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AstraZeneca

Deltyba
delamanid

Package leaflet: Information for the patient


Deltyba 50 mg film-coated tablets

delamanid


imageThis medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).


What Deltyba 50 mg film-coated tablets look like and contents of the pack

Deltyba 50 mg film-coated tablets are round, and yellow.


Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Otsuka Novel Products GmbH Erika-Mann-Straße 21

80636 München

Germany

Tel: +49 (0)89 206020 500


Manufacturer:

R-Pharm Germany GmbH Heinrich-Mack-Straße 35

89257 Illertissen

Germany


image

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:


BE

Otsuka Novel Products GmbH

Tél/Tel: +49 (0)89 206020 500

LT

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


BG

Otsuka Novel Products GmbH

Teл.: +49 (0)89 206020 500

LU

Otsuka Novel Products GmbH

Tél/Tel: +49 (0)89 206020 500


CZ

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

HU

Otsuka Novel Products GmbH

Tel.: +49 (0)89 206020 500


DK

Otsuka Novel Products GmbH

Tlf: +49 (0)89 206020 500

MT

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


DE

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

NL

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


EE

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

NO

Otsuka Novel Products GmbH

Tlf: +49 (0)89 206020 500


EL

Otsuka Novel Products GmbH

Τηλ: +49 (0)89 206020 500

AT

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


ES

Otsuka Pharmaceutical S.A. Tel: +34 93 208 10 20

PL

Otsuka Novel Products GmbH

Tel.: +49 (0)89 206020 500

FR

Otsuka Pharmaceutical France SAS Tél. : +33 (0)1 47 08 00 00

PT

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


HR

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

RO

Ewopharma Romania SRLTel.: +40 (0)21 260

13 44; +40 (0)21 260 14 07


IE

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

SI

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


IS

Otsuka Novel Products GmbH

Sími: +49 (0)89 206020 500

SK

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


IT

Otsuka Pharmaceutical Italy S.r.l.

Tel: +39 (0)2 00632710

FI

Otsuka Novel Products GmbH

Puh/Tel: +49 (0)89 206020 500


CY

Otsuka Novel Products GmbH

Τηλ: +49 (0)89 206020 500

SE

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


LV

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500

UK (XI)

Otsuka Novel Products GmbH

Tel: +49 (0)89 206020 500


This leaflet was last revised in <{MM/YYYY}>.


This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and

this leaflet will be updated as necessary.


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