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

Kovaltry (octocog alfa) – Conditions or restrictions regarding supply and use - B02BD02

Updated on site: 08-Oct-2017

Medication nameKovaltry
ATC CodeB02BD02
Substanceoctocog alfa
ManufacturerBayer Pharma AG

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

Name and address of the manufacturer of the biological active substance

Bayer HealthCare LLC 800 Dwight Way Berkeley

CA 94710 United States

Name and address of the manufacturer responsible for batch release

Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany

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 requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates 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.

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

 

 

Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of

12/2018

Kovaltry in previously untreated patients the MAH should submit the results of the

 

ongoing study “13400 - Leopold Kids Part B”

 

Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of

12/2020

 

long-term treatment with Kovaltry, the MAH should submit the results of the ongoing

 

study “13400 - Leopold Kids extension”

 

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