SAPROPTERIN Dipharma cpr disp 100 mg fl 120 pce

7680682240029 CH-68224 A16AX07 07.99.0.
SAPROPTERIN Dipharma cpr disp 100 mg fl 120 pce
SAPROPTERIN Dipharma cpr disp 100 mg fl 120 pce
SAPROPTERIN Dipharma cpr disp 100 mg fl 120 pce
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Details

Product number
6822401
CPT
-
Packaging group
120
Unit
Tablette(n)
Composition
sapropterini dihydrochloridum 100 mg corresp. sapropterinum 77 mg, acidum ascorbicum, natrii stearylis fumaras corresp. natrium 0.529 mg, copovidonum, mannitolum 119.65 mg, crospovidonum, riboflavinum, silica colloidalis anhydrica, pro compresso.

Articles (1)

Sapropterin Dipharma 100 mg, compressa dispersibile
Tabletten
120
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
17/08/2023
Professional SmPC
Français
17/08/2023
Professional SmPC
Italien
17/08/2023
Patient information leaflet
Allemand
02/06/2023
Patient information leaflet
Français
02/06/2023
Patient information leaflet
Italien
02/06/2023

Detailed composition

Substance Quantity Type Category
sapropterini dihydrochloridum
100.0 MG Substance WIZUS
sapropterinum
77.0 MG Substance Wirkstoff (Principe actif)
acidum ascorbicum
- Substance HNIDK
natrii stearylis fumaras
- Substance HNIDK
natrium
0.529 MG Substance HBESI
copovidonum
- Substance HNIDK
mannitolum
119.65 MG Substance HNIDK
crospovidonum
- Substance HNIDK
riboflavinum
- Substance HNIDK
silica colloidalis anhydrica
- Substance HNIDK

Reimbursement information

Public price
CHF 2135.55
Specialties list
Yes
Generic
Yes

Reimbursement limitation

SL addition date: 01/07/2023

Authorization holder

Dipharma SA

6830 Chiasso

Authorization information

Swissmedic authorization number
68224
Drug name
Sapropterin Dipharma, compressa dispersibile
Galenic form
TABLH
ATC Code
A16AX07
Authorization status
Z
Dispensation category
B
First authorization
23/02/2022
Authorization expiration date
31/12/9999
IT number
07.99.0.
Domain
Human medicine

Packaging details

Description (FR)
SAPROPTERIN Dipharma cpr disp 100 mg fl 120 pce
Description (DE)
SAPROPTERIN Dipharma Disp Tabl 100 mg Fl 120 Stk
Market launch
23/02/2022
Narcotic (BTM)
No

Original drug

Kuvan, Tabletten
CHF 692.25
View original

Other packaging sizes

SAPROPTERIN Dipharma cpr disp 100 mg fl 30 pce
30 TABL
View
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