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Tadalafil Generics (tadalafil) – Labelling - G04BE08

Updated on site: 12-Jul-2017

Medication nameTadalafil Generics
ATC CodeG04BE08
Substancetadalafil
ManufacturerMYLAN S.A.S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Tadalafil Generics 20 mg film-coated tablets tadalafil

2.STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 20 mg tadalafil.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

28 film-coated tablets

56 film-coated tablets

28 x 1 film-coated tablets

56 x 1 film-coated tablets

5.METHOD AND ROUTE 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

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

Mylan S.A.S.

117 Allée des Parcs

69800 Saint-Priest France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1153/001

EU/1/16/1153/002

EU/1/16/1153/003

EU/1/16/1153/004

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Tadalafil Generics 20 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

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Generics 20 mg film-coated tablets tadalafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Mylan S.A.S.

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.OTHER

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