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Adempas (riociguat) – Labelling - C02KX05

Updated on site: 05-Oct-2017

Medication nameAdempas
ATC CodeC02KX05
Substanceriociguat
ManufacturerBayer AG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets riociguat

2.STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg riociguat.

3.LIST OF EXCIPIENTS

Contains lactose. Read the package leaflet before use.

4.PHARMACEUTICAL FORM AND CONTENTS

42 film-coated tablets

84 film-coated tablets

90 film-coated tablets

294 film-coated tablets

5.METHOD AND ROUTE OF ADMINISTRATION

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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bayer AG

51368 Leverkusen

Germany

Bayer (logo)

12.MARKETING AUTHORISATION NUMBER

Adempas 0.5 mg – pack of 42 film-coated tablets - EU/1/13/907/001

Adempas 0.5 mg – pack of 84 film-coated tablets - EU/1/13/907/002

Adempas 0.5 mg – pack of 90 film-coated tablets - EU/1/13/907/003

Adempas 0.5 mg – pack of 294 film-coated tablets - EU/1/13/907/016

Adempas 1 mg – pack of 42 film-coated tablets - EU/1/13/907/004

Adempas 1 mg – pack of 84 film-coated tablets - EU/1/13/907/005

Adempas 1 mg – pack of 90 film-coated tablets - EU/1/13/907/006

Adempas 1 mg – pack of 294 film-coated tablets - EU/1/13/907/017

Adempas 1.5 mg – pack of 42 film-coated tablets - EU/1/13/907/007

Adempas 1.5 mg – pack of 84 film-coated tablets - EU/1/13/907/008

Adempas 1.5 mg – pack of 90 film-coated tablets - EU/1/13/907/009

Adempas 1.5 mg – pack of 294 film-coated tablets - EU/1/13/907/018

Adempas 2 mg – pack of 42 film-coated tablets - EU/1/13/907/010

Adempas 2 mg – pack of 84 film-coated tablets - EU/1/13/907/011

Adempas 2 mg – pack of 90 film-coated tablets - EU/1/13/907/012

Adempas 2 mg – pack of 294 film-coated tablets - EU/1/13/907/019

Adempas 2.5 mg – pack of 42 film-coated tablets - EU/1/13/907/013

Adempas 2.5 mg – pack of 84 film-coated tablets - EU/1/13/907/014

Adempas 2.5 mg – pack of 90 film-coated tablets - EU/1/13/907/015

Adempas 2.5 mg – pack of 294 film-coated tablets - EU/1/13/907/020

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Adempas 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg

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 BLISTER - PACKS OF 42, 84, 90, 294 FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Adempas 0.5 mg tablets Adempas 1 mg tablets Adempas 1.5 mg tablets Adempas 2 mg tablets Adempas 2.5 mg tablets riociguat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Bayer (Logo)

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN

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