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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

Acomplia (rimonabant) – Conditions or restrictions regarding supply and use - A08AX01

Updated on site: 05-Oct-2017

Medication nameAcomplia
ATC CodeA08AX01
Substancerimonabant
Manufacturersanofi-aventis
Medicinal product no longer authorised

B. CONDITIONS OF THE MARKETING AUTHORISATION

A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE

sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy

Name and address of the manufacturers responsible for batch release

 

Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France

 

authorised

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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

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

no

 

The MAH must ensure that the system of pharmacovigilance is in place and functioning before the

product is placed on the market.

 

product

 

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

An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.

Medicinal

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

 

ACOMPLIA 20 mg film-coated tablets

 

 

authorised

 

 

 

 

 

 

 

rimonabant

 

 

 

 

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

Each tablet contains 20 mg of rimonabant.

 

 

 

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

Also contains lactose monohydrate.

 

longer

 

 

 

 

 

 

 

 

See leaflet for further information.

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

14 film-coated tablets

 

no

 

 

 

 

28 film-coated tablets

 

 

 

 

 

 

 

30 film-coated tablets

 

 

product

 

 

 

 

56 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

 

 

70x1 film coated-tablets

 

 

 

 

 

 

84 film-coated tablets

 

 

 

 

 

 

 

 

90 film-coated tablets

 

 

 

 

 

 

 

98 film-coated tablets

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

Oral use.

 

 

 

 

Medicinal

 

 

 

 

 

 

Read the package leaflet before use

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

8. EXPIRY DATE

authorised

 

 

 

 

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

sanofi-aventis

174 avenue de France F-75013 Paris France

12. MARKETING AUTHORISATION NUMBER(S)

 

 

 

EU/1/06/344/001

 

 

longer

 

 

 

EU/1/06/344/002

 

 

no

 

 

 

EU/1/06/344/003

 

 

 

 

 

EU/1/06/344/004

 

 

 

 

 

EU/1/06/344/005

 

 

 

 

 

 

EU/1/06/344/006

 

 

 

 

 

 

EU/1/06/344/010

 

 

 

 

 

 

EU/1/06/344/011

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

product

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

Medicinal

 

 

 

 

 

 

 

ACOMPLIA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters of the presentations of 14, 28, 56, 84 and 98 film-coated tablets

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

ACOMPLIA 20 mg film-coated tablets

 

 

authorised

 

 

 

 

 

rimonabant

 

 

 

 

 

 

 

 

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

 

 

sanofi-aventis

 

 

 

 

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

 

 

 

 

Monday

product

no

 

 

 

Tuesday

 

 

 

 

 

 

 

Wednesday

 

 

 

 

Thursday

 

 

 

 

 

Friday

 

 

 

 

 

Saturday

 

 

 

 

 

Sunday

 

 

 

 

Medicinal

 

 

 

 

 

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters of the presentations of 30, 70 x 1 and 90 film-coated tablets

 

1.

NAME OF THE MEDICINAL PRODUCT

 

 

 

ACOMPLIA 20 mg film-coated tablets

 

 

authorised

 

 

 

 

 

rimonabant

 

 

 

 

 

 

 

 

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

 

 

sanofi-aventis

 

 

 

 

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

 

Lot

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

 

 

 

 

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

Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle label for the presentations of 28, 98 and 500 film-coated tablets

1.

NAME OF THE MEDICINAL PRODUCT

 

ACOMPLIA 20 mg film-coated tablets

authorised

 

rimonabant

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

Each tablet contains 20 mg of rimonabant.

3. LIST OF EXCIPIENTS

Also contains lactose monohydrate.

See leaflet for further information.

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

 

 

longer

 

 

28 film-coated tablets

no

 

 

 

98 film-coated tablets

 

 

 

 

 

500 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Oral 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

 

 

 

 

 

 

 

 

 

 

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

Medicinal

 

 

 

 

 

 

 

 

 

EU/1/06/344/007
EU/1/06/344/008
EU/1/06/344/009
12. MARKETING AUTHORISATION NUMBER(S)
sanofi-aventis 174 avenue de F-75013 Paris France
11. NAME

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINALauthorisedPRODUCTS, IF

APPROPRIATE

AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

France

13. BATCH NUMBER

Lot

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

 

 

 

longer

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

no

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

product

 

 

 

 

ACOMPLIA

 

 

Medicinal

 

 

 

 

 

 

 

 

 

 

 

 

Comments

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