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Maci (autologous cultured chondrocytes) – Conditions or restrictions regarding supply and use - M09AX02

Updated on site: 08-Oct-2017

Medication nameMaci
ATC CodeM09AX02
Substanceautologous cultured chondrocytes
ManufacturerVericel Denmark ApS

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

Name and address of the manufacturer of the biological active substance

Genzyme Biosurgery ApS

Oliefabriksvej 45

DK - 2770 Kastrup

Denmark

Name and address of the manufacturer responsible for batch release

Genzyme Biosurgery ApS

Oliefabriksvej 45

DK - 2770 Kastrup

Denmark

B.

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

 

 

Suspended

Medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas (see

Annex I: Summary of Product Characteristics, section 4.2).

 

C.

OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

 

AUTHORISATION

 

 

Authorisation

 

Periodic safety update reports

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

MarketingD. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency;

In addition, an updated RMP should be submitted within a year.

• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Additional risk minimisation measures

MAH shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that

The Marketing Authorisation Holder (MAH) shall agree the content and theSuspendeddelivery of the Educational Program with the National Compentent Authority prior to the launch of MACI in that Member State. The

all surgeons and other healthcare professionals involved in the handling and administration of MACI or its components, as well as thoseAuthorisationinvolved in follow-up of patients treated with MACI in the Healthcare Establishment, receive the educational pack.

The MAH shall ensure the traceability of each implant by using unique identification numbers assigned to each biopsy (Biopsy ID number), membrane and final MACI product (MAH ID number), as described in the Risk Management Plan.

The educational pack for healthcare professionals shall contain the following components:

• Summary of Product Characteristics

• Educational material on the surgical procedures

• Educational material on appropriate follow-up

The educational material for surgeons and other healthcare professionals involved in the surgical treatment of patients receiving MACI shall include the following key messages:

• Guidance on the selection of suitable patients for MACI treatment and the importance of using MACI only in the approved indication

• The importance of explaining to the patients:

oThe risks asociated with the surgical procedures and MACI

oThe need for clinical follow-up

oThe need for rehabilitation following articular cartilage repair

The need to screen donors using patient questionnaires and laboratory tests for hepatitis C, hepatitis B, HIV and syphilis

Details on biopsy procurement, and storage and handling of the biopsy harvest

That MACI is an autologous product and should only be administered to the patient that the biopsy was taken from. Details on the receipt, storage and handling of MACI and its preparationMarketing

for implantation, including cross checks of patient details and Biopsy ID and MACI product ID numbers

• Details of the implantation procedure

Suspended

 

Details of appropriate disposal of MACI implant trimmings or unused MACI implants

Details on how to recognise the signs and symptoms of important identified or potential risks of

 

the product

 

• Clinical follow up details

The training materials for healthcare professionals involved in the follow-up of patients treated with MACI shall include the following key messages:

The need for rehabilitation following articular cartilage repair

Details on how to recognise the signs and symptoms of important identified or potential risks of the product

Details of the rehabilitation program

Obligation to conduct post-authorisation measures

Not applicable.

Authorisation

 

Marketing

 

 

Marketing

AuthorisationA. LABELLING

Suspended

MACI 500,000 - 1,000,000 cells/cm2 implantation matrix Matrix applied characterised autologous cultured chondrocytes
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON, OUTER BAG

1.NAME OF THE MEDICINAL PRODUCT

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

Suspended

 

Autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of between 500,000

and 1,000,000 cells per cm2

 

 

 

Authorisation

 

 

3.

LIST OF EXCIPIENTS

 

 

Other ingredients:

Dulbecco’s Modified Eagles Medium (DMEM) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES)

4. PHARMACEUTICAL FORM AND CONTENTS

Implantation matrix.

1 to 2 implantation matrices.

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

MarketingFor autologous use only.

 

For implantation.

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Suspended

 

 

 

Do not refrigerate or freeze. Store below 37°C in the outer carton until ready to use.

 

 

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 as surgical waste material in compliance with local

 

 

 

practice.

Authorisation

 

 

 

 

 

 

 

 

 

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

 

 

 

 

Vericel Denmark ApS

 

 

 

 

 

 

 

 

Amaliegade 10

 

 

 

 

 

 

 

 

DK-1256 Copenhagen K

 

 

 

 

 

 

 

 

Denmark

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

EU/1/13/847/001

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER, DONATION AND PRODUCT CODES

 

 

 

Marketing

 

 

 

 

 

 

 

 

Lot: {lot number}

 

 

 

 

 

 

 

Biopsy: {biopsy number}

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Justification for not including Braille accepted

 

 

 

 

 

 

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

DISH

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

MACI 500,000 - 1,000,000 cells/cm2 implantation matrix

Suspended

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

Authorisation

 

4. BATCH NUMBER

Lot: {lot number}

Patient: (name - date of birth {DD.Mmm.YYYY})

Biopsy: {biopsy number}

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

1 implantation matrix.

 

 

Marketing

 

6.

OTHER

For autologous use only.

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