English
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

Dutrebis (lamivudine / raltegravir potassium) – Conditions or restrictions regarding supply and use - J05AR16

Updated on site: 06-Oct-2017

Medication nameDutrebis
ATC CodeJ05AR16
Substancelamivudine / raltegravir potassium
ManufacturerMerck Sharp

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Merck Sharp & Dohme B.V.

Waarderweg 39

NL-2031 BN Haarlem

The Netherlands

B.

 

authorised

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product

Characteristics, section 4.2).

 

C.

OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

 

AUTHORISATION

 

Periodic safety update reports

The marketing authorisation holder shall submit the firstlongerperiodic saf ty 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 u der Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-p rtal.

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

An updated RMP shouldproductbe submitted:

 

Risk Management Plan (RMP)

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

At the request of the European Medicines Agency;

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

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

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton

1. NAME OF THE MEDICINAL PRODUCT

DUTREBIS 150 mg/300 mg film-coated tablets lamivudine/raltegravir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravirauthorised(as p tassium)

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

60 film-coated tablets

 

 

longer

 

 

 

 

 

 

5.

METHOD AND ROUTES OF ADMINISTRATION

 

Read the package leaflet before use.

no

 

 

Oral 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.

 

 

 

 

 

product

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

 

 

 

8.

EXPIRY DATE

 

 

 

EXP

 

 

 

 

 

 

 

 

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

Medicinal

 

 

 

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

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/995/001

13. BATCH NUMBER

 

Batch

 

 

 

longer

 

 

 

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

14.

 

15.

INSTRUCTIONS ON USE

no

 

 

 

 

 

 

 

16.

 

product

 

 

 

INFORMATION IN BRAILLE

 

 

 

DUTREBIS

 

 

 

Medicinal

 

 

 

authorised

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label
1. NAME OF THE MEDICINAL PRODUCT
DUTREBIS 150 mg/300 mg film-coated tablets lamivudine/raltegravir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravir (as p tassium)

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

Contains lactose.

 

 

 

authorised

 

See leaflet for further information.

 

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

60 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTES OF ADMINISTRATION

 

 

 

 

 

 

 

 

 

longer

 

 

 

Read the package leaflet before use.

no

 

 

 

 

Oral 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 each of children.

 

 

 

 

 

 

 

 

 

product

 

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

 

 

 

 

 

 

 

 

8.

EXPIRY DATE

 

 

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

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

MSD + logo

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/995/001

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

longer

 

product

no

Medicinal

 

 

 

authorised

Comments

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
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed