.

Rua Alfredo da Silva, 16

2610-016 Amadora

Portugal

Calcitonina de Salmão Ostinate 200 U.I. Solução para Pulverização Nasal

200 IU./dose

nasal spray, solution

nasal use

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Calsyn 200

200 IU./dose

nasal spray, solution

nasal use

Portugal

| BIOSAÚDE - PRODUTOS FARMACÊUTICOS, LDA. |
| --- |
| Av. José Malhoa - Edifício Malhoa Plaza no 2, piso-escritório 2.2 |
| 1070-325 Lisboa |
| Portugal |

BIOSAÚDE - PRODUTOS FARMACÊUTICOS, LDA.

Av. José Malhoa - Edifício Malhoa Plaza no 2, piso-escritório 2.2

1070-325 Lisboa

Portugal

Osteodon

200 IU/dose

nebuliser solution

nasal use

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2, Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Calcitonina de Salmão Farmoz 200 U.I. Solução para Pulverização Nasal

200 IU/dose

nasal spray, solution

nasal use

Portugal

| ToLife - Produtos Farmacêuticos, S.A. |
| --- |
| Avenida do Forte, 3 - Edificio Suécia III, |
| Piso 1 |
| 2794-093 Carnaxide |
| Portugal |

ToLife - Produtos Farmacêuticos, S.A.

Avenida do Forte, 3 - Edificio Suécia III,

Piso 1

2794-093 Carnaxide

Portugal

Calcitonina de Salmão Tolife 200 UI solução para pulverização nasal

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 - Venda Nova |
| 2700-487 Amadora |
| Portugal |

Generis Farmacêutica, S.A.

Rua João de Deus, 19 - Venda Nova

2700-487 Amadora

Portugal

Calcitonina de Salmão Generis 200 U.I. Solução para Pulverização Nasal

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Arrowblue Produtos Farmacêuticos S.A. |
| --- |
| Av. D. João II, Torre Fernão de Magalhães - 10 Esqo |
| 1998-025 Lisboa |
| Portugal |

Arrowblue Produtos Farmacêuticos S.A.

Av. D. João II, Torre Fernão de Magalhães - 10 Esqo

1998-025 Lisboa

Portugal

Calcitonina de Salmão Arrowblue

200 IU/dose

nasal spray, solution

nasal use

Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo 3465-157 |
| Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo 3465-157

Santiago de Besteiros

Portugal

Calcitonina de Salmão Labesfal

200 IU/dose

nasal spray, solution

nasal use

Romania

| NOVENDIA PHARMACEUTICALS LTD. |
| --- |
| 425 Irakliou Avenue, 14122 Atena, Grecia |

NOVENDIA PHARMACEUTICALS LTD.

425 Irakliou Avenue, 14122 Atena, Grecia

NYLEX 100 UI/dose

1 100 IU/ml

nasal spray, solution

nasal use

Romania

| NOVENDIA PHARMACEUTICALS LTD. |
| --- |
| 425 Irakliou Avenue, 14122 Atena, Grecia |

NOVENDIA PHARMACEUTICALS LTD.

425 Irakliou Avenue, 14122 Atena, Grecia

NYLEX

100 IU/ml

solution for injection

intramuscular use, subcutaneous use

Romania

| NOVENDIA PHARMACEUTICALS LTD. |
| --- |
| 425 Irakliou Avenue, 14122 Atena, Grecia |

NOVENDIA PHARMACEUTICALS LTD.

425 Irakliou Avenue, 14122 Atena, Grecia

NYLEX

2 200 IU/ml

nasal spray, solution

nasal use

Romania

NOVARTIS PHARMA GmbH, Roonstrasse 25D-90429 Nürnberg, Germania

MIACALCIC

50 IU/ml

solution for injection

intramuscular use, subcutaneous use

Slovak Republic

| ratiopharm International GmbH Graf-Arco-Strasse 3, |
| --- |
| Ulm D-89070 Germany |

ratiopharm International GmbH Graf-Arco-Strasse 3,

Ulm D-89070 Germany

Calcitonin-ratiopharm 200 Nasal

200 IU

nasal spray, solution

nasal use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

Miacalcic 50 IU/1 ml

50 IU/1 ml

solution for injection, concentrate for solution for infusion

subcutaneous use, intramuscular use, intravenous use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

Miacalcic 100 IU/1 ml

100 IU/1 ml

solution for injection, concentrate for solution for infusion

subcutaneous use, intramuscular use, intravenous use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

Miacalcic Nasal 100

100 IU

nasal spray, solution

nasal use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Praha 4 |
| 140 00 Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Praha 4

140 00 Czech Republic

Miacalcic Nasal 200

200 IU

nasal spray, solution

nasal use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1, |
| Alanno 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1,

Alanno 65020

Italy

Osteodon 200 IU.

200 IU

nasal spray, solution

nasal use

Slovak Republic

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00 |
| Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00

Brno

Czech Republic

TONOCALCIN 100 IU nosová aerodisperzia

100 IU/0,1 ml

nasal spray, solution

nasal use

Slovak Republic

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00 |
| Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00

Brno

Czech Republic

TONOCALCIN 200 IU nosová aerodisperzia

200 IU/0,1 ml

nasal spray, solution

nasal use

Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nurnberg 90429, Germany

Miacalcic 100 i.e./ml raztopina za injiciranje ali infundiranje

100 i.e./ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nurnberg 90429, Germany

Miacalcic 200 i.e./odmerek pršilo za nos, raztopina

2 200 i.e./ml

nasal spray, solution

nasal use

Spain

ALMIRALL, S.A. Ronda General Mitre, 151 08022 Barcelona

CALCITONINA ALMIRALL 100 UI solución inyectable

100 IU

solution for injection

intramuscular use, subcutaneous use

Spain

ALMIRALL, S.A. Ronda General Mitre, 151 08022 Barcelona

CALCITONINA ALMIRALL 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Spain

ALMIRALL, S.A. Ronda General Mitre, 151 08022 Barcelona

CALCITONINA ALMIRALL 200 UI solución para pulverización nasal en envase unidosis

200 IU

nasal spray, solution

nasal use

Spain

MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando San Fernando de Henares Madrid 28830 spain

CALCITONINA HUBBER 100 UI solución inyectable

100 IU

solution for injection

intramuscular use, subcutaneous use

Spain

MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando San Fernando de Henares Madrid 28830 spain

CALCITONINA HUBBER 200 UI solución para pulverización nasal multidosis

200 IU

nasal spray, solution

nasal use

Spain

SANOFI AVENTIS, S.A. Josep Plá, 2 Barcelona 08019 SPAIN

CALSYNAR 100 UI polvo y disolvente para solución inyectable

100 IU

solution for injection

intramuscular use, subcutaneous use

Spain

SANOFI AVENTIS, S.A. Josep Plá, 2 Barcelona 08019 SPAIN

CALSYNAR 200 UI solucion para pulverizacion nasal

200 IU

nasal spray, solution

nasal use

Spain

SANOFI AVENTIS, S.A. Josep Plá, 2 Barcelona 08019 SPAIN

CALSYNAR 200 UI solucion para pulverizacion nasal en envase unidosis

200 IU

nasal spray, solution

nasal use

Spain

SANOFI AVENTIS, S.A. Josep Plá, 2 Barcelona 08019 SPAIN

CALSYNAR 50 UI polvo y disolvente para solución inyectable

50 IU

powder and solvent for solution for injection

intramuscular use, subcutaneous use

Spain

NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain

MIACALCIC 100 UI solución inyectable y para perfusión

100 IU

solution for injection

intramuscular use, subcutaneous use

Spain

NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain

MIACALCIC 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Spain

NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain

OSEOTOTAL 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Spain

LABORATORIO PADRO, S.A. Gran Via de les Corts Catalanes, 764 barcelona 08013 Spain

OSPOR 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Spain

ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14 03006 Alicante

OSTEOBION 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Spain

ALFA WASSERMANN, S.P.A.Via Enrico Fermi, 1 Alanno Scalo (Pescaro) 65020 ITALIA

TONOCALTIN 200 UI solución para pulverización nasal

200 IU

nasal spray, solution

nasal use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Miacalcic®

100 IU/ml

solution for Injection/infusion

intramuscular use, subcutaneous use

The Netherlands

| Novartis Pharma B.V. Raapopseweg 1 |
| --- |
| 6824 DP ARNHEM |

Novartis Pharma B.V. Raapopseweg 1

6824 DP ARNHEM

Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie

100 IU/ml

solution for injection/infusion

subcutaneous use, intramuscular use, intravenous use

United Kingdom

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Miacalcic 50 IU/ml Ampoules

50 IU/ml

solution for injection

subcutaneous use, intramuscular use, intravenous use

United Kingdom

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Miacalcic 100 IU/ml Ampoules

100 IU/ml

solution for injection

subcutaneous use, intramuscular use, intravenous use

United Kingdom

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Miacalcic 200 IU Nasal Spray

200 IU

nasal spray, solution

nasal use

United Kingdom

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Miacalcic 400 IU/2 ml Solution for Injection and infusion

400 IU

solution for injection

subcutaneous use, intramuscular use, intravenous use

---

ANNEX III

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | CP-Pharma Handelsgesellschaft mbH |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

Member State

EU/EEA

Applicant

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Belgium

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Czech republic

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Denmark

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

France

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Germany

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Hungary

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Ireland

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Italy

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

The Netherlands

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Poland

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

Spain

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

United Kingdom

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13 |
| D-31303 Burgdorf |
| Germany |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

D-31303 Burgdorf

Germany

Melosolute 40 mg/ml solution for injection for cattle, pigs and horses

meloxicam

Solution for injection

40 mg/ml

Cattle, pigs and horses

Cattle and horses – intravenous

Pigs - intramuscular

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | (Invented) name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Spain | PENSA PHARMA, S.A.U. |
| C/ Jorge Comín |
| (médico pediatra), 3-bajos 46015 Valencia |
| Spain |

Member State

EU/EEA

Marketing authorisation holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Spain

PENSA PHARMA, S.A.U.

C/ Jorge Comín

(médico pediatra), 3-bajos 46015 Valencia

Spain

FENOFIBRATO PENSA 160 mg comprimidos recubiertos con película EFG

160 mg

Film-coated tablet

Oral use

Spain

| LABORATORIOS RANBAXY, S.L. Passeig de Gracia, |
| --- |
| 9 08007 Barcelona |

LABORATORIOS RANBAXY, S.L. Passeig de Gracia,

9 08007 Barcelona

FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG

160 mg

Film-coated tablet

Oral use

---