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Enyglid (repaglinide) – Labelling - A10BX02

Updated on site: 06-Oct-2017

Medication nameEnyglid
ATC CodeA10BX02
Substancerepaglinide
ManufacturerKrka, d.d., Novo mesto

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Enyglid 0.5 mg tablets

Repaglinide

2.STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 0.5 mg repaglinide.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

tablet

30 tablets

60 tablets

90 tablets

120 tablets

180 tablets

270 tablets

360 tablets

5.METHOD AND ROUTE 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 WARNINGS, 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBERS

30 tablets: EU/1/09/580/001

60 tablets: EU/1/09/580/002

90 tablets: EU/1/09/580/003

120 tablets: EU/1/09/580/004

180 tablets: EU/1/09/580/019

270 tablets: EU/1/09/580/005

360 tablets: EU/1/09/580/006

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Enyglid 0.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Enyglid 0.5 mg tablets

Repaglinide

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Enyglid 1 mg tablets

Repaglinide

2.STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 1 mg repaglinide.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

tablet

30 tablets

60 tablets

90 tablets

120 tablets

180 tablets

270 tablets

360 tablets

5.METHOD AND ROUTE 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 WARNINGS, 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBERS

30 tablets: EU/1/09/580/007

60 tablets: EU/1/09/580/008

90 tablets: EU/1/09/580/009

120 tablets: EU/1/09/580/010

180 tablets: EU/1/09/580/020

270 tablets: EU/1/09/580/011

360 tablets: EU/1/09/580/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Enyglid 1 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Enyglid 1 mg tablets

Repaglinide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Enyglid 2 mg tablets

Repaglinide

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 2 mg repaglinide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

30 tablets

60 tablets

90 tablets

120 tablets

180 tablets

270 tablets

360 tablets

5. METHOD AND ROUTE 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 WARNINGS, 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBERS

30 tablets: EU/1/09/580/013

60 tablets: EU/1/09/580/014

90 tablets: EU/1/09/580/015

120 tablets: EU/1/09/580/016

180 tablets: EU/1/09/580/021

270 tablets: EU/1/09/580/017

360 tablets: EU/1/09/580/018

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Enyglid 2 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Enyglid 2 mg tablets

Repaglinide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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