English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Kolbam (cholic acid) – Labelling - A05AA03

Updated on site: 08-Oct-2017

Medication nameKolbam
ATC CodeA05AA03
Substancecholic acid
ManufacturerRetrophin Europe Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Kolbam 50 mg hard capsules cholic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 50 mg cholic acid

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Hard capsule. 90 capsules.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Do not chew.

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

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in original package in order to protect from light.

Use within 3 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return any unused medicine to your pharmacist for disposal

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Retrophin Europe Limited, Palmerston House, Fenian Street

Dublin 2, Ireland

12.MARKETING AUTHORISATION NUMBER

EU/1/13/895/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Kolbam 50 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kolbam 50 mg hard capsules cholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 50 mg cholic acid

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule 90 capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not chew.

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

Do not store above 30°C.

Store in original package in order to protect from light.

Use within 3 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return any unused medicine to your pharmacist for disposal

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Retrophin Europe Limited, Palmerston House, Fenian Street

Dublin 2, Ireland

12. MARKETING AUTHORISATION NUMBER

EU/1/13/895/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Kolbam 250 mg hard capsules cholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 250 mg cholic acid

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule. 90 capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not chew.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in original package in order to protect from light.

Use within 3 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return any unused medicine to your pharmacist for disposal

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Retrophin Europe Limited, Palmerston House, Fenian Street

Dublin 2, Ireland

12. MARKETING AUTHORISATION NUMBER

EU/1/13/895/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kolbam 250 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kolbam 250 mg hard capsules cholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 250 mg cholic acid

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule 90 capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not chew.

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

Do not store above 30°C.

Store in original package in order to protect from light.

Use within 3 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return any unused medicine to your pharmacist for disposal

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Retrophin Europe Limited, Palmerston House, Fenian Street

Dublin 2, Ireland

12. MARKETING AUTHORISATION NUMBER

EU/1/13/895/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed