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Revasc (desirudin) – Conditions or restrictions regarding supply and use - B01AE01

Updated on site: 09-Oct-2017

Medication nameRevasc
ATC CodeB01AE01
Substancedesirudin
ManufacturerCanyon Pharmaceuticals Ltd.

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

 

Boehringer Ingelheim RCV GmbH & Co KG (BI RCV)

 

Dr. Boehringer Gasse 5 - 11

 

1121 Vienna

 

Austria

authorised

Name and address of the manufacturer responsible for batch release

 

Canyon Pharmaceuticals GmbH

 

Unter Gereuth 10

 

D-79353 Bahlingen a.K.

 

Germany

 

B.CONDITIONS OF THE MARKETING AUTHORISATION

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

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

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

Not applicable.

product

no

 

 

 

• OTHER CONDITIONS

 

Pharmacovigilance system

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.

Medicinal

 

 

 

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A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES

1. NAME OF THE MEDICINAL PRODUCT

Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 ATU per vial.

authorised

3.LIST OF EXCIPIENTS

Powder: magnesium chloride, sodium hydroxide

Solvent: mannitol, water for injections

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

longer

 

Powder and solvent for solution for injection

 

 

 

15mg of powder in a vial and 0.5ml of solve t in an ampoule

 

Pack size of 2

 

no

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Reconstitute immediately bef e use with solvent provided. Read the package leaflet before use.

 

Subcutaneous use on y.

 

 

 

 

 

product

 

 

 

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

 

Medicinal

 

 

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25ºC.

After reconstitution, immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).

Keep the vial and ampoule in the outer carton in order to protect from light.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINALauthorisedPRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERCanyon Pharmaceuticals Limited7th Floor52-54 Gracechurch StreetLondon EC3V 0EH

 

United Kingdom

 

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12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/97/043/001

no

 

 

13.

BATCH NUMBER

 

 

 

 

 

 

Batch

14.GENERAL CLASSIFICATION SUPPLYFOR

 

 

 

 

 

 

 

product

 

Medicinal product subject to medical prescription.

 

Medicinal

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

16.

INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES
1. NAME OF THE MEDICINAL PRODUCT
Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 ATU per vial.

authorised

3.LIST OF EXCIPIENTS

Powder: magnesium chloride, sodium hydroxide

Solvent: mannitol, water for injections

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

longer

 

Powder and solvent for solution for injection

 

 

 

15mg of powder in a vial and 0.5ml of solve t in an ampoule

 

Pack size of 10

 

no

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Reconstitute immediately bef e use with solvent provided. Read the package leaflet before use.

 

Subcutaneous use on y.

 

 

 

 

 

product

 

 

 

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

 

Medicinal

 

 

8.EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25ºC.

After reconstitution, immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).

Keep the vial and ampoule in the outer carton in order to protect from light.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINALauthorisedPRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERCanyon Pharmaceuticals Limited7th Floor52-54 Gracechurch StreetLondon EC3V 0EH

 

United Kingdom

 

longer

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/97/043/002

no

 

 

13.

BATCH NUMBER

 

 

 

 

 

 

Batch

14. GENERAL CLASSIFICATION SUPPLYFOR

 

 

 

 

 

 

 

 

 

product

 

 

Medicinal product subject to medical prescription.

 

 

 

 

Medicinal

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

16.

INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE
1. NAME OF THE MEDICINAL PRODUCT
Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 ATU per vial.

authorised

3.LIST OF EXCIPIENTS

Powder: magnesium chloride, sodium hydroxide

Solvent: mannitol, water for injections

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

longer

 

Powder and solvent for solution for injection

 

 

 

15mg of powder in a vial and 0.5ml of solve t in an ampoule

 

Pack size of 1

 

no

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Reconstitute immediately bef e use with solvent provided. Read the package leaflet before use.

 

Subcutaneous use on y.

 

 

 

 

 

product

 

 

 

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

 

Medicinal

 

 

8.EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25ºC.

After reconstitution, immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).

Keep the vial and ampoule in the outer carton in order to protect from light.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINALauthorisedPRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERCanyon Pharmaceuticals Limited7th Floor52-54 Gracechurch StreetLondon EC3V 0EH

 

United Kingdom

 

longer

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/97/043/003

no

 

 

13.

BATCH NUMBER

 

 

 

 

 

 

Batch

14. GENERAL CLASSIFICATION SUPPLYFOR

 

 

 

 

 

 

 

 

 

product

 

 

Medicinal product subject to medical prescription.

 

 

 

 

Medicinal

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

16.

INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL: 15mg

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

Revasc 15 mg/0.5 ml

Powder for injection

Desirudin

Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

 

Batch

 

 

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no

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

15mg of desirudin

product

 

 

Medicinal

 

 

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

AMPOULE LABEL: 0.5ml SOLVENT

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

Revasc 15 mg/ 0.5ml

Solvent for parenteral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

 

Batch

 

 

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5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

 

 

no

 

 

0.5ml of water for injections with 3% (w/v) of mannit l

Medicinal

product

 

 

 

 

 

authorised

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