Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration)

Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Sandostatin 0,05 mg/ml — Ampullen 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Sandostatin 0,1 mg/ml — Ampullen 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Sandostatin 0,5 mg/ml — Ampullen 0,5 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,5 mg/ml

Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria Sandostatin 0,2 mg/ml — Durchstechflasche 0,2 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,2 mg/ml

Belgium N.V. Novartis Pharma S.A. Medialaan 40, 1800 Vilvoorde Belgium Sandostatine 0,1 mg/ml Solution for injection Injection or infusion 0,1 mg/ml

Belgium N.V. Novartis Pharma S.A. Medialaan 40, 1800 Vilvoorde Belgium Sandostatine 0,5 mg/ml Solution for injection Injection or infusion 0,5 mg/ml

Bulgaria Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany Sandostatin 0,1 mg/ml Solution for injection Subcutaneous use or intravenous use 0,1 mg/ml

Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 0,05 mg/ml Solution for injection Injection 0,05 mg/ml

Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 0,1 mg/ml Solution for injection Injection 0,1 mg/ml

Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,05 mg/ml 0,05 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,05 mg/ml

Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,1 mg/ml 0,1 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,1 mg/ml

Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,5 mg/ml 0,5 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,5 mg/ml

Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,2 mg/ml 0,2 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,2 mg/ml

Denmark Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

Denmark Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Denmark Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 1 mg/5 ml Solution for injection or concentrate for solution for infusion Injection or infusion 1 mg/5 ml

Estonia Novartis Finland OY Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,1 mg/ml Solution for injection Subcutaneous use 0,1 mg/ml

Finland Novartis Finland OY Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,05 mg/ml Solution for injection Subcutaneous use or intravenous use 0,05 mg/ml

Finland Novartis Finland OY Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,1 mg/ml Solution for injection Subcutaneous use or intravenous use 0,1 mg/ml

Finland Novartis Finland OY Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,5 mg/ml Solution for injection Subcutaneous use or intravenous use 0,5 mg/ml

France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France Sandostatine 0,05 mg/1ml Solution for injection Subcutaneous use or intravenous use 0,05 mg/ml

France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France Sandostatine 0,1 mg/1ml Solution for injection Subcutaneous use or intravenous use 0,1 mg/ml

France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France Sandostatine 0,5 mg/1ml Solution for injection Subcutaneous use or intravenous use 0,5 mg/ml

Germany Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 50 ug 0,05 mg/ml Solution for injection Injection 0,05 mg/ml

Germany Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 100 ug 0,1 mg/ml Solution for injection Injection 0,1 mg/ml

Germany Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 500 ug 0,5 mg/1ml Solution for injection Injection 0,5 mg/1ml

Germany Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 1000 ug 1 mg/5 ml Solution for injection Injection 1 mg/5 ml

Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis 144 51 Athens Greece Sandostatin 0,1 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,1 mg/ml

Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis 144 51 Athens Greece Sandostatin 0,5 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,5 mg/ml

Hungary Novartis Hungária Kft. (Pharma részlege) Bartók Béla út 43-47 1114 Budapest Hungary Sandostatin 0,1 mg/ml oldatos injekció 0,1 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,1 mg/ml

Hungary Novartis Hungária Kft. (Pharma részlege) Bartók Béla út 43-47 1114 Budapest Hungary Sandostatin 0,2 mg/ml oldatos injekció 0,2 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use or intravenous use 0,2 mg/ml

Iceland Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 50 mcg/ml Solution for injection Subcutaneous use or intravenous use 50 mcg/ml

Iceland Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 100 mcg/ml Solution for injection Subcutaneous use or intravenous use 100 mcg/ml

Iceland Novartis Healthcare A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark Sandostatin 200 mcg/ml Solution for injection Subcutaneous use or intravenous use 200 mcg/ml

Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 50 mcg/ml Solution for s.c. or i.v. injection Injection or infusion 50 mcg/ml

Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 100 mcg/ml Solution for s.c. injection or concentrate for solution for i.v. injection Injection or infusion 100 mcg/ml

Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 500 mcg/ml Solution for s.c. injection or concentrate for solution for i.v. injection or concentrate for solution for i.v. infusion Injection or infusion 500 mcg/ml

Italy Novartis Farma S.p.A. Largo Umberto Boccioni 1 21040 Origgio Italy Sandostatina 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

Italy Novartis Farma S.p.A. Largo Umberto Boccioni 1 21040 Origgio Italy Sandostatina 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Italy Novartis Farma S.p.A. Largo Umberto Boccioni 1 21040 Origgio Italy Sandostatina 0,5 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,5 mg/ml

Italy Novartis Farma S.p.A. Largo Umberto Boccioni 1 21040 Origgio Italy Sandostatina 1 mg/5 ml Solution for injection or concentrate for solution for infusion Injection or infusion 1 mg/5 ml

Latvia Novartis Finland OY Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,1 mg/ml šķīdums injekcijām 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Lithuania Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland Sandostatin 0,1 mg/ml Solution for injection Subcutaneous use or intravenous use 0,1 mg/ml

Luxembourg Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 50 ug 0 ,05 mg/ml Solution for injection Injection 0,05 mg/ml

Luxembourg N.V. Novartis Pharma S.A. Medialaan 40, 1800 Vilvoorde Belgium Sandostatine 0,1 mg/ml Solution for injection Injection 0,1 mg/ml

Luxembourg N.V. Novartis Pharma S.A. Medialaan 40, 1800 Vilvoorde Belgium Sandostatine 0,5 mg/ml Solution for injection Injection 0,5 mg/ml

Luxembourg Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 1000 ug 1 mg/5 ml Solution for injection Injection 1 mg/5 ml

Malta Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin 0,5 mg/1 ml ampoules 0,5 mg/ml Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion) Injection or infusion 0,5 mg/ml

Malta Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin multidose vials 1 mg/5 ml (0,2 mg/ml) 0,2 mg/ml Solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion) Injection or infusion 0,2 mg/ml

The Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandostatine 0,05 mg/ml, injectievloeistof 1 ml 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

The Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandostatine 0,1 mg/ml, injectievloeistof 1 ml 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

The Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandostatine 0,5 mg/ml, oplossing voor injectie 1 ml 0,5 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,5 mg/ml

The Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandostatine 0,2 mg/ml, injectievloeistof 5 ml 0,2 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,2 mg/ml

Norway Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo Norway Sandostatin 0,05 mg/ml Solution for injection Injection or infusion 0,05 mg/ml

Norway Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo Norway Sandostatin 0,1 mg/ml Solution for injection Injection or infusion 0,1 mg/ml

Norway Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo Norway Sandostatin 0,2 mg/ml Solution for injection Injection or infusion 0,2 mg/ml

Poland Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 50 mcg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 50 mcg/ml

Poland Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 100 mcg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 100 mcg/ml

Portugal Novartis Farma — Produtos Farmacêuticos S.A. Av. Professor Doutor Cavaco Silva, 10 E Taguspark 2740-255 Porto Salvo Portugal Sandostatina 0,05 mg/ml Solution for injection Subcutaneous use Intravenous use 0,05 mg/ml

Portugal Novartis Farma — Produtos Farmacêuticos S.A. Av. Professor Doutor Cavaco Silva, 10 E Taguspark 2740-255 Porto Salvo Portugal Sandostatina 0,1 mg/ml Solution for injection Subcutaneous use Intravenous use 0,1 mg/ml

Portugal Novartis Farma — Produtos Farmacêuticos S.A. Av. Professor Doutor Cavaco Silva, 10 E Taguspark 2740-255 Porto Salvo Portugal Sandostatina 0,5 mg/ml Solution for injection Subcutaneous use Intravenous use 0,5 mg/ml

Portugal Novartis Farma — Produtos Farmacêuticos S.A. Avenida Professor Doutor Cavaco Silva, n.o 10E Taguspark 2740-255 Porto Salvo Portugal Sandostatina 0,2 mg/ml Solution for injection Subcutaneous use Intravenous use 0,2 mg/ml

Romania Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany SANDOSTATIN 0,1 mg/ml soluţie injectabilă 0,1 mg/ml Solution for injection Subcutaneous use Intravenous use 0,1 mg/ml

Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — Nusle Czech Republic Sandostatin 0,5 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,5 mg/ml

Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Praha 4 — NusleCzech Republic Sandostatin 1 mg/5 ml Solution for injection or concentrate for solution for infusion Injection or infusion 1 mg/5 ml

Slovenia Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 0,05 mg/ml raztopina za injiciranje/infundiranje 0,05 mg/ml Solution for injection or infusion Injection or infusion 0,05 mg/ml

Slovenia Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 0,1 mg/ml raztopina za injiciranje/infundiranje 0,1 mg/ml Solution for injection or infusion Injection or infusion 0,1 mg/ml

Slovenia Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg Germany Sandostatin 0,5 mg/ml raztopina za injiciranje/infundiranje 0,5 mg/ml Solution for injection or infusion Injection or infusion 0,5 mg/ml

Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Sandostatin 50 microgramos/ml solución inyectable 0,05 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,05 mg/ml

Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Sandostatin 100 microgramos/ml solución inyectable 0,1 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,1 mg/ml

Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Sandostatin 200 microgramos/ml solución inyectable 0,2 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,2 mg/ml

Sweden Novartis Sverige AB Kemistvägen 1B/Box 1150 183 11 Täby Sweden Sandostatin 0,05 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,05 mg/ml

Sweden Novartis Sverige AB Kemistvägen 1B/Box 1150 183 11 Täby Sweden Sandostatin 0,1 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,1 mg/ml

Sweden Novartis Sverige AB Kemistvägen 1B/Box 1150 183 11 Täby Sweden Sandostatin 0,5 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,5 mg/ml

Sweden Novartis Sverige AB Kemistvägen 1B/Box 1150 183 11 Täby Sweden Sandostatin 0,2 mg/ml Solution for injection or concentrate for solution for infusion Injection or infusion 0,2 mg/ml

United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin ampoules 50 mcg/ml solution for injection or concentrate for solution for infusion 0,05 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,05 mg/ml

United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin ampoules 100 mcg/ml solution for injection or concentrate for solution for infusion 0,1 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,1 mg/ml

United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandostatin ampoules 500 mcg/ml solution for injection or concentrate for solution for infusion 0,5 mg/ml Solution for injection or concentrate for solution for infusion Subcutaneous use Intravenous use 0,5 mg/ml