PENTASA

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

Active ingredients

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

1
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  
 PENTASA Prolonged release granules MPI, EU: SmPC Health Products Regulatory Authority (IE)
 PENTASA Suppository 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 10254Q, 12198B, 12203G, 2214M, 2287J, 3413P, 8753Q
BR Câmara de Regulação do Mercado de Medicamentos 521400802176419, 521400805116417, 521400806139410, 521400808141315, 521401801114310, 521401802110319, 521415070005803
CA Health Products and Food Branch 02099683, 02153521, 02153556, 02153564, 02399466
DE Bundesinstitut für Arzneimittel und Medizinprodukte 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
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 1086-MEE-0615, 2189-MEE-0516, 5735-MAE-03-10, 5779-MAE-05-10
EE Ravimiamet 1023815, 1023826, 1352810, 1352821, 1352832, 1352843, 1352854, 1500185, 1512795, 1730876
ES Centro de información online de medicamentos de la AEMPS 60151, 60152, 60853, 62670, 77022, 77668, 79555
FI Lääkealan turvallisuus- ja kehittämiskeskus 021196, 021508, 034512, 104836, 164039, 194132, 466153
FR Base de données publique des médicaments 61951546, 62217530, 62289729, 66154593, 66357483, 69694541
GB Medicines & Healthcare Products Regulatory Agency 137012, 147097, 147098, 176248, 195214, 26097, 28201, 283908, 32571, 368190, 373670, 373912, 376973, 379932, 379934, 38659
HK Department of Health Drug Office 37044, 37099, 54514, 57788, 57790, 62218, 64784
HR Agencija za lijekove i medicinske proizvode HR-H-120226953, HR-H-282835727, HR-H-296920131, HR-H-589842039, HR-H-729224011
IE Health Products Regulatory Authority 39004, 39066, 46820, 53496, 59080, 59560, 59657, 59690, 59700, 59705
IL מִשְׂרַד הַבְּרִיאוּת 2824, 2895, 4142, 6869, 6966, 699, 7956
IT Agenzia del Farmaco 027130044, 027130069
JP 医薬品医療機器総合機構 2399009D2020, 2399009F1149, 2399009F2030, 2399715J1020, 2399715X1023
LT Valstybinė vaistų kontrolės tarnyba 1001535, 1001536, 1032894, 1032895, 1054528, 1054529, 1054530, 1057359, 1057360
MT Medicines Authority AA1314/00301, AA1314/00302, AA1314/00303
MX Comisión Federal para la Protección contra Riesgos Sanitarios 063M98, 537M97, 611M2004
NG Registered Drug Product Database B4-9899, B4-9900, B4-9901, B4-9989
NL Z-Index G-Standaard 14207028
NL Z-Index G-Standaard, PRK 116882, 25178, 31860, 34215, 44334, 79820, 92673
NZ Medicines and Medical Devices Safety Authority 12388, 14098, 17724, 5279, 5280, 5281, 5282
PL Rejestru Produktów Leczniczych 100052287, 100052293, 100095902, 100099662, 100279186, 100279200, 100342520
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W58054001, W58055001, W58461001, W61355001, W61355002
SG Health Sciences Authority 07740P, 07883P, 13448P, 14456P, 14479P, 15137P, 15614P
TN Direction de la Pharmacie et du Médicament 55230210, 55230211, 5523022, 5523023, 5523024, 5523025, 5523026, 5523027, 5523028, 5523029
TR İlaç ve Tıbbi Cihaz Kurumu 8697621030114, 8697621030596, 8697621030602, 8697621220126, 8697621220270, 8697621890138, 8697621910201
US FDA, National Drug Code 54092-189, 54092-191
ZA Health Products Regulatory Authority 33/11/0088, 43/11/0013, 43/11/0014, 44/11/0888, A40/11/0374

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