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Paglitaz (pioglitazone hydrochloride) – Conditions or restrictions regarding supply and use - A10BG03

Updated on site: 09-Oct-2017

Medication namePaglitaz
ATC CodeA10BG03
Substancepioglitazone hydrochloride
ManufacturerKrka, d.d., Novo mesto

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

KRKA, d.d., Novo mesto Šmarješka cesta 6

8501 Novo mesto Slovenia

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

The printed package leaflet of the medicinal product must state the name and address of the

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLYauthorisedAND USEMedicinal product subject to medical prescription.manufacturer responsible for the release of the concerned batch.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

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no

At the time of granting the marketing authorisati n, the submission of periodic safety update

product

 

reports is not required for this medicinal product. However, the marketing authorisation holder shall submit periodic safety update reports for his medicinal product if the product is included 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

 

Medicinal

Risk Management Plan (RMP)

The MAH shall p rform the required pharmacovigilance activities and interventions detailed in the agreed R P 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.

Additional risk minimisation measures

The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone. Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.

-This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.

-The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.

The Prescriber Guide should highlight the following:

 

 

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Patient selection criteria including that Pioglitazone should not be used as first line therapy and

 

emphasising the need for regular review of treatment benefit.

 

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The risk bladder cancer and relevant risk minimisation advice.

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The risk of heart failure and relevant risk minimisation advice.

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authorised

Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures

 

and heart failure).

 

 

 

 

 

 

 

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