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Jinarc (tolvaptan) – Conditions or restrictions regarding supply and use - C03XA01

Updated on site: 08-Oct-2017

Medication nameJinarc
ATC CodeC03XA01
Substancetolvaptan
ManufacturerOtsuka Pharmaceutical Europe Ltd

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

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

AndersonBrecon (UK) Limited

Units 2-7, Wye Valley Business Park,

Brecon Road

Hay-on-Wye, Hereford, Herefordshire

HR3 5PG

United Kingdom

Almac Pharma Services Ltd

Almac House,

20 Seagoe Industrial State

Craigavon

BT63 5QD

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 the first periodic safety 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 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.

Additional risk minimisation measures

Prior to launch of Jinarc in each Member State the Marketing Authorisation Holder must agree the content and format of the educational programme, including communication media and distribution modalities with each National Competent Authority. The MAH must ensure that all healthcare professionals and patients/carers who are expected to prescribe and/or use JINARC have access to/are provided with the following educational package

Physician educational material

Patient information pack

The educational programme is aimed at ensuring awareness about the potential risk of hepatotoxicity and providing guidance on how to manage this risk and the importance of pregnancy prevention prior to the initiation and during the treatment with Jinarc.

The physician educational material should contain:

The Summary of product Characteristics

Healthcare professionals training material

The healthcare professional training material shall contain the following key elements

the risk of hepatotoxicity associated with the use of Jinarc

the importance of pregnancy prevention, before and during treatment with Jinarc

The patient information pack should contain:

The Patient information leaflet

Patient/Carer educational material

A Patient Alert Card

The Patient/Carer educational material shall contain the following key messages:

the risk of hepatotoxicity associated with the use of Jinarc

the importance of pregnancy prevention, before and during treatment with Jinarc

The Patient Alert Card shall contain the following key messages:

• Signs or symptoms of liver toxicity and severe dehydration

• Advice if such symptoms occur

Obligation to conduct post-authorisation measures

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

Description

Due date

A post non-interventional authorization safety study to investigate the risks of:

 

Hepatotoxicity

 

Basal cell carcinoma

 

Glaucoma

 

associated with the use of Jinarc.

 

In addition the study should also provide information on

 

• Pregnancy outcomes, in patients treated with Jinarc

 

• Patterns of drug utilisation, especially with regards to off-label use and use in

 

 

patients over 50 years old

 

• ADRs associated with long term use of Jinarc

 

Final study report should be submitted by:

4 Quarter 2022

 

Description

Due date

Post Authorisation Efficacy Study (PAES): In order to further define the efficacy of

 

tolvaptan in patients with more advanced renal dysfunction on a primary endpoint related

 

to GFR rather than TKV the MAH should submit the Final study report of Study 156-13-

 

210 by:

Feb-2018

Post Authorisation Efficacy Study (PAES): In order to show whether the observed short-

 

term effects of tolvaptan on the rate of renal function decline translate into favourable

 

long-term outcomes such as ADPKD related morbidity and mortality, including longer-

 

term effects on GFR decline and progression of disease leading to dialysis or

 

transplantation the MAH should submit the results of the open-label extension to the

 

pivotal trial study 156-08-271. A comparison of progression shall be made to the expected

 

untreated progression rate.

 

The final clinical study report should be submitted by:

June-2016

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