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Sabervel (irbesartan) – Labelling - C09CA04

Updated on site: 10-Oct-2017

Medication nameSabervel
ATC CodeC09CA04
Substanceirbesartan
ManufacturerPharmathen S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Sabervel 75 mg film-coated tablets irbesartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 75 mg irbesartan

3.LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

See leaflet for further information

4.

PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

 

longer

56 film-coated tablets

 

 

90 film-coated tablets

 

no

98 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

OF THE SIGHT AND REACH OF CHILDREN

 

 

 

product

 

 

Keep out of the s ght and reach of children.

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

8.MedicinalEXPIRY DATE

 

 

EXP

9.SPECIAL STORAGE CONDITIONS

authorised

MUST BE STORED OUT

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

Pharmathen S.A.

6, Dervenakion str., 153 51 Pallini

Attiki, Greece

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/765/001

EU/1/12/765/002

EU/1/12/765/007

EU/1/12/765/010

13.

BATCH NUMBER

 

longer

Lot

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

no

 

Medicinal product subject to medical prescription.

 

15.

 

product

 

 

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

 

 

Medicinal

 

 

 

Sabervel 75 mg

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Sabervel 75 mg film-coated tablets irbesartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

 

 

 

authorised

 

 

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

Lot

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

 

 

 

 

 

product

no

 

 

Medicinal

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Sabervel 150 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg irbesartan

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

 

 

See leaflet for further information

 

longer

4.

 

 

 

 

PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

 

 

 

56 film-coated tablets

 

 

no

 

90 film-coated tablets

 

 

 

 

 

 

 

98 film-coated tablets

 

product

 

 

5.

 

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

 

 

Medicinal

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

OF THE SIGHT AND REACH OF CHILDREN

 

Keep out of the s ght and reach of children.

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

authorised

MUST BE STORED OUT

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

Pharmathen S.A. 6, Dervenakion str.,

153 51 Pallini

Attiki, Greece

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/765/003

EU/1/12/765/004

EU/1/12/765/008

EU/1/12/765/011

13. BATCH NUMBER

Lot

 

 

no

longer

 

 

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

 

Medicinal product subject to medical prescrip ion.

 

15.

INSTRUCTIONS ON USE

 

 

Medicinal

 

 

 

16.

INFORMATION IN BRAILLE

 

 

Sabervel 150 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Sabervel 150 mg film-coated tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3.

EXPIRY DATE

 

 

 

authorised

EXP

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

longer

 

Lot

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Sabervel 300 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg irbesartan

3. LIST OF EXCIPIENTS

Excipients: also contains lactose monohydrate.

 

 

See leaflet for further information

 

longer

4.

 

 

 

 

PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

 

 

 

56 film-coated tablets

 

 

no

 

90 film-coated tablets

 

 

 

 

 

 

 

98 film-coated tablets

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

product

 

 

Oral use. Read the package leaflet before use.

 

 

Medicinal

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

OF THE SIGHT AND REACH OF CHILDREN

 

Keep out of the s ght and reach of children.

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

authorised

MUST BE STORED OUT

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

Pharmathen S.A.

6, Dervenakion str., 153 51 Pallini

Attiki, Greece

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/765/005

EU/1/12/765/006

EU/1/12/765/009

EU/1/12/765/012

13.

BATCH NUMBER

 

longer

Lot

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

no

 

Medicinal product subject to medical prescription.

 

15.

 

product

 

 

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

 

 

Medicinal

 

 

 

Sabervel 300 mg

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Sabervel 300 mg film-coated tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3.

EXPIRY DATE

 

 

 

authorised

EXP

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

longer

 

Lot

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

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