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Tamiflu (oseltamivir) – Labelling - J05AH02

Updated on site: 10-Oct-2017

Medication nameTamiflu
ATC CodeJ05AH02
Substanceoseltamivir
ManufacturerRoche Registration Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1.NAME OF THE MEDICINAL PRODUCT

Tamiflu 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 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 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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/003

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

tamiflu 30 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 30 mg capsules

Oseltamivir

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

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

Tamiflu 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 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 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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/004

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tamiflu 45 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 45 mg capsules

Oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

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

Tamiflu 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 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 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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/001

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tamiflu 75 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 75 mg capsules

Oseltamivir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

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

Tamiflu 6 mg/ml powder for oral suspension

Oseltamivir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 bottle contains 390 mg of oseltamivir. Final volume of the bottle after reconstitution is 65 ml. Each ml of suspension contains 6 mg oseltamivir.

3. LIST OF EXCIPIENTS

Also contains sorbitol.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 bottle

Also contains 1 plastic bottle adapter, 1 plastic measuring cup (55 ml), 1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

For oral use after reconstitution

Shake bottle well before use

Caution: dispenser graduated in millilitre (ml)

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

Powder: Do not store above 30°C

After reconstitution, store below 25 °C for 10 days

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/005

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tamiflu

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for bottle

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 6 mg/ml powder for oral suspension

Oseltamivir

2.METHOD OF ADMINISTRATION

For oral use after reconstitution

Shake bottle well before use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

The volume of the reconstituted suspension is 65 ml 1 ml contains 6 mg oseltamivir

6.OTHER

Powder: Do not store above 30 ºC

Oral suspension: Store below 25 °C for 10 days

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 12 mg/ml powder for oral suspension

Oseltamivir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 bottle contains 900 mg of oseltamivir. Final volume of the bottle after reconstitution is 75 ml. Each ml of suspension contains 12 mg oseltamivir.

3. LIST OF EXCIPIENTS

Also contains sorbitol.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 bottle

Also contains 1 plastic bottle adapter, 1 plastic measuring cup (52 ml) and 1 plastic oral dispenser

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

For oral use after reconstitution

Shake bottle well 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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Powder: Do not store above 30°C

After reconstitution, store below 25 °C for 10 days or in a refrigerator (2 °C - 8 °C) for 17 days

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/222/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tamiflu

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for bottle

1. NAME OF THE MEDICINAL PRODUCT

Tamiflu 12 mg/ml powder for oral suspension

Oseltamivir

2. METHOD OF ADMINISTRATION

Read the package leaflet before use

For oral use after reconstitution

Shake bottle well before use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

The volume of the reconstituted suspension is 75 ml 1 ml contains 12 mg oseltamivir

6. OTHER

Also contains sorbitol.

Powder: Do not store above 30 ºC

Oral suspension: Store below 25 °C for 10 days or in a refrigerator (2 °C - 8 °C) for 17 days

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