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Orphacol (cholic acid) – Labelling - A05AA03

Updated on site: 09-Oct-2017

Medication nameOrphacol
ATC CodeA05AA03
Substancecholic acid
ManufacturerLaboratoires CTRS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Orphacol 50 mg hard capsules cholic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 50 mg cholic acid.

3.LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules

60 hard capsules

120 hard 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store below 30°C.

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

Laboratoires CTRS 63, rue de l’Est

92100 Boulogne-Billancourt France

E-mail: ctrs@ctrs.fr

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/870/001 [30 hard capsules]

EU/1/13/870/002 [60 hard capsules]

EU/1/13/870/003 [120 hard capsules]

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Orphacol 250 mg hard capsules cholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 250 mg cholic acid.

3. LIST OF EXCIPIENTS

Contains lactose. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules

60 hard capsules

120 hard 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 OUTOF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store below 30°C.

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

Laboratoires CTRS 63, rue de l’Est

92100 Boulogne-Billancourt France

E-mail: ctrs@ctrs.fr

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/870/004 [30 hard capsules]

EU/1/13/870/005 [60 hard capsules]

EU/1/13/870/006 [120 hard capsules]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number} NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Orphacol 50 mg capsules cholic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Laboratoires CTRS

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Orphacol 250 mg capsules cholic acid

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Laboratoires CTRS

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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