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MabCampath (alemtuzumab) – Conditions or restrictions regarding supply and use - L01XC04

Updated on site: 08-Oct-2017

Medication nameMabCampath
ATC CodeL01XC04
Substancealemtuzumab
ManufacturerGenzyme Europe B.V.

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 Pharma GmbH & Co. KG

 

authorised

 

 

Birkendorfer Strasse 65

 

 

 

D-88397 Biberach an der Riss

 

 

 

Deutschland

 

 

 

Genzyme Flanders bvba

 

 

 

Cipalstraat 8

 

 

 

2440 Geel

 

 

 

Belgium

 

 

 

Name and address of the manufacturer responsible for batch release

 

Genzyme Ltd.

 

longer

 

37 Hollands Road

 

 

 

 

 

Haverhill, Suffolk CB9 8PU

 

 

 

United Kingdom

 

 

 

Genzyme Ireland Limited.

 

 

 

IDA Industrial Park

 

 

 

Old Kilmeaden Road

 

 

 

Waterford

no

 

 

Ireland

 

 

 

 

 

Bayer Schering Pharma AG

 

 

 

Müllerstrasse 178

 

 

 

D-13342 Berlin

 

 

 

Deutschland

 

 

 

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 1: Summary of Product

Medicinal

Characteristics, sectionproduct4.2).

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT

The MAH shall agree the details of an educational brochure with the National Competent

Authorities.

The MAH shall ensure that all doctors who prescribe MabCampath are provided with a healthcare professional information pack containing the following:

Educational brochure

Summary of Product Characteristics (SPC) and Package Leaflet and Labelling

OTHER CONDITIONS

Key elements to be included in the educational brochure

 

 

The risk of opportunistic infections, in particular CMV viraemia

 

 

Recommendation to avoid vaccination with live vaccines for at least 12 months following

 

MabCampath therapy

 

The risk of infusion reactions

authorised

Risk Management Plan

o Need for premedication

o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration

o That the risk of infusion reactions is highest in first week of therapy

o That if the reaction is moderate or severe dosing should continue at the same level ( no dose escalation) until each dose is well tolerated

o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation

The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.

(PSUR).

 

longer

The MAH commits to performing the studies and additional pharmacovigilance activities detailed in

the Pharmacovigilance Plan, as agreed in version 3.3 of the Risk Mana m nt Plan (RMP) presented

in Module 1.8.2. of the Marketing Authorisation Application a

d a y subsequent updates of the RMP

agreed by the CHMP.

 

 

As per the CHMP Guideline on Risk Management Systems f

medicinal products for human use, the

updated RMP should be submitted at the same time as the next Periodic Safety Update Report

In addition, an updated RMP should be submitted:

 

 

product

 

When new information is received

hat may impact on the current Safety Specification,

 

Pharmacovigilance Plan or risk minimisationno activities

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

 

reached

 

 

At the request of the EMA

 

 

Medicinal

 

 

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

 

MabCampath 10 mg/ml concentrate for solution for infusion

 

 

 

Alemtuzumab

 

 

 

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

One ml contains 10 mg of alemtuzumab.

 

 

 

 

 

Each ampoule contains 30 mg of alemtuzumab.

 

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

Other ingredients:

 

 

 

 

 

 

Disodium edetate, polysorbate 80, potassium chloride, potassium dihydro phosphate, sodium

 

chloride, dibasic sodium phosphate, water for injections.

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

longer

 

 

 

Concentrate for solution for infusion

no

 

 

 

 

3 x 3 ml ampoules

 

 

 

 

 

30 mg/3 ml

 

 

 

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

Intravenous use.

 

 

 

 

 

 

Read the package leaflet bef re 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

 

 

 

 

 

EXP

 

 

 

 

 

 

Medicinal

 

 

 

 

 

Read the leaflet for the shelf life of the reconstituted product.

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

 

 

Store in a refrigerator (2°C-8°C).

 

 

 

 

 

Do not freeze.

 

 

 

 

 

 

 

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

authorised

 

 

 

 

 

 

 

 

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

 

 

 

 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

 

 

 

 

APPROPRIATE

 

 

 

 

 

Any spillage or waste material should be disposed of by incineration.

 

 

 

 

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

 

Marketing Authorisation Holder:

 

 

 

 

 

Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands

 

 

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/01/193/001

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

longer

 

 

 

 

Lot

no

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

 

product

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Justific tion for not including Braille accepted

 

 

 

 

Medicinal

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

AMPOULE

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

longer

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 mg/3 ml

 

 

product

no

 

6. OTHER

 

 

Medicinal

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

 

MabCampath 30 mg/ml concentrate for solution for infusion

 

 

 

Alemtuzumab

 

 

 

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

One ml contains 30 mg of alemtuzumab.

 

 

 

 

 

Each vial contains 30 mg of alemtuzumab.

 

 

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

Other ingredients:

 

 

 

 

 

 

Disodium edetate, polysorbate 80, potassium chloride, potassium dihydro phosphate, sodium

 

chloride, dibasic sodium phosphate, water for injections.

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

longer

 

 

 

Concentrate for solution for infusion

no

 

 

 

 

3 x 1 ml vials

 

 

 

 

 

30 mg/ml

 

 

 

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

Intravenous use.

 

 

 

 

 

 

Read the package leaflet bef re 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

 

 

 

 

 

EXP

 

 

 

 

 

 

Medicinal

 

 

 

 

 

Read the leaflet for the shelf life of the reconstituted product.

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

 

 

Store in a refrigerator (2°C-8°C).

 

 

 

 

 

Do not freeze.

 

 

 

 

 

 

 

Store in the original package in order to protect from light,.

authorised

 

 

 

 

 

 

 

 

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

 

 

 

 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

 

 

 

 

APPROPRIATE

 

 

 

 

 

Any spillage or waste material should be disposed of by incineration.

 

 

 

 

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

 

Marketing Authorisation Holder:

 

 

 

 

 

Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands

 

 

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER (S)

 

 

 

 

EU/1/01/193/002

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

longer

 

 

 

 

Lot

no

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

 

product

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Justific tion for not including Braille accepted

 

 

 

 

Medicinal

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 mg/ml

 

 

product

no

 

6. OTHER

 

 

Medicinal

 

 

 

 

 

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