Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
RIVOTRIL
|
Active substances:
|
|
ATC code:
|
N03AE01
|
Dosage form:
|
tablet
|
Strength:
|
2mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated December 30, 2021)
|
Package information leaflet (PIL):
|
EST (last updated December 30, 2021)
|
Labelling:
|
(last updated October 20, 2021)
|
Indication:
|
Epilepsy.
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Cheplapharm Arzneimittel GmbH
|
Marketing authorization number:
|
053694
|
Marketing authorization issued on:
|
June 14, 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Assessment report:
|
|
Description
|
Additional condition
|
Väljastamisel kehtib koguseline piirang
|
60 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml
|
Ei ole lubatud väljastada korduvretsepti
|
|
Väljastamisel kehtib koguseline piirang
|
60 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml, erandina epilepsia raviks kuni kaks kuud
|
Ei ole lubatud väljastada korduvretsepti
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1004544
|
RIVOTRIL
|
tablet
|
2mg 30TK
|
Prescription
|
100% 50%
|
|
17.04.2023
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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