This brand name is authorized in Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Misoprostol

Misoprostol is an analogue of naturally occurring prostaglandin E1 which promotes peptic ulcer healing and symptomatic relief. Misoprostol protects the gastroduodenal mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions, the proteolytic activity of the gastric fluid, and increasing bicarbonate and mucus secretion.

Read about Misoprostol

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
CYTOTEC Tablet Medicines & Healthcare Products Regulatory Agency (GB) 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
A02BB01 Misoprostol A Alimentary tract and metabolism → A02 Drugs for acid related disorders → A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) → A02BB Prostaglandins
Discover more medicines within A02BB01

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 28652-11-08
Country: EE Ravimiamet Identifier(s): 1178579, 1183711, 1253078, 1269457, 1364611, 1434383, 1697373, 1713721, 1737390, 1767337, 1813823, 1839360, 1843792
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 58403
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 003455, 003469
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 142139, 21871, 32243
Country: HK Department of Health Drug Office Identifier(s): 26808
Country: IE Health Products Regulatory Authority Identifier(s): 19445, 19951
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 1078
Country: JP 医薬品医療機器総合機構 Identifier(s): 2329024F1025, 2329024F2021
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1090503, 1090539, 1090636
Country: MT Medicines Authority Identifier(s): AA565/34302, AA565/34303
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 105M84
Country: NL Z-Index G-Standaard, PRK Identifier(s): 30732
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 4446
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100016512, 100307824, 100362013, 100426003, 100458525, 100459762, 100463602
Country: SG Health Sciences Authority Identifier(s): 03501P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699543010151
Country: US FDA, National Drug Code Identifier(s): 0025-1451, 0025-1461, 55289-248
Country: ZA Health Products Regulatory Authority Identifier(s): S/11.10/392

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.