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Glidipion (Pioglitazone Actavis Group) (pioglitazone hydrochloride) – Labelling - A10BG03

Updated on site: 07-Oct-2017

Medication nameGlidipion (Pioglitazone Actavis Group)
ATC CodeA10BG03
Substancepioglitazone hydrochloride
ManufacturerActavis Group PTC ehf   

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Glidipion 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

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

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/1/12/756/001 [14 tablets]

EU/1/12/756/002 [28 tablets]

EU/1/12/756/003 [30 tablets]

EU/1/12/756/004 [50 tablets]

EU/1/12/756/005 [56 tablets]

EU/1/12/756/006 [84 tablets]

EU/1/12/756/007 [90 tablets]

EU/1/12/756/008 [98 tablets]

EU/1/12/756/009 [100 tablets]

13.MANUFACTURER’S BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Glidipion 15 mg

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

1. NAME OF THE MEDICINAL PRODUCT

Glidipion 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

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

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/1/12/756/010 [14 tablets]

EU/1/12/756/011 [28 tablets]

EU/1/12/756/012 [30 tablets]

EU/1/12/756/013 [50 tablets]

EU/1/12/756/014 [56 tablets]

EU/1/12/756/015 [84 tablets]

EU/1/12/756/016 [90 tablets]

EU/1/12/756/017 [98 tablets]

EU/1/12/756/018 [100 tablets]

13. MANUFACTURER’S BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Glidipion 30 mg

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

1. NAME OF THE MEDICINAL PRODUCT

Glidipion 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

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

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/1/12/756/019 [14 tablets]

EU/1/12/756/020 [28 tablets]

EU/1/12/756/021 [30 tablets]

EU/1/12/756/022 [50 tablets]

EU/1/12/756/023 [56 tablets]

EU/1/12/756/024 [84 tablets]

EU/1/12/756/025 [90 tablets]

EU/1/12/756/026 [98 tablets]

EU/1/12/756/027 [100 tablets]

13. MANUFACTURER’S BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Glidipion 45 mg

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 BLISTERS OR STRIPS BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Glidipion 15 mg tablets

pioglitazone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf. (logo)

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5. OTHER (FOR CALENDARISED PACKS SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Glidipion 30 mg tablets

pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf. (logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER (FOR CALENDARISED PACKS SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Glidipion 45 mg tablets

pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf. (logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER (FOR CALENDARISED PACKS SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

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