POMBILITI subst sèche 105 mg flac

7680678040015 CH-67804 A16AB23 07.14.0.

Active substances:

POMBILITI subst sèche 105 mg flac
POMBILITI subst sèche 105 mg flac
POMBILITI subst sèche 105 mg flac
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Details

Product number
6780401
CPT
-
Packaging group
1
Unit
Ampulle(n)
Composition
cipaglucosidasum alfa 105 mg, natrii citras dihydricus corresp. natrium 10.5 mg, acidum citricum monohydricum, mannitolum, polysorbatum 80, pro vitro.

Articles (1)

Pombiliti 105 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
07/08/2025
Patient information leaflet
Français
07/08/2025
Patient information leaflet
Italien
07/08/2025
Professional SmPC
Allemand
05/08/2025
Professional SmPC
Français
05/08/2025
Professional SmPC
Italien
05/08/2025

Detailed composition

Substance Quantity Type Category
cipaglucosidasum alfa
105.0 MG Substance Wirkstoff (Principe actif)
natrii citras dihydricus
- Substance HNIDK
natrium
10.5 MG Substance HBESI
acidum citricum monohydricum
- Substance HNIDK
mannitolum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK

Reimbursement information

Public price
CHF 1096.00
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/01/2025

Authorization holder

Amicus Therapeutics Switzerland GmbH

8008 Zürich

Authorization information

Swissmedic authorization number
67804
Drug name
Pombiliti, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Galenic form
PULPI
ATC Code
A16AB23
Authorization status
Z
Dispensation category
A
First authorization
04/07/2024
Authorization expiration date
03/07/2029
IT number
07.14.0.
Domain
Human medicine
Field of application
Behandlung der Glykogenspeicherkrankheit Typ II (Morbus Pompe)

Packaging details

Description (FR)
POMBILITI subst sèche 105 mg flac
Description (DE)
POMBILITI Trockensub 105 mg Durchstf
Market launch
04/07/2024
Narcotic (BTM)
No

Other packaging sizes

POMBILITI subst seche 105 mg 10 pce
10 AMP
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