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Enzepi (pancreas powder) – Conditions or restrictions regarding supply and use - A09AA02

Updated on site: 06-Oct-2017

Medication nameEnzepi
ATC CodeA09AA02
Substancepancreas powder
ManufacturerAllergan Pharmaceuticals International Ltd

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

Name and address of the manufacturer of the biological active substance

Nordmark Arzneimittel GmbH & Co. KG Pinnauallee 4

25436 Uetersen GERMANY

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

Adare Pharmaceuticals Srl

 

 

Via Martin Luther King 13

 

 

20060 Pessano Con Bornago

 

 

ITALY

 

authorised

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

AUTHORISATION

longer

 

 

 

Periodic safety update reports

 

 

no

 

 

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 publishedproducton the European medicines web-portal.

The marketing authorisation holder shall s bmit the first periodic safety update report for this product within 6 months following authorisati n.

D. CONDITIONSMedicinalOR 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.

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