SAPROPTERIN Spirig HC 100 mg p sol buv 120 pce

7680698710028 CH-69871 A16AX07 07.99.0.

Reimbursement limitations:

SAPROPT.Spir

En cas de défaut congénital et prouvé de la synthèse de BH4 (aussi connu sous …

SAPROPTERIN Spirig HC 100 mg p sol buv 120 pce
SAPROPTERIN Spirig HC 100 mg p sol buv 120 pce
SAPROPTERIN Spirig HC 100 mg p sol buv 120 pce
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Details

Product number
6987101
CPT
-
Packaging group
120
Unit
Flasche(n)
Composition
sapropterini dihydrochloridum 100 mg corresp. sapropterinum 76.79 mg, mannitolum, crospovidonum, calcii hydrogenophosphas, E 300, E 101, natrii stearylis fumaras corresp. natrium 0.29 mg, pro compresso.

Articles (1)

Sapropterin Spirig HC 100 mg, Tabletten zur Herstellung einer Lösung zum Einnehmen
Tabletten
120
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
30/01/2025
Patient information leaflet
Français
30/01/2025
Patient information leaflet
Italien
30/01/2025
Professional SmPC
Allemand
30/01/2025
Professional SmPC
Français
30/01/2025
Professional SmPC
Italien
30/01/2025

Detailed composition

Substance Quantity Type Category
(N/A)
100.0 MG Substance WIZUS
(N/A)
76.79 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance ANTON
(N/A)
- Substance FTODK
(N/A)
- Substance HNIDK
(N/A)
0.29 MG Substance HBESI

Reimbursement information

Public price
CHF 3052.75
Specialties list
Yes
Generic
Yes

Reimbursement limitation

SL addition date: 01/05/2025

Authorization holder

Spirig HealthCare AG

4622 Egerkingen

Authorization information

Swissmedic authorization number
69871
Drug name
Sapropterin Spirig HC, Tabletten zur Herstellung einer Lösung zum Einnehmen
Galenic form
TABLH
ATC Code
A16AX07
Authorization status
Z
Dispensation category
B
First authorization
18/10/2024
Authorization expiration date
17/10/2029
IT number
07.99.0.
Domain
Human medicine
Field of application
Behandlung der Hyperphenylalaninämie

Packaging details

Description (FR)
SAPROPTERIN Spirig HC 100 mg p sol buv 120 pce
Description (DE)
SAPROPTERIN Spirig HC 100 mg f Lös z Einne 120 Stk
Market launch
18/10/2024
Narcotic (BTM)
No

Original drug

Kuvan, Tabletten
CHF 692.25
View original

Other packaging sizes

SAPROPTERIN Spirig HC 100 mg p sol buv 30 pce
30 FLAS
View