SOMATULINE

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Estonia, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SOMATULINE contains one active pharmaceutical ingredient (API):

1 Lanreotide UNII IEU56G3J9C - LANREOTIDE ACETATE

Lanreotide is an octapeptide analogue of natural somatostatin. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. Read about Lanreotide

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SOMATULINE LA Powder for suspension for injection	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
SOMATULINE AUTOGEL Solution for injection	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
H01CB03	Lanreotide	H Systemic hormonal preparations, excl. Sex hormones and insulins → H01 Pituitary and hypothalamic hormones and analogues → H01C Hypothalamic hormones → H01CB Somatostatin and analogues
Discover more medicines within H01CB03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11289E, 11315M, 11316N, 11513Y, 11527Q, 11736Q, 5777C, 5778D, 5779E, 6423C, 6424D, 6425E
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 539214010000603, 539214010000703, 539214010000803, 539220120001407, 539220120001507, 539220120001607
Country: CA	Health Products and Food Branch	Identifier(s): 02283395, 02283409, 02283417
Country: EE	Ravimiamet	Identifier(s): 1043941, 1134560, 1134571, 1134582
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 006941, 006988, 007002
Country: FR	Base de données publique des médicaments	Identifier(s): 63787825, 63871159, 67919092, 68758076
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 198889, 198892, 198894, 41496
Country: HK	Department of Health Drug Office	Identifier(s): 51884, 51885, 51886
Country: IE	Health Products Regulatory Authority	Identifier(s): 88007, 88056, 88173, 88296
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6249, 6250, 6256
Country: JP	医薬品医療機器総合機構	Identifier(s): 2499413G1025, 2499413G2021, 2499413G3028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1012441, 1013933, 1013940, 1013942
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 540M2004
Country: NL	Z-Index G-Standaard	Identifier(s): 14309580, 14844990, 14845008, 14845016
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 54534, 68926, 68934, 68942
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19300, 19301, 19302
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100087104, 100128903, 100128910, 100128932
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W58628001
Country: SG	Health Sciences Authority	Identifier(s): 14289P, 14290P, 14291P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 5723031H, 5723032H, 5723033H, 5723034H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699783950101, 8699783950118, 8699783950125
Country: US	FDA, National Drug Code	Identifier(s): 15054-1060, 15054-1090, 15054-1120
Country: ZA	Health Products Regulatory Authority	Identifier(s): 45/21.12/1022, 45/21.12/1023, 45/21.12/1024