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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Quixidar (fondaparinux sodium) – Conditions or restrictions regarding supply and use - B01AX05

Updated on site: 09-Oct-2017

Medication nameQuixidar
ATC CodeB01AX05
Substancefondaparinux sodium
ManufacturerGlaxo Group Ltd.
Not applicable.

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Glaxo Wellcome Production 1, rue de l’Abbaye

F-76960 Notre Dame de Bondeville

France

B. CONDITIONS OF THE MARKETING AUTHORISATION

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISTION HOLDER

Medicinal product subject to medical prescription.

authorised

 

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

OTHER CONDITIONS

Pharmacovigilance system

longer

 

The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version

 

 

no

presented in Module 1.8.1. of the Marketing Authorisation Application, 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 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application 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 received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities

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

At the request of the EMEA.

Medicinal

 

 

 

longer

 

A. LABELLING

 

Product

no

 

Medicinal

 

 

 

 

 

authorised

One pre-filled syringe (0.3 ml) contains 1.5 mg fondaparinux sodium.
Quixidar 1.5 mg/0.3 ml solution for injection Fondaparinux sodium
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX

1.NAME OF THE MEDICINAL PRODUCT

2.STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3.LIST OF EXCIPIENTS

Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection, 2 pre-filled syringes with an automatic safety system

 

Solution for injection, 7 pre-filled syringes with an automatic safety system

 

Solution for injection, 10 pre-filled syringes with an automaticlongersafety system

 

Solution for injection, 20 pre-filled syringes with an automatic safety system

 

 

 

 

no

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Subcutaneous use

 

 

 

Read the package leaflet before use.

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Product

 

 

Keep out of the reach and sight of children.

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

 

 

 

8.

EXPIRY DATE

 

 

 

Medicinal

 

 

EXP {month/year}

9.SPECIAL STORAGE CONDITIONS

Do not freeze.

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 authorised

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/02/207/005- 2 pre-filled syringes

 

 

 

 

EU/1/02/207/006 - 7 pre-filled syringes

 

longer

 

 

EU/1/02/207/007 - 10 pre-filled syringes

 

 

 

 

 

 

 

EU/1/02/207/008 - 20 pre-filled syringes

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

 

Batch {number}

 

no

 

 

 

14.

 

 

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

Product

 

 

 

 

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Quixidar 1.5 mg/0.3 ml injection fondaparinux Na

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP {month/year}

4.BATCH NUMBER

 

5. CONTENTS BY WEIGHT, BY VOLUME ORlongerBY UNIT

 

Batch {number}

 

 

 

 

Product

no

 

 

Medicinal

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER BOX

1. NAME OF THE MEDICINAL PRODUCT

Quixidar 2.5 mg/0.5 ml solution for injection

Fondaparinux sodium

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium.

authorised

 

 

 

 

3.

LIST OF EXCIPIENTS

 

Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection, 2 pre-filled syringes with an automaticlongersafety system

Solution for injection, 7 pre-filled syringes with an automatic safety system

Solution for injection, 10 pre-filled syringes withnoan automatic safety system

Solution for injection, 20 pre-filled syringes with an automatic safety system

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intravenous use

Read the package leaflet before use.

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACHProductAND SIGHT OF CHILDREN

 

Keep out of the reach and sight of children.

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

 

8.

EXPIRY DATE

 

Medicinal

EXP {month/year}

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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 AUTHORISATIONauthorisedHOLDERGlaxo Group LtdGreenfordMiddlesexUB6 0NNUnited Kingdom12. MARKETING AUTHORISATION NUMBER(S)

13.

BATCH NUMBER

 

longer

 

 

EU/1/02/207/001 - 2 pre-filled syringes

 

 

 

 

EU/1/02/207/002 - 7 pre-filled syringes

 

 

 

 

EU/1/02/207/003 - 10 pre-filled syringes

 

 

 

 

EU/1/02/207/004 - 20 pre-filled syringes

 

 

 

 

 

 

 

 

 

 

 

Batch {number}

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14.

 

Product

 

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Quixidar 2.5 mg/0.5 ml injection fondaparinux Na

SC/IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

 

5. CONTENTS BY WEIGHT, BY VOLUME ORlongerBY UNIT

 

Batch {number}

 

 

 

 

Product

no

 

 

Medicinal

 

 

 

authorised

One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Quixidar 5 mg/0.4 ml solution for injection Fondaparinux sodium
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX

1. NAME OF THE MEDICINAL PRODUCT

2. STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3. LIST OF EXCIPIENTS

Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection, 2 pre-filled syringes with an automatic safety system

 

Solution for injection, 7 pre-filled syringes with an automatic safety system

 

Solution for injection, 10 pre-filled syringes with an automaticlongersafety system

 

Solution for injection, 20 pre-filled syringes with an automatic safety system

 

 

 

 

no

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Subcutaneous use

 

 

 

Read the package leaflet before use.

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Product

 

 

Keep out of the reach and sight of children.

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

Body weight below 50 kg

 

 

Medicinal

 

 

 

8.

EXPIRY DATE

 

 

EXP {month/year}

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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 AUTHORISATIONauthorisedHOLDERGlaxo Group LtdGreenfordMiddlesexUB6 0NNUnited Kingdom12. MARKETING AUTHORISATION NUMBER(S)

 

EU/1/02/207/009- 2 pre-filled syringes

 

longer

 

 

 

 

EU/1/02/207//010 - 7 pre-filled syringes

 

 

 

EU/1/02/207/011 - 10 pre-filled syringes

 

 

 

EU/1/02/207/018 - 20 pre-filled syringe

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

Batch {number}

no

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

Medicinal

 

 

 

16.

INFORMATIONProductIN BRAILLE

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Quixidar 5 mg/0.4 ml injection fondaparinux Na

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

 

5. CONTENTS BY WEIGHT, BY VOLUME ORlongerBY UNIT

 

Batch {number}

 

 

 

 

Product

no

 

 

Medicinal

 

 

 

authorised

One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Quixidar 7.5 mg/0.6 ml solution for injection Fondaparinux sodium
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX

1. NAME OF THE MEDICINAL PRODUCT

2. STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3. LIST OF EXCIPIENTS

Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection, 2 pre-filled syringes with an automatic safety system

 

Solution for injection, 7 pre-filled syringes with an automatic safety system

 

Solution for injection, 10 pre-filled syringes with an automaticlongersafety system

 

Solution for injection, 20 pre-filled syringes with an automatic safety system

 

 

 

 

no

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Subcutaneous use

 

 

 

Read the package leaflet before use.

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Product

 

 

Keep out of the reach and sight of children.

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

Body weight 50-100 kg

 

 

 

Medicinal

 

 

 

8.

EXPIRY DATE

 

 

EXP {month/year}

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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 AUTHORISATIONauthorisedHOLDERGlaxo Group LtdGreenfordMiddlesexUB6 0NNUnited Kingdom12. MARKETING AUTHORISATION NUMBER(S)

 

EU/1/02/207/012- 2 pre-filled syringes

 

longer

 

 

 

 

EU/1/02/207/013 - 7 pre-filled syringes

 

 

 

EU/1/02/207/014 - 10 pre-filled syringes

 

 

 

EU/1/02/207/019 - 20 pre-filled syringe

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

Batch {number}

no

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

Medicinal

 

 

 

16.

INFORMATIONProductIN BRAILLE

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

 

 

Quixidar 7.5 mg/0.6 ml injection

 

 

authorised

 

 

 

 

 

 

 

fondaparinux Na

 

 

 

 

 

 

SC

 

 

 

 

 

 

 

 

 

 

 

 

 

2.

METHOD OF ADMINISTRATION

 

 

 

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

 

 

 

EXP {month/year}

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

 

 

Batch {number}

 

no

 

 

 

 

5.

 

 

 

 

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

Medicinal

Product

 

 

 

 

 

 

 

One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX

1. NAME OF THE MEDICINAL PRODUCT

2. STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3. LIST OF EXCIPIENTS

Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection, 2 pre-filled syringes with an automatic safety system

 

Solution for injection, 7 pre-filled syringes with an automatic safety system

 

Solution for injection, 10 pre-filled syringes with an automaticlongersafety system

 

Solution for injection, 20 pre-filled syringes with an automatic safety system

 

 

 

 

no

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Subcutaneous use

 

 

 

Read the package leaflet before use.

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

Product

 

 

Keep out of the reach and sight of children.

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

Body weight above 100 kg

 

 

Medicinal

 

 

 

8.

EXPIRY DATE

 

 

EXP {month/year}

9. SPECIAL STORAGE CONDITIONS

Do not freeze.

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 AUTHORISATIONauthorisedHOLDERGlaxo Group LtdGreenfordMiddlesexUB6 0NNUnited Kingdom12. MARKETING AUTHORISATION NUMBER(S)

 

EU/1/02/207/015 - 2 pre-filled syringes

 

longer

 

 

 

 

EU/1/02/207/016 - 7 pre-filled syringes

 

 

 

EU/1/02/207/017 - 10 pre-filled syringes

 

 

 

EU/1/02/207/020 - 20 pre-filled syringe

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

Batch {number}

no

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

Medicinal

 

 

 

16.

INFORMATIONProductIN BRAILLE

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Quixidar 10 mg/0.8 ml injection fondaparinux Na

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP {month/year}

4. BATCH NUMBER

 

5. CONTENTS BY WEIGHT, BY VOLUME ORlongerBY UNIT

 

Batch {number}

 

 

 

 

Product

no

 

 

Medicinal

 

 

 

authorised

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