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SKYCLARYS 50 mg, hard capsule 90 capsules

Active ingredients: OMAVÉLOXOLONE

Commercialized according to BDPMDispensing in France: Prescription only
Hard capsule90 capsulesorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
SKYCLARYS 50 mg, gélule
Pharmaceutical form
gélule
Route of administration
orale
Presentation description
1 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 90 gélule(s)
Marketing authorisation holder
BIOGEN NETHERLANDS (PAYS-BAS)
Reimbursement according to BDPM
—
Approval for use in healthcare institutions
non
Commercialization declaration date
1 Oct 2024
Prescription and dispensing conditions
Prescription only
  • List I: prescription-only medicine
  • Requires special monitoring during treatment
  • Initial prescription by a hospital doctor
  • Prescribed by specialists only
Original BDPM wording: liste I · médicament nécessitant une surveillance particulière pendant le traitement · prescription initiale hospitalière annuelle · prescription réservée aux spécialistes et services GENETIQUE MEDICALE · prescription réservée aux spécialistes et services NEUROLOGIE · prescription réservée aux spécialistes et services NEUROPEDIATRIE
Enhanced ANSM monitoring
Yes

BDPM identifiers

CIS63167621CIP73028510CIP133400930285107

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
OMAVÉLOXOLONEgélule50 mg · une géluleSA

Information is based on BDPM data and is for reference only. Consult a doctor before use.

Similar medicines

Similar medicines are listed using the official BDPM catalog. Availability must be checked separately. Consult a doctor or pharmacist before switching medicines.

The current BDPM data does not list similar medicines for this product.