SIGNIFOR

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

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

1
UNII 98H1T17066 - PASIREOTIDE
 

Pasireotide is a novel cyclohexapeptide, injectable somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors. Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing’s disease.

 
Read more about Pasireotide

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SIGNIFOR Powder and solvent for suspension for injection MPI, EU: SmPC European Medicines Agency (EU)
 SIGNIFOR Solution for injection MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
H01CB05 Pasireotide 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 H01CB05

Authorization and marketing

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

Country Identification scheme Identifier(s)
BR Câmara de Regulação do Mercado de Medicamentos 576921020000617, 576921020000717, 576921020000817
CA Health Products and Food Branch 02413299, 02413302, 02413310
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria H5300513, H6070713, H6080713
EE Ravimiamet 1580655, 1580666, 1580677, 1580688, 1580699, 1580701, 1580712, 1580723, 1580734, 1580745, 1580756, 1580767, 1713800, 1713811, 1713822, 1713833, 1713844, 1753208, 1753219
ES Centro de información online de medicamentos de la AEMPS 112753013, 112753014, 112753016
FI Lääkealan turvallisuus- ja kehittämiskeskus 382849, 466629, 483533, 493675
FR Base de données publique des médicaments 60368028, 64400612, 64714278, 66311151, 67724733, 68045233, 68990053, 69935063
GB Medicines & Healthcare Products Regulatory Agency 212072, 212075, 212078, 298974, 298983, 298994, 356059, 356062
HK Department of Health Drug Office 62456, 62457, 62458
IL מִשְׂרַד הַבְּרִיאוּת 7121, 7122
IT Agenzia del Farmaco 042032019, 042032021, 042032033, 042032045, 042032058, 042032060, 042032072, 042032084, 042032096, 042032108, 042032110, 042032122, 042032134, 042032146, 042032159, 042032161, 042032173, 042032185, 042032197
LT Valstybinė vaistų kontrolės tarnyba 1066383, 1066384, 1066385, 1066386, 1066387, 1066388, 1066389, 1066390, 1066391, 1066392, 1066393, 1066394, 1076182, 1076183, 1076184, 1076186, 1076187, 1084006, 1084007
NL Z-Index G-Standaard, PRK 103519, 103527, 126047, 126055, 126063
NZ Medicines and Medical Devices Safety Authority 17224, 17225, 17226
PL Rejestru Produktów Leczniczych 100274591, 100274600, 100274616, 100331283, 100331290, 100331308, 100394272, 100394295
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66950001, W66951001, W66951002, W66952001, W66952002, W66953001, W66954001, W67087001, W67087002, W67087003, W67087004, W67088001, W67088002, W67088003, W67088004, W67090001, W67090002, W67090003, W67090004
SG Health Sciences Authority 14457P, 14458P, 14459P
TR İlaç ve Tıbbi Cihaz Kurumu 8699960580138, 8699960580145, 8699960580152, 8699960580169, 8699960580176, 8699960580183, 8699960580190, 8699960580206, 8699960580213, 8699960580220, 8699960580237, 8699960580244
US FDA, National Drug Code 0078-0633, 0078-0634, 0078-0635, 55292-131, 55292-132, 55292-133

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