Not the law itself: Notice

Address https://gelex.eu/eli/EU/notice/oj/C/2012/124/02@2012-04-27/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

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

ANNEX

Anx_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

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

Versions

1. 2012-04-27