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Eurartesim (piperaquine tetraphosphate / dihydroartemisinin) – Labelling - P01BF05

Updated on site: 06-Oct-2017

Medication nameEurartesim
ATC CodeP01BF05
Substancepiperaquine tetraphosphate / dihydroartemisinin
ManufacturerSigma-Tau Industrie Farmaceutiche Riunite S.p.A

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Eurartesim 160 mg/20 mg film-coated tablets piperaquine tetraphosphate/artenimol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 160 mg of piperaquine tetraphosphate (as the tetrahydrate) and 20 mg of artenimol.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet 3 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

Take at least 3 hours before or after food.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C

Store in the original package in order to protect from light and moisture.

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

Sigma Tau Industrie Farmaceutiche Riunite s.p.a. Viale Shakespeare 47

00144 Rome Italy

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/716/005 3 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Eurartesim

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] SN: {number} [serial number]

NN: {number} [national reimbursement number or other national number identifying the medicinal product]

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Eurartesim 160 mg/20 mg tablets piperaquine tetraphosphate/artenimol

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Sigma Tau S.p.A.

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

Eurartesim 320 mg/40 mg film-coated tablets piperaquine tetraphosphate / artenimol

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 320 mg of piperaquine tetraphosphate (as the tetrahydrate ) and 40 mg of artenimol.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets. 3 tablets

Film-coated tablets. 6 tablets

Film-coated tablets. 9 tablets

Film-coated tablets. 12 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

Take at least 3 hours before or after food.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

Store in the original package in order to protect from light and moisture.

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

Sigma Tau Industrie Farmaceutiche Riunite s.p.a. Viale Shakespeare 47

00144 Rome Italy

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/716/001 3 film-coated tablets

EU/1/11/716/002 6 film-coated tablets

EU/1/11/716/003 9 film-coated tablets

EU/1/11/716/004 12 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Eurartesim

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] SN: {number} [serial number]

NN: {number} [national reimbursement number or other national number identifying the medicinal product]

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Eurartesim 320 mg/40 mg tablets piperaquine tetraphosphate / artenimol

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sigma Tau S.p.A

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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