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Tadalafil Mylan (tadalafil) – Labelling - G04BE08

Updated on site: 10-Oct-2017

Medication nameTadalafil Mylan
ATC CodeG04BE08
Substancetadalafil
ManufacturerGenerics (UK) Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 2.5 mg film-coated tablets tadalafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg tadalafil

3.LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

56 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Once daily

Read the package leaflet before 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

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/961/008

EU/1/14/961/009

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Tadalafil Mylan 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

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 2.5 mg film-coated tablets tadalafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Generics [UK] Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 5 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg tadalafil

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

84 film-coated tablets

98 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily

Read the package leaflet before 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

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/961/012

EU/1/14/961/013

EU/1/14/961/014

EU/1/14/961/015

EU/1/14/961/016

EU/1/14/961/017

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tadalafil Mylan 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

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 5 mg film-coated tablets tadalafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Generics [UK] Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 10 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg tadalafil

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

4 film-coated tablets

12 film-coated tablets

24 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/961/001

EU/1/14/961/010

EU/1/14/961/011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tadalafil Mylan 10 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 Mylan 10 mg film-coated tablets tadalafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Generics [UK] Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Mylan 20 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg tadalafil

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 film-coated tablets

4 film-coated tablets

8 film-coated tablets

12 film-coated tablets

24 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/961/002

EU/1/14/961/003

EU/1/14/961/004

EU/1/14/961/005

EU/1/14/961/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tadalafil Mylan 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 Mylan 20 mg film-coated tablets tadalafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Generics [UK] Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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