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DOVPRELA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1824779
Name of medicinal product:
DOVPRELA
Active substances:
Pretomanid
Estonian
,
English
,
Latin
ATC code:
J04AK08
Dosage form:
tablet
Route of administration:
oral use
Strengh:
200mg
Amount in package:
182TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
üksikannuseline blister
Indication:
Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrugresistant (MDR) tuberculosis (TB), see sections 4.2, 4.4 and 5.1. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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:
Mylan IRE Healthcare Limited
Marketing authorization number:
EU/1/20/1437
Marketing authorization issued on:
July 31, 2020
Marketing authorization expires on:
November 16, 2028
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: January 18, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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