SANDIMMUN

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Ciclosporin UNII 83HN0GTJ6D - CYCLOSPORINE
	Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.
	Read more about Ciclosporin

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-9672	Tablet	Sandimmun Neoral® 25mg TAB 25 mg 5 X 10	33 RNW-PP-343304 Sandimmun Neoral® 25mg CICLOSPORIN 25MG Cyclosporin -25mg, Macrogolglycerol hydroxystearate / Polyoxyl 40 hydrogenated castor oil -101.25mg, Corn oil-mono-ditriglycerides - 86mg, Ethanol Anhydrous - 25mg, Propylene glycol -25mg, a-Tocopherol - 0.25mg Apr-72 Drugs Imported Products 510 Prescription Only Medicine (POM) 8/1/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 arit.onwusah@novartis.com Catalent Germany Eberbach GmbH, Catalent Germany Eberbach GmbH Gammelsbacher Str.2 69412 Eberbach Baden-Wurttemberg Germany, Germany	30/11/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SANDIMMUN Concentrate for solution for infusion	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
L04AD01	Ciclosporin	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AD Calcineurin inhibitors
Discover more medicines within L04AD01

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	5631J, 6109M
BR	Câmara de Regulação do Mercado de Medicamentos	526513301157311, 526513302153318, 526513402115310, 526513403138314, 526513404118317, 526513405114315
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00042777, 00042783, 00165385, 00165391, 00165416, 00165422, 00165439, 00165445, 00424645, 00424668, 01593692, 01688613, 01688814, 01688843, 01895223, 01895246, 02560430, 03633148, 03633154, 04289233, 04680210, 04680227, 04680233, 04680256, 04781135, 04781141, 04781158, 04781164, 04964025, 04994670, 04994687, 04994693, 05392364, 05392370, 05392387, 05392393, 05392401, 05392418, 07669686, 08760064, 08763890, 08763909, 08763915, 08763921, 08763938, 08763944, 08775746, 08816304, 08816310, 08816327, 08816333, 08816356, 08816362, 08898874, 08898880, 08898897, 08898905, 09282419, 12638104, 16774761, 17448288, 17448294, 17848668, 17848674
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	20.241-1-08-02, 20.243-1-08-02
EE	Ravimiamet	1008526, 1008548, 1008559, 1235135, 1693548, 1731855, 1787474, 1865279
ES	Centro de información online de medicamentos de la AEMPS	56798, 56799, 56800, 60318, 60319, 60320
FI	Lääkealan turvallisuus- ja kehittämiskeskus	061937, 466482, 467563, 467720, 586107
FR	Base de données publique des médicaments	62935801
GB	Medicines & Healthcare Products Regulatory Agency	23546, 23548, 23550, 27800, 27804, 34908
HK	Department of Health Drug Office	20029, 38058, 38059, 38060, 38061, 51354
HR	Agencija za lijekove i medicinske proizvode	HR-H-141846183, HR-H-144486729, HR-H-547220134, HR-H-725462434, HR-H-861000959
IE	Health Products Regulatory Authority	88165, 88166, 88167, 88168, 88169
IL	מִשְׂרַד הַבְּרִיאוּת	3005, 3006, 3007, 3008
IT	Agenzia del Farmaco	029453014, 029453026, 029453038, 029453053
JP	医薬品医療機器総合機構	3999004S1036, 3999406A1032
LT	Valstybinė vaistų kontrolės tarnyba	1001739, 1001740, 1001741, 1090664, 1090665
MT	Medicines Authority	AA565/46501, MA1249/02701, MA1249/02702, MA1249/02703
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	099M84, 106M84, 223M90
NG	Registered Drug Product Database	04-9672
NZ	Medicines and Medical Devices Safety Authority	3909, 3910, 3911, 3912, 3913, 3914
PL	Rejestru Produktów Leczniczych	100059881, 100059898, 100059906, 100059912, 100085223, 100247000
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W01231001, W51398001, W51399001
SG	Health Sciences Authority	00520P, 08176P, 08177P, 08178P, 08179P, 09871P
TN	Direction de la Pharmacie et du Médicament	10283111H, 10283112H, 10283151H, 10283261H, 10283262H, 10283263H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504190007, 8699504190052, 8699504590005, 8699504760057
ZA	Health Products Regulatory Authority	29/34/0056, 29/34/0058, 29/34/0059, 35/34/0132, Q/34/271, R/34/267