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Rivastigmine Hexal (rivastigmine) – Labelling - N06DA03

Updated on site: 10-Oct-2017

Medication nameRivastigmine Hexal
ATC CodeN06DA03
Substancerivastigmine
ManufacturerHexal AG  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX

1.NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 1.5 mg hard capsules

Rivastigmine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

56 hard capsules

112 hard capsules

5.METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/001

EU/1/09/589/002

EU/1/09/589/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Rivastigmine HEXAL 1.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 1.5 mg hard capsules

Rivastigmine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

HEXAL AG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

FOLDING BOX AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 1.5 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

250 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 1.5 mg [folding box only]

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 3 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 3 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

56 hard capsules

112 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/005

EU/1/09/589/006

EU/1/09/589/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 3 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 3 mg hard capsules

Rivastigmine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

HEXAL AG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

FOLDING BOX AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 3 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 3 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

250 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 3 mg [folding box only]

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 4.5 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

56 hard capsules

112 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/009

EU/1/09/589/010

EU/1/09/589/011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 4.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 4.5 mg hard capsules

Rivastigmine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

HEXAL AG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

FOLDING BOX AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 4.5 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

250 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 4.5 mg [folding box only]

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 6 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 6 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

56 hard capsules

112 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/013

EU/1/09/589/014

EU/1/09/589/015

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 6 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 6 mg hard capsules

Rivastigmine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

HEXAL AG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

FOLDING BOX AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 6 mg hard capsules

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 capsule contains 6 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

250 hard capsules

5. METHOD AND ROUTE(S) 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

To be swallowed whole without crushing or opening.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/016

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 6 mg[folding box only]

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

FOLDING BOX AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Rivastigmine HEXAL 2 mg/ml oral solution

Rivastigmine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains 2.0 mg rivastigmine present as rivastigmine hydrogen tartrate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

50 ml

120 ml

5. METHOD AND ROUTE(S) 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

Do not store above 30°C. Do not refrigerate or freeze.

Store in an upright position.

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

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/589/017

EU/1/09/589/018

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

Use Rivastigmine HEXAL oral solution within 1 month of opening the bottle.

16. INFORMATION IN BRAILLE

Rivastigmine HEXAL 2 mg/ml [folding box only]

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