PENTASA

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

Active ingredients

The drug PENTASA 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 about Mesalazine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PENTASA Suppository	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
PENTASA Prolonged release granules	Health Products Regulatory Authority (IE)	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
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)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10254Q, 12198B, 12203G, 2214M, 2287J, 3413P, 8753Q
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 521400802176419, 521400805116417, 521400806139410, 521400808141315, 521401801114310, 521401802110319, 521415070005803
Country: CA	Health Products and Food Branch	Identifier(s): 02099683, 02153521, 02153556, 02153564, 02399466
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00565908, 00565914, 00565920, 00700967, 01296379, 01296385, 01977978, 01977984, 01977990, 01978009, 01978015, 02048465, 02051852, 02200111, 02200140, 02452491, 02452516, 02565999, 02566013, 02592660, 02593205, 02593292, 02593346, 02593441, 02648337, 02648366, 02815976, 02815982, 04034303, 04034326, 04034332, 04617080, 04617157, 06051435, 06848033, 09012720, 09012737, 09012743, 09205904, 09205910, 09234320, 09234337, 09234343, 09234366, 10020624, 11009872, 11071463, 11071486, 13423328, 13423334, 14398153, 15226980, 15292959, 15585650, 15657013, 16792612, 17203612
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 1086-MEE-0615, 2189-MEE-0516, 5735-MAE-03-10, 5779-MAE-05-10
Country: EE	Ravimiamet	Identifier(s): 1023815, 1023826, 1352810, 1352821, 1352832, 1352843, 1352854, 1500185, 1512795, 1730876
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 60151, 60152, 60853, 62670, 77022, 77668, 79555
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 021196, 021508, 034512, 104836, 164039, 194132, 466153
Country: FR	Base de données publique des médicaments	Identifier(s): 61951546, 62217530, 62289729, 66154593, 66357483, 69694541
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 137012, 147097, 147098, 176248, 195214, 26097, 28201, 283908, 32571, 368190, 373670, 373912, 376973, 379932, 379934, 38659
Country: HK	Department of Health Drug Office	Identifier(s): 37044, 37099, 54514, 57788, 57790, 62218, 64784
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-120226953, HR-H-282835727, HR-H-296920131, HR-H-589842039, HR-H-729224011
Country: IE	Health Products Regulatory Authority	Identifier(s): 39004, 39066, 46820, 53496, 59080, 59560, 59657, 59690, 59700, 59705
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 2824, 2895, 4142, 6869, 6966, 699, 7956
Country: IT	Agenzia del Farmaco	Identifier(s): 027130044, 027130069
Country: JP	医薬品医療機器総合機構	Identifier(s): 2399009D2020, 2399009F1149, 2399009F2030, 2399715J1020, 2399715X1023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1001535, 1001536, 1032894, 1032895, 1054528, 1054529, 1054530, 1057359, 1057360
Country: MT	Medicines Authority	Identifier(s): AA1314/00301, AA1314/00302, AA1314/00303
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 063M98, 537M97, 611M2004
Country: NG	Registered Drug Product Database	Identifier(s): B4-9899, B4-9900, B4-9901, B4-9989
Country: NL	Z-Index G-Standaard	Identifier(s): 14207028
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 116882, 25178, 31860, 34215, 44334, 79820, 92673
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 12388, 14098, 17724, 5279, 5280, 5281, 5282
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100052287, 100052293, 100095902, 100099662, 100279186, 100279200, 100342520
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W58054001, W58055001, W58461001, W61355001, W61355002
Country: SG	Health Sciences Authority	Identifier(s): 07740P, 07883P, 13448P, 14456P, 14479P, 15137P, 15614P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 55230210, 55230211, 5523022, 5523023, 5523024, 5523025, 5523026, 5523027, 5523028, 5523029
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8697621030114, 8697621030596, 8697621030602, 8697621220126, 8697621220270, 8697621890138, 8697621910201
Country: US	FDA, National Drug Code	Identifier(s): 54092-189, 54092-191
Country: ZA	Health Products Regulatory Authority	Identifier(s): 33/11/0088, 43/11/0013, 43/11/0014, 44/11/0888, A40/11/0374