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Rivastigmine 3M Health Care Ltd (rivastigmine) – Conditions or restrictions regarding supply and use - N06DA03

Updated on site: 10-Oct-2017

Medication nameRivastigmine 3M Health Care Ltd
ATC CodeN06DA03
Substancerivastigmine
Manufacturer3M Health Care Limited
Periodic Safety Update Reports

C. OTHER CONDITIONS AND REQUIREMENTS OF THE AUTHORISATION

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Enestia

Klöcknerstraat 1, 3930 Hamont-Achel

Belgium

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).authorised

MARKETING

not required for this medicinal product. However, the marketinglongerauthorisation holder shall submit

At the time of granting the marketing authorisation, the submission of periodic safety update reports is

periodic safety update reports for this 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 and published on the European medicines web-portal

D. CONDITIONS OR RESTRICTIONS WITHno REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCTRisk Management Planproduct(RMP)

The MAH shall perform the requi ed pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent

At theMedicinalrequest of the European Medicines Agency;

When v r the risk management system is modified, especially as the result of new information being r c iv d 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 ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements:

Summary of Product CharacteristicsPatient reminder card

Instructions to provide patients and caregivers with the patient reminder card The patient reminder card should contain the following key messages:

Take off the previous patch before putting ONE new patch on.Only one patch per day.

Do not cut the patch into pieces.

 

 

 

Press the patch firmly in place for at least 30 seconds using the palm of the hand.

How to use the reminder card to record patch application and removal.

 

 

 

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