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Emselex (darifenacin hydrobromide) – Labelling - G04BD10

Updated on site: 06-Oct-2017

Medication nameEmselex
ATC CodeG04BD10
Substancedarifenacin hydrobromide
ManufacturerMerus Labs Luxco S.à R.L.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Emselex 7.5 mg prolonged-release tablets

Darifenacin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 7.5 mg darifenacin (as hydrobromide).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

7 tablets

14 tablets

28 tablets

49 tablets

56 tablets

98tablets

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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/001

 

 

 

7 tablets (PVC/CTFE/alu blisters)

EU/1/04/294/002

14 tablets (PVC/CTFE/alu blisters)

 

 

EU/1/04/294/003

28 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/004

49 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/005

56 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/006

98 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/015

7 tablets (PVC/PVDC/alu blisters)

 

EU/1/04/294/016

14 tablets (PVC/PVDC/alu blisters)

 

EU/1/04/294/017

28 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/018

49 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/019

56 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/020

98 tablets (PVC/PVDC/alu blisters)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Emselex 7.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Emselex 7.5 mg prolonged-release tablets

Darifenacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 7.5 mg darifenacin (as hydrobromide).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

140 tablets

Multipack comprising 10 packs, each containing 14 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/013

 

 

(PVC/CTFE/alu blisters)

 

EU/1/04/294/027

(PVC/PVDC/alu blisters)

 

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Emselex 7.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Emselex 7.5 mg prolonged-release tablets

Darifenacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 7.5 mg darifenacin (as hydrobromide).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

Component of a multipack comprising 10 packs, each containing 14 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/013

 

 

(PVC/CTFE/alu blisters)

 

EU/1/04/294/027

(PVC/PVDC/alu blisters)

 

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Emselex 7.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Emselex 7.5 mg prolonged-release tablets

Darifenacin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Merus Labs Luxco S.à R.L.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Emselex 15 mg prolonged-release tablets

Darifenacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg darifenacin (as hydrobromide).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

7 tablets

14 tablets

28 tablets

49 tablets

56 tablets

98tablets

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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/007

 

 

 

7 tablets (PVC/CTFE/alu blisters)

EU/1/04/294/008

14 tablets (PVC/CTFE/alu blisters)

 

 

EU/1/04/294/009

28 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/010

49 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/011

56 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/012

98 tablets (PVC/CTFE/alu blisters)

 

EU/1/04/294/021

7 tablets (PVC/PVDC/alu blisters)

 

EU/1/04/294/022

14 tablets (PVC/PVDC/alu blisters)

 

EU/1/04/294/023

28 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/024

49 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/025

56 tablets (PVC/PVDC/alu blisters)

EU/1/04/294/026

98 tablets (PVC/PVDC/alu blisters)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Emselex 15 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Emselex 15 mg prolonged-release tablets

Darifenacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg darifenacin (as hydrobromide).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

140 tablets

Multipack comprising 10 packs, each containing 14 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/014

 

 

(PVC/CTFE/alu blisters)

 

EU/1/04/294/028

(PVC/PVDC/alu blisters)

 

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Emselex 15 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Emselex 15 mg prolonged-release tablets

Darifenacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg darifenacin (as hydrobromide).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

Component of a multipack comprising 10 packs, each containing 14 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the blister packs in the outer carton in order to protect from light.

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/294/014

 

 

(PVC/CTFE/alu blisters)

 

EU/1/04/294/028

(PVC/PVDC/alu blisters)

 

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Emselex 15 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Emselex 15 mg prolonged-release tablets

Darifenacin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Merus Labs Luxco S.à R.L.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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