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

Revestive (teduglutide) – Conditions or restrictions regarding supply and use - A16AX08

Updated on site: 09-Oct-2017

Medication nameRevestive
ATC CodeA16AX08
Substanceteduglutide
ManufacturerShire Pharmaceuticals Ireland Ltd

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

Name and address of the manufacturer of the biological active substance

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringer-Gasse 5-11

A-1121 Vienna

Austria

Name and address of the manufacturer responsible for batch release

Shire Pharmaceuticals Ireland Limited

5 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

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 REGARDS 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.

Obligations to conduct post-authorisation measures

 

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

 

 

 

Description

Due date

 

 

International Short Bowel Syndrome Registry

 

Non-interventional study (NIS) to gather further safety data, in order to further

 

elucidate the potential and identified risk as outlined in the RMP, based on a

 

CHMP approved protocol.

 

Interim data for the NIS should be provided every second year.

Four interim reports

 

 

will be provided

 

 

within six months

 

 

after the data lock

 

 

points (i.e., Q4 2016,

 

 

Q4 2018, Q4 2020,

 

 

and Q4 2022).

Final study report

Q3 2031

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