Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-03-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012094EN.01001301.xml










30.3.2012   


EN


Official Journal of the European Union


C 94/13





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012

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

2012/C 94/02
—   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




6.2.2012


Fortekor and associated names -


See Annex I


See Annex I


8.2.2012




27.2.2012


Somatropin


See Annex II


See Annex II


29.2.2012




17.2.2012


Pholcodine-containing medicinal products - Art 31 (maintain)


See Annex III


See Annex III


20.2.2012







—   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




13.2.2012


Buflomedil


See Annex IV


See Annex IV


14.2.2012






(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 VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, INDICATIONS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES













Member State
EU/EEA


Marketing authorisation holder


Name


INN


Strengths


Pharmaceutical forms


Animal species


Indications




Austria







Novartis Animal Health GmbH




Biochemiestraße 10




6250 Kundl




Austria






Fortekor 5 mg - Filmtabletten für Hunde und Katzen


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Treatment of heart failure in dogs
Treatment of chronic renal insufficiency in cats




Austria







Novartis Animal Health GmbH




Biochemiestraße 10




6250 Kundl




Austria






Fortekor 20 mg - Filmtabletten für Hunde


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs




Austria







Novartis Animal Health GmbH




Biochemiestraße 10




6250 Kundl




Austria






Fortekor 2,5 mg Gourmet


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Treatment of heart failure in dogs.
Treatment of chronic renal insufficiency in cats




Belgium







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






FORTEKOR 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dog: Treatment of heart failure
Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.




Belgium







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






FORTEKOR FLAVOUR 5


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure




Belgium







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure




Belgium







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor Flavour 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure




Belgium







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 2,5


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dog: Treatment of heart failure
Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.




Czech Republic







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 5 mg potahované tablety


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Treatment of heart failure in dogs
Treatment of chronic renal insufficiency in cats




Czech Republic







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 20 mg potahované tablety


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs




Denmark







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor Vet. 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Heart diseases in dogs




Denmark







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor Vet. 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Heart disease in dogs




Denmark







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor Vet. 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs


Heart disease in dogs




Finland







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Kööpenhamina




Tanska






Fortekor vet. 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Heart failure in dogs




Finland







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Kööpenhamina




Tanska






Fortekor vet. 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Heart failure in dogs




Finland







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Kööpenhamina




Tanska






Fortekor vet. 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs


Cardiac failure in dogs, chronic renal insufficiency in cats




France







Novartis Sante Animale S.A.S.




14 Boulevard Richelieu




92500 Rueil Malmaison




France






FORTEKOR F 5


Benazepril hydrochloride


5 mg


Tablets


Dogs and cats


For dogs over 5 kg
Treatment of heart failure
For cats over 2,5 kg
Treatment of chronic renal insufficiency




France







Novartis Sante Animale S.A.S.




14 Boulevard Richelieu




92500 Rueil Malmaison




France






FORTEKOR F 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


For dogs over 20 kg
Treatment of heart failure




France







Novartis Sante Animale S.A.S.




14 Boulevard Richelieu




92500 Rueil Malmaison




France






FORTEKOR 2,5


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


For dogs over 2,5 kg
Treatment of heart failure
For cats over 2,5 kg
Treatment of chronic renal insufficiency




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40




81379 München




Germany






Fortekor Flavour 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs


Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40




81379 München




Germany






Fortekor 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40




81379 München




Germany






Fortekor Flavour 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40




81379 München




Germany






Fortekor 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40




81379 München




Germany






Fortekor Flavour 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin




Greece







PREMIER SHUKUROGLOU HELLAS




Av.Mesogeion 198




15561 HOLARGOS




GREECE






FORTEKOR 5 mg


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs


Treatment of heart failure




Greece







PREMIER SHUKUROGLOU HELLAS




Av.Mesogeion 198




15561 HOLARGOS




GREECE






FORTEKOR 20 mg


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure




Greece







PREMIER SHUKUROGLOU HELLAS




Av.Mesogeion 198




15561 HOLARGOS




GREECE






FORTEKOR Flavour 5


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure




Greece







PREMIER SHUKUROGLOU HELLAS




Av.Mesogeion 198




15561 HOLARGOS




GREECE






FORTEKOR Flavour 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure




Hungary







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






Fortekor 5 mg ízesített tabletta


Benazepril hydrochloride


5 mg


Tablets


Dogs


For the treatment of heart failure in dogs.




Hungary







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






Fortekor 20 mg ízesített tabletta


Benazepril hydrochloride


20 mg


Tablets


Dogs


For the treatment of heart failure in dogs.




Ireland







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






FORTEKOR 5 mg film-coated tablets for dogs and cats.


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Treatment of heart failure in dogs. Treatment of chronic renal insufficiency in cats.




Ireland







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






Fortekor 20 mg Film-coated tablets for Dogs


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure in dogs.




Ireland







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






Fortekor 2,5 mg tablets for Dogs and Cats


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Treatment of heart failure in dogs. Treatment of chronic renal insufficiency in cats.




Italy







Novartis Animal Health S.p.A.




largo Boccioni 1




21040 Origgio (VA)




Italy






Fortekor 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria. Cats: Treatment of chronic renal insufficiency.




Italy







Novartis Animal Health S.p.A.




largo Boccioni 1




21040 Origgio (VA)




Italy






Fortekor Flavour 5


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure at 2nd- 3rd and 4th stage. Slow down of the progression of renal damage in chronic kidney disease with proteinuria.




Italy







Novartis Animal Health S.p.A.




largo Boccioni 1




21040 Origgio (VA)




Italy






Fortekor 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria.




Italy







Novartis Animal Health S.p.A.




largo Boccioni 1




21040 Origgio (VA)




Italy






Fortekor Flavour 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure at 2nd- 3rd and 4th stage. Slow down of the progression of renal damage in chronic kidney disease with proteinuria.




Italy







Novartis Animal Health S.p.A.




largo Boccioni 1




21040 Origgio (VA)




Italy






Fortekor 2,5


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria. Cats: Treatment of chronic renal insufficiency.




Luxembourg







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






FORTEKOR 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dog: Treatment of heart failure
Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.




Luxembourg







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






FORTEKOR Flavour 5


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure




Luxembourg







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure




Luxembourg







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor Flavour 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure




Luxembourg







Novartis Consumer Health B.V.




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 2,5


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dog: Treatment of heart failure
Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.




Norway







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor vet 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.




Norway







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor vet 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.




Norway







Novartis Healthcare A/S Animal Health




Lyngbyvej 172




2100 København Ø




Danmark






Fortekor vet 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dog: Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.
Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is > 1.




Poland







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 5, tabletki powlekane dla pśow i kotów


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


For dogs -Treatment of heart failure
For cats -Treatment of chronic renal insufficiency




Poland







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 20, tabletki powlekane dla pśow


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


For dogs -Treatment of heart failure




Portugal







Novartis Farma-Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial, Edifício 8 Quinta da Beloura




2710-444 Sintra




Portugal






FORTEKOR 5 mg comprimidos revestidos para cães e gatos


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dogs: Treatment of heart failure
Cats: Treatment of renal insufficiency




Portugal







Novartis Farma-Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial, Edifício 8 Quinta da Beloura




2710-444 Sintra




Portugal






FORTEKOR Palatável 5 mg comprimidos para cães e gatos


Benazepril hydrochloride


5 mg


Tablets


Dogs and cats


Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.
Cats: Treatment of chronic renal insufficiency.




Portugal







Novartis Farma-Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial, Edifício 8 Quinta da Beloura




2710-444 Sintra




Portugal






FORTEKOR 20 mg comprimidos revestidos para cães


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Dogs: Treatment of heart failure




Portugal







Novartis Farma-Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial, Edifício 8 Quinta da Beloura




2710-444 Sintra




Portugal






FORTEKOR Palatável 20 mg comprimidos para cães


Benazepril hydrochloride


20 mg


Tablets


Dogs


Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.




Portugal







Novartis Farma-Produtos Farmacêuticos, S.A.




Rua do Centro Empresarial, Edifício 8 Quinta da Beloura




2710-444 Sintra




Portugal






FORTEKOR Palatável 2,5 mg comprimidos para cães e gatos


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.
Cats: Treatment of chronic renal insufficiency.




Romania







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs


For treatment of heart failure in dogs.




Romania







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


For treatment of heart failure in dogs.




Slovakia







Novartis Animal Health d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 5 mg tbl.ad us.vet


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Treatment of heart failure in dogs. Treatment of chronic kidney insufficiency in cats.




Slovenia







Novartis Veterina d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 5 mg filmsko obložene tablete za pse


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs.




Slovenia







Novartis Veterina d.o.o.




Verovškova 57




1000 Ljubljana




Slovenia






FORTEKOR 20 mg filmsko obložene tablete za pse


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs.




Spain







NOVARTIS SANIDAD ANIMAL, S.L.




Calle de la Marina, 206




08013 Barcelona




Spain






FORTEKOR 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dogs: Treatment of heart failure.
Diuretics and/or antiarrhythmics may be used with benazepril when judged appropriate by the veterinarian, but whenever it is thought to be appropriate benazepril alone may be used.
Cats: Treatment of chronic renal insufficiency.




Spain







NOVARTIS SANIDAD ANIMAL, S.L.




Calle de la Marina, 206




08013 Barcelona




Spain






FORTEKOR SABOR 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.




Spain







NOVARTIS SANIDAD ANIMAL, S.L.




Calle de la Marina, 206




08013 Barcelona




Spain






FORTEKOR 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Dogs: Treatment of heart failure. Diuretics and/or antiarrhythmics may be used with benazepril when judged appropriate by the veterinarian, but whenever it is thought to be appropriate benazepril alone may be used.




Spain







NOVARTIS SANIDAD ANIMAL, S.L.




Calle de la Marina, 206




08013 Barcelona




Spain






FORTEKOR SABOR 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.




Spain







NOVARTIS SANIDAD ANIMAL, S.L.




Calle de la Marina, 206




08013 Barcelona




Spain






FORTEKOR SABOR 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.
Cats: Treatment of chronic renal insufficiency.




Sweden







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Köpenhamn




Danmark






Fortekor vet 5 mg


Benazepril hydrochloride


5 mg


Tablets


Dogs


Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.




Sweden







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Köpenhamn




Danmark






Fortekor vet 20 mg


Benazepril hydrochloride


20 mg


Tablets


Dogs


Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.




Sweden







Novartis Healthcare A/S, Animal Health




Lyngbyvej 172




2100 Köpenhamn




Danmark






Fortekor vet 2,5 mg


Benazepril hydrochloride


2,5 mg


Tablets


Dogs


Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.




The Netherlands







Novartis Consumer Health BV




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 5


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.
The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.
Cats: Treatment of chronic renal failure.




The Netherlands







Novartis Consumer Health BV




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






FORTEKOR FLAVOUR 5


Benazepril hydrochloride


5 mg


Tablets


Dogs and cats


Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.
The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.
Cats: Treatment of chronic renal failure.




The Netherlands







Novartis Consumer Health BV




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 20


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.
The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.




The Netherlands







Novartis Consumer Health BV




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor Flavour 20


Benazepril hydrochloride


20 mg


Tablets


Dogs


Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.




The Netherlands







Novartis Consumer Health BV




Claudius Prinsenlaan 142




4818 CP Breda




The Netherlands






Fortekor 2,5


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy. Cats: Treatment of chronic renal failure.




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






Fortekor 5 mg Film-coated Tablets for Dogs and Cats


Benazepril hydrochloride


5 mg


Film-coated tablets


Dogs and cats


Treatment of heart failure in dogs.
Treatment of chronic renal insufficiency in cats.




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






Fortekor 20 mg Film-coated tablets for Dogs


Benazepril hydrochloride


20 mg


Film-coated tablets


Dogs


Treatment of heart failure in dogs.




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey




GU16 7SR




United Kingdom






Fortekor 2,5 mg tablets for Dogs and Cats


Benazepril hydrochloride


2,5 mg


Tablets


Dogs and cats


Treatment of heart failure in dogs.
Treatment of chronic renal insufficiency in cats.







ANNEX II

LIST OF THE INVENTED NAME(S), PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State
EU/EEA


Marketing authorisaton holder


Product name


Strength


Pharmaceutical form


Route of administration




AT - Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1




1210 Wien




Austria






Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


12 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1




1210 Wien




Austria






Genotropin 5,3 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Pfizer Corporation Austria Gesellschaft m.b.H.




Floridsdorfer Hauptstraße 1




1210 Wien




Austria






Genotropin MiniQuick 0,2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


0,2 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Eli Lilly GmbH




Kölblgasse 8- 10




1030 Wien




Austria






Humatrope 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


12 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Eli Lilly GmbH




Kölblgasse 8- 10




1030 Wien




Austria






Humatrope 24 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


24 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Eli Lilly GmbH




Kölblgasse 8- 10




1030 Wien




Austria






Humatrope 6 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


6 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen


10 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin FlexPro 15 mg/1,5 ml Injektionslösung in einem Fertigpen


15 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen


5 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin NordiFlex 10 mg/1,5 ml - Injektionslösung in einem Fertigpen


10 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin NordiFlex 15 mg/1,5 ml - Injektionslösung in einem Fertigpen


15 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin NordiFlex 5 mg/1,5 ml - Injektionslösung in einem Fertigpen


5 mg/1,5 ml


solution for injection, in pre-filled pen


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin SimpleXx 10 mg/1,5 ml - Injektionslösung


10 mg/1,5 ml


solution for injection


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin SimpleXx 15 mg/1,5 ml - Injektionslösung


15 mg/1,5 ml


solution for injection


Subcutaneous use




AT - Austria







Novo Nordisk Pharma GmbH




Opernring 3-5




1010 Wien




Austria






Norditropin SimpleXx 5 mg/1,5 ml - Injektionslösung


5 mg/1,5 ml


solution for injection


Subcutaneous use




AT - Austria







Merck Gesellschaft mbH




Zimbagasse 5




1147 Wien




Austria






Saizen 8 mg click.easy - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


8 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Merck Gesellschaft mbH




Zimbagasse 5




1147 Wien




Austria






Saizen 1,33 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


1,33 mg


powder and solvent for solution for injection


Subcutaneous use




AT - Austria







Merck Gesellschaft mbH




Zimbagasse 5




1147 Wien




Austria






Saizen 5,83 mg/ml Injektionslösung


5,83 mg/ml


solution for injection


Subcutaneous use




AT - Austria







Merck Gesellschaft mbH




Zimbagasse 5




1147 Wien




Austria






Saizen 8 mg/ml Injektionslösung


8 mg/ml


solution for injection


Subcutaneous use




AT - Austria







Ferring Arzneimittel GmbH




Wienerbergstr. 11, Vienna Twin Tower Turm West 10.OG




1100 Wien,




Austria






Zomacton 10 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze


10 mg/ml


powder and solvent for solution for injection in a prefilled pen


Subcutaneous use




AT - Austria







Ferring Arzneimittel GmbH




Wienerbergstr. 11, Vienna Twin Tower Turm West 10.OG




1100 Wien,




Austria






Zomacton 4 mg - Trockenstechampullen mit Lösungsmittel


4 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


12 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


5 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


0,2 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


0,4 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


0,6 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


0,8 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


1 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


1,2 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


1,4 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


1,6 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


1,8 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







PFIZER SA




Bld de la Plaine, 17




1050 Brussels




Belgium






Genotonorm Miniquick


2 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







ELI LILLY BENELUX SA




Rue de l'Etuve 52/1




1000 Brussels




Belgium






Humatrope


6 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







ELI LILLY BENELUX SA




Rue de l'Etuve 52/1




1000 Brussels




Belgium






Humatrope


12 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







ELI LILLY BENELUX SA




Rue de l'Etuve 52/1




1000 Brussels




Belgium






Humatrope


24 mg


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


10 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


15 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


5 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


10 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


15 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


5 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


10 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


15 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


5 mg/1,5 ml


Solution for injection


Subcutaneous use




BE - Belgium







FERRING NV




Hopmarkt 9 b3




9300 Aalst




Belgium






Zomacton


10 mg/ml


powder and solvent for solution for injection


Subcutaneous use




BE - Belgium







FERRING NV




Hopmarkt 9 b3




9300 Aalst




Belgium






Zomacton


4 mg


powder and solvent for solution for injection


Subcutaneous use




BG - Bulgaria







Ferring GmbH,




Wittland 11,




D-24109 Kiel,




Germany






Zomacton


4 mg


powder and solvent for solution for injection


subcutaneous use




BG - Bulgaria







Pfizer Enterprises SARL,




Rond-point du Kirchberg,




51, Avenue J.F. Kennedy,




L-1855 Luxembourg,




Luxembourg






Genotropin


16 IU (5,3 mg)


powder and solvent for solution for injection


subcutaneous use




BG - Bulgaria







Pfizer Enterprises SARL,




Rond-point du Kirchberg,




51, Avenue J.F. Kennedy,




L-1855 Luxembourg,




Luxembourg






Genotropin


36 IU (12 mg)


powder and solvent for solution for injection


subcutaneous use




BG - Bulgaria







Novo Nordisk A/S,




Novo Alle,




DK-2880 Bagsvaerd,




Denmark






Norditropin Simplex


5 mg/1,5 ml


solution for injection


subcutaneous use




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 5 MG/1,5 ML


5 mg/1,5 ml


SOLUTION FOR INJECTION


SUBCUTANEOUS INJECTION




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 10 MG/1,5 ML


10 MG/1,5 ML


SOLUTION FOR INJECTION


SUBCUTANEOUS INJECTION




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 15 MG/1,5 ML


15 MG/1,5 ML


SOLUTION FOR INJECTION


SUBCUTANEOUS INJECTION




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN FLEX PRO 5 mg/1,5 ml PF PEN SOLUTION FOR INJECTION


5 mg/1,5 ml


SOLUTION FOR INJECTION IN A PRE-FILLED PEN


SUBCUTANEOUS INJECTION




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN FLEX PRO 10 mg/1,5 ml SOL FOR INJECTION PF PEN


10 MG/1,5 ML


SOLUTION FOR INJECTION IN A PRE-FILLED PEN


SUBCUTANEOUS INJECTION




CY - Cyprus







NOVO NORDISK A/S,




Novo Allé,




DK-2880 BAGSVAERD,




DENMARK






NORDITROPIN FLEX PRO 15 mg/1,5 ml SOL FOR INJECTION PF PEN


15 MG/1,5 ML


SOLUTION FOR INJECTION IN A PRE-FILLED PEN


SUBCUTANEOUS INJECTION




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin SimpleXx 15 mg/1,5 ml


10 MG/ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin SimpleXx 10 mg/1,5 ml


6,7 MG/ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin SimpleXx 5 mg/1,5 ml


3,3 MG/ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Merck Serono Europe Ltd




56 Marsh Wall




London




N14 9TP




United Kingdom






Saizen 8 mg click.easy


5,83 MG/ML


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







Merck Serono Europe Ltd




56 Marsh Wall




London




N14 9TP




United Kingdom






SAIZEN 5,83 MG/ML INJEKČNÍ ROZTOK


5,83 MG/ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Merck Serono Europe Ltd




56 Marsh Wall




London




N14 9TP




United Kingdom






SAIZEN 8 MG/ML INJEKČNÍ ROZTOK


8 MG/ML


Solution for injection


subcutaneous use




CZ - Czech Republic







PFIZER spol. s r.o.,




Stroupežnického 17,




150 00 Praha 5,




Czech Republic






GENOTROPIN 16 m.j. (5,3 mg)


16 UT/ML


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







PFIZER spol. s r.o.,




Stroupežnického 17,




150 00 Praha 5,




Czech Republic






GENOTROPIN 36 m.j. (12 mg)


36 UT/ML


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







Ferring GmbH,




Wittland 11,




D-24109 Kiel,




Germany






ZOMACTON 4 mg


1,3 mg/ml or 3,3 mg/ml after diluting with water


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







ELI LILLY ČR, s.r.o.,




Pobřežní 12,




180 00 Praha 8,




Czech Republic






Humatrope 18 IU (6 mg)


18 UT


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







ELI LILLY ČR, s.r.o.,




Pobřežní 12,




180 00 Praha 8,




Czech Republic






Humatrope 36 IU (12 mg)


36 UT


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







ELI LILLY ČR, s.r.o.,




Pobřežní 12,




180 00 Praha 8,




Czech Republic






Humatrope 72 IU (24 mg)


72 UT


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







Ferring GmbH,




Wittland 11,




D-24109 Kiel,




Germany






ZOMACTON 10 mg


10 MG/1 ML


Powder and solvent for solution for infusion


subcutaneous use




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin FlexPro 5 mg/1,5 ml


5 MG/1,5 ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin FlexPro 10 mg/1,5 ml


10 MG/1,5 ML


Solution for injection


subcutaneous use




CZ - Czech Republic







Novo Nordisk A/S,




Novo Allé,




2880 Bagsvaerd,




Denmark






Norditropin FlexPro 15 mg/1,5 ml


15 MG/1,5 ML


Solution for injection


subcutaneous use




DE - Germany







Ferring GmbH




Wittland 11




D-24109 Kiel






hGH-Ferring 12 (4 mg)


4,32 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Ferring GmbH




Wittland 11




D-24109 Kiel






ZOMACTON 10 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze


10,0 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Ferring GmbH




Wittland 11




D-24109 Kiel






Zomacton 4 mg


4,32 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Lilly Deutschland GmbH




Teichweg 3




D-35396 Gießen






Humatrope für Pen 12 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


12,0 mg


Powder and solvent for solution for injection


Subcutanous use,
intramuscular use




DE - Germany







Lilly Deutschland GmbH




Teichweg 3




D-35396 Gießen






Humatrope für Pen 24 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


24,0 mg


Powder and solvent for solution for injection


Subcutanous use,
intramuscular use




DE - Germany







Lilly Deutschland GmbH




Teichweg 3




D-35396 Gießen






Humatrope für Pen 6 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


6,0 mg


Powder and solvent for solution for injection


Subcutanous use,
intramuscular use




DE - Germany







Merck Serono GmbH




Alsfelder Str. 17




D-64289 Darmstadt






Saizen 8 mg click.easy


8,0 mg


Powder and solvent for solution for injection


Subcutanous use,
intramuscular use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen


6,7 mg


Solution for injection, in pre-filled pen


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin FlexPro 15 mg/1,5 ml Injektionslösung in einem Fertigpen


10,0 mg


Solution for injection, in pre-filled pen


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen


3,3 mg


Solution for injection, in pre-filled pen


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin NordiFlex 10 mg/1,5 ml Injektionslöung in einem Fertigpen


6,7 mg


Solution for injection


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin NordiFlex 15 mg/1,5 ml Injektionslöung in einem Fertigpen


10,0 mg


Solution for injection


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin NordiFlex 5 mg/1,5 ml Injektionslöung in einem Fertigpen


3,3 mg


Solution for injection


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin Simplexx 10 mg/1,5 ml Injektionslösung


10,0 mg


Solution for injection


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin Simplexx 15 mg/1,5 ml Injektionslösung


15,0 mg


Solution for injection


Subcutanous use




DE - Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz






Norditropin Simplexx 5 mg/1,5 ml Injektionslösung


5,0 mg


Solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






Genotropin 12 mg


12,0 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






Genotropin 5 mg/ml


5,8 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






Genotropin 5,3 mg


5,3 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 0,2 mg


0,2 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 0,4 mg


0,4 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 0,6 mg


0,6 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 0,8 mg


0,8 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,0 mg


1,0 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,2 mg


1,2 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,4 mg


1,4 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,6 mg


1,6 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 1,8 mg


1,8 mg


Powder and solvent for solution for injection


Subcutanous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






GENOTROPIN MiniQuick 2,0 mg


2,0 mg


Powder and solvent for solution for injection


Subcutanous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


1,3 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


5,3 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


5 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin


12 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,2 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,4 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,6 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


0,8 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,0 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,2 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,4 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,6 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


1,8 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup,




Denmark






Genotropin Miniquick


2,0 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Eli Lilly Danmark A/S,




Nybrovej 110,




DK-2800 Kongens Lyngby,




Denmark






Humatrope


6 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Eli Lilly Danmark A/S,




Nybrovej 110,




DK-2800 Kongens Lyngby,




Denmark






Humatrope


12 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Eli Lilly Danmark A/S,




Nybrovej 110,




DK-2800 Kongens Lyngby,




Denmark






Humatrope


24 mg


powder and solvens for injection, solution


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Flexpro


10 mg/1,5 mL


Solution for injection, prefilled pen


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Flexpro


15 mg/1,5 mL


Solution for injection, prefilled pen


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Flexpro


5 mg/1,5 mL


Solution for injection, prefilled pen


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin NordiFlex


5 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin NordiFlex


10 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin NordiFlex


15 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Nordilet


5 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Nordilet


10 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Nordilet


15 mg/1,5 mL


Solution for injection, prefilled syringe


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Simplexx


5 mg/1,5 mL


Solution for injection


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Simplexx


10 mg/1,5 mL


Solution for injection


subcutaneous use




DK - Denmark







Novo Nordisk A/S,




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin Simplexx


15 mg/1,5 mL


Solution for injection


subcutaneous use




DK - Denmark







Ferring Lægemidler A/S,




Kay Fiskers Plads 11,




DK-2300 Købenahvn S,




Denmark






Zomacton


4 mg


powder and solvens for solution for injection


subcutaneous use




DK - Denmark







Ferring Lægemidler A/S,




Kay Fiskers Plads 11,




DK-2300 Købenahvn S,




Denmark






Zomacton


10 mg/mL


powder and solvens for solution for injection, prefilled syringe


subcutaneous use




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN SIMPLEXX


5 MG/1,5 ML CARTRIDGE


Solution for Injection


Subcutaneous




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN SIMPLEXX


10 MG/1,5 ML CARTRIDGE


Solution for Injection


Subcutaneous




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN SIMPLEXX


15 MG/1,5 ML CARTRIDGE


Solution for Injection


Subcutaneous




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN FLEXPRO


5 MG/1,5 ML


Injection Solution Prefilled Syringe


Subcutaneous




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN FLEXPRO


10 MG/1,5 ML


Injection Solution Prefilled Syringe


Subcutaneous




EL - Greece







NOVO NORDISK HELLAS




Panagouli 80 & Agias Triadas 65,




Agia Paraskevi 15343






NORDITROPIN FLEXPRO


15 MG/1,5 ML


Injection Solution Prefilled Syringe


Subcutaneous




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN


5 mg /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN(WITH PRESERVATIVE)


5,3 mg /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN(WITH PRESERVATIVE)


12 mg /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN


1 mg /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN


1,4 mg /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN


2 mg (6IU) /CARTRIDGE


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






GENOTROPIN


5 mg /CARTRIDGE with preservative


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous use




EL - Greece







Merck A.E. Hellas




Kifisias Avenue 41-45 (Building B)




Marousi 15123




Athens




Greece






SAIZEN


3,33 MG/VIAL (MULTI DO


Powder and Solvent for solution for Injection


Subcutaneous
Intramuscular




EL - Greece







Merck A.E. Hellas




Kifisias Avenue 41-45 (Building B)




Marousi 15123




Athens




Greece






SAIZEN


8 MG/VIAL


Powder and Solvent for solution for Injection


Subcutaneous
Intramuscular




EL - Greece







Merck A.E. Hellas




Kifisias Avenue 41-45 (Building B)




Marousi 15123




Athens




Greece






SAIZEN


5,83 MG/VIAL


Solution for Injection


Subcutaneous




EL - Greece







Merck A.E. Hellas




Kifisias Avenue 41-45 (Building B)




Marousi 15123




Athens




Greece






SAIZEN


8 MG/ML


Solution for Injection


Subcutaneous




EL - Greece







FARMASERV LILLY AEBE




15TH Km NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14564,




P.O. BOX 51288






HUMATROPE


6 MG/ CARTRIDGE


Powder and Solvent for solution for Injection


Subcutaneous




EL - Greece







FARMASERV LILLY AEBE




15TH Km NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14564,




P.O. BOX 51288






HUMATROPE


12 MG/ CARTRIDGE


Powder and Solvent for solution for Injection


Subcutaneous




EL - Greece







FARMASERV LILLY AEBE




15TH Km NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14564,




P.O. BOX 51288






HUMATROPE


24 MG/ CARTRIDGE


Powder and Solvent for solution for Injection


Subcutaneous




EL - Greece







FERRING HELLAS S.A.




GKYZI 3,




MAROUSI 15125






ZOMACTON


4 MG/VIAL


Powder and Solvent for solution for Injection


Subcutaneous




EL - Greece







FERRING HELLAS S.A.




GKYZI 3,




MAROUSI 15125






ZOMACTON


10 MG/VIAL + 1 ML SOLV


Powder and Solvent for solution for Injection


Subcutaneous




ES - Spain







LILLY, S.A.




Avda. de la Industria, 30




Alcobendas




28108 MADRID






HUMATROPE 6 mg polvo y disolvente para solución inyectable


6 mg


powder for solution


Subcutaneous use




ES - Spain







LILLY, S.A.




Avda. de la Industria, 30




Alcobendas




28108 MADRID






HUMATROPE 12 mg polvo y disolvente para solución inyectable


12 mg


powder for solution


Subcutaneous use




ES - Spain







LILLY, S.A.




Avda. de la Industria, 30




Alcobendas




28108 MADRID






HUMATROPE 24 mg polvo y disolvente para solución inyectable


24 mg


powder for solution


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 0,4 mg polvo y disolvente para solución inyectable


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 0,8 mg polvo y disolvente para solución inyectable


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable


1,0 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 1,2 mg polvo y disolvente para solución inyectable


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 1,6 mg polvo y disolvente para solución inyectable


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable


1,8 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable


2 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM KABIPEN 5,3 mg polvo y disolvente para solución inyectable


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable


12 mg


Powder and solvent for solution for injection


Subcutaneous use




ES - Spain







PFIZER, S.A.




Avda. de Europa, 20 B.




Parque Empresarial La Moraleja




Alcobendas




28108 MADRID






GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable


12 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN NORDIFLEX 5 mg / 1,5 ml solución inyectable


5 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable


10 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable


15 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN SIMPLEXx 5 mg/1,5 ml solución inyectable


5 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN SIMPLEXx 10 mg/1,5 ml solución inyectable


10 mg


powder for solution


Subcutaneous use




ES - Spain







NOVO NORDISK A/S




Novo Alle




DK-2880 Bagsvaerd






NORDITROPIN SIMPLEXx 15 mg/1,5 ml solución inyectable


15 mg


powder for solution


Subcutaneous use




ES - Spain







FERRING, S.A.U




Gobelas, 11.




Urbanización La Florida.




28023 Madrid






ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable


10 mg


powder for solution


Subcutaneous use




ES - Spain







MERCK S.L.




Maria de Molina, 40




28006 Madrid






SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable


8 mg


powder for solution


Subcutaneous use




ES - Spain







FERRING, S.A.U




Gobelas, 11.




Urbanización La Florida.




28023 Madrid






ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable


4 mg


powder for solution


Subcutaneous use




ET - Estonia







Ferring GmbH




Wittland 11




D-24109 Kiel




Germany






ZOMACTON


4 mg


Powder and solvent for solution for injection in pre-filled syringe


subcutaneous use




ET - Estonia







Ferring GmbH




Wittland 11




D-24109 Kiel




Germany






ZOMACTON


10 mg


Powder and solvent for solution for injection in pre-filled syringe


subcutaneous use




ET - Estonia







Merck Serono S.p.A.




Via Casilina 125




I-00176 Roma




Italy






SAIZEN 8 MG CLICK.EASY


8 mg


Powder and solvent for solution for injection


subcutaneous use




ET - Estonia







Pfizer Enterprises SARL




Round-Point du Kirchberg




51, Avenue J.F. Kennedy




L-1855




Luxembourg






GENOTROPIN


5,3 mg


Powder and solvent for solution for injection


subcutaneous use




ET - Estonia







Pfizer Enterprises SARL




Round-Point du Kirchberg




51, Avenue J.F. Kennedy




L-1855




Luxembourg






GENOTROPIN


12 mg


Powder and solvent for solution for injection


subcutaneous use




FI - Finland







Ferring Lääkkeet Oy,




Piispansilta 11 A,




PL 23,




02241 Espoo,




Finland






Zomacton


10 mg/ml


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Ferring Lääkkeet Oy,




Piispansilta 11 A,




PL 23,




02241 Espoo,




Finland






Zomacton


4 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Merck Oy,




Pihatörmä 1 C,




02240 Espoo,




Finland






Saizen click.easy


8 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Merck Oy,




Pihatörmä 1 C,




02240 Espoo,




Finland






Saizen


8 mg/ml


Solution for Injection


Subcutaneous use




FI - Finland







Merck Oy,




Pihatörmä 1 C,




02240 Espoo,




Finland






Saizen


5,83 mg/ml


Solution for Injection


Subcutaneous use




FI - Finland







Eli Lilly Finland Oy Ab,




Rajatorpantie 41 C,




PL 16,




01641 Vantaa,




Finland






Humatrope


12 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Eli Lilly Finland Oy Ab,




Rajatorpantie 41 C,




PL 16,




01641 Vantaa,




Finland






Humatrope


24 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Eli Lilly Finland Oy Ab,




Rajatorpantie 41 C,




PL 16,




01641 Vantaa,




Finland






Humatrope


6 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Pfizer Oy,




Tietokuja 4,




00330 Helsinki,




Finland






Genotropin


12 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Pfizer Oy,




Tietokuja 4,




00330 Helsinki,




Finland






Genotropin


5 mg


Powder and solvent for solution for injection


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Flexpro


5 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Flexpro


10 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Flexpro


15 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Nordiflex


5 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Nordiflex


10 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Nordiflex


15 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Simplexx


5 mg/1,5 ml


Solution for injection


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Simplexx


10 mg/1,5 ml


Solution for injection


Subcutaneous use




FI - Finland







Novo Nordisk A/S,




Novo Allé,




2880 BAGSVAERD,




Denmark






Norditropin Simplexx


15 mg/1,5 ml


Solution for injection


Subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM 12 mg, poudre et solvant pour solution injectable


12 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM 5 mg, poudre et solvant pour solution injectable


5 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM 5,3 mg, poudre et solvant pour solution injectable


5,3 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 0,2 mg, poudre et solvant pour solution injectable


0,2 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable


0,4 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 0,6 mg, poudre et solvant pour solution injectable


0,6 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable


0,8 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable


1 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 1,2 mg, poudre et solvant pour solution injectable


1,2 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable


1,4 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 1,6 mg, poudre et solvant pour solution injectable


1,6 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable


1,8 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







PFIZER HOLDING France




23-25, avenue du Docteur Lannelongue




75014 Paris-




France






GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable


2 mg


Powder and solvent for solution for injection


subcutaneous use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris-




France






MAXOMAT 1,3 mg, poudre et solvant pour solution injectable


1,3 mg


Powder and solvent for solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE NORDIFLEX 10 mg/1,5 ml, solution injectable en stylo prérempli


10 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE NORDIFLEX 15 mg/1,5 ml, solution injectable en stylo prérempli


15 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE NORDIFLEX 5 mg/1,5 ml, solution injectable en stylo prérempli


5 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE FLEXPRO 10 mg/1,5 ml, solution injectable en stylo prérempli


10 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE FLEXPRO 15 mg/1,5 ml, solution injectable en stylo prérempli


15 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE FLEXPRO 5 mg/1,5 ml, solution injectable en stylo prérempli


5 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE SIMPLEXX 10 mg/1,5 ml, solution injectable


10 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE SIMPLEXX 15 mg/1,5 ml, solution injectable


15 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







NOVO NORDISK PHARMACEUTIQUE SAS




Le Palatin




30 rue de Valmy




92800 Puteaux-




France






NORDITROPINE SIMPLEXX 5 mg/1,5 ml, solution injectable


5 mg/1,5 ml


Solution for injection


subcutaneous




FR - France







LILLY France




13, rue Pagès




92158 Suresnes Cedex






UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable


12 mg/3 ml


Powder and solvent for solution for injection


subcutaneous




FR - France







LILLY France




13, rue Pagès




92158 Suresnes Cedex






UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable


24 mg/3 ml


Powder and solvent for solution for injection


subcutaneous




FR - France







LILLY France




13, rue Pagès




92158 Suresnes Cedex






UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable


6 mg/3 ml


Powder and solvent for solution for injection


subcutaneous




FR - France







FERRING SAS




7, rue Jean-Baptiste Clément




94250 Gentilly-




France






ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie


10 mg/ml


Powder and solvent for solution for injection


subcutaneous




FR - France







FERRING SAS




7, rue Jean-Baptiste Clément




94250 Gentilly-




France






ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose


4 mg


Powder and solvent for solution for injection


subcutaneous




FR - France







MERCK SANTE




37, rue Saint-Romain




69008 Lyon




France






SAIZEN 1,33 mg, poudre et solvant pour solution injectable


1,33 mg


Powder and solvent for solution for injection


subcutaneous




FR - France







MERCK SANTE




37, rue Saint-Romain




69008 Lyon




France






SAIZEN 3,33 mg, poudre et solvant pour solution injectable


3,33


Powder and solvent for solution for injection


subcutaneous




FR - France







MERCK SANTE




37, rue Saint-Romain




69008 Lyon




France






SAIZEN 8 mg, poudre et solvant pour solution injectable


8


Powder and solvent for solution for injection


subcutaneous




FR - France







MERCK SANTE




37, rue Saint-Romain




69008 Lyon




France






SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable


8


Powder and solvent for solution for injection


subcutaneous




HU - Hungary







Eli Lilly Nederland BV




Grootslag 1-5




3991 RA Houten




Netherlands






HUMATROPE 18 NE (6 mg) injekció patronban


1,9 mg/ml


powder and solvent for injection


subcutaneous use




HU - Hungary







Eli Lilly Nederland BV




Grootslag 1-5




3991 RA Houten




Netherlands






HUMATROPE 36 NE (12 mg) injekció patronban


3,8 mg/ml


powder and solvent for injection


subcutaneous use




HU - Hungary







Eli Lilly Nederland BV




Grootslag 1-5




3991 RA Houten




Netherlands






HUMATROPE 72 NE (24 mg) injekció patronban


7,6 mg/ml


powder and solvent for injection


subcutaneous use




HU - Hungary







Novo Nordisk A/S




Novo Alle




2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 5 mg/1,5 ml oldatos injekció


3,3 mg/ml


solution for injection


subcutaneous use




HU - Hungary







Novo Nordisk A/S




Novo Alle




2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 10 mg/1,5 ml oldatos injekció


6,7 mg/ml


solution for injection


subcutaneous use




HU - Hungary







Novo Nordisk A/S




Novo Alle




2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 15 mg/1,5 ml oldatos injekció


10 mg/ml


solution for injection


subcutaneous use




HU - Hungary







Merck Kft.




Bocskai út 134-146.




1113




Budapest




Hungary






SAIZEN click easy 8 mg por és oldószer oldatos injekcióhoz


8 mg (24 NE) /1,5 ml


powder and solvent for solution for injection


parenteral use




HU - Hungary







Ferring Magyarország Kft.




Váci út 140.




1138




Budapest




Hungary






ZOMACTON 4 mg por és oldószer oldatos injekcióhoz


1,3 mg/ml or 3,3 mg/ml


powder and solvent for solution for injection


subcutaneous use




HU - Hungary







Pfizer Kft.




Alkotás u. 53




1123




Budapest




Hungary






GENOTROPIN 5,3 mg por és oldószer oldatos injekcióhoz


16 NE (5,3 mg/ml)


powder and solvent for solution for injection


subcutaneous use




HU - Hungary







Pfizer Kft.




Alkotás u. 53




1123




Budapest




Hungary






GENOTROPIN 12 mg por és oldószer oldatos injekcióhoz


36 NE (12 mg/ml)


powder and solvent for solution for injection


subcutaneous use




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin 5,3 mg powder and solvent for solution for injection


5,3 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin 12 mg powder and solvent for solution for injection


12 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick 0,2 mg, powder and solvent for solution for injection


0,2 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick 0,4 mg, powder and solvent for solution for injection


0,4 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick 0,6 mg, powder and solvent for solution for injection


0,6 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick 0,8 mg, powder and solvent for solution for injection


0,8 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick, 1,0 mg, powder and solvent for solution for injection


1,0 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick, 1,2 mg, powder and solvent for solution for injection


1,2 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genetropin MiniQuick, 1,4 mg powder and solvent for Solution for Injection


1,4 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick, 1,6 mg, powder and solvent for solution for injection


1,6 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick, 1,8 mg, powder and solvent for solution for injection


1,8 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Pharmacia Laboratories Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin MiniQuick, 2,0 mg, powder and solvent for solution for injection


2,0 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin SimpleXx 5 mg / 1,5 ml, solution for injection.


5 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin SimpleXx 10 mg / 1,5 ml, solution for injection


10 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin SimpleXx 15 mg / 1,5 ml, solution for injection.


15 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin NordiFlex 5 mg/1,5 ml, solution for injection, in pre-filled pen


5 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin NordiFlex 10 mg/1,5 ml, solution for injection, in pre-filled pen


10 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Novo Nordisk A/S,




Novo Alle,




DK-2880, Bagsvaerd,




Denmark






Norditropin NordiFlex 15 mg/1,5 ml, solution for injection, in pre-filled pen


15 mg/1,5 ml


solution for injection


Subcutanous injection




IE - Ireland







Serono Limited,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex,




TW14 8NX,




England






Saizen 1,33 mg powder and solvent for solution for injection


1,33 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Serono Limited,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex,




TW14 8NX,




England






Saizen 3,33 mg powder and solvent for solution for injection


3,33 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Serono Limited,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex,




TW14 8NX,




England






Saizen 8 mg click.easy powder and solvent for solution for injection.


8 mg


solution for injection


Subcutanous injection




IE - Ireland







Merck Serono Limited,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex,




TW14 8NX,




England






Saizen 5,83 mg/ml Solution for Injection


5,83 mg


solution for injection


Subcutanous injection




IE - Ireland







Merck Serono Limited,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex,




TW14 8NX,




England






Saizen 8 mg/ml Solution for Injection


8 mg


solution for injection


Subcutanous injection




IE - Ireland







Ferring Ireland Ltd.,




United Drug House,




Magna Drive,




Magna Business Park,




Citywest Road,




Dublin 24,




Ireland






Zomacton 4 mg, powder and solvent for solution for injection


4 mg


Powder and solvent for solution


Subcutanous injection




IE - Ireland







Ferring Ireland Ltd.,




United Drug House,




Magna Drive,




Magna Business Park,




Citywest Road,




Dublin 24,




Ireland






Zomacton 10 mg, powder and solvent for solution for injection


10 mg


Powder and solvent for solution


Subcutanous injection




IS - Iceland







Pfizer APS




Lautrupvang 8




DK 2750 Ballerup




Denmark






Genotropin


5 mg


Powder and solvent for solution for injection


s.c.




IS - Iceland







Pfizer APS




Lautrupvang 8




DK 2750 Ballerup




Denmark






Genotropin


12 mg


Powder and solvent for solution for injection


s.c.




IS - Iceland







Pfizer APS




Lautrupvang 8




DK 2750 Ballerup




Denmark






Genotropin


5,3 mg


Powder and solvent for solution for injection


s.c.




IS - Iceland







Eli Lilly Danmark




Nybrovej 110




2800 Lyngby




Denmark






Humatrop 24 mg


24 mg /Cartridge


Powder and solvent for solution for injection


s.c.




IS - Iceland







Eli Lilly Danmark




Nybrovej 110




2800 Lyngby




Denmark






Humatrop 6 mg


6 mg /Cartridge


Powder and solvent for solution for injection


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin FlexPro


15/1,5 mg/ml Pre-filled pen


Solution for injection


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin FlexPro


10/1,5 mg/ml Pre-filled pen


Solution for injection


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin FlexPro


5/1,5 mg/ml Pre-filled pen


Solution for injection


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin NordiFlex


15/1,5 mg/ml /Cartridge


Solution for injection, prefilled pen


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin NordiFlex


10/1,5 mg/ml /Cartridge


Solution for injection, prefilled pen


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin NordiFlex


5/1,5 mg/ml /Cartridge


Solution for injection, prefilled pen


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin SimplexX


15/1,5 mg/ml/ Cartridge


Solution for injection, Cartridge


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin SimplexX


10/1,5 mg/ml/ Cartridge


Solution for injection, Cartridge


s.c.




IS - Iceland







Novo Nordisk AS




Novo Allé




DK-2880 Bagsværd




Denmark






Norditropin SimplexX


5/1,5 mg/ml/ Cartridge


Solution for injection, Cartridge


s.c.




IS - Iceland







Merck AB




SE-195 87 Stockholm




Sweden






Saizen click easy 8 mg


8 mg


Powder and solvent for solution for injection


s.c.




IS - Iceland







Merck AB




SE-195 87 Stockholm




Sweden






Saizen 5,83 mg/ml 5,83 mg/ml


5,83 mg/ml 5,8 mg/ml


Solution for injection Single dose container


s.c.




IS - Iceland







Merck AB




SE-195 87 Stockholm




Sweden






Saizen 8 mg/ml 8 mg/ml


Saizen 8 mg/ml 8 mg/ml


Solution for injection Single dose container


s.c.




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin


5,3 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin


12 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,2 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,4 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,6 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


0,8 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,2 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,4 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,6 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


1,8 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Pfizer Italia S.r.l.




Via Valbondione 113




00188 Rome




Italy






Genotropin Miniquick


2 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN


1,33 mg/ml


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN


3,33 mg (0,67 mg/ml)


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN


8 mg (2,96 mg/ml)


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN (CLICK.EASY)


8 mg (5,83 mgml)


powder and solvent for solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN


5,83 mg/ml


solution for injection


subcutaneous use




IT - Italy







Merck Serono S.p.A.




Via Casilina, 125




00176 Roma




Italy






SAIZEN


8 mg/ml


solution for injection


subcutaneous use




IT - Italy







FERRING SpA




VIA SENIGALLIA, 18/2




20161 MILANO






ZOMACTION


4 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







FERRING SpA




VIA SENIGALLIA, 18/2




20161 MILANO






ZOMACTION


10 mg/ml


powder and solvent for solution for injection


subcutaneous use




IT - Italy







ELI LILLY ITALIA SpA




VIA GRAMSCI, 731/733




SESTO FIORENTINO




50019 FIRENZE






HUMATROPE


6 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







ELI LILLY ITALIA SpA




VIA GRAMSCI, 731/733




SESTO FIORENTINO




50019 FIRENZE






HUMATROPE


12 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







ELI LILLY ITALIA SpA




VIA GRAMSCI, 731/733




SESTO FIORENTINO




50019 FIRENZE






HUMATROPE


24 mg


powder and solvent for solution for injection


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX


5 mg/1,5 ml


solution for injection in pre-filled syringe


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX


10 mg/1,5 ml


solution for injection in pre-filled syringe


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX


15 mg/1,5 ml


solution for injection in pre-filled syringe


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


5 mg/1,5 ml


solution for injection


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


10 mg/1,5 ml


solution for injection


subcutaneous use




IT - Italy







NOVO NORDISK A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


15 mg/1,5 ml


solution for injection


subcutaneous use




IT - Italy







BAKER ITALIA SpA




VIA DI PORTA PINCIANA, 6




00187 ROMA






ZIMOSER


1,33 mg/ml


powder and solvent for solution for injection


subcutaneous use




LT - Lithuania







Ferring GmbH,




Wittland 11,




D-24109 Kiel,




Germany






ZOMACTON


10 mg/ml


Powder and solvent for solution for injection in pre-filled syringe


Subcutaneous use




LT - Lithuania







Ferring GmbH,




Wittland 11,




D-24109 Kiel,




Germany






ZOMACTON


4 mg


Powder and solvent for solution for injection


Subcutaneous use




LT - Lithuania







Eli Lilly Holdings Limited,




Lilly House




Priestley Road




Basingstoke




Hampshire




RG24 9NL,




United Kingdom






Humatrope


6 mg


Powder and solvent for solution for injection


Subcutaneous use




LT - Lithuania







Eli Lilly Holdings Limited,




Lilly House




Priestley Road




Basingstoke




Hampshire




RG24 9NL,




United Kingdom






Humatrope


12 mg


Powder and solvent for solution for injection


Subcutaneous use




LT - Lithuania







Novo Nordisk A/S,




Novo Allé




DK-2880 Bagsværd,




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


Solution for injection


Subcutaneous use




LT - Lithuania







Novo Nordisk A/S,




Novo Allé




DK-2880 Bagsværd,




Denmark






Norditropin SimpleXx


10 mg/1,5 ml


Solution for injection


Subcutaneous use




LT - Lithuania







Pfizer Europe MA EEIG.,




Sandwich, Kent,




CT13, 9NJ,




United Kingdom






Genotropin


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




LT - Lithuania







Pfizer Europe MA EEIG.,




Sandwich, Kent,




CT13, 9NJ,




United Kingdom






Genotropin


12 mg


Powder and solvent for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotorm


1,3 mg


powder and solvent for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotorm


12 mg


Powder and solvent for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotorm


5 mg


Powder and solvent for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotorm


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


0,2 mg


powder for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


0,4 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


0,6 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


0,8 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


1 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


1,4 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


1,5 mg


powder for solution for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


1,6 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


1,8 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Pfizer SA




17, BD de la Plaine




B-1050 Bruxelles






Genotonorm Miniquick


2 mg


powder for injection


Subcutaneous use




LU - Luxembourg







Ferring SA




9 Hopmarkt




B-9300 Aalst






Zomacton


12 UI


powder for solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Simplexx


5 mg


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Simplexx


15 mg


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Simplexx


10 mg


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Simplexx


10 mg/1,5 ml


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Nordiflex


5 mg/1,5 ml


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Nordiflex


10 mg/1,5 ml


solution for injection


subcutaneous




LU - Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles






Norditropin Nordiflex


15 mg/1,5 ml


solution for injection


subcutaneous




LU - Luxembourg







Ferring SA




9 Hopmarkt




B-9300 Aalst






Zomacton-10


10 mg


powder & solvant for solution for injection


subcutaneous




LU - Luxembourg







Ely Lilly Benelux SA




52, rue de l'Etuve




B-1000 Bruxelles






Humatrope


6 mg


powder for injection


subcutaneous & intramuscular




LU - Luxembourg







Ely Lilly Benelux SA




52, rue de l'Etuve




B-1000 Bruxelles






Humatrope


12 mg


powder for injection


subcutaneous & intramuscular




LU - Luxembourg







Ely Lilly Benelux SA




52, rue de l'Etuve




B-1000 Bruxelles






Humatrope


24 mg


powder for injection


subcutaneous & intramuscular




LV - Latvia







Merck Serono S.p.A.,




Via Casilina 125,




I-00176 Roma,




Italy






Saizen 8 mg click.easy powder and solvent for solution for injection


8 mg


powder and solvent for solution for injection


Subcutaneous use




LV - Latvia







Ferring GmbH,




Wittland 11,




24109 Kiel,




Germany






Zomacton 4 mg powder and solvent for solution for injection


4 mg


powder and solvent for solution for injection


Subcutaneous use




LV - Latvia







Ferring GmbH,




Wittland 11,




24109 Kiel,




Germany






Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe


4 mg


powder and solvent for solution for injection in pre-filled syringe


Subcutaneous use




LV - Latvia







Pfizer Health AB,




Vetenskapsvagen 10,




SE-191 90 Sollentuna,




Sweden






Genotropin 5,3 mg powder and solvent for solution for injection


5,3 mg


powder and solvent for solution for injection


Subcutaneous use




LV - Latvia







Pfizer Health AB,




Vetenskapsvagen 10,




SE-191 90 Sollentuna,




Sweden






Genotropin 12 mg powder and solvent for solution for injection


12 mg


powder and solvent for solution for injection


Subcutaneous use




MT - Malta







Serono Ltd




Bedfont Cross,




Stanwell Road




Feltham,




Middlesex




TW14 8NX0






Saizen 8 mg click.easy


8 MG


Powder and solvent for solution for injection


Subcutaneous
Intramuscular




MT - Malta







Eli Lilly & Co. Ltd.




Lilly House,




Priestley Road,




Basingstoke,




Hampshire




RG24 9NL,




United Kingdom






Humatrope


6 MG


Powder and Solvent for Solution for Injection


Subcutaneous
Intramuscular




MT - Malta







Eli Lilly & Co. Ltd.




Lilly House,




Priestley Road,




Basingstoke,




Hampshire




RG24 9NL,




United Kingdom






Humatrope


12 MG


Powder and Solvent for Solution for Injection


Subcutaneous
Intramuscular




MT - Malta







Eli Lilly & Co. Ltd.




Lilly House,




Priestley Road,




Basingstoke,




Hampshire




RG24 9NL,




United Kingdom






Humatrope


24 MG


Powder and Solvent for Solution for Injection


Subcutaneous
Intramuscular




MT - Malta







NovoNordisk A/S




Novo Alle,




DK - 2880 Bagsvaerd,




Denmark






Norditropin SimpleXx


Somatropin 5 mg/1,5 ml Somatropin 10 mg/1,5 ml


Solution for Injeciton


Subcutaneous




MT - Malta







Pfizer Hellas S.A.




234, Messoghion Ave.,




Neo Psychiko 15451,




Athens,




Greece






Genotropin 5,3 mg powder and solvent for solution for injection


5,3 mg/ml


Powder and Solvent for Solution for Injection in cartridge


Subcutaneous Use




NL - Netherlands







Pfizer BV,




Rivium Westlaan 142,




2909 LD CAPELLE A/D IJSSEL D –




Nederland






Genotropin


5 mg


Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie


Subcutaneous use




NL - Netherlands







Pfizer BV,




Rivium Westlaan 142,




2909 LD CAPELLE A/D IJSSEL D –




Nederland






Genotropin


12 mg


Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie


Subcutaneous use




NL - Netherlands







Eli Lilly Nederland BV




Grootslag 1-5




3991 RA HOUTEN




Nederland






Humatrope


6, 12, 24 mg


Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin FlexPro


5 mg/1,5 ml


Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin FlexPro


10 mg/1,5 ml


Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin FlexPro


15 mg/1,5 ml


Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin SimpleXx


5 mg/1,5 ml


Solution for injection (oplossing voor injectie)


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin SimpleXx


10 mg/1,5 ml


Solution for injection (oplossing voor injectie)


SC




NL - Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




Nederland






Norditropin SimpleXx


15 mg/1,5 ml


Solution for injection (oplossing voor injectie)


SC




NL - Netherlands







Ferring BV




Polariavenue 132




2132JX Hoofddorp –




Nederland






Zomacton


10 mg/ml


Solution for injection in pre-filled-syringe (oplossing voor injectie in een voorgevulde spuit)


SC




NL - Netherlands







Ferring BV




Polariavenue 132




2132JX Hoofddorp –




Nederland






Zomacton


4 mg/ml


Powder for solution for injection (poeder voor injectievloeistof)


sc




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


0,2 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


0,4 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


0,6 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


0,8 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


1 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


1,2 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


1,4 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


1,6 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


1,8 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


2 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


5 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Pfizer AS,




Postboks 3,




1324 Lysaker,




Norway






Genotropin


12 mg


powder and solution for injection


Subcutaneous use




NO - Norway







Elly Lilly Norge AS,




Grensevien 99,




0663 Oslo,




Norway






Humatrope


6 mg


powder and solution for injection


injection




NO - Norway







Elly Lilly Norge AS,




Grensevien 99,




0663 Oslo,




Norway






Humatrope


12 mg


powder and solution for injection


injection




NO - Norway







Elly Lilly Norge AS,




Grensevien 99,




0663 Oslo,




Norway






Humatrope


24 mg


powder and solution for injection


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin SimpleXx


5 mg / 1,5 mL


solution for injection


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin SimpleXx


10 mg / 1,5 mL


solution for injection


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin SimpleXx


15 mg/ 1,5 mL


solution for injection


injection




NO - Norway







Merck




AB, 195 87 Stockholm,




Sweden






Saizen click easy


8 mg


powder and solution for injection


injection




NO - Norway







Ferring Legemidler AS,




Postboks 4445,




0403 Oslo,




Norway






Zomacton


4 mg


powder and solution for injection


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin NordiFlex


5 mg/ 1,5 mL,


solution for injection in prefilled syringe


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin NordiFlex


10 mg/ 1,5 mL


solution for injection in prefilled syringe


injection




NO - Norway







NovoNordisk A/S,




Novo Allé,




2880 Bagsværd,




Danmark






Norditropin NordiFlex


15 mg/ 1,5 mL


solution for injection in prefilled syringe


injection




PL - Poland







Pfizer Europe MA EEIG




Ramsgate Road,




CT13 9 NJ,




Sandwich, Kent,




United Kingdom






Genotropin 5,3


16 j.m. (5,3 mg)


Powder and solvent for solution for injection


Subcutaneous Use




PL - Poland







Pfizer Europe MA EEIG




Ramsgate Road,




CT13 9 NJ,




Sandwich, Kent,




United Kingdom






Genotropin 12


36 j.m. (12 mg)


Powder and solvent for solution for injection


Subcutaneous Use




PL - Poland







Novo Nordisk A/S




Novo Alle,




Bagsvaerd, DK-2880,




Denmark






Norditropin FlexPro


5 g/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous




PL - Poland







Novo Nordisk A/S




Novo Alle,




Bagsvaerd, DK-2880,




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


Solution for injection


Subcutaneous




PL - Poland







Novo Nordisk A/S




Novo Alle,




Bagsvaerd, DK-2880,




Denmark






Norditropin SimpleXx


10 mg/1,5 ml


Solution for injection


Subcutaneous




PL - Poland







Industria Farmaceutica Serono S.p. A




Via Casilina, 125,




Rome, 00176,




Italy






Saizen 8 mg click.easy


24 j.m. (8 mg), [17,5 j.m. (5,83 mg)/ml]


Powder and solvent for solution for injection


Subcutaneous




PT - Portugal







Ferring Portuguesa - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.




Rua Alexandre Herculano - Edifício 1, Piso 6,




2795-240 Linda-a-Velha,




Portugal






Zomacton


4 mg/3,5 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Ferring Portuguesa - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.




Rua Alexandre Herculano - Edifício 1, Piso 6,




2795-240 Linda-a-Velha,




Portugal






Zomacton


10 mg/ml


Powder and solvent for solution for injection in pre-filled syringe


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin


12 mg/1 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin


5,3 mg/1 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


2 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,2 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,4 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,6 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


0,8 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,2 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,4 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,6 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin Miniquick


1,8 mg/0,25 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10,




2740-271 Porto Salvo




Portugal






Genotropin


5 mg/1 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Lilly-Portugal, Produtos Farmacêuticos, Lda.




Rua Cesário Verde, no 5, 4o Piso,




Linda-a-Pastora,




2790-326 Queijas,




Portugal






Humatrope


6 mg/3,17 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Lilly-Portugal, Produtos Farmacêuticos, Lda.




Rua Cesário Verde, no 5, 4o Piso,




Linda-a-Pastora,




2790-326 Queijas,




Portugal






Humatrope


12 mg/3,15 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Lilly-Portugal, Produtos Farmacêuticos, Lda.




Rua Cesário Verde, no 5, 4o Piso,




Linda-a-Pastora,




2790-326 Queijas,




Portugal






Humatrope


24 mg/3,15 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Merck, S.A.




Rua Alfredo da Silva, 3 C,




1300-040 Lisboa,




Portugal






Saizen


1,3 mg/1 ml


Powder and solvent for solution for injection


Subcutaneous use;
Intramuscular use




PT - Portugal







Merck, S.A.




Rua Alfredo da Silva, 3 C,




1300-040 Lisboa,




Portugal






Saizen


3,3 mg/5 ml


Powder and solvent for solution for injection


Subcutaneous use;
Intramuscular use




PT - Portugal







Merck, S.A.




Rua Alfredo da Silva, 3 C,




1300-040 Lisboa,




Portugal






Saizen


8 mg/5 ml


Powder and solvent for solution for injection


Subcutaneous use;
Intramuscular use




PT - Portugal







Merck, S.A.




Rua Alfredo da Silva, 3 C,




1300-040 Lisboa,




Portugal






Saizen "Click Easy"


8 mg/1,37 ml


Powder and solvent for solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.




Quinta da Fonte - Edifício D. José - Piso 1,




2780-730 Paço d' Arcos,




Portugal






Norditropin Nordiflex


5 mg/1,5 ml


Solution for injection


Subcutaneous use




PT – Portugal







Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.




Quinta da Fonte - Edifício D. José - Piso 1,




2780-730 Paço d' Arcos,




Portugal






Norditropin Nordiflex


10 mg/1,5 ml


Solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.




Quinta da Fonte - Edifício D. José - Piso 1,




2780-730 Paço d' Arcos,




Portugal






Norditropin Nordiflex


15 mg/1,5 ml


Solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


Solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin SimpleXx


10 mg/1,5 ml


Solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin SimpleXx


15 mg/1,5 ml


Solution for injection


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin FlexPro


5 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin FlexPro


10 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




PT - Portugal







Novo Nordisk, A/S




Novo Allé,




DK-2880 Bagsvaerd,




Denmark






Norditropin FlexPro


15 mg/1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




RO - Romania







PFIZER EUROPE MA EEIG




Ramsgate Road,




Sandwich, Kent




CT13 9NJ, UK






GENOTROPIN 16 UI (5,3 mg)


16 UI (5,3 mg)


powder and solvent for solution for injection


subcutaneous use




RO - Romania







FERRING GmbH




Wittland 11,




D – 24109 Kiel,




Germany






ZOMACTON 4 mg (12 UI)


4 mg (12 UI)


powder and solvent for solution for injection


subcutaneous use




RO - Romania







NOVO NORDISK A/S




Novo Allé,




DK-2880 Bagsværd,




Denmark






Norditropin SimpleXx 5 mg/1,5 ml


5 mg/1,5 ml


solution for injection in cartridges


subcutaneous use




RO - Romania







NOVO NORDISK A/S




Novo Allé,




DK-2880 Bagsværd,




Denmark






NORDITROPIN FlexPro 5 mg/1,5 ml


5 mg/1,5 ml


solution for injection in pen


subcutaneous use




RO - Romania







NOVO NORDISK A/S




Novo Allé,




DK-2880 Bagsværd,




Denmark






NORDITROPIN FlexPro 10 mg/1,5 ml


10 mg/1,5 ml


solution for injection in pen


subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin®


5 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin®


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin®


12 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


0,2 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


0,4 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


0,6 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


0,8 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


1 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


1,2 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


1,4 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


1,6 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


1,8


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Pfizer




AB 191 90 Sollentuna




Sweden






Genotropin Mini Quick


2 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex®


5 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex®


10 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex®


15 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


5 mg/1,5 ml


Solution for injection


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


10 mg/1,5 ml


Solution for injection


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


15 mg/1,5 ml


Solution for injection


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Somatropin Novo Nordisk


5 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Somatropin Novo Nordisk


10 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Somatropin Novo Nordisk


15 mg/1,5 ml


Solution for injection, pre-filled pen


Subcutaneous use




SE - Sweden







Ferring Läkemedel




Box 4041




AB 203 11 Malmö




Sweden






Zomacton


4 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Ferring Läkemedel




Box 4041




AB 203 11 Malmö




Sweden






Zomacton


10 mg/ml


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Eli Lilly Sweden




Box 721




AB 169 27 Solna




Sweden






Humatrope®


6 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Eli Lilly Sweden




Box 721




AB 169 27 Solna




Sweden






Humatrope®


12 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







Eli Lilly Sweden




Box 721




AB 169 27 Solna




Sweden






Humatrope®


24 mg


Powder and solvent for solution for injection


Subcutaneous use




SE - Sweden







E. Merck




AB 195 87 Stockholm




Sweden






Saizen® click.easy®


8 mg


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







Pfizer Luxembourg SARL,




51 av. J.-F. Kennedy,




1855 Luxembourg






Genotropin 5,3 mg/ml prašek in vehikel za raztopino za injiciranje


5,3 mg/ ml


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







Pfizer Luxembourg SARL,




51 av. J.-F. Kennedy,




1855 Luxembourg






Genotropin 12 mg/ml prašek in vehikel za raztopino za injiciranje


12 mg/ ml


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







Eli Lilly farmacevtska družba, d.o.o.,




Brnčičeva 41g,




1231 Ljubljana- Črnuče,




Slovenia






Humatrope 6 mg prašek in vehikel za raztopino in injiciranje


6 mg


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







Eli Lilly farmacevtska družba, d.o.o.,




Brnčičeva 41g,




1231 Ljubljana- Črnuče,




Slovenia






Humatrope 12 mg prašek in vehikel za raztopino in injiciranje


12 mg


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







Eli Lilly farmacevtska družba, d.o.o.,




Brnčičeva 41g,




1231 Ljubljana- Črnuče,




Slovenia






Humatrope 24 mg prašek in vehikel za raztopino in injiciranje


24 mg


Powder and solvent for solution for injection


Subcutaneous use




SI - Slovenia







NovoNordis A/S,




Novo Alle,




Basvaerd,




DK






Norditropin FlexPro 10 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku


6,7 mg/1 ml


Solution for injection in pre-filled pen


Subcutaneous use




SI - Slovenia







NovoNordis A/S,




Novo Alle,




Basvaerd,




DK






Norditropin FlexPro 15 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku


10 mg/1 ml


Solution for injection in pre-filled pen


Subcutaneous use




SI - Slovenia







NovoNordis A/S,




Novo Alle,




Basvaerd,




DK






Norditropin SimpleXx 5 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku


3,3 mg/ 1 ml


Solution for injection in cartridge


Subcutaneous use




SI - Slovenia







NovoNordis A/S,




Novo Alle,




Basvaerd,




DK






Norditropin SimpleXx 10 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku


6,7 mg/ 1 ml


Solution for injection in cartridge


Subcutaneous use




SI - Slovenia







NovoNordis A/S,




Novo Alle,




Basvaerd,




DK






Norditropin SimpleXx 15 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku


10 mg/ 1 ml


Solution for injection in cartridge


Subcutaneous use




SK - Slovakia







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich Kent




CT13 9NJ




United Kingdom






GENOTROPIN 5,3 mg


5,3 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Pfizer Europe MA EEIG




Ramsgate Road,




Sandwich Kent




CT13 9NJ




United Kingdom






GENOTROPIN 12 mg


12 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Eli Lilly ČR, s.r.o.




Pobřežní 394/12




186 00 Praha




Czech Republic






HUMATROPE 18 IU (6 mg)


6 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Eli Lilly ČR, s.r.o.




Pobřežní 394/12




186 00 Praha




Czech Republic






HUMATROPE 36 IU (12 mg)


12 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Eli Lilly ČR, s.r.o.




Pobřežní 394/12




186 00 Praha




Czech Republic






HUMATROPE 72 IU (24 mg)


24 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DENMARK






Norditropin FlexPro 10 mg/1,5 ml


10 mg/ 1,5 ml


Solution for injection in pre-filled pen


Subcutaneous use




SK - Slovakia







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DENMARK






Norditropin FlexPro 5 mg/1,5 ml


5 mg/ 1,5 mg


Solution for injection in pre-filled pen


Subcutaneous use




SK - Slovakia







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DENMARK






Norditropin SimpleXx 10 mg/1,5 ml


10 mg/1,5 ml


Solution for injection


Subcutaneous use




SK - Slovakia







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DENMARK






Norditropin SimpleXx 5 mg/1,5 ml


5 mg/1,5 ml


Solution for injection


Subcutaneous use




SK - Slovakia







Merck Serono S.p.A.




Via Casilina 125




00176 Roma




Italy






Saizen 5,83 mg/ ml injekčný roztok


5,83 mg/1 ml


Solution for injection


Subcutaneous use




SK - Slovakia







Merck Serono S.p.A.




Via Casilina 125




00176 Roma




Italy






Saizen 8 mg/ ml injekčný roztok


8 mg/1 ml


Solution for injection


Subcutaneous use




SK - Slovakia







Merck Serono S.p.A.




Via Casilina 125




00176 Roma




Italy






Saizen 8 mg click.easy


8 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Ferring GmbH




Wittland 11




Kiel




Germany






Zomacton 4 mg


4 mg


Powder and solvent for solution for injection


Subcutaneous use




SK - Slovakia







Ferring GmbH




Wittland 11




Kiel




Germany






Zomacton 10 mg


10 mg


Powder and solvent for solution for injection


Subcutaneous use




UK - United Kingdom







Eli Lilly & Company Limited,




Lilly House,




Priestly Road,




Basingstoke,




Hampshire




RG24 9NL,




UK






Humatrope 6 mg For Injection


6 mg


powder for injection


intramuscular and subcutaneous use




UK - United Kingdom







Eli Lilly & Company Limited,




Lilly House,




Priestly Road,




Basingstoke,




Hampshire




RG24 9NL,




UK






Humatrope 12 mg For Injection


12 mg


powder for injection


subcutaneous use




UK - United Kingdom







Eli Lilly & Company Limited,




Lilly House,




Priestly Road,




Basingstoke,




Hampshire




RG24 9NL,




UK






Humatrope 24 mg For Injection


24 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin 5,3 mg


5,3 mg


powder and solvent for solution for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin 12 mg


12 mg


powder and solvent for solution for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 0,2 mg


0,2 mg


powder and solvent for solution for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 0,4 mg


0,4 mg


powder and solvent for solution for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 0,6 mg


0,6 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 0,8 mg


0,8 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 1 mg


1 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 1,2 mg


1,2 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 1,4 mg


1,4 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 1,6 mg


1,6 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 1,8 mg


1,8 mg


powder for injection


subcutaneous use




UK - United Kingdom







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






Genotropin Miniquick 2 mg


2 mg


powder for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Simplexx 5 mg/1,5 ml


5 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Simplexx 10 mg/1,5 ml


10 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Simplexx 15 mg/1,5 ml


15 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Flexpro 5 mg/1,5 ml


5 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Flexpro 10 mg/1,5 ml


10 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Flexpro 15 mg/1,5 ml


15 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Nordiflex 5 mg/1,5 ml


5 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Nordiflex 10 mg/1,5 ml


10 mg


solution for injection


subcutaneous use




UK - United Kingdom







Novo Nordisk Limited,




Broadfield Park,




Brighton Road,




Crawley,




West Sussex




RH11 9RT,




UK






Norditropin Nordiflex 15 mg/1,5 ml


15 mg


solution for injection


subcutaneous use




UK - United Kingdom







Ferring Phamraceuticals Limited,




The Courtyard,




Waterside Drive,




Langley,




Berkshire




SL3 6EZ,




UK






Zomacton 4 mg injection


4 mg


powder for solution for injection


subcutaneous use




UK - United Kingdom







Ferring Phamraceuticals Limited,




The Courtyard,




Waterside Drive,




Langley,




Berkshire




SL3 6EZ,




UK






Zomacton 10 mg powder for solution for injection (pre-filled syringe)


10 mg


powder for solution for injection


subcutaneous use




UK - United Kingdom







Serono Limted,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex




TW14 8NX,




UK






Saizen 4IU


1,33 mg


powder for injection


intramuscular and subcutaneous use




UK - United Kingdom







Serono Limted,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex




TW14 8NX,




UK






Saizen 10IU


3,33 mg


powder for injection


intramuscular and subcutaneous use




UK - United Kingdom







Serono Limted,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex




TW14 8NX,




UK






Saizen 8 mg ClickEasy


8 mg


powder for solution for injection


subcutaneous use




UK - United Kingdom







Serono Limted,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex




TW14 8NX,




UK






Saizen 5,83 mg/ml Solution for Injection


5,83 mg


solution for injection


subcutaneous use




UK - United Kingdom







Serono Limted,




Bedfont Cross,




Stanwell Road,




Feltham,




Middlesex




TW14 8NX,




UK






Saizen 8 mg/ml Solution for Injection


8 mg


solution for injection


subcutaneous use







ANNEX III

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












Member State EU/EEA


Marketing authorisation holder


INN


Strength


Product name


Pharmaceutical form


Route of administration




Belgium







Medgenix Benelux




Vliegveld 21




8560 Wevelgem




Belgium






pholcodine 15 mg/15 ml
Sulfogaiacol 300 mg/15 ml


1,00 mg/ml
(pholcodine)


Broncho-Pectoralis Pholcodine


Syrup


Oral use




Belgium







Medgenix Benelux




Vliegveld 21




8560 Wevelgem




Belgium






pholcodine eucalyptolum
camphora syntheticum
gaiacolum
phenolum


10,00 mg
120 mg
156 mg
50 mg
10 mg


Eucalyptine Pholcodine
(Adult)


Suppository


Rectal use




Belgium







Medgenix Benelux




Vliegveld 21




8560 Wevelgem




Belgium






pholcodine eucalyptolum
camphora syntheticum
gaiacolum
phenolum


5,00 mg
80 mg
100 mg
30 mg
6 mg


Eucalyptine Pholcodine
(Child)


Suppository


Rectal use




Belgium







Novum Pharma




Latem Business Park




Xavier De Cocklaan 66




box 3




9830 Sint-Martens-Latem




Belgium






pholcodine 5 mg/5 ml
Doxylaminii succinas 5 mg/5 ml
Kalii guaiacolsulfonas 47,5 mg/5 ml
Natrii benzoas 50 mg/5 ml


1,00 mg/ml
(pholcodine)


Pholco-mereprine


Syrup


Oral use




Belgium







Sanofi-Aventis Belgium NV




Culliganlaan 1C




1831 Diegem




Belgium






pholcodine 0,12 g


1,20 mg/ml


Cotrane Folcodine


Syrup


Oral use




France







AEROCID




248 bis, rue Gabriel Péri




B.P. 126




94232 Cachan Cedex




FRANCE






myrte (huile essentielle de) (deterpenee); alpha-terpinéol;
pholcodine


0,05 g/100 g;
0,0025 g/100 g;
0,05 g/100 g


Myrtine Enfants, sirop


Syrup


Oral use




France







AMIDO




37, avenue Gabriel Péri




BP 232




92503 Rueil-Malmaison Cedex




FRANCE






coquelicot (petale de) (extrait sec de); pholcodine;
sodium (benzoate de)


0,2/100 g,
0,075 g/100 g
1 g/100 g


Pulmadol Enfants, sirop


Syrup


Oral use




France







BAYER SANTE FAMILIALE




33, rue de l'Industrie




74240 Gaillard




FRANCE






pholcodine


0,075 g/100 g


Broncorinol toux seche enfants, sirop


Syrup


Oral use




France







BAYER SANTE FAMILIALE




33, rue de l'Industrie




74240 Gaillard




FRANCE






pholcodine


0,100 g/100 g


Broncorinol adultes toux seche pholcodine, sirop


Syrup


Oral use




France







BOUCHARA RECORDATI




68, rue Marjolin




92300 Levallois-Perret




FRANCE






biclotymol; chlorphénamine (maléate de); pholcodine


0,2 g/100 ml;
0,012 g/100 ml;
0,120 g/100 ml


Hexapneumine adultes, sirop


Syrup


Oral use




France







BOUCHARA RECORDATI




68, rue Marjolin




92300 Levallois-Perret




FRANCE






biclotymol; chlorphénamine (maléate de); pholcodine


0,15/100 ml;
0,01 g/100 ml
0,1 g/100 ml


Hexapneumine enfants, sirop


Syrup


Oral use




France







BOUCHARA RECORDATI




68, rue Marjolin




92300 Levallois-Perret




FRANCE






biclotymol;
cinéole;
pholcodine


0,0800 g;
0,0700 g;
0,0050 g


Hexapneumine enfants, suppositoire


Suppository


Rectal use




France







BOUCHARA RECORDATI




68, rue Marjolin




92300 Levallois-Perret




FRANCE






biclotymol;
cinéole;
pholcodine


0,160 g;
0,140 g;
0,015 g


Hexapneumine adultes, suppositoire


Suppository


Rectal use




France







BRIDOUX




6, rue Salengro




62160 Bully les Mines




FRANCE






pholcodine;
sodium (benzoate de)


0,0846 g/100 g; 2 g/100 g


Pulmosodyl adulte, sirop


Syrup


Oral use




France







COOPER




Place Lucien-Auvert




77020 Melun Cedex




FRANCE






pholcodine; érysimum (extrait sec d')


1 mg/ml;
1,5 mg/ml


Clarix toux seche pholcodine erysimum adultes, sirop


Syrup


Oral use




France







COOPER




Place Lucien-Auvert




77020 Melun Cedex




FRANCE






pholcodine;
érysimum (extrait sec d')


0,1 g/100 ml;
0,150 g/100 ml


Clarix toux seche pholcodine erysimum adultes sans sucre, sirop édulcoré au maltitol liquide et au cyclamate de sodium


Syrup


Oral use




France







FERLUX




24, avenue d'Aubière




BP 151




63804 Cournon d'Auvergne Cedex




FRANCE






pholcodine


133 mg/100 ml


Dimetane sans sucre 133 mg/100 ml, sirop


Syrup


Oral use




France







GENEVRIER




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




FRANCE






pholcodine


0,0850 g/100 ml


Codotussyl toux seche enfants, sirop


Syrup


Oral use




France







GENEVRIER




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




FRANCE






pholcodine


133 mg/100 ml


Codotussyl toux seche adultes, sirop


Syrup


Oral use




France







GENEVRIER




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




FRANCE






cinéole;
pholcodine


0,05 g
0,005 g


Codotussyl Enfants, suppositoire


Suppository


Rectal use




France







GENEVRIER




280, rue de Goa




Les Trois Moulins - Parc de Sophia Antipolis




06600 Antibes




FRANCE






cinéole;
pholcodine


0,1 g;
0,02 g


Codotussyl adultes, suppositoire


Suppository


Rectal use




France







HEPATOUM




1 bis, rue de Plaisance




94130 Nogent Sur Marne




FRANCE






chlorphénamine (maléate de); pholcodine


0,01300 g/100 ml;
0,08 g/100 ml


Broncalene adultes, sirop


Syrup


Oral use




France







HEPATOUM




1 bis, rue de Plaisance




94130 Nogent Sur Marne




FRANCE






chlorphénamine (maléate de); pholcodine


0,01 g/100 ml;
0,0500 g/100 ml


Broncalene enfants, sirop


Syrup


Oral use




France







HEPATOUM




1 bis, rue de Plaisance




94130 Nogent Sur Marne




FRANCE






chlorphénamine (maléate de); pholcodine


0,0133 g/100 ml
0,08 g/100 ml


Broncalene adultes sans sucre, sirop édulcoré à la saccharine sodique


Syrup


Oral use




France







MEDIFLOR




37, rue St Romain




69008 Lyon




FRANCE






guaïfénésine;
pholcodine


0,200 g/100 ml;
0,100 g/100 ml


Ephedromel, sirop


Syrup


Oral use




France







MEDIFLOR




37, rue St Romain




69008 Lyon




FRANCE






pholcodine; sulfogaïacol


0,050 g/100 g;
3 g/100 g


Pectoral Richelet sans sucre, solution buvable édulcorée à la saccharine sodique


Oral solution


Oral use




France







PIERRE FABRE MEDICAMENT




45, place Abel Gance




92100 Boulogne Billancourt




FRANCE






erysimum (sommite fleurie d') (extrait fluide de);
pholcodine


2,4 g/100 g;
0,082 g/100 g


Polery enfants, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,060 g/100 ml


Rhinathiol enfants toux seche 0,06 % pholcodine, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,060 g/100 ml


Respilene enfants 3 mg/5 ml, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,12 g/100 ml


Pholcodine delalande adultes 0,12 %, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,12 g/100 ml


Pharmakod 0,12 % adultes toux seche, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,12 g/100 ml


Rhinathiol adultes toux seche 0,12 % pholcodine, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,12 g/100 ml


Pholcodine winthrop adultes 0,12 %, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine;
sodium (ténoate de)


0,133 g/100 ml;
1 g


Trophires adultes, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine


0,12 g/100 ml


Respilene adultes 0,12 pour cent, sirop


Syrup


Oral use




France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






pholcodine;
sodium (ténoate de)


0,06 g/100 ml
1 g/100 ml


Trophires enfants, sirop


Syrup


Oral use




France







UCB PHARMA




420 Avenue Estienne d'Orves




Défense Ouest




92700 Colombes




FRANCE






MYRTE (huile essentielle de) (deterpenee);
pholcodine


20 mg;
18 mg


Atouxx adultes, capsule


Capsule


Oral use




France







URGO




42, rue de Longvic




BP 157




21304 Chenôve Cedex




FRANCE






pholcodine


0,200 g/100 ml


Humex adultes toux seche pholcodine, sirop


Syrup


Oral use




France







URGO




42, rue de Longvic




BP 157




21304 Chenôve Cedex




FRANCE






pholcodine


0,125 g/100 ml


Humex enfants toux seche pholcodine, sirop


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






pholcodine


1,31 mg/ml


Flucalyptol toux seche pholcodine 1,31 mg/ml, sirop


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






pholcodine


1,31 mg/ml


Biocalyptol, sirop


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






pholcodine


131 mg/100 ml


Flucalyptol toux seche pholcodine 1,31 mg/ml sans sucre, sirop edulcoré à la saccharine sodique et au maltitol liquide


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






gaïacol;
pholcodine


19,750 mg/100 ml;
131 mg/100 ml


Biocalyptol a la pholcodine, sirop


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






pholcodine


131 mg/100 ml


Biocalyptol 6,55 mg/5 ml sans sucre, sirop édulcoré à la saccharine sodique et au maltitol liquide


Syrup


Oral use




France







ZAMBON FRANCE




13, rue René Jacques




92138 Issy-les-Moulineaux Cedex




FRANCE






pholcodine;
érysimum (extrait sec d')


0,1/100 ml;
0,150/100 ml


Pholcodyl, sirop


Syrup


Oral use




Ireland







GlaxoSmithKline Consumer Healthcare (Ireland) Limited,




Stonemasons Way,




Rathfarnham,




Dublin 16,




Ireland






Paracetamol, Pseudoephedrine hydrochloride, Pholcodine


500 mg,
30 mg,
5 mg


Day Nurse Capsules


Capsule, hard


Oral use




Ireland







GlaxoSmithKline Consumer Healthcare (Ireland) Limited,




Stonemasons Way,




Rathfarnham,




Dublin 16,




Ireland






Paracetamol, Pseudoephedrine hydrochloride, Pholcodine


500 mg,
30 mg,
5 mg


Solpadeine Cold & Flu Capsules


Capsule, hard


Oral use




Ireland







Pinewood Laboratories Ltd,




Ballymacarbry,




Clonmel,




Co. Tipperary,




Ireland






Pholcodine


5 mg


Pholcodex 5 mg/5 ml oral solution


Oral solution


Oral use




Ireland







The Boots Company Plc,




1 Thane Road West,




Nottingham,




NG2 3AA,




United Kingdom






Paracetamol, Pseudoephedrine hydrochloride, Pholcodine


500 mg
30 mg,
5 mg


Nirolex day cold & flu capsules


Capsule, hard


Oral use




Ireland







The Boots Company Plc,




1 Thane Road West,




Nottingham,




NG2 3AA,




United Kingdom






Paracetamol,
Pseudoephedrine hydrochloride,
Pholcodine


1 000 mg/30 ml, 60 mg/30 ml
10 mg/30 ml,


Nirolex day cold & flu oral solution


Oral solution


Oral use




Lithuania







ORIVAS UAB,




J.Jasinskio 16B




LT-01112 Vilnius,




Lithuania






Pholcodine,
Chlorphenamine,
Biclotymol


120 mg
12 mg
200 mg/100 ml


Hexapneumine Adults


Syrup


Oral use




Lithuania







ORIVAS UAB,




J.Jasinskio 16B




LT-01112 Vilnius,




Lithuania






Pholcodine,
Chlorphenamine,
Biclotymolm


100 mg
10 mg
150 mg/100 ml


Hexapneumine Children


Syrup


Oral use




Luxembourg







COOPERATION PHARM.FRANCAISE




PLACE LUCIEN AUVERT




77020 MELUN CEDEX




France






Erysimum extr.sec
Pholcodine


0,150 g
0,100 g


Clarix


Syrup


Oral use




Luxembourg







COOPERATION PHARM.FRANCAISE




PLACE LUCIEN AUVERT




77020 MELUN CEDEX




France






Erysimum extr.sec
Pholcodine


0,150 g
0,100 g


Clarix sans sucre


Syrup


Oral use




Luxembourg







Eurogenerics S.A.




ESPLANADE HEYSEL, B.22




1020 BRUXELLES




Belgium






Pholcodine
phenylephrine hcl


100 mg/100 ml
67 mg/100 ml


Pectorhinyl


Syrup


Oral use




Luxembourg







Eurogenerics S.A.




ESPLANADE HEYSEL, B.22




1020 BRUXELLES




Belgium






Pholcodine
phenylephrine hcl


50 mg/100 ml
50 mg/100 ml


pectorhinyl junior


Syrup


Oral use




Luxembourg







MEDGENIX BENELUX S.A




21, VLIEGVELD




8560 WEVELGEM




Belgium






camphre
eucalyptol
gaiacol
phenol
pholcodine


156 mg
120 mg
50 mg
10 mg
10 mg


Eucalyptine-Pholcodine Adultes


Suppository


Rectal use




Luxembourg







MEDGENIX BENELUX S.A




21, VLIEGVELD




8560 WEVELGEM




Belgium






camphre
eucalyptol
gaiacol
phenol
pholcodine


100 mg
80 mg
30 mg
6 mg
5 mg


Eucalyptine-Pholcodine Enfants


Suppository


Rectal use




Luxembourg







NOVUM PHARMA




66-3, XAVIER DE COCKLAAN




9830 SINT-MARTENS-LATEM




Belgium






doxylamine
pholcodine
benzoate sodique
sulfogaiacol


5 mg
5 mg
50 mg
47,5 mg


Pholco Mereprine


Syrup


Oral use




Luxembourg







SANOFI-AVENTIS BELGIUM




1C, CULLIGANLAAN




1831 DIEGEM




Belgium






pholcodine
thiophene carboxylate
eucalyptus huile essentielle
parahydroxybenzoate de methyle
parahydroxybenzoate de propyle


0,060 g
1 g
0,250 ml
0,080 g
0,030 g/100 ml


Trophires Enfants


Syrup


Oral use




Luxembourg







SANOFI-AVENTIS BELGIUM




1C, CULLIGANLAAN




1831 DIEGEM




Belgium






pholcodine
thiophene carboxylate
eucalyptus huile essentielle
parahydroxybenzoate de methyle
parahydroxybenzoate de propyle


0,133 g
1 g
0,250 ml
0,080 g
0,030 g


Trophires Adultes


Syrup


Oral use




Luxembourg







SANOFI-AVENTIS BELGIUM




1C, CULLIGANLAAN




1831 DIEGEM




Belgium






Pholcodine


1,2 mg/ml


Cotrane Pholcodine


Syrup


Oral use




Malta







Beecham Group PLC




980, Great West Road




Brentford,




Middlesex




TW 8 9 GS




United Kingdom






Paracetamol,
Pseudoephedrine Hydrochloride,
Pholcodine


500 mg
30 mg
5 mg


Day Nurse


Hard capsules


Oral use




Malta







Beecham Group PLC




980, Great West Road




Brentford,




Middlesex




TW 8 9 GS




United Kingdom






Paracetamol
Pseudoephedrine Hydrochloride
Pholcodine


Active Ingredient per 30 ml
Paracetamol 1 g
Pseudoephedrine Hydrochloride 60 mg
Pholcodine 10 mg


Day Nurse


Oral solution


Oral use




Malta







Thornton & Ross Limited




Linthwaite Huddersfield




West Yorkshire




HD7 5QH




United Kingdom






Pholcodine,
Ephedrine Hydrochloride,
Chlorphenamine Maleate


Pholcodine BP 5,0 mg
Ephedrine Hydrochloride BP 8,0 mg
Chlorphenamine Maleate BP 2,0 mg


Cofsed Liquid


Oral suspension


Oral use




Slovenia







Alkaloid d.o.o.,




Slandrova ulica 4,




1231 Ljubljana,




Slovenia






pholcodine


0,8 mg/ml


Folkodin Alkaloid 0,8 mg/ml peroralna raztopina za otroke


Oral solution


Oral use




Slovenia







Alkaloid d.o.o.,




Slandrova ulica 4,




1231 Ljubljana,




Slovenia






pholcodine


1 mg/ml


Folkodin Alkaloid 1 mg/ml peroralna raztopina


Oral solution


Oral use




Slovenia







Alkaloid d.o.o.,




Slandrova ulica 4,




1231 Ljubljana,




Slovenia






pholcodine


10 mg


Folkodin Alkaloid 10 mg trde kapsule


Capsule, hard


Oral use




Spain







ROTTAPHARM,




S.L.Avda. Diagonal, 67-69




08019 Barcelona




Spain






pholcodine;
cineol;
cherry laurel water;
menthol;
terpineol;
benzocaine


4 mg
3 mg
5 mg
4 mg
2 mg
1 mg


Caltoson Balsamico


Tablets


Oral use




United Kingdom







Alliance Pharmaceuticals Limited,




Avonbridge House, Bath Road, Chippenham,




Wiltshire,




SN15 2BB,




United Kingdom






pholcodine


5 mg


Pavacol-D


Oral liquid


Oral use




United Kingdom







Ayrton Saunders Limited,




North Way,




Walworth Industrial Estate, Andover,




Hampshire,




SP10 5AZ,




United Kingdom






pholcodine


5 mg


Pholcodine Linctus BP


Oral solution


Oral use




United Kingdom







Ayrton Saunders Limited,




North Way,




Walworth Industrial Estate, Andover,




Hampshire,




SP10 5AZ,




United Kingdom






pholcodine


5 mg


Cupal Linctus


Oral liquid


Oral use




United Kingdom







Beecham Group PLC,




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






Psedoephedrine Hydrochloride; Pholcodine; Paracetamol


60 mg;
10 mg,
1 000 mg


Day Nurse


Oral solution


Oral use




United Kingdom







Beecham Group PLC,




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






Psedoephedrine Hydrochloride;
Pholcodine; Paracetamol


30 mg,
5 mg,
500 mg


Day Nurse


Capsules


Oral use




United Kingdom







Beecham Group PLC,




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






Promethazine Hydrochloride, Paracetamol,
Dextromethorphan hydrobromide
Pholcodine;
Pseudoephedrine


10 mg
500 mg
7,5 mg
5 mg
30 mg


Day and Night Nurse capsules
(nb this is a combination of Day Nurse and Night Nurse capsules in one pack)


Capsules


Oral use




United Kingdom







Beecham Group PLC,




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






Pholcodine;
Diphenhydramine hydrochloride


3,75 mg/5 ml;
12,5 mg/5 ml


Cough Nurse Night Time Syrup


Oral liquid


Oral use




United Kingdom







Bell Sons & Company Druggist limited.




Gifford House, Slaidburn Crescent, Southport,




Mersyside,




PR9 9AL,




United Kingdom






pholcodine


0,1 % w/w


Bell Pholcodine Linctus


Oral liquid


Oral use




United Kingdom







Bell Sons & Company Druggist limited.




Gifford House, Slaidburn Crescent, Southport,




Mersyside,




PR9 9AL,




United Kingdom






pholcodine


0,2 % w/w


Bell Strong Pholcodine Linctus


Oral liquid


Oral use




United Kingdom







Ernest Jackson and company Limited,




29 High Street, Crediton,




Devon,




EX17 3AP,




United Kingdom






pholcodine


0,12 % w/w


Potter's Pholcodine cough pastilles


Lozenge


Oral use




United Kingdom







LCM Limited,




Linthwaite,Huddersfield,




West Yorkshire,




HD7 5QH,




United Kingdom






pholcodine


5 mg


Pholcodine Linctus BP


Oral solution


Oral use




United Kingdom







Line Range Limited, c/o Orbis consumer products Limited,




Cunard Road, Park Royal,




London




NW10 6PN,




United Kingdom






Pseudoephedrine Hydrochloride; Pholcodine; Diphenhydramine Hydrochloride; Paracetamol;
Ethanol


6,67 mg,
1,67 mg,
1,67 mg,
100 mg,
96 % 1 ml


Night time Cold relief


Oral solution


Oral use




United Kingdom







Line Range Limited, c/o Orbis consumer products Limited,




Cunard Road, Park Royal,




London




NW10 6PN,




United Kingdom






Pseudoephedrine Hydrochloride; Pholcodine;
Paracetamol


6,67 mg/5 ml,
1,67 mg/5 ml, 100 mg/5 ml


Day time cold relief


Oral liquid


Oral use




United Kingdom







LPC Medical (UK) Limited,




2 Covent Garden Close, Luton,




Bedfordshire,




LU4 8QB,




United Kingdom






pholcodine


10 mg


Hill's Balsam Dry cough liquid


Oral solution


Oral use




United Kingdom







Mcneil Products Limited,




Regulatory Affairs, Dorking Road,




Walton Oaks,




KT20 7NS,




United Kingdom






pholcodine


2 mg


Benylin Children's dry cough


Syrup


Oral use




United Kingdom







Novartis Consumer Health UK Limited,




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






Promethazine Hydrochloride; Pholcodine


1,5 mg,
1,5 mg


Tixylix night cough oral solution


Oral solution


Oral use




United Kingdom







Novartis Consumer Health UK Limited,




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






Psedoephedrine Hydrochloride; Chlorpheniramine maleate; Pholcodine


20 mg,
2 mg,
5 mg


Tixylix cough and Cold


Syrup


Oral use




United Kingdom







Novartis Consumer Health UK Limited,




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






Pholcodine


4 mg


Tixylix Dry cough


Oral solution


Oral use




United Kingdom







Pinewood Laboratories Limited,




Ballymacarbry,




Clonmel,




Co Tipperary,




Ireland






pholcodine


5 mg


Pholcodine Cough Linctus


Syrup


Oral use




United Kingdom







Pinewood Laboratories Limited,




Ballymacarbry,




Clonmel,




Co Tipperary,




Ireland






pholcodine


10 mg


Strong Pholcodine Linctus BP


Oral solution


Oral use




United Kingdom







Sterling Pharmaceuticals Limited,




288 Upper Balsall Heath Road,




Birmingham,




B12 9DR,




United Kingdom






pholcodine


5 mg


Pholcodine Linctus BP.


Oral solution


Oral use




United Kingdom







Sterling Pharmaceuticals Limited,




288 Upper Balsall Heath Road,




Birmingham,




B12 9DR,




United Kingdom






pholcodine


10 mg


Strong Pholcodine Linctus BP.


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






diphenhydramine Chloride;
Pholcodine


12,5 mg
3,75 mg


Boots cough relief for Adults Liquid


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






diphenhydramine Chloride;
Pholcodine


12,5 mg,
1,5 mg


Boots cough relief for Children Syrup


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Pholcodine


2 mg


Boots Dry Cough Syrup 6 years+


Syrup


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Paracetamol, Pseudoephedrine Hydrochloride, Pholcodine


3,333 % w/v,
0,2 % w/v,
0,033 % w/v


Boots Night cough relief oral solution


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Paracetamol; Pseudoephedrine Hydrochloride;
Pholcodine


3,333 % w/v,
0,2 % w/v
0,033 % w/v


Boots Day cold and Flu relief oral solution


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Paracetamol; Pseudoephedrine Hydrochloride;
Diphenhydramine Hydrochloride; Pholcodine


3,333 % w/v,
0,2 % w/v,
0,083 % w/v,
0,033 % w/v


Boots Pharmacy cold and Flu night liquid


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Pholcodine; Paracetamol; Psedoephedrine Hydrochloride


5 mg
500 mg
30 mg


Boots Pharmacy cold and Flu Day capsules


Capsules


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Pholcodine; Paracetamol;
Diphenhydramine Psedoephedrine Hydrochloride


5 mg,
500 mg,
12,5 mg
30 mg


Boots Pharmacy Cold and Flu Night Capsules


Capsules


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






pholcodine


0,1 % w/w


Boots Pholcodine Linctus BP


Oral solution


Oral use




United Kingdom







The Boots company PLC,




1 Thane Road West,




Nottingham,




NG2 3AA




United Kingdom






Pholcodine; Paracetamol; diphenhydramine hydrochloride;
Pseudoephedrine hydrochloride


5 mg
500 mg
12,5 mg
30 mg


Boots Pharmacy Cold and Flu 24 Hour Capsules
(Nb this is a pack containing a combination of Day and Night capsules)


Capsules


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






Pholcodine; Ephedrine Hydrochloride; Chlorpheniramine maleate


5 mg,
8 mg,
2 mg


Cofsed Linctus


Oral liquid


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






Pholcodine; Ephedrine Hydrochloride;
Chlorpheniramine maleate


2 mg,
4 mg,
1 mg


Cofsed Paediatric Linctus


Oral liquid


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






pholcodine


5 mg


Care Pholcodine 5 mg/5 ml Oral solution


Oral liquid


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






pholcodine


2 mg


Galenphol Paediatric Linctus oral liquid 2,0 mg/5 ml


Oral liquid


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






pholcodine


10 mg


Galenphol Strong Linctus


Oral solution


Oral use




United Kingdom







Thornton & Ross Limited,




Linthwaite, Huddersfield,




West Yorkshire,




HD7 5QH




United Kingdom






pholcodine


5 mg


Covonia Dry cough sugar free formula


Oral liquid


Oral use




United Kingdom







Wise Pharmaceuticals Limited,




7 Oxford Street,




Manchester,




M1 4PB,




United Kingdom






pholcodine


5 mg


Pholcodine Linctus BP


Oral solution


Oral use




United Kingdom







Wise Pharmaceuticals Limited,




7 Oxford Street,




Manchester,




M1 4PB,




United Kingdom






pholcodine


10 mg


Strong Pholcodine Linctus


Oral solution


Oral use







ANNEX IV

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











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria







S.Med Handels GmbH




Zachgasse1, Vienna




AT-1220




Austria






BufloMed ‧S.Med‧ 300 mg Filmtabletten


300 mg


film-coated tablet


oral use




Austria







S.Med Handels GmbH




Zachgasse1, Vienna




AT-1220




Austria






BufloMed ‧S.Med‧ retard 600 mg Filmtabletten


600 mg


prolonged-release tablet


oral use




Belgium







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






Loftyl


150 mg


coated tablet


oral use




Belgium







Amdipharm Limited




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






Loftyl


50 mg/5 ml


solution for injection


intramuscular and intravenous use




Cyprus







MEDOCHEMIE LTD, 1-10 Constantinoupoleos street




P.O.Box 51409




3505 Lemesos




Cyprus






Ikelan solution for injection or infusion 50 mg/5 ml


50 mg/5 ml


injection


Intramuscular and intravenous use




France







BIOGARAN




15, boulevard Charles de Gaulle




92700 COLOMBES




FRANCE






BUFLOMEDIL BIOGARAN 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







QUALIMED




117, allée des Parcs




69800 SAINT-PRIEST




France






BUFLOMEDIL QUALIMED 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







TEVA SANTE




Le Palatin 1, 1 cours du Triangle




92936 PARIS LA DEFENSE CEDEX




France






BUFLOMEDIL TEVA 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







ACTAVIS France




La Boursidière Centre d’Affaires




92357 LE PLESSIS ROBINSON




France






BUFLOMEDIL ACTAVIS 150 mg, comprimé


150 mg


Tablet


oral use




France







AMDIPHARM LTD




Temple Chambers 3




Burlington Road




DUBLIN 4




IRELAND






LOFTYL 50 mg/5 ml, solution injectable


50 mg/5 ml


Solution for injection


Intramuscular and intravenous use




France







AMDIPHARM LTD




Temple Chambers 3,




Burlington Road




DUBLIN 4




IRELAND






LOFTYL 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 LYON




FRANCE






BUFLOMEDIL ARROW 150 mg, comprimé


150 mg


Tablet


oral use




France







CEPHALON FRANCE




20, rue Charles Martigny




94700 MAISONS-ALFORT




FRANCE






FONZYLANE 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







CRISTERS




22 quai Gallieni




92150 SURESNES




FRANCE






BUFLOMEDIL CRISTERS 150 mg, comprimé


150 mg


Tablet


oral use




France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 BOULOGNE BILLANCOURT Cedex




FRANCE






BUFLOMEDIL EG 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







LABORATOIRE RATIOPHARM




19, boulevard Paul Vaillant Couturier




94200 IVRY SUR SEINE




France






BUFLOMEDIL RATIOPHARM 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







MYLAN SAS




117, allée des Parcs




69800 SAINT-PRIEST




France






BUFLOMEDIL MYLAN 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 PUTEAUX




France






BUFLOMEDIL RPG 150 mg, comprimé pelliculé


150 mg


Film-coated tablet


oral use




France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 PUTEAUX




France






BUFLOMEDIL RPG 150 mg, comprimé


150 mg


Tablet


oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 LEVALLOIS-PERRET




France






BUFLOMEDIL SANDOZ 150 mg, comprimé


150 mg


Tablet


oral use




France







ZYDUS FRANCE




25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 NANTERRE




France






BUFLOMEDIL ZYDUS 150 mg, comprimé


150 mg


Tablet


oral use




Germany







Amdipharm Limited




Temple Chamcers, 3




Burlington Road




IRL- DUBLIN 4




Irland






Bufedil long Retardtabletten


600 mg


Prolonged-release tablet


oral use




Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren




Germany






Buflomedil AbZ, 600 mg Retardtabletten


600 mg


Prolonged-release tablet


oral use




Germany







Actavis Deutschland GmbH & Co. KG




Elisabeth-Selbert-Str. 1




D-40764 Langenfeld




Germany






Buflo-Puren 300


300 mg


Film-coated tablet


oral use




Germany







Actavis Deutschland GmbH & Co. KG




Elisabeth-Selbert-Str. 1




D-40764 Langenfeld




Germany






BUFLO-Puren 600 retard


600 mg


Prolonged-release tablet


oral use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42a




D-13407 Berlin






Buflomedil-CT 150 mg Filmtabletten


150 mg


Film-coated tablet


oral use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42a




D-13407 Berlin






Buflomedil-CT 300 mg Filmtabletten


300 mg


Film-coated tablet


oral use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42a




D-13407 Berlin






Buflomedil-CT 50 mg/5 ml Ampullen


50 mg / 5 ml


Solution for injection, solution for infusion


Intravenous and intramuscular use




Germany







CT Arzneimittel GmbH




Lengeder Str. 42a




D-13407 Berlin






Buflomedil-CT 600 mg Retardtabletten


600 mg


Prolonged-release tablet


oral use




Germany







ratiopharm GmbH




Graf-Arco-STr. 3




D-89079 Ulm




Germany






Buflomedil-ratiopharm 300 mg Filmtabletten


300 mg


Film-coated tablet


oral use




Germany







ratiopharm GmbH




Graf-Arco-STr. 3




D-89079 Ulm




Germany






Buflomedil-ratiopharm 600 mg Retardtabletten


600 mg


Prolonged-release tablet


oral use




Germany







Riemser Arzneimittel AG




An der Wiek 7




D-17493 Greifswald - Insel Riems




Germany






Complamin Buflomedil 600 mg retard


600 mg


Prolonged-release tablet


oral use




Germany







Riemser Arzneimittel AG




An der Wiek 7




D-17493 Greifswald - Insel Riems




Germany






Complamin Buflomedil Injekt


50 mg / 5 ml


Solution for injection


intravenous and intramuscular use




Germany







Sanofi-Aventis Deutschland GmbH




Industriepark Höchst, Gebäude K703




D-65926 Frankfurt am Main




Germany






Defluina peri


300 mg


Film-coated tablet


oral use




Germany







Sanofi-Aventis Deutschland GmbH




Industriepark Höchst, Gebäude K703




D-65926 Frankfurt am Main




Germany






Deflunia peri mite


150 mg


Film-coated tablet


oral use




Germany







Stadapharm GmbH




Stadastr. 2 – 18




D-61118 Bad Vilbel






Buflomedil Stada 150 mg Filmtabletten


150 mg


Film-coated tablet


oral use




Germany







Stadapharm GmbH




Stadastr. 2 – 18




D-61118 Bad Vilbel






Buflomedil Stada 300 mg Filmtabletten


300 mg


Film-coated tablet


oral use




Greece







BROS LTD




AYGIS AND GALINIS 15




KIFISSIA




14564 ATHENS




Greece






THIOCODIN


150 MG/TAB


COATED TABLET


oral use




Greece







BROS LTD




AYGIS AND GALINIS 15




KIFISSIA




14564 ATHENS




Greece






THIOCODIN


300 MG/TAB


COATED TABLET


oral use




Greece







AMDIPHARM LIMITED, IRELAND




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






LOFTYL


150 MG/TAB


FILM COATED TABLET


oral use




Greece







AMDIPHARM LIMITED, IRELAND




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






LOFTYL


300 MG/TAB


FILM COATED TABLET


oral use




Greece







AMDIPHARM LIMITED, IRELAND




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






LOFTYL


150 MG/ML


ORAL DROPS SOLUTION


oral use




Greece







AMDIPHARM LIMITED, IRELAND




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






LOFTYL


50 MG/5 ML


SOLUTION FOR INJECTION


INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR




Greece







AMDIPHARM LIMITED, IRELAND




Temple Chambers




3 Burlington Road




Dublin 4




Ireland






LOFTYL


600 MG/TAB


CONTROLLED RELEASE TABLET


oral use




Greece







BIOSPRAY ABEE




18TH KM MARATHONOS AVENUE




PALLINI




15344 Athens




Greece






BOTAMIRAL


300 MG/TAB


FILM COATED TABLET


oral use




Greece







FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES




ACHAIAS AND TRIZOINIAS




NEA KIFISSIA




14564 Athens




Greece






VANOGEL


150 MG/ML


ORAL DROPS SOLUTION


oral use




Greece







FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES




ACHAIAS AND TRIZOINIAS




14565 NEA KIFISSIA




Greece






VANOGEL


300 MG/TAB


FILM COATED TABLET


oral use




Greece







HELP ABEE




VALAORITOU 10,




144 52 METAMORFOSI ATTIKIS




Greece






VARDOLIN


150 MG/ML


ORAL DROPS SOLUTION


oral use




Greece







HELP ABEE




VALAORITOU 10,




144 53 METAMORFOSI ATTIKIS




Greece






VARDOLIN


150 MG/TAB


FILM COATED TABLET


oral use




Greece







HELP ABEE




VALAORITOU 10,




144 54 METAMORFOSI ATTIKIS




Greece






VARDOLIN


300 MG/TAB


FILM COATED TABLET


oral use




Greece







HELP ABEE




VALAORITOU 10,




144 55 METAMORFOSI ATTIKIS




Greece






VARDOLIN


600 MG/TAB


CONTROLLED RELEASE TABLET


oral use




Greece







NORMA HELLAS S.A.




MENANDROU 54




10431 ATHENS




Greece






FLUBIR


150 MG/TAB


FILM COATED TABLET


oral use




Greece







NORMA HELLAS S.A.




MENANDROU 54




10432 ATHENS




Greece






FLUBIR


300 MG/TAB


FILM COATED TABLET


oral use




Greece







RAFARM A.E.B.E.




KORINTHOU 12,




15451 NEO PSYCHIKO




Greece






ZELIAN


150 MG/TAB


FILM COATED TABLET


oral use




Greece







RAFARM A.E.B.E.




KORINTHOU 12,




15451 NEO PSYCHIKO




Greece






ZELIAN


300 MG/TAB


FILM COATED TABLET


oral use




Greece







BIOSTAM KAL. MPOUGA AND CO




DIAKRIAS 6




ZOGRAFOU




157 73 Athens




Greece






CHLOROFARM-S


300 MG/TAB


FILM COATED TABLET


oral use




Greece







ANFARM HELLAS




PERIKLEOUS 53-57




105 60 ATHENS




Greece






BLADIRON


300 MG/TAB


FILM COATED TABLET


oral use




Greece







ANFARM HELLAS




PERIKLEOUS 53-57




105 60 ATHENS




Greece






BLADIRON


150 MG/ML


ORAL DROPS SOLUTION


oral use




Greece







A. NIKOLAKOPOULOS AND CO




GALATSIOU AVENUE 115,




11146 ATHENS




Greece






IRRODAN RETARD


600 MG/TAB


SUSTAINED RELEASE TABLET


oral use




Greece







MEDICHROM S.A.




6Km MARKOPOULOU-KOROPI AVENUE




19003 MARKOPOPULO MESOGEIWN




Greece






BUFLODIL


300 MG/TAB


FILM COATED TABLET


oral use




Greece







ELPEN SA PHARMACEUTICAL INDUSTRY




MARATHONOS AVENUE 95




19009 PIKERMI ATTIKIS




Greece






PENPURIN


150 MG/TAB


FILM COATED TABLET


oral use




Greece







ELPEN SA PHARMACEUTICAL INDUSTRY




MARATHONOS AVENUE 95




19010 PIKERMI ATTIKIS




Greece






PENPURIN


300 MG/TAB


FILM COATED TABLET


oral use




Greece







ELPEN SA PHARMACEUTICAL INDUSTRY




MARATHONOS AVENUE 95




19011 PIKERMI ATTIKIS




Greece






PENPURIN


150 MG/ML


ORAL DROPS SOLUTION


oral use




Greece







ELPEN SA PHARMACEUTICAL INDUSTRY




MARATHONOS AVENUE 95




19012 PIKERMI ATTIKIS




Greece






PENPURIN


600 MG/TAB


CONTROLLED RELEASE TABLET


oral use




Greece







VIOFAR LTD




ETHNIKIS ANTISTASEOS AND




TRIFYLLIAS




13671 ACHARNES




Greece






SULODIL


300 MG/TAB


FILM COATED TABLET


oral use




Greece







VIOFAR LTD




ETHNIKIS ANTISTASEOS AND




TRIFYLLIAS




13672 ACHARNES




Greece






SULODIL


600 MG/TAB


CONTROLLED RELEASE TABLET


oral use




Italy







AMDIPHARM LTD




Temple Chambers,




3 Burlington Road,




Dublin 4




IRELAND






LOFTYL


150 mg/ml


oral drop, solution


oral use




Italy







AMDIPHARM LTD




Temple Chambers,




3 Burlington Road,




Dublin 4




IRELAND






LOFTYL


10 mg/ml


solution for injection


intramuscular and intravenous use




Italy







AMDIPHARM LTD




Temple Chambers,




3 Burlington Road,




Dublin 4




IRELAND






LOFTYL


300 mg/10 ml


oral solution


oral use




Italy







AMDIPHARM LTD




Temple Chambers,




3 Burlington Road,




Dublin 4




IRELAND






LOFTYL


600 mg


prolonged-release tablet


oral use




Italy







AMDIPHARM LTD




Temple Chambers,




3 Burlington Road,




Dublin 4




IRELAND






LOFTYL


300 mg


tablet


oral use




Italy







BIOMEDICA FOSCAMA GROUP SpA




Via della Giuliana 73




00195 Roma




Italy






IRRODAN


10 mg/ml


solution for injection


intramuscular and intravenous use




Italy







BIOMEDICA FOSCAMA GROUP SpA




Via della Giuliana 73




00195 Roma




Italy






IRRODAN


150 mg/ml


oral drop, solution


oral use




Italy







BIOMEDICA FOSCAMA GROUP SpA




Via della Giuliana 73




00195 Roma




Italy






IRRODAN


300 mg


tablet


oral use




Italy







LABORATORIO FARMACEUTICO C.T. S.r.l.




Strada Solaro n. 75-77




Villa Sayonara - Sanremo –




18038 IMPERIA




Italy






BUFLOCIT


300 mg


capsule, hard


oral use




Italy







LABORATORIO FARMACEUTICO C.T. S.r.l.




Strada Solaro n. 75-77




Villa Sayonara - Sanremo –




18038 IMPERIA




Italy






BUFLOCIT


150 mg


capsule, hard


oral use




Italy







LABORATORIO FARMACEUTICO C.T. S.r.l.




Strada Solaro n. 75-77




Villa Sayonara - Sanremo –




18038 IMPERIA




Italy






BUFLOCIT


600 mg


prolonged-release tablet


oral use




Luxembourg







AMDIPHARM LIMITED




3, TEMPLE CHAMBERS




IRL DUBLIN






Loftyl


50 mg


solution for injection


Intramuscular and intravenous use




Luxembourg







Amdipharm Limited




Temple Chambers,




3 Burlington Road




Dublin 4




Ireland






Loftyl


150 mg


tablets


oral use




Portugal







Amdipharm Limited




Temple Chambers




3, Burlington Road




Dublin 4




Ireland






Loftyl 300


300 mg


Coated tablet


oral use




Portugal







Amdipharm Limited




Temple Chambers,




3 Burlington Road




Dublin 4




Ireland






Loftyl Forte


600 mg


Prolonged-release tablet


oral use




Netherlands







Amdipharm Limited




Temple Chambers,




3 Burlington Road




Dublin 4




Ireland






Loftyl


150 mg


tablets


oral use




Spain







Amdipharm Limited




Temple Chambers,




3 Burlington Road




Dublin 4




Ireland






LOFTON 150 mg comprimidos recubiertos


150 mg


coated tablet


oral use




Spain







Amdipharm Limited




Temple Chambers,




3 Burlington Road




Dublin 4




Ireland






LOFTON 150 mg/ml gotas orales en solución


150 mg/ml


oral drops solution


oral use




Poland







ICN Polfa Rezszów S.A.




Przemysłowa 2




35-959 Rzeszów,




Poland Office in Warsaw:




ul. Marynarska 15




02-674 Warszawa,




Poland






Buvasodil


150 mg


film coated tablets


oral use




Poland







ICN Polfa Rezszów S.A.




Przemysłowa 2




35-959 Rzeszów,




Poland Office in Warsaw:




ul. Marynarska 15




02-674 Warszawa,




Poland






Buvasodil


300 mg


film coated tablets


oral use