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ORPHACOL
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1624980
Name of medicinal product:
ORPHACOL
Active substances:
Cholic acid
Estonian
,
English
,
Latin
ATC code:
A05AA03
Dosage form:
capsule, hard
Route of administration:
oral use
Strengh:
250mg
Amount in package:
120TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to 3â-Hydroxy-Ä5-C27-steroid oxidoreductase deficiency or Ä4-3-Oxosteroid-5â-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Labelling:
Last imported to Estonia:
Never imported to Estonia
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Laboratoires C.T.R.S.
Marketing authorization number:
EU/1/13/870
Marketing authorization issued on:
September 16, 2013
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: May 2, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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