Product Information: Deltyba®

Active Substance: Delamanid
Prescription Only Medicine

Austria / Österreich

For Healthcare Professionals / Für Angehörige der Heilberufe:
Summary of Product Characteristics / Fachinformation
Deltyba 50 mg film-coated tablets / Deltyba 50 mg Filmtabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen (PDF)

Additional risk minimisation material / Schulungsmaterial:
Additional risk minimisation materials for Healthcare Professionals / Leitfaden fuer Angehörige der Heilberufe (PDF)

For patients / Für Patienten:
Patient Information Leaflet / Gebrauchsinformation
Deltyba 50 mg film-coated tablets / Deltyba 50 mg Filmtabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen (PDF)

Additional risk minimisation material / Schulungsmaterial:
Additional risk minimisation material for patients / Leitfaden fuer Patienten (PDF)

 

Czech Republic / Česká republika

For Healthcare Professionals / Pro zdravotníky:
Summary of Product Characteristics / SOUHRN ÚDAJŮ O PŘÍPRAVKU
Deltyba 50 mg film-coated tablets / Deltyba 50 mg potahované tablety (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergovatelné tablety (PDF)

Additional risk minimisation material / Dalsi materiál pro minimalizaci rizik
Additional risk minimisation materials for Healthcare Professionals / Vzdělávací materiál pro poskytovatele zdravotní péče (PDF)

For patients / Pro patienty:
Patient Information Leaflet / Příbalová informace
Deltyba 50 mg film-coated tablets / Deltyba 50 mg potahované tablety (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergovatelné tablety (PDF)

Additional risk minimisation material / Dalsi materiál pro minimalizaci rizik
Additional risk minimisation materials for patients / Vzdělávací materiál pro pacienty (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)

 

Finland / Suomi / Finland

For Healthcare Professionals / Terveydenhuollon ammattilaisille / För vårdpersonal:
Summary of Product Characteristics / VALMISTEYHTEENVETO / RODUKTRESUMÉ
Deltyba 50 mg kalvopäällysteiset tabletit (PDF) – Suomalainen
Deltyba 50 mg filmdragerade tabletter (PDF) – Ruotsin kieli
Deltyba 25 mg dispergoituvat tabletit (PDF) – Suomalainen
Deltyba 25 mg dispergerbara tabletter (PDF) – Ruotsin kieli

Additional risk minimisation material / Riskienminimoinnin lisämateriaaleja / Ytterligare riskminimeringsmaterial:
Terveydenhuollon ammattilaisille tarkoitetun koulutusmateriaalin (PDF) – Suomalainen
Ytterligare riskminimeringsmaterial för vårdpersonal (PDF) – Ruotsin kieli

For patients / Potilaalle / För patienter:
Patient Information Leaflet / Pakkausseloste / Bipacksedel
Deltyba 50 mg kalvopäällysteiset tabletit (PDF) – Suomalainen
Deltyba 50 mg filmdragerade tabletter (PDF) – Ruotsin kieli
Deltyba 25 mg dispergoituvat tabletit (PDF) – Suomalainen
Deltyba 25 mg dispergerbara tabletter (PDF) – Ruotsin kieli

Additional risk minimisation material / Riskienminimoinnin lisämateriaaleja / Ytterligare riskminimeringsmaterial:
Potilaille tarkoitettu koulutusmateriaali (PDF) – Suomalainen
Ytterligare riskminimeringsmaterial för patienter (PDF) – Ruotsin kieli

 

France / France

For Healthcare Professionals / Pour les professionnels de santé:
Summary of Product Characteristics / Résumé des caractéristiques du produit
Deltyba 50 mg film-coated tablets / Deltyba 50 mg comprimés pelliculés (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg comprimés dispersibles (PDF)

Additional risk minimisation material / Mesures additionnelles de réduction du risque
Additional risk minimisation materials for Healthcare Professionals /Brochure d’informations destinée aux professionnels de santé (PDF)

For patients / Pour les patients:
Patient Information Leaflet / Notice : Information du patient
Deltyba 50 mg film-coated tablets / Deltyba 50 mg comprimés pelliculés (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg comprimés dispersibles (PDF)

Additional risk minimisation material / Mesures additionnelles de réduction du risque
Additional risk minimisation materials for patients /Brochure à destination des patientes en âge de procréer (PDF)

 

Germany / Deutschland

For Healthcare Professionals / Für Angehörige der Heilberufe:
Summary of Product Characteristics / Fachinformation
Deltyba 50 mg film-coated tablets / Deltyba 50 mg Filmtabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen (PDF)

Additional risk minimisation material / Schulungsmaterial:
Additional risk minimisation materials for Healthcare Professionals / Leitfaden fuer Angehörige der Heilberufe (PDF)

For patients / Für Patienten:
Patient Information Leaflet / Gebrauchsinformation
Deltyba 50 mg film-coated tablets / Deltyba 50 mg Filmtabletten (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen (PDF)

Additional risk minimisation material / Schulungsmaterial:
Additional risk minimisation material for patients / Leitfaden fuer Patienten (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 / România

For Healthcare Professionals / Pentru Profesioniștii din domeniul sănătății:
Summary of Product Characteristics / Sumarul Caracteristicilor Produsului
Deltyba 50 mg film-coated tablets / Deltyba 50 mg comprimate filmate (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg comprimate dispersabile (PDF)

Additional risk minimisation material / Material adițional pentru minimizarea riscului:
Additional risk minimisation materials for Healthcare Professionals / Materiale adiționale pentru reducerea la minim a riscurilor pentru Profesioniștii din domeniul sănătății (PDF)

For patients /Pentru pacienți:
Patient Information Leaflet / Prospect: Informații pentru utilizator
Deltyba 50 mg film-coated tablets / Deltyba 50 mg comprimate filmate (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg comprimate dispersabile (PDF)

Additional risk minimisation material / Material adițional pentru minimizarea riscului:
Additional risk minimisation material for patients / Materiale adiționale pentru reducerea la minim a riscurilor pentru pacienți (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)

 

Sweden/Sverige

For Healthcare Professionals / För vårdpersonal:
Summary of Product Characteristics / PRODUKTRESUMÉ
Deltyba 50 mg film-coated tablets / Deltyba 50 mg filmdragerade tabletter (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergerbara tabletter (PDF)

Additional risk minimisation material / Ytterligare riskminimeringsmaterial:
Ytterligare riskminimeringsmaterial för vårdpersonal (PDF)

For patients / För patienter:
Patient Information Leaflet / Bipacksedel
Deltyba 50 mg film-coated tablets / Deltyba 50 mg filmdragerade tabletter (PDF)
Deltyba 25 mg dispersible tablets / Deltyba 25 mg dispergerbara tabletter (PDF)

Additional risk minimisation material / Ytterligare riskminimeringsmaterial:
Additional risk minimisation material for patients / Ytterligare riskminimeringsmaterial för patienter (PDF)

 

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

EMA

Information current as of 26-10-2022
Reference ONP-DEL-2200007