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Leganto (rotigotine) – Labelling - N04BC09

Updated on site: 08-Oct-2017

Medication nameLeganto
ATC CodeN04BC09
Substancerotigotine
ManufacturerUCB Manufacturing Ireland Ltd  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1.NAME OF THE MEDICINAL PRODUCT

Leganto 1 mg/24 h transdermal patch rotigotine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 1 mg of rotigotine per 24 hours.

Each patch of 5 cm2 contains 2.25 mg of rotigotine.

3.LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/001 [7 transdermal patches]

EU/1/11/695/003 [28 transdermal patches]

EU/1/11/695/004 [30 transdermal patches]

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

leganto 1 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 1 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 1 mg of rotigotine per 24 hours.

Each patch of 5 cm2 contains 2.25 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/007 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 1 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 1 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 1 mg of rotigotine per 24 hours.

Each patch of 5 cm2 contains 2.25 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/007 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 1 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 1 mg/24 h transdermal patch rotigotine

Transdermal use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 2 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 2 mg of rotigotine per 24 hours.

Each patch of 10 cm2 contains 4.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/010 [7 transdermal patches]

EU/1/11/695/012 [28 transdermal patches]

EU/1/11/695/013 [30 transdermal patches]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 2 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 2 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 2 mg of rotigotine per 24 hours.

Each patch of 10 cm2 contains 4.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/016 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 2 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 2 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 2 mg of rotigotine per 24 hours.

Each patch of 10 cm2 contains 4.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/016 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 2 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 2 mg/24 h transdermal patch rotigotine

Transdermal use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 3 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 3 mg of rotigotine per 24 hours.

Each patch of 15 cm2 contains 6.75 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/019 [7 transdermal patches]

EU/1/11/695/021 [28 transdermal patches]

EU/1/11/695/022 [30 transdermal patches]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 3 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 3 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 3 mg of rotigotine per 24 hours.

Each patch of 15 cm2 contains 6.75 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/025 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 3 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 3 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 3 mg of rotigotine per 24 hours.

Each patch of 15 cm2 contains 6.75 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/025 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 3 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 3 mg/24 h transdermal patch rotigotine

Transdermal use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 4 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 4 mg of rotigotine per 24 hours.

Each patch of 20 cm2 contains 9.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/028 [7 transdermal patches]

EU/1/11/695/030 [28 transdermal patches]

EU/1/11/695/031 [30 transdermal patches]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 4 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 4 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 4 mg of rotigotine per 24 hours.

Each patch of 20 cm2 contains 9.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/034 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 4 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 4 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 4 mg of rotigotine per 24 hours.

Each patch of 20 cm2 contains 9.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/034 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 4 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 4 mg/24 h transdermal patch rotigotine

Transdermal use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 6 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 6 mg of rotigotine per 24 hours.

Each patch of 30 cm2 contains 13.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/037 [7 transdermal patches]

EU/1/11/695/039 [28 transdermal patches]

EU/1/11/695/040 [30 transdermal patches]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 6 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 6 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 6 mg of rotigotine per 24 hours.

Each patch of 30 cm2 contains 13.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/043 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 6 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 6 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 6 mg of rotigotine per 24 hours.

Each patch of 30 cm2 contains 13.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/043 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 6 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 6 mg/24 h transdermal patch rotigotine

Transdermal use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 [28] [30] PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 8 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 8 mg of rotigotine per 24 hours.

Each patch of 40 cm2 contains 18.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches

28 transdermal patches

30 transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/046 [7 transdermal patches]

EU/1/11/695/048 [28 transdermal patches]

EU/1/11/695/049 [30 transdermal patches]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 8 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

OUTER LABEL (WITH BLUE BOX)

BOX OF 84 PATCHES CONTAINING 2 BOXES OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 8 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 8 mg of rotigotine per 24 hours.

Each patch of 40 cm2 contains 18.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (2 packs of 42) transdermal patches

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/052 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 8 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACKS ONLY

INTERMEDIATE CARTON (WITHOUT BLUE BOX)

BOX OF 42 PATCHES

1. NAME OF THE MEDICINAL PRODUCT

Leganto 8 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 8 mg of rotigotine per 24 hours.

Each patch of 40 cm2 contains 18.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

42 transdermal patches. Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/052 [84 transdermal patches (2 packs of 42)]

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 8 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 8 mg/24 h transdermal patch rotigotine

Transdermal use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE

1. NAME OF THE MEDICINAL PRODUCT

Leganto 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h

Transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Leganto 2 mg/24 h

Each patch releases 2 mg of rotigotine per 24 hours.

Each patch of 10 cm2 contains 4.5 mg of rotigotine.

Leganto 4 mg/24 h

Each patch releases 4 mg of rotigotine per 24 hours.

Each patch of 20 cm2 contains 9.0 mg of rotigotine.

Leganto 6 mg/24 h

Each patch releases 6 mg of rotigotine per 24 hours.

Each patch of 30 cm2 contains 13.5 mg of rotigotine.

Leganto 8 mg/24 h

Each patch releases 8 mg of rotigotine per 24 hours.

Each patch of 40 cm2 contains 18.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Treatment initiation pack

Each pack of 28 transdermal patches for a 4 week treatment schedule contains: 7 transdermal patches of Leganto 2 mg/24 h

7 transdermal patches of Leganto 4 mg/24 h

7 transdermal patches of Leganto 6 mg/24 h

7 transdermal patches of Leganto 8 mg/24 h

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/055

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 PATCHES – WEEK 1

1. NAME OF THE MEDICINAL PRODUCT

Leganto 2 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 2 mg of rotigotine per 24 hours.

Each patch of 10 cm2 contains 4.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches. Week 1.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Transdermal 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

EXP:

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/055

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 2 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL – WEEK 1

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 2 mg/24 h transdermal patch rotigotine

Transdermal use

Week 1

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 PATCHES – WEEK 2

1. NAME OF THE MEDICINAL PRODUCT

Leganto 4 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 4 mg of rotigotine per 24 hours.

Each patch of 20 cm2 contains 9.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches. Week 2.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/055

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 4 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL – WEEK 2

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 4 mg/24 h transdermal patch rotigotine

Transdermal use

Week 2

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 PATCHES – WEEK 3

1. NAME OF THE MEDICINAL PRODUCT

Leganto 6 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 6 mg of rotigotine per 24 hours.

Each patch of 30 cm2 contains 13.5 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches. Week 3.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/055

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 6 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL - WEEK 3

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 6 mg/24 h transdermal patch rotigotine

Transdermal use

Week 3

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 7 PATCHES – WEEK 4

1. NAME OF THE MEDICINAL PRODUCT

Leganto 8 mg/24 h transdermal patch rotigotine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each patch releases 8 mg of rotigotine per 24 hours.

Each patch of 40 cm2 contains 18.0 mg of rotigotine.

3. LIST OF EXCIPIENTS

Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)

Contains E223. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 transdermal patches. Week 4

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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 30°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

UCB Manufacturing Ireland Ltd.

Shannon, Industrial Estate,

Co. Clare, Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/695/055

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

leganto 8 mg/24 h

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET LABEL – WEEK 4

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Leganto 8 mg/24 h transdermal patch rotigotine

Transdermal use

Week 4

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6. OTHER

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