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Lumigan (bimatoprost) – Labelling - S01EE03

Updated on site: 08-Oct-2017

Medication nameLumigan
ATC CodeS01EE03
Substancebimatoprost
ManufacturerAllergan Pharmaceuticals Ireland

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR SINGLE BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.1 mg/ml, eye drops, solution

Bimatoprost

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.1 mg bimatoprost

3.LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 1 x 3 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular 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

Remove contact lenses before use.

8.EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened:

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/003

13.BATCH NUMBER

Batch:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

LUMIGAN 0.1 mg/ml

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

CARTON CONTAINING THREE BOTTLES

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.1 mg/ml, eye drops, solution

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.1 mg bimatoprost

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 3 x 3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular 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 and children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Remove contact lenses before use.

8. EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened (1):

Opened (2):

Opened (3):

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/004

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.1 mg/ml

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 SMALL IMMEDIATE PACKAGING UNITS

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0.1 mg/ml, eye drops, solution

Bimatoprost

Ocular use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

Exp:

Discard 4 weeks after first opening

4.BATCH NUMBER

Batch:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR SINGLE BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/ml, eye drops, solution

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 1 x 3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular 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

Remove contact lenses before use.

8. EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened:

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/001

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/ml

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

CARTON CONTAINING THREE BOTTLES

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/ml, eye drops, solution

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 3 x 3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular 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

Remove contact lenses before use.

8. EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened (1):

Opened (2):

Opened (3):

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/002

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/ml

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 SMALL IMMEDIATE PACKAGING UNITS

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0.3 mg/ml, eye drops, solution

Bimatoprost

Ocular use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

Discard 4 weeks after first opening

Exp:

4. BATCH NUMBER

Batch:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 5 SINGLE-DOSE CONTAINERS

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost.

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 5 x 0.4 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Do not store above 25°C.

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

Discard the opened single-dose container immediately after use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

For single use only

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose

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

OUTER CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost.

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 30 x 0.4 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Once the tray is opened, the single dose containers should be used within 30 days.

9. SPECIAL STORAGE CONDITIONS

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

Discard the opened single-dose container immediately after use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

For single use only

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose

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

OUTER CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost.

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 90 x 0.4 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Once the tray is opened, the single dose containers should be used within 30 days.

9. SPECIAL STORAGE CONDITIONS

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

Discard the opened single-dose container immediately after use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

For single use only

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose

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 FOR 30 AND 90 PACK LID OF TRAY CONTAINING 30 SINGLE-DOSE CONTAINERS

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container

Bimatoprost

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost.

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 30 x 0.4 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Once the tray is opened, the single dose containers should be used within 30 days.

9. SPECIAL STORAGE CONDITIONS

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

Discard the opened single-dose container immediately after use.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

For single use only

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

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 SMALL IMMEDIATE PACKAGING UNITS

SINGLE-DOSE CONTAINER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0,3 mg/mL

Bimatoprost

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

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