EZMEKLY cpr disp 1 mg 42 pce

7680703920015 CH-70392 L01EE05 07.16.1.

Active substances:

Mirdametinibum

No images available

Details

Product number
7039201
CPT
-
Packaging group
42
Unit
Tablette(n)
Composition
mirdametinibum 1 mg, cellulosum microcristallinum, carmellosum natricum conexum, magnesii stearas, aromatica (Traube) cum amyli hydrolysati solida et amylum modificatum et triacetinum, sucralosum, pro compresso corresp. natrium max. 0.6 mg.

Articles (1)

Ezmekly 1 mg, Tabletten zur Herstellung einer Suspension zum Einnehmen
Tabletten zur Herstellung einer Suspension zum Einnehmen
42
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
18/04/2026
Professional SmPC
Français
18/04/2026
Professional SmPC
Italien
18/04/2026
Patient information leaflet
Allemand
17/04/2026
Patient information leaflet
Français
17/04/2026
Patient information leaflet
Italien
17/04/2026

Detailed composition

Substance Quantity Type Category
mirdametinibum
1.0 MG Substance Wirkstoff (Principe actif)
cellulosum microcristallinum
- Substance HNIDK
carmellosum natricum conexum
- Substance HNIDK
magnesii stearas
- Substance HNIDK
aromatica
- Substance AROMA
amyli hydrolysati solida
- Substance HNIDK
amylum modificatum
- Substance HNIDK
triacetinum
- Substance HNIDK
sucralosum
- Substance HNIDK
natrium
- Substance HBESI

Reimbursement information

Public price
CHF 5157.15
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/09/2026

Authorization holder

Merck (Schweiz) AG

6300 Zug

Authorization information

Swissmedic authorization number
70392
Drug name
Ezmekly, Tabletten zur Herstellung einer Suspension zum Einnehmen
Galenic form
TABLH
ATC Code
L01EE05
Authorization status
B
Dispensation category
A
First authorization
09/04/2026
Authorization expiration date
09/04/2028
IT number
07.16.1.
Domain
Human medicine
Field of application
Symptomatische und inoperable plexiforme Neurofibrome bei Patienten mit Neurofibromatose Typ 1 (NF1).

Packaging details

Description (FR)
EZMEKLY cpr disp 1 mg 42 pce
Description (DE)
EZMEKLY Disp Tabl 1 mg 42 Stk
Market launch
08/06/2026
Narcotic (BTM)
No

Other packaging sizes

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