Product Information: Deltyba®

Active Substance: Delamanid
Prescription Only Medicine

Austria

For Healthcare Professionals:
Summary of Product Characteristics (German):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (German):
Deltyba 50 mg film-coated tablets (PDF)

 

Estonia / Eesti

For Healthcare Professionals / Tervishoiutöötajatele:
Summary of Product Characteristics / Ravimi omaduste kokkuvõte
Deltyba 50 mg film-coated tablets / Deltyba 50 mg õhukese polümeerikattega tabletid (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergeeruvad tabletid (PDF)

Additional risk minimisation material / Täiendav riskide minimeerimise materjal:
Additional risk minimisation materials for Healthcare Professionals / Täiendav riskide minimeerimise materjal tervishoiutöötajatele (PDF)

For patients / Patsientidele:
Patient Information Leaflet / Patsiendi infoleht
Deltyba 50 mg film-coated tablets / Deltyba 50 mg õhukese polümeerikattega tabletid (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergeeruvad tabletid (PDF)

Additional risk minimisation material / Täiendav riskide minimeerimise materjal:
Additional risk minimisation material for patients / Täiendav riskide minimeerimise materjal patsientidele (PDF)

 

France

For Healthcare Professionals:
Summary of Product Characteristics (French):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (French):
Deltyba 50 mg film-coated tablets (PDF)

 

Germany

For Healthcare Professionals:
Summary of Product Characteristics (German):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (German):
Deltyba 50 mg film-coated tablets (PDF)

 

Italy

For Healthcare Professionals:
Summary of Product Characteristics (Italian):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (Italian):
Deltyba 50 mg film-coated tablets (PDF)

 

Latvia / Latvija

For Healthcare Professionals / Veselības aprūpes speciālistiem:
Summary of Product Characteristics / Zāļu apraksts
Deltyba 50 mg film-coated tablets / Deltyba 50 mg apvalkotās tablets (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg disperģējamās tablets (PDF)

Additional risk minimisation material / Papildus riska mazināšanas materiāls:
Additional risk minimisation materials for Healthcare Professionals/
Papildus riska mazināšanas materiāls veselības aprūpes speciālistiem (PDF)

For patients / Pacientiem:
Patient Information Leaflet / Pamācība pacientiem
Deltyba 50 mg film-coated tablets / Deltyba 50 mg apvalkotās tablets (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg disperģējamās tablets (PDF)

Additional risk minimisation material / Papildus riska mazināšanas materiāls:
Additional risk minimisation material for patients / Papildus riska mazināšanas materiāls pacientiem (PDF)

 

Lithuania / Lietuva

For Healthcare Professionals / Sveikatos priežiūros specialistams:
Summary of Product Characteristics / Preparato charakteristikų santrauka
Deltyba 50 mg film-coated tablets / Deltyba 50 mg plėvele dengtos tabletės (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg disperguojamosios tabletės (PDF)

Additional risk minimisation material / Papildoma rizikos mažinimo medžiaga:
Additional risk minimisation materials for Healthcare Professionals/
Papildoma rizikos mažinimo medžiaga sveikatos priežiūros specialistams (PDF)

For patients / Pacientams:
Patient Information Leaflet / Pakuotės lapelis
Deltyba 50 mg film-coated tablets / Deltyba 50 mg plėvele dengtos tabletės (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg disperguojamosios tabletės (PDF)

Additional risk minimisation material / Papildoma rizikos mažinimo medžiaga:
Additional risk minimisation material for patients / Papildoma rizikos mažinimo medžiaga pacientams (PDF)

 

The Netherlands / Nederland

For Healthcare Professionals / Voor zorgverleners:
Summary of Product Characteristics / Samenvatting van de productkenmerken
Deltyba 50 mg film-coated tablets / Deltyba 50 mg filmomhulde tabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergeerbare tabletten (PDF)

Additional risk minimisation material / Additioneel risicominimalisatiemateriaal:
Deltyba additioneel risicominimalisatiemateriaal voor zorgverleners (PDF)

For patients / Voor de patiënt
Patient Information Leaflet / Bijsluiter: informatie voor de patiënt
Deltyba 50 mg film-coated tablets / Deltyba 50 mg filmomhulde tabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergeerbare tabletten (PDF)

Additional risk minimisation material / Additioneel risicominimalisatiemateriaal
Deltyba additioneel risicominimalisatiemateriaal voor de patiënt (PDF)

 

Romania

For Healthcare Professionals:
Summary of Product Characteristics (Romanian):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (Romanian):
Deltyba 50 mg film-coated tablets (PDF)

 

Spain

For Healthcare Professionals:
Summary of Product Characteristics (Spanish):
Deltyba 50 mg film-coated tablets (PDF)

For Patients:
Patient Information Leaflet (Spanish):
Deltyba 50 mg film-coated tablets (PDF)

 

For other European languages, please visit the European Medicines Agency page:

EMA

 

Information current as of 10-01-2022
Reference ONP-COP-2000001