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Actos (pioglitazone hydrochloride) – Labelling - A10BG03

Updated on site: 05-Oct-2017

Medication nameActos
ATC CodeA10BG03
Substancepioglitazone hydrochloride
ManufacturerTakeda Pharma A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Actos 15 mg tablets

Pioglitazone

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg pioglitazone (as hydrochloride).

3.LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

50 tablets

56 tablets

84 tablets

90 tablets

98 tablets

112 tablets

196 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

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

Takeda Pharma A/S

Dybendal Alle 10,

DK-2630 Taastrup

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/150/00714 tablets

EU/1/00/150/001 28 tablets

EU/1/00/150/016 30 tablets

EU/1/00/150/002 50 tablets

EU/1/00/150/009 56 tablets

EU/1/00/150/017 84 tablets

EU/1/00/150/018 90 tablets

EU/1/00/150/003 98 tablets

EU/1/00/150/025 112 tablets

EU/1/00/150/026 196 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Actos 15 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Actos 30 mg tablets

Pioglitazone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg pioglitazone (as hydrochloride).

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

50 tablets

56 tablets

84 tablets

90 tablets

98 tablets

112 tablets

196 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

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

Takeda Pharma A/S

Dybendal Alle 10,

DK-2630 Taastrup

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/150/00814 tablets

EU/1/00/150/004 28 tablets

EU/1/00/150/019 30 tablets

EU/1/00/150/005 50 tablets

EU/1/00/150/010 56 tablets

EU/1/00/150/020 84 tablets

EU/1/00/150/021 90 tablets

EU/1/00/150/006 98 tablets

EU/1/00/150/027 112 tablets

EU/1/00/150/028 196 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actos 30 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Actos 45 mg tablets

Pioglitazone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 45 mg pioglitazone (as hydrochloride).

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

50 tablets

56 tablets

84 tablets

90 tablets

98 tablets

112 tablets

196 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

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

Takeda Pharma A/S

Dybendal Alle 10,

DK-2630 Taastrup

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/150/01114 tablets

EU/1/00/150/012 28 tablets

EU/1/00/150/022 30 tablets

EU/1/00/150/013 50 tablets

EU/1/00/150/014 56 tablets

EU/1/00/150/023 84 tablets

EU/1/00/150/024 90 tablets

EU/1/00/150/015 98 tablets

EU/1/00/150/029 112 tablets

EU/1/00/150/030 196 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actos 45 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Actos 15 mg tablets

Pioglitazone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda (logo)

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER (FOR CALENDARISED PACKS)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Actos 30 mg tablets

Pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda (logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER (FOR CALENDARISED PACKS)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Actos 45 mg tablets

Pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda (logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER (FOR CALENDARISED PACKS)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

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