FENISTIL

This brand name is authorized in Austria, Croatia, Cyprus, Germany, Israel, Lithuania, Malta, Netherlands, Poland, Romania, Spain, Turkey.

Active ingredients

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

1	Dimetindene UNII 6LL60J9E0O - DIMETHINDENE MALEATE
	Dimetindene is an antihistaminic of the alkylamine group. Its action is the result of the capture of histamine Η1 subunits. It has mild anticholinergic and sedative action.
	Read more about Dimetindene

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FENISTIL Oral drops, solution	MPI, EU: SmPC	Υπουργείο Υγείας (CY)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
D04AA13	Dimetindene	D Dermatologicals → D04 Antipruritics, incl. antihistamines, anesthetics, etc. → D04A Antipruritics, incl. antihistamines, anesthetics, etc. → D04AA Antihistamines for topical use
Discover more medicines within D04AA13
R06AB03	Dimetindene	R Respiratory system → R06 Antihistamines for systemic use → R06A Antihistamines for systemic use → R06AB Substituted alkylamines
Discover more medicines within R06AB03

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00376975, 00376981, 01329096, 01669981, 01669998, 01939854, 02137619, 03032667, 03177265, 03293445, 03293451, 03293468, 04959538, 04959596, 04959604, 04959610, 09887683, 09887743, 09887766, 12550409
ES	Centro de información online de medicamentos de la AEMPS	0228308, 37189-7-6-2010, 54083, 63138, LT-1-95-0933-001
HR	Agencija za lijekove i medicinske proizvode	HR-H-290145057, HR-H-870677704
IL	מִשְׂרַד הַבְּרִיאוּת	1095, 2469, 5220
LT	Valstybinė vaistų kontrolės tarnyba	1008855, 1008856
MT	Medicines Authority	MA1177/00201
NL	Z-Index G-Standaard	14341255
NL	Z-Index G-Standaard, PRK	5142
PL	Rejestru Produktów Leczniczych	100023972, 100023989, 100258250, 100265439, 100310418, 100325733, 100326508, 100345084, 100345434, 100352693, 100354108, 100362562, 100366420, 100375814, 100386597, 100400156, 100400311, 100420957, 100423128, 100423134, 100429480, 100440411, 100443786
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63446001, W63446002
TR	İlaç ve Tıbbi Cihaz Kurumu	8681291340178