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 or Article 38 of Directive 2001/82/EC)
Date: 2013-03-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013093EN.01000801.xml










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)
)

2013/C 93/02
—   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







—   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







—   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






(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 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






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






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






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






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






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






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






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






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






Miacalcic


50 IU/0,5 ml


solution for injection/infusion


subcutaneous use, intramuscular use




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






Miacalcic


200 IU/2 ml


nasal spray, solution


nasal use




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






Miacalcic


50 IU/0,5 ml


solution for injection


subcutaneous use, intramuscular use




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






Steocalcin


100 IU


pre-filled syringe


subcutaneous use, intramuscular use, intravenous use




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






Steocalcin


50 IU


solution for injection


subcutaneous use, intramuscular use, intravenous use




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






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






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






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






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






Miacalcic


100 IU/ml


solution for injection


intravenous use subcutaneous use, intramuscular use




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






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






Cadens


100 IU/ml


solution for injection


intramuscular use, intravenous use, subcutaneous use




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






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






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






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






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






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






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






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






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






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






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






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






Staporos


100 IU/ml


solution for injection


intramuscular use, intravenous use, subcutaneous use




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






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






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






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






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






Calcihexal 100


100 IU/1 ml


solution for injection


intravenous use, intramuscular use, subcutaneous use




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






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






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






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






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






Calcitonin-ratiopharm Nasenspray


100 IU/dose


nasal spray, solution


nasal use




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






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






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






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






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






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






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






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






MIACALCIC


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






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






NYLEX


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCO


100 IU/1ML AMP


solution for injection


intramuscular use, subcutaneous use




Greece







IASIS PHARMACEUTICALS




FYLIS AVENUE 137, KAMATERO 13452






CALCO


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALSYNAR


100 IU/1ML AMP


solution for injection


intramuscular use, subcutaneous use




Greece







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






CALSYNAR


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






TOSICALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






GENECALCIN


100 IU/1ML AMP


solution for injection


intramuscular use, subcutaneous use




Greece







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






GENECALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






TONOCALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






OSTIFIX


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






MIADENIL


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






NORCALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






NEOSTESIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






ALCITON


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






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






RAFACALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






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






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






TENDOLON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






LATONINA


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CROCALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






IRICALCIN


100 IU/1ML AMP


solution for injection


intramuscular use, subcutaneous use




Greece







VOCATE PHARMACEUTICALS SA




GOUNARI 150,




GLYFADA 16674






IRICALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







VOCATE PHARMACEUTICALS SA




GOUNARI 150,




GLYFADA 16674






IRICALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







ADEPHARM




MARNI 54




ATHENS






SALMOTEN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






VELKACALCIN


100 IU/1ML AMP


solution for injection


intramuscular use




Greece







BROS LTD




AYGIS AND GALINIS 15




KIFISSIA






BROSIDON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







BROS LTD




AYGIS AND GALINIS 15




KIFISSIA






BROSIDON


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






ROTHRIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







EVAGGELOS KALOFOLIAS IAPHARM




MENANDROU 54




ATHENS 10431






ROTHRIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCI-10


200 IU/DOSE


nasal spray, solution


nasal use




Greece







PHARMANEL PHARMACEUTICALS SA




MARATHONOS 106




GERAKAS 15344






AUROCALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






TRANSCALCIUM


200 IU/DOSE


nasal spray, solution


nasal use




Greece







VIVAX PHARMACEUTICALS LTD, DERVENAKION 38




GERAKAS 15344






CALCICONTROL


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






MIOSER


100 IU/1ML AMP


solution for injection


intravenous use, intramuscular use, subcutaneous use




Greece







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






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






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






REDICALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






ARSIPOR


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






DOCTADRYLE


200 IU/DOSE


nasal spray, solution


nasal use




Greece







BIOSPRAY ABEE




FAVIEROU STREET 39




Athens 10438






CALCITON


200 IU/DOSE


nasal spray, solution


nasal use




Greece







MEDITRINA LTD




HERAKLEITOU 117




HALANDRI 15238






OSTOPLUS


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALSAL


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






OSIVAN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






NOPREMIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






LIXOCAM


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALSATON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALTEC


200 IU/DOSE


nasal spray, solution


nasal use




Greece







IAMATICA MON. LTD




CHALANDRIOU 6A




AGIA PARASKEVI






IAMACALCIN


200 IU/DOSE


nasal spray, solution


nasal use




Greece







FERAKON LTD




MENANDROU 85




ATHENS






PLUSTON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






ALFATON


200 IU/DOSE


nasal spray, solution


nasal use




Greece







IASIS PHARMACEUTICALS




FYLIS AVENUE 137, KAMATERO 13451






OSANIT


100 IU/DOSE


nasal spray, solution


nasal use




Greece







IASIS PHARMACEUTICALS




FYLIS AVENUE 137, KAMATERO 13451






OSANIT


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCITONIN/TARGET


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






SALMOCALCIN


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCIPHAR


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






FARMICALCINE


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






ZYOSTON


200 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALOSTON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCIDERON


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






CALCYTONIL


100 IU/DOSE


nasal spray, solution


nasal use




Greece







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






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






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






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






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






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






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






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






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






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






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






Calcitonin 100 Jelfa


100 IU/ml


Injection


subcutaneous use




Poland







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






Miacalcic


100 IU/ml


solution for injection


intramuscular use, intravenous use, subcutaneous use




Poland







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






Tonocalcin


200 IU/dose


nasal spray, liquid


nasal use




Poland







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






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






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






Osseocalcina 200


200 IU/dose


nasal spray, solution


nasal use




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






Salcat


200 IU/dose


nasal spray, solution


nasal use




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






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






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






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






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






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






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






Calcitonina de Salmão Labesfal


200 IU/dose


nasal spray, solution


nasal use




Romania







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






NYLEX


100 IU/ml


solution for injection


intramuscular use, subcutaneous use




Romania







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






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






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






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






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






Miacalcic Nasal 200


200 IU


nasal spray, solution


nasal use




Slovak Republic







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






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






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






Miacalcic®


100 IU/ml


solution for Injection/infusion


intramuscular use, subcutaneous use




The Netherlands







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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG


160 mg


Film-coated tablet


Oral use