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Telmisartan Actavis (telmisartan) – Labelling - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Actavis
ATC CodeC09CA07
Substancetelmisartan
ManufacturerActavis Group PTC ehf

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton for blister

1.NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 20 mg tablets

telmisartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

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

Store in the original package 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/001 (14 tablets blister)

EU/1/10/639/002 (28 tablets blister)

EU/1/10/639/003 (30 tablets blister)

EU/1/10/639/004 (56 tablets blister)

EU/1/10/639/005 (84 tablets blister)

EU/1/10/639/006 (90 tablets blister)

EU/1/10/639/007 (98 tablets blister)

EU/1/10/639/008 (100 tablets blister)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Telmisartan Actavis 20 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 20 mg tablets

telmisartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis logo

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Carton for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 20 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/009 (30 tablets container)

EU/1/10/639/010 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Actavis 20 mg

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 20 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis logo

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/009 (30 tablets container)

EU/1/10/639/010 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton for blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 40 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

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

Store in the original package 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/011 (14 tablets blister)

EU/1/10/639/012 (28 tablets blister)

EU/1/10/639/013 (30 tablets blister)

EU/1/10/639/014 (56 tablets blister)

EU/1/10/639/015 (84 tablets blister)

EU/1/10/639/016 (90 tablets blister)

EU/1/10/639/017 (98 tablets blister)

EU/1/10/639/018 (100 tablets blister)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Actavis 40 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 40 mg tablets

telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Carton for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 40 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/019 (30 tablets container)

EU/1/10/639/020 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Actavis 40 mg

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 40 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis logo

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/019 (30 tablets container)

EU/1/10/639/020 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton for blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 80 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

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 reachof children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/021 (14 tablets blister)

EU/1/10/639/022 (28 tablets blister)

EU/1/10/639/023 (30 tablets blister)

EU/1/10/639/024 (56 tablets blister)

EU/1/10/639/025 (84 tablets blister)

EU/1/10/639/026 (90 tablets blister)

EU/1/10/639/027 (98 tablets blister)

EU/1/10/639/028 (100 tablets blister)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Actavis 80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 80 mg tablets

telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Carton for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 80 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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 reachof children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/029 (30 tablets container)

EU/1/10/639/030 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Actavis 80 mg

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Actavis 80 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

250 tablets

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 REACHOF CHILDREN

Keep out of the sight and reachof children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Contains desiccant, do not eat.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the container tightly closed 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

Actavis logo

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/639/029 (30 tablets container)

EU/1/10/639/030 (250 tablets container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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