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

Telzir (fosamprenavir calcium) – Conditions or restrictions regarding supply and use - J05AE07

Updated on site: 10-Oct-2017

Medication nameTelzir
ATC CodeJ05AE07
Substancefosamprenavir calcium
ManufacturerViiV Healthcare UK Limited  

A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Film-coated tablets

Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom

Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain

Oral suspension

Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany

or

Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom

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.

B 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 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.

D. 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;

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

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