Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
FLEBAVEN
|
Active substances:
|
|
ATC code:
|
C05CA03
|
Dosage form:
|
film-coated tablet
|
Strength:
|
500mg
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated May 9, 2022)
|
Package information leaflet (PIL):
|
EST (last updated May 9, 2022)
|
Labelling:
|
(last updated November 29, 2021)
|
Indication:
|
is indicated in adults for:
- Treatment of signs and symptoms of chronic venous disease, such as pain, feeling of heaviness, leg tiredness, restless legs, night cramps, leg oedema and trophic changes.
- Treatment of symptoms related to acute haemorrhoidal disease.
|
Safety features:
|
No
|
Marketing authorization holder:
|
KRKA, d.d., Novo mesto
|
Marketing authorization number:
|
948417
|
Marketing authorization issued on:
|
September 12, 2017
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
(last updated September 12, 2017)
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1706565
|
FLEBAVEN
|
film-coated tablet
|
500mg 15TK
|
OTC
|
|
|
|
|
|
1706576
|
FLEBAVEN
|
film-coated tablet
|
500mg 30TK
|
OTC
|
|
|
|
|
|
1706587
|
FLEBAVEN
|
film-coated tablet
|
500mg 60TK
|
OTC
|
|
|
|
|
|
1706598
|
FLEBAVEN
|
film-coated tablet
|
500mg 90TK
|
OTC
|
|
|
|
|
|
1706600
|
FLEBAVEN
|
film-coated tablet
|
500mg 120TK
|
OTC
|
|
|
|
|
|
1748864
|
FLEBAVEN
|
film-coated tablet
|
500mg 150TK
|
OTC
|
|
|
|
|
|
1748875
|
FLEBAVEN
|
film-coated tablet
|
500mg 180TK
|
OTC
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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