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Deltyba (delamanid) – Labelling - J04AK06

Updated on site: 06-Oct-2017

Medication nameDeltyba
ATC CodeJ04AK06
Substancedelamanid
ManufacturerOtsuka Novel Products GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTONS FOR BLISTER PACKS

1.NAME OF THE MEDICINAL PRODUCT

Deltyba 50 mg film-coated tablets delamanid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains: 50 mg delamanid

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

40 tablets

48 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

Not applicable.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

None

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/875/001 40 film-coated tablets

EU/1/13/875/004 48 film-coated tablets

13.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Deltyba 50 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON FOR BOTTLE PACKS AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Deltyba 50 mg film-coated tablets delamanid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains: 50 mg delamanid

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

50 tablets

300 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Not applicable.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

None

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/875/002 50 film-coated tablets

EU/1/13/875/003 300 film-coated tablets

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Aluminium/Aluminium

1. NAME OF THE MEDICINAL PRODUCT

Deltyba 50 mg film-coated tablets delamanid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Short title: OTSUKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER<, DONATION AND PRODUCT CODES>

LOT

5.OTHER

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