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Ebilfumin (oseltamivir) – Labelling - J05AH02

Updated on site: 06-Oct-2017

Medication nameEbilfumin
ATC CodeJ05AH02
Substanceoseltamivir
ManufacturerActavis Group PTC ehf

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Label for HDPE tablet container and outer carton for tablet container and blister

1.NAME OF THE MEDICINAL PRODUCT

Ebilfumin 30 mg hard capsules

Oseltamivir

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

10 hard capsules

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

Store below 25 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

Actavis Group PTC ehf.

Hafnarfjörður

Iceland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/915/001 (10 hard capsules blister)

EU/1/14/915/002 (10 hard capsules container)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

[Only applicable for outer packaging:]

Ebilfumin 30 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

[Only applicable for outer packaging:]

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

[Only applicable for outer packaging:]

PC: {number} SN: {number} NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Ebilfumin 30 mg hard capsules

Oseltamivir

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Label for HDPE tablet container and outer carton for tablet container and blister

1. NAME OF THE MEDICINAL PRODUCT

Ebilfumin 45 mg hard capsules

Oseltamivir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

10 hard capsules

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

Store below 25 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

Actavis Group PTC ehf.

Hafnarfjörður

Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/915/003 (10 hard capsules container)

EU/1/14/915/004 (10 hard capsules blister)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

[Only applicable for outer packaging:]

Ebilfumin 45 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

[Only applicable for outer packaging:]

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[Only applicable for outer packaging:]

PC: {number} SN: {number} NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Ebilfumin 45 mg hard capsules

Oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Label for HDPE tablet container and outer carton for tablet container and blister

1. NAME OF THE MEDICINAL PRODUCT

Ebilfumin 75 mg hard capsules

Oseltamivir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

10 hard capsules

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

Store below 25 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

Actavis Group PTC ehf.

Hafnarfjörður

Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/915/005 (10 hard capsules blister)

EU/1/14/915/006 (10 hard capsules container)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

[Only applicable for outer packaging:]

Ebilfumin 75 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

[Only applicable for outer packaging:]

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[Only applicable for outer packaging:]

PC: {number} SN: {number} NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Ebilfumin 75 mg hard capsules

Oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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