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Efavirenz Teva (efavirenz) – Labelling - J05AG03

Updated on site: 06-Oct-2017

Medication nameEfavirenz Teva
ATC CodeJ05AG03
Substanceefavirenz
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK CONTAINING

OF <30><30x1><90><90 x 1> EFAVIRENZ TEVA 600 mg FILM-COATED TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Efavirenz Teva 600 mg film-coated tablets

Efavirenz

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg efavirenz.

3.LIST OF EXCIPIENTS

It also contains lactose monohydrate. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

30 x 1 film-coated-tablets

90 x 1 film-coated tablets

90 film-coated tablets

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

9.SPECIAL STORAGE CONDITIONS

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

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/742/001 (30 x 1 – blister PVC/PVDC/alu)

EU/1/11/742/002 (30 – blister PVC/PVDC/alu)

EU/1/11/742/003 (90 – blister PVC/PVDC/alu)

EU/1/11/742/006 (30 x 1 – blister alu/alu)

EU/1/11/742/007 (30 – blister alu/alu)

EU/1/11/742/008 (90 – blister alu/alu)

EU/1/11/742/011 (90 x 1 – blister PVC/PVDC/alu)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Efavirenz Teva 600 mg film-coated tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER BUNDLE LABEL FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLET) - WITH THE BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Efavirenz Teva 600 mg film-coated tablets

Efavirenz

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg efavirenz.

3. LIST OF EXCIPIENTS

The tablet also contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 90 (3 packs of 30 x 1) film-coated 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

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

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

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/742/004 (bundle multi-pack – blister PVC/PVDC/alu)

EU/1/11/742/009 (bundle multi-pack – blister alu/alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Efavirenz Teva 600 mg film-coated tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Efavirenz Teva 600 mg film-coated tablets

Efavirenz

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg efavirenz.

3. LIST OF EXCIPIENTS

The tablet also contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 90 (3 packs of 30 x 1) film-coated 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

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

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

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/742/005 (carton multi-pack – blister PVC/PVDC/alu)

EU/1/11/742/010 (carton multi-pack – blister alu/alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Efavirenz Teva 600 mg film-coated tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER CARTON

COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Efavirenz Teva 600 mg film-coated tablets

Efavirenz

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg efavirenz.

3. LIST OF EXCIPIENTS

The tablet also contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 x 1 film-coated tablets. Component of a multipack, can’t be sold separately.

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

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

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

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/742/001 (30 x 1 – blister PVC/PVDC/alu)

EU/1/11/742/006 (30 x 1 – blister alu/alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Efavirenz Teva 600 mg film-coated tablets

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 EFAVIRENZ TEVA 600 mg FILM-COATED TABLET: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Efavirenz Teva 600 mg film-coated tablets

Efavirenz

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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