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Zydelig (idelalisib) – Conditions or restrictions regarding supply and use - L01XX47

Updated on site: 11-Oct-2017

Medication nameZydelig
ATC CodeL01XX47
Substanceidelalisib
ManufacturerGilead Sciences International Ltd

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

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 marketing authorisation holder shall submit the first periodic safety update report for this product within 8 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 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 dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

 

Obligation to conduct post-authorisation measures

 

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

 

 

 

Description

Due date

The applicant should submit the final study report for Phase 3 extension

31 December

study GS-US-312-0117, to evaluate the efficacy and safety of idelalisib

(GS-1101) in combination with rituximab for previously treated CLL.

 

Updates on PFS, OS and duration of response for patients with or without

 

17p deletion/TP53 mutation and the whole population should be submitted.

 

The applicant should submit the final study report for Phase 2 study 101-09 to

31 December

evaluate the efficacy and safety of idelalisib in subjects with indolent B-cell NHL

refractory to rituximab and alkylating agents.

 

Updates on safety and efficacy results including overall survival and updates of

 

the analyses of subjects with baseline lymphopenia, should be submitted.

 

The applicant should submit the final study report for the extension study 101-99.

30 September

 

 

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