SOMATULINE

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

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 more about Lanreotide

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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