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Tekturna (aliskiren) – Labelling - C09XA02

Updated on site: 10-Oct-2017

Medication nameTekturna
ATC CodeC09XA02
Substancealiskiren
ManufacturerNovartis Europharm Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 150 mg film-coated tablets

Aliskiren

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).

3. LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTSlonger7 film-coated tablets14 film-coated tablets28 film-coated tablets30 film-coated tablets50 film-coated tablets

 

56 film-coated tablets

 

no

 

90 film-coated tablets

product

 

 

 

5.

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Oral use.

 

 

 

Read the package leaflet bef e use.

 

 

Medicinal

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

Keep out of the reach and sight of children.

 

 

OTHER SPECIAL WARNING(S), IF NECESSARY

 

7.

 

EXPIRY DATE

 

 

 

8.

 

 

 

EXP

 

 

 

authorised

MUST BE STORED OUT

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from 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

 

 

Novartis Europharm Limited

 

 

authorised

 

 

Wimblehurst Road

 

 

 

 

 

 

 

Horsham

 

 

 

 

 

 

 

West Sussex, RH12 5AB

 

 

 

 

 

 

United Kingdom

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

EU/1/07/408/001

 

 

 

 

longer

 

 

 

7 film-coated tablets

 

 

 

 

EU/1/07/408/002

 

14 film-coated tablets

 

 

 

 

 

EU/1/07/408/003

 

28 film-coated tablets

 

 

 

 

EU/1/07/408/004

 

30 film-coated tablets

 

 

 

 

EU/1/07/408/005

 

50 film-coated tablets

no

 

 

 

EU/1/07/408/006

 

56 film-coated tablets

 

 

 

 

EU/1/07/408/008

product

 

 

 

 

 

 

90 film-coated able s

 

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

Tekturna 150 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

BLISTER (CALENDAR)

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 150 mg film-coated tablets

Aliskiren

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

 

 

 

EXP

 

 

 

 

 

 

 

 

longer

 

 

4.

BATCH NUMBER

 

 

 

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

product

no

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Monday

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday

 

 

 

 

 

 

 

 

 

 

Wednesday

 

 

 

 

 

 

 

Thursday

 

 

 

 

 

 

 

 

Friday

 

 

 

 

 

 

 

 

 

 

Saturday

 

 

 

 

 

 

 

Sunday

 

 

 

 

 

 

Medicinal

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

 

 

Tekturna 150 mg film-coated tablets

 

 

 

 

 

 

Aliskiren

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

authorised

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

 

Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14 film-coated tablets

 

 

longer

 

 

 

 

 

 

 

 

 

 

Component of a multipack comprising 20 packs, each contai i

g 14 tablets.

 

 

28 film-coated tablets

 

 

 

 

 

 

 

 

Component of a multipack comprising 3 packs, each c

ntaining 28 tablets.

 

 

 

49 film-coated tablets

 

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

Component of a multipack comprising 2 packs, each c

ntaining 49 tablets.

 

 

 

 

 

 

 

 

 

 

 

 

5.

 

 

product

 

 

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

 

Oral use.

 

 

 

 

 

 

 

Read the package leaflet bef e use.

 

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

 

Keep out of the reach and sight of children.

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

 

 

 

 

 

 

 

 

8.

EXPIRY DATE

 

 

 

 

 

 

 

EXP

 

 

 

 

 

 

 

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from 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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/408/007

84 film-coated tablets (3x28)

 

EU/1/07/408/009

98 film-coated tablets (2x49)

 

EU/1/07/408/010

280 film-coated tablets (20x14)

13. BATCH NUMBER

 

Lot

 

 

longer

 

 

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

14.

 

 

 

product

 

 

Medicinal product subject to medical pres rip ion.no

 

 

INSTRUCTIONS ON USE

 

 

15.

 

 

INFORMATION IN BRAILLE

 

 

16.

 

 

Medicinal

 

 

 

Tekturna 150 mg

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 150 mg film-coated tablets

Aliskiren

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

84 film-coated tablets

Multipack comprising 3 packs, each containing 28 tablets. 98 film-coated tablets

Multipack comprising 2 packs, each containing 49 tab ets.

 

 

 

280 film-coated tablets

 

 

 

 

longer

 

 

 

Multipack comprising 20 packs, each contai i g 14 tablets.

 

 

5.

 

 

 

no

 

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

Oral use.

 

 

 

 

 

 

 

Read the package leaflet bef e use.

 

 

 

 

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

 

 

6.

 

 

 

 

 

 

product

 

 

 

 

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Keep out of the reach and sight of children.

 

 

 

 

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

7.

 

EXPIRY DATE

 

 

 

 

 

 

8.

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

 

 

EXP

authorised

MUST BE STORED OUT

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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

MedicinalTekturna 150 mg
EU/1/07/408/007
EU/1/07/408/009
EU/1/07/408/010

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

84 film-coated tablets (3x28)

98 film-coated tablets (2x49)

280 film-coated tablets (20x14)

13. BATCH NUMBER

Lot

 

 

longer

14.

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical pres rip ion.

 

 

 

no

 

15.

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

 

 

 

product

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 300 mg film-coated tablets

Aliskiren

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).

3. LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTSlonger7 film-coated tablets14 film-coated tablets28 film-coated tablets30 film-coated tablets50 film-coated tablets

 

56 film-coated tablets

 

no

 

5.

 

product

 

 

 

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Oral use.

 

 

 

Read the package leaflet bef e use.

 

 

 

 

 

Medicinal

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

Keep out of the reach and sight of children.

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

EXPIRY DATE

 

 

 

8.

 

 

 

EXP

 

 

 

authorised

MUST BE STORED OUT

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from 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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/07/408/011

 

7 film-coated tablets

 

 

 

 

 

EU/1/07/408/012

 

14 film-coated tablets

 

 

 

 

 

EU/1/07/408/013

28 film-coated tablets

 

longer

 

 

EU/1/07/408/014

30 film-coated tablets

 

 

 

 

 

 

 

EU/1/07/408/015

50 film-coated tablets

 

 

 

 

EU/1/07/408/016

56 film-coated tablets

 

 

 

BATCH NUMBER

 

 

 

13.

 

 

 

 

Lot

 

 

 

 

no

 

 

 

 

 

 

 

 

 

 

14.

 

product

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

Medicinal product subject to me ical prescription.

 

 

INSTRUCTIONS ON USE

 

 

 

15.

 

 

 

Medicinal

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

Tekturna 300 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

BLISTER (CALENDAR)

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 300 mg film-coated tablets

Aliskiren

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

 

 

 

EXP

 

 

 

 

 

 

 

 

longer

 

 

4.

BATCH NUMBER

 

 

 

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

product

no

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Monday

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday

 

 

 

 

 

 

 

 

 

 

Wednesday

 

 

 

 

 

 

 

Thursday

 

 

 

 

 

 

 

 

Friday

 

 

 

 

 

 

 

 

 

 

Saturday

 

 

 

 

 

 

 

Sunday

 

 

 

 

 

 

Medicinal

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

 

 

Tekturna 300 mg film-coated tablets

 

 

 

 

 

 

Aliskiren

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

authorised

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

 

Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14 film-coated tablets

 

 

longer

 

 

 

 

 

 

 

 

 

 

Component of a multipack comprising 20 packs, each contai i

g 14 tablets.

 

 

28 film-coated tablets

 

 

 

 

 

 

 

 

Component of a multipack comprising 3 packs, each c

ntaining 28 tablets.

 

 

 

30 film-coated tablets

 

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

Component of a multipack comprising 3 packs, each c

ntaining 30 tablets.

 

 

 

49 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

product

 

 

 

 

 

 

Component of a multipack comprising 2 pa ks, each containing 49 tablets.

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

 

Oral use.

 

 

 

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

 

Keep out of the reach and sight of children.

 

 

 

 

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

8.EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from 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 AUTHORISATIONauthorisedHOLDERNovartis Europharm LimitedWimblehurst RoadHorshamWest Sussex, RH12 5ABUnited Kingdom

12.

 

 

 

 

longer

MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/07/408/017

84 film-coated tablets (3x28)

 

 

 

 

 

EU/1/07/408/018

90 film-coated tablets (3x30)

 

 

 

 

 

EU/1/07/408/019

98 film-coated tablets (2x49)

 

 

 

 

 

EU/1/07/408/020

280 film-coated tablets (20x14)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

product

no

 

 

 

13.

BATCH NUMBER

 

 

 

 

Lot

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal

 

 

 

 

 

 

 

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

Tekturna 300 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tekturna 300 mg film-coated tablets

Aliskiren

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

84 film-coated tablets

Multipack comprising 3 packs, each containing 28 tablets. 90 film-coated tablets

Multipack comprising 3 packs, each containing 30 tab ets.

 

 

 

98 film-coated tablets

 

 

 

 

longer

 

 

 

Multipack comprising 2 packs, each containi g 49 tablets.

 

 

 

 

 

 

 

 

280 film-coated tablets

 

 

 

 

 

 

 

 

Multipack comprising

20 packs, each on aining 14 tablets.

 

 

 

 

 

 

 

 

 

no

 

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

5.

 

 

 

Oral use.

 

 

 

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

 

 

product

 

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT

 

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Keep out of the reach and sight of children.

 

 

 

 

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

7.

 

 

Medicinal

 

 

 

 

 

 

 

 

 

8. EXPIRY DATE

EXP

authorised

MUST BE STORED OUT

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from 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 AUTHORISATIONauthorisedHOLDERNovartis Europharm LimitedWimblehurst RoadHorshamWest Sussex, RH12 5ABUnited Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

longer

 

 

EU/1/07/408/017

 

84 film-coated tablets (3x28)

 

 

 

 

 

 

 

 

 

EU/1/07/408/018

 

90 film-coated tablets (3x30)

 

 

 

 

 

EU/1/07/408/019

98 film-coated tablets (2x49)

 

 

 

 

 

EU/1/07/408/020

 

 

no

 

 

 

 

280 film-coated tablets (20x14)

 

 

 

 

 

 

 

 

 

 

 

13.

 

product

 

 

 

 

 

BATCH NUMBER

 

 

 

 

 

 

Lot

 

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

Tekturna 300 mg

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