Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-04-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012124EN.01001201.xml










27.4.2012   


EN


Official Journal of the European Union


C 124/12





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012

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

2012/C 124/02
—   Refusal of 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




6.3.2012


Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and ass. names


See Annex I


See Annex I


7.3.2012






(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 MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State
EU/EEA


Marketing authorisaton holder


Product name


Strength


Pharmaceutical form


Route of administration




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




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




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




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




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




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




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




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




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




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


5 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


10 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Simplexx


15 mg/1,5 ml


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


5 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


10 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Nordiflex


15 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


5 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


10 mg/1,5 mL


solution for injection


subcutaneous use




Belgium







NOVO NORDISK PHARMA SA




Boulevard international 55




1070 Brussels




Belgium






Norditropin Flexpro


15 mg/1,5 mL


solution for injection


subcutaneous use




Bulgaria







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 mL


solution for injection


subcutaneous use




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 use




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 use




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 use




Cyprus







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 5 mg/1,5 ml


5 mg/1,5 mL


solution for injection


subcutaneous use




Cyprus







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 10 mg/1,5 ml


10 mg/1,5 mL


solution for injection


subcutaneous use




Cyprus







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 15 mg/1,5 ml


15 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx 5 mg/1,5 ml


5 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx 10 mg/1,5 ml


10 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx 15 mg/1,5 ml


15 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro 5 mg/1,5 ml


5 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro 10 mg/1,5 ml


10 mg/1,5 mL


solution for injection


subcutaneous use




Czech Republic







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro 15 mg/1,5 ml


15 mg/1,5 mL


solution for injection


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 mL


solution for injection


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 mL


solution for injection


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


15 mg/1,5 mL


solution for injection


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex


5 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex


10 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin NordiFlex


15 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Flexpro


5 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Flexpro


10 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Denmark







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Flexpro


15 mg/1,5 mL


solution for injection, prefilled pen


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Simplexx


5 mg/1,5 mL


solution for injection


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Simplexx


10 mg/1,5 mL


solution for injection


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Simplexx


15 mg/1,5 mL


solution for injection


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Nordiflex


5 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Nordiflex


10 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




Finland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Nordiflex


15 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




Finland







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




Finland







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




Finland







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




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


5 mg/1,5 mL


solution for injection


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


10 mg/1,5 mL


solution for injection


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


15 mg/1,5 mL


solutrion for injection


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


5 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


10 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


15 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


5 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


10 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




France







Novo Nordisk, Coeur Défense –




100, avenue du Général de Gaulle –




92400 Courbevoie




France






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


15 mg/1,5 mL


solution for injection in pre-filled pen


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






Norditropin Simplexx 5 mg/1,5 ml Injektionslösung


5 mg/1,5 mL


solution for injection


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






Norditropin Simplexx 10 mg/1,5 ml Injektionslösung


10 mg/1,5 mL


solution for injection


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






Norditropin Simplexx 15 mg/1,5 ml Injektionslösung


15 mg/1,5 mL


solution for injection


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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


5 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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


10 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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


15 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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




Germany







Novo Nordisk Pharma GmbH




Brucknerstr. 1




D-55127 Mainz




Germany






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




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin SimpleXx 5 mg/1,5 mL cartridge


5 mg/1,5 mL


solution for injection


subcutaneous use




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin SimpleXx 10 mg/1,5 mL cartridge


10 mg/1,5 mL


solution for injection


subcutaneous use




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin SimpleXx 15 mg/1,5 mL cartridge


15 mg/1,5 mL


solution for injection


subcutaneous use




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin FlexPro 5 mg/1,5 mL


5 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin FlexPro 10 mg/1,5 mL


10 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Greece







Novo Nordisk Hellas Ltd.




A. Panagouli 80 & Aghias Triados 65.




153 43 Aghia Paraskevi,




Athens




Greece






Norditropin FlexPro 15 mg/1,5 mL


15 mg/1,5 mL


solution for injection, in pre-filled pen


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 5 mg/1,5 ml oldatos injekció


5 mg/1,5 mL


solution for injection


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 10 mg/1,5 ml oldatos injekció


10 mg/1,5 mL


solution for injection


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SimpleXx 15 mg/1,5 ml oldatos injekció


15 mg/1,5 mL


solution for injection


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FlexPro 5 mg/1,5 ml oldatos injekció előretöltött injekciós tollban


5 mg/1,5 mL


solution for injection (in prefilled pen)


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FlexPro 10 mg/1,5 ml oldatos injekció előretöltött injekciós tollban


10 mg/1,5 mL


solution for injection (in prefilled pen)


subcutaneous use




Hungary







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FlexPro 15 mg/1,5 ml oldatos injekció előretöltött injekciós tollban


15 mg/1,5 mL


solution for injection (in prefilled pen)


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


5 mg/1,5 mL


solution for injection


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


10 mg/1,5 mL


solution for injection


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


15 mg/1,5 mL


solution for injection


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




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


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




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


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




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


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro 5 mg/1,5 ml Solution for Injection, Pre-filled Pen


5 mg/1,5 ml


solution for injection


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro 10 mg/1,5 ml Solution for Injection, Pre-filled Pen


10 mg/1,5 ml


solution for injection


subcutaneous use




Ireland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


15 mg/1,5 ml


solution for injection


subcutaneous use




Italy







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


5 mg/1,5 ml


solution for injection


subcutaneous use




Italy







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


10 mg/1,5 ml


solution for injection


subcutaneous use




Italy







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXX


15 mg/1,5 ml


solution for injection


subcutaneous use




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




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




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




Italy







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




Italy







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




Italy







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




Lithuania







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin Simplexx


10 mg/1,5 ml


solution for injection


subcutaneous use




Lithuania







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


solution for injection


subcutaneous use




Lithuania







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




Lithuania







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




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Simplexx


5 mg/1,5 mL


solution for injection


subcutaneous use




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Simplexx


10 mg/1,5 mL


solution for injection


subcutaneous use




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Simplexx


15 mg/1,5 mL


solution for injection


subcutaneous use




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Nordiflex


5 mg/1,5 mL


solution for injection


subcutaneous use




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Nordiflex


10 mg/1,5 mL


solution for injection


subcutaneous use




Luxembourg







Novo Nordisk Pharma




Riverside Business Park




B-1070 Bruxelles




Belgium






Norditropin Nordiflex


15 mg/1,5 mL


solution for injection


subcutaneous use




Malta







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 mL


solution for injeciton


subcutaneous use




Malta







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 mL


solution for injeciton


subcutaneous use




Malta







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro


5 mg/1,5 ml


solution for injection, in a pre-filled pen


subcutaneous use




Malta







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro


10 mg/1,5 ml


solution for injection, in a pre-filled pen


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin SimpleXx


5 mg/1,5 mL


solution for injection (oplossing voor injectie)


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin SimpleXx


10 mg/1,5 mL


solution for injection (oplossing voor injectie)


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin SimpleXx


15 mg/1,5 mL


solution for injection (oplossing voor injectie)


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin FlexPro


5 mg/1,5 mL


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


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin FlexPro


10 mg/1,5 mL


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


subcutaneous use




The Netherlands







Novo Nordisk B.V.




Flemingweg 18,




2408 AV ALPHEN A/D RIJN




The Netherlands






Norditropin FlexPro


15 mg/1,5 mL


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


subcutaneous use




Poland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 mL


solution for injection


subcutaneous use




Poland







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 mL


solution for injection


subcutaneous use




Poland







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




Portugal







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


solution for injection


subcutaneous use




Portugal







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 ml


solution for injection


subcutaneous use




Portugal







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


15 mg/1,5 ml


solution for injection


subcutaneous use




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




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




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




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




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




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




Romania







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 ml


solution for injection


subcutaneous use




Romania







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 ml


solution for injection


subcutaneous use




Romania







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




Romania







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




Slovakia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


5 mg/1,5 mL


solution for injection


subcutaneous use




Slovakia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin SimpleXx


10 mg/1,5 mL


solution for injection


subcutaneous use




Slovakia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro


5 mg/1,5 mL


solution for injection


subcutaneous use




Slovakia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin FlexPro


10 mg/1,5 mL


solution for injection


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


5 mg/1,5 mL


solution for injection


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


10 mg/1,5 mL


solution for injection


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


15 mg/1,5 mL


solution for injection


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


5 mg/1,5 mL


solution for injection in pre-filed pen


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


10 mg/1,5 mL


solution for injection in pre-filed pen


subcutaneous use




Slovenia







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






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


15 mg/1,5 mL


solution for injection in pre-filed pen


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXx 5 mg/1,5 ml solución inyectable


5 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXx 10 mg/1,5 ml solución inyectable


10 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN SIMPLEXx 15 mg/1,5 ml solución inyectable


15 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX 5 mg/1,5 ml solución inyectable


5 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable


10 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable


15 mg/1,5 mL


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO 5 mg/1,5 ml


5 mg/1,5 ml


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO 10 mg/1,5 ml


10 mg/1,5 ml


solution for injection


subcutaneous use




Spain







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






NORDITROPIN FLEXPRO 15 mg/1,5 ml


15 mg/1,5 ml


solution for injection


subcutaneous use




Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


5 mg/1,5 ml


solution for injection


subcutaneous use




Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


10 mg/1,5 ml


solution for injection


subcutaneous use




Sweden







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




Denmark






Norditropin® SimpleXx®


15 mg/1,5 ml


solution for injection


subcutaneous use




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




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




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




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




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




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




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin SimpleXx


5 mg/1,5 ml


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin SimpleXx


10 mg/1,5 ml


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin SimpleXx


15 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Nordiflex 5 mg/1,5 ml


5 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Nordiflex 10 mg/1,5 ml


10 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Nordiflex 15 mg/1,5 ml


15 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Flexpro


5 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Flexpro


10 mg/1,5 mL


solution for injection


subcutaneous use




United Kingdom







Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,




West Sussex




RH11 9RT




United Kingdom






Norditropin Flexpro


15 mg/1,5 mL


solution for injection


subcutaneous use