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Aerinaze (desloratadine / pseudophedrine sulphate) – Conditions or restrictions regarding supply and use - R01BA52

Updated on site: 05-Oct-2017

Medication nameAerinaze
ATC CodeR01BA52
Substancedesloratadine / pseudophedrine sulphate
ManufacturerMerck Sharp

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

SP Labo N.V.

Industriepark 30

2220 Heist-op-den-Berg

Belgium

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

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)

Not applicable.

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