CYTOTEC

This brand name is authorized in United States. It is also authorized in Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Misoprostol UNII 0E43V0BB57 - 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 more about Misoprostol

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
CYTOTEC 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
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)
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	28652-11-08
EE	Ravimiamet	1178579, 1183711, 1253078, 1269457, 1364611, 1434383, 1697373, 1713721, 1737390, 1767337, 1813823, 1839360, 1843792
ES	Centro de información online de medicamentos de la AEMPS	58403
FI	Lääkealan turvallisuus- ja kehittämiskeskus	003455, 003469
GB	Medicines & Healthcare Products Regulatory Agency	142139, 21871, 32243
HK	Department of Health Drug Office	26808
IE	Health Products Regulatory Authority	19445, 19951
IL	מִשְׂרַד הַבְּרִיאוּת	1078
JP	医薬品医療機器総合機構	2329024F1025, 2329024F2021
LT	Valstybinė vaistų kontrolės tarnyba	1090503, 1090539, 1090636
MT	Medicines Authority	AA565/34302, AA565/34303
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	105M84
NG	Registered Drug Product Database	B4-0307
Switch country to Nigeria in order to find specific presentations of CYTOTEC
NL	Z-Index G-Standaard, PRK	30732
NZ	Medicines and Medical Devices Safety Authority	4446
PL	Rejestru Produktów Leczniczych	100016512, 100307824, 100362013, 100426003, 100458525, 100459762, 100463602
SG	Health Sciences Authority	03501P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699543010151
US	FDA, National Drug Code	0025-1451, 0025-1461, 55289-248
ZA	Health Products Regulatory Authority	S/11.10/392