SALOFALK

This brand name is authorized in Australia, Austria, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, Germany, Hong Kong SAR China, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Mesalazine UNII 4Q81I59GXC - MESALAMINE
	Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
	Read more about Mesalazine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SALOFALK Gastro-resistant tablet	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
A07EC02	Mesalazine	A Alimentary tract and metabolism → A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents → A07E Intestinal antiinflammatory agents → A07EC Aminosalicylic acid and similar agents
Discover more medicines within A07EC02

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	10257W, 11554D, 5461K, 8598M, 8599N, 8616L, 8617M, 8731M, 8768L, 9206M
CA	Health Products and Food Branch	02112760, 02112787, 02112795, 02112809, 02242146
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00077988, 00111656, 00126416, 00126422, 00165356, 00165362, 00165379, 00165698, 00165706, 00174378, 00174384, 00201721, 00201738, 00204257, 00204263, 00204286, 00213842, 00213859, 00247516, 00248243, 00248266, 00271176, 00425366, 00713852, 00714099, 00714171, 00714277, 00714308, 00867377, 00867383, 00867414, 01128831, 01128908, 01128972, 01265723, 01550346, 01559896, 01559904, 01559910, 01662654, 01662660, 01851119, 01851183, 01896955, 02145487, 02145493, 02145501, 02145524, 02145530, 02145547, 02175821, 02175844, 02232200, 02232217, 02232223, 02396344, 02396350, 03407127, 03407133, 03407156, 03549287, 03549293, 03628733, 03640094, 03755302, 03811816, 03853542, 03853559, 03853565, 04015381, 04656513, 04656536, 04656542, 04964048, 04964054, 04964060, 04965579, 05737018, 05737024, 06164837, 06164843, 06639789, 06766370, 06785657, 06785686, 06810763, 06810786, 06810792, 06836774, 06836797, 06901738, 06920003, 06920026, 07224636, 07233405, 07233411, 07233428, 07371656, 07371662, 07371679, 07401794, 07452805, 07544660, 07544677, 07733415, 07736419, 07736425, 08670668, 08670674, 08888686, 08888692, 08894830, 09204974, 09204980, 09206186, 09206192, 09206329, 09303593, 09303601, 09303618, 09605035, 09636219, 09636231, 09745693, 09772537, 10041891, 10041916, 10054818, 10054824, 10054830, 10228810, 10736127, 10736156, 10942223, 11383702, 11383719, 11383725, 11606527, 11654319, 11654325, 11726421, 12344905, 12344911, 12344928, 12367823, 12367846, 12367852, 12368857, 12368886, 12368900, 12511361, 13420347, 13420353, 13420382, 13515622, 13515639, 13581116, 13581122, 13650320, 13650343, 13650366, 14026977, 14026983, 14027008, 14027014, 14033279, 14054382, 14054399, 14054407, 14054413, 14054436, 14145989, 14240452, 14240469, 14403581, 14403635, 15328284, 15328290, 15875282, 15875299, 16351954, 16351960, 16502502, 16502672, 16504116, 16811982, 17448271
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	2540-MEE-0217
EE	Ravimiamet	1044829, 1044841, 1044863, 1083125, 1083147
ES	Centro de información online de medicamentos de la AEMPS	65771, 65772, 70134, 70453, 71881, 73372, 74791
FI	Lääkealan turvallisuus- ja kehittämiskeskus	039609, 075591, 547154
GB	Medicines & Healthcare Products Regulatory Agency	156401, 182428, 183069, 196418, 26094, 28195, 351295, 40265, 40359, 52275, 52278
HK	Department of Health Drug Office	53382, 58825, 58826, 59672, 59673, 59674, 59675, 65052, 65053
HR	Agencija za lijekove i medicinske proizvode	HR-H-056926689, HR-H-096573039, HR-H-293118992, HR-H-366666368, HR-H-371400988, HR-H-717303526, HR-H-842627661
IE	Health Products Regulatory Authority	44016, 44028, 44032, 44053, 44059, 44072, 44082, 44087, 53516
LT	Valstybinė vaistų kontrolės tarnyba	1001734, 1001735, 1001736, 1032830, 1055648, 1055649, 1055650, 1055651, 1055652, 1055653, 1072023
MT	Medicines Authority	AA565/51602
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	014M90, 046M89, 326M2014
NL	Z-Index G-Standaard	15563294, 15563308, 15563316
NL	Z-Index G-Standaard, PRK	24562, 25305, 25445, 37370, 44334, 68918, 69426, 87866, 98353
PL	Rejestru Produktów Leczniczych	100059591, 100084962, 100087239, 100111268, 100233280, 100314706, 100314758, 100314770
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W04124001, W04124002, W04125003, W04125004, W04126001, W04126002, W04127003, W04127004, W04128001, W43161001, W56484001, W56484002, W56484003, W56484004, W56484005, W56484006, W56484007
SG	Health Sciences Authority	02576P, 02643P, 09296P, 09340P, 10918P, 14426P, 14427P, 14428P, 14429P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699543040066, 8699543040073, 8699543130019, 8699543240022, 8699543240039, 8699543240046, 8699543240053, 8699543330013, 8699543890012, 8699543890029, 8699543890036, 8699543920016
ZA	Health Products Regulatory Authority	43/11.10/0086, 43/11.10/0195, 43/11.10/0196, 43/11.10/0700