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Tasmar (tolcapone) – Labelling - N04BX01

Updated on site: 10-Oct-2017

Medication nameTasmar
ATC CodeN04BX01
Substancetolcapone
ManufacturerMeda AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

Outer Carton and bottle label, 30, 60, 100, 200 film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

Tasmar 100 mg film-coated tablets

Tolcapone

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg tolcapone

3.LIST OF EXCIPIENTS

Also contains lactose.

See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

100 film-coated tablets

200 film-coated tablets

.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. For oral use.

The tablets should be swallowed whole. Do not break or crush tablet.

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

Meda AB

Pipers väg 2A

S-170 09 Solna

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/97/044/007 30 tablets

EU/1/97/044/008 60 tablets

EU/1/97/044/003 100 tablets

EU/1/97/044/0010 200 tablets

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Tasmar 100 mg (only applicable for the outer carton)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton for blister packs [ 30 and 60 film-coated tablets]

1. NAME OF THE MEDICINAL PRODUCT

Tasmar 100 mg film-coated tablets

Tolcapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg tolcapone

3. LIST OF EXCIPIENTS

Also contains lactose.

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. For oral use.

The tablets should be swallowed whole. Do not break or crush tablet.

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

Meda AB

Pipers väg 2A

S-170 09 Solna

Sweden

12. MARKETING AUTHORISATION NUMBER

EU/1/97/044/001 30 tablets

EU/1/97/044/002 60 tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasmar 100 mg (only applicable for the outer packaging

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Tasmar 100 mg film-coated tablets

Tolcapone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Meda AB.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton and bottle label, 100 film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Tasmar 200 mg film-coated tablets

Tolcapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg tolcapone tolcapone 200 mg

3. LIST OF EXCIPIENTS

Also contains lactose.

See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. For oral use.

The tablets should be swallowed whole. Do not break or crush tablet.

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

Meda AB

Pipers väg 2A

S-170 09 Solna

Sweden

12. MARKETING AUTHORISATION NUMBER

EU/1/97/044/006 100 tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasmar 200 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

Outer Carton and blister packs, 30 and 60 film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Tasmar 200 mg film-coated tablets

Tolcapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg tolcapone tolcapone 200 mg

3. LIST OF EXCIPIENTS

Also contains lactose

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. For oral use

The tablets should be swallowed whole. Do not break or crush tablet.

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

Meda AB

Pipers väg 2A

S-170 09 Solna

Sweden

12. MARKETING AUTHORISATION NUMBER

EU/1/97/044/004 30 tablets

EU/1/97/044/005 60 tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasmar 200 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Tasmar 200 mg film-coated tablets

Tolcapone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Meda AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

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