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Exalief (eslicarbazepine acetate) – Conditions or restrictions regarding supply and use - N03AF04

Updated on site: 06-Oct-2017

Medication nameExalief
ATC CodeN03AF04
Substanceeslicarbazepine acetate
ManufacturerBIAL - Portela

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

BIAL - Portela & Cª , S.A.

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

B. CONDITIONS OF THE MARKETING AUTHORISATION

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE

MARKETING AUTHORISATION HOLDER

authorised

Medicinal product subject to medical prescription.

 

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable.

OTHER CONDITIONS

Pharmacovigilance system

 

no

longer

 

 

The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing

Authorisation, is in place and functioning before and whilst the product is on the market.

Risk Management plan

product

 

 

The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of he Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Appli ation and any subsequent updates of the RMP agreed by the CHMP.

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

In addition, an updated RMP should be submitted

When new information is eceived that may impact on the current Safety Specification,

Pharmacovigilance Plan or risk minimisation activities

MedicinalWithin 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

At the request of the European Medicines Agency

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

 

 

authorised

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

authorised

 

Box of 7, 14 or 28 tablets

 

 

 

 

 

 

 

 

 

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

Exalief 400 mg tablets

 

 

 

Eslicarbazepine acetate

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

Each tablet contains 400 mg of eslicarbazepine acetate.

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

longer

 

 

 

 

7 tablets

 

 

 

14 tablets

 

 

 

 

28 tablets

 

 

 

 

 

 

 

 

 

5.

 

no

 

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Oral use.

6.SPECIAL WARNINGproductTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.MedicinalEXPIRY 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

BIAL-Portela & Cª, S.A.

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/520/001 7 tablets - ALU/ALU blister

EU/1/09/520/002 14 tablets - ALU/ALU blister

EU/1/09/520/003 28 tablets - ALU/ALU blister

EU/1/09/520/004 7 tablets - PVC/ALU blister

EU/1/09/520/005 14 tablets - PVC/ALU blister

EU/1/09/520/006 28 tablets - PVC/ALU blister

13.

BATCH NUMBER

 

 

longer

 

 

 

Lot

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

no

 

15.

INSTRUCTIONS ON USE

 

 

 

16.

 

product

 

 

INFORMATION IN BRAILLE

 

 

Exalief 400 mg

 

 

 

Medicinal

 

 

 

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

ALU/ALU blister

PVC/ALU blister

1. NAME OF THE MEDICINAL PRODUCT

Exalief 400 mg tablets

Eslicarbazepine acetate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BIAL

3.

EXPIRY DATE

 

 

longer

 

 

 

EXP

 

 

 

 

4.

BATCH NUMBER

 

 

 

Lot

 

 

no

 

5.

OTHER

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

authorised

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

authorised

 

Box of 30 or 60 tablets

 

 

 

 

 

 

 

 

 

 

 

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

Exalief 600 mg tablets

 

 

 

 

Eslicarbazepine acetate

 

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

Each tablet contains 600 mg of eslicarbazepine acetate.

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

30 tablets

 

longer

 

 

 

 

 

 

60 tablets

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Oral use.

no

 

 

 

Read the package leaflet before use.

 

 

6. SPECIAL WARNING

productTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. Medicinal

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

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/520/007 30 tablets - ALU/ALU blister

EU/1/09/520/008 60 tablets - ALU/ALU blister

EU/1/09/520/009 30 tablets - PVC/ALU blister

EU/1/09/520/010 60 tablets - PVC/ALU blister

13. BATCH NUMBER

Lot

14.

GENERAL CLASSIFICATION FOR SUPPLY

longer

Medicinal product subject to medical prescription.

 

15.

INSTRUCTIONS ON USE

no

16.

INFORMATION IN BRAILLE

 

Exalief 600 mg

product

 

 

Medicinal

 

 

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

ALU/ALU blister

PVC/ALU blister

1. NAME OF THE MEDICINAL PRODUCT

Exalief 600 mg tablets

Eslicarbazepine acetate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BIAL

3.

EXPIRY DATE

 

 

longer

 

 

 

EXP

 

 

 

 

4.

BATCH NUMBER

 

 

 

Lot

 

 

no

 

5.

OTHER

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE

PACKAGING

 

 

authorised

 

 

 

HPDE bottles carton and HPDE bottles of 90 tablets

 

 

 

 

 

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

Exalief 600 mg tablets

 

 

 

Eslicarbazepine acetate

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

Each tablet contains 600 mg of eslicarbazepine acetate.

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

90 tablets

 

longer

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Oral use.

no

 

 

Read the package leaflet before use.

 

 

6. SPECIAL WARNINGproductTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. Medicinal

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

BIAL-Portela & Cª, S.A.

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/520/011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

 

longer

 

 

15.

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

no

 

Exalief 600 mg

 

 

 

 

 

 

 

 

 

 

(outer pack only)

 

 

 

Medicinal

product

 

 

 

 

 

authorised

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

authorised

 

Box of 20, 30, 60 or 90 tablets

 

 

 

 

 

 

 

 

 

 

 

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

Exalief 800 mg tablets

 

 

 

 

Eslicarbazepine acetate

 

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

Each tablet contains 800 mg of eslicarbazepine acetate.

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

longer

 

 

 

 

20 tablets

 

 

 

 

30 tablets

 

 

 

 

 

60 tablets

 

 

 

 

 

90 tablets

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Oral use.

no

 

 

 

 

 

6.SPECIAL WARNINGproductTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. MedicinalEXPIRY 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

BIAL-Portela & Cª, S.A.

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/520/012

20 tablets - ALU/ALU blister

 

 

 

EU/1/09/520/013

30 tablets - ALU/ALU blister

 

 

 

EU/1/09/520/014

60 tablets - ALU/ALU blister

 

 

 

EU/1/09/520/015

90 tablets - ALU/ALU blister

 

 

 

EU/1/09/520/016

20 tablets - PVC/ALU blister

 

 

 

 

EU/1/09/520/017

30 tablets - PVC/ALU blister

 

 

longer

EU/1/09/520/018

60 tablets - PVC/ALU blister

 

 

 

 

 

 

EU/1/09/520/019

90 tablets - PVC/ALU blister

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

no

 

 

 

15.

 

 

product

 

 

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

 

 

Exalief 800 mg

 

 

 

 

 

 

Medicinal

 

 

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

ALU/ALU blister

PVC/ALU blister

1. NAME OF THE MEDICINAL PRODUCT

Exalief 800 mg tablets

Eslicarbazepine acetate

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BIAL

3.

EXPIRY DATE

 

 

longer

 

 

 

EXP

 

 

 

 

4.

BATCH NUMBER

 

 

 

Lot

 

 

no

 

5.

OTHER

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING

HPDE bottles carton and HPDE bottles of 90 tablets

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

Exalief 800 mg tablets

 

 

authorised

 

 

 

 

 

Eslicarbazepine acetate

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

Each tablet constains 800 mg of eslicarbazepine acetate.

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

longer

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

90 tablets

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Oral use.

no

 

 

 

 

 

6.SPECIAL WARNINGproductTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. MedicinalEXPIRY 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

BIAL-Portela & Cª, S.A.

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/520/020

13. BATCH NUMBER

Lot

Exalief 800 mg

 

 

longer

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

15.

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

no

 

 

 

 

 

 

(outer pack only)

 

product

 

 

 

 

Medicinal

 

 

 

 

 

 

 

 

 

authorised

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