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Evra (norelgestromin / ethinyl estradiol) – Conditions or restrictions regarding supply and use - G03AA13

Updated on site: 06-Oct-2017

Medication nameEvra
ATC CodeG03AA13
Substancenorelgestromin / ethinyl estradiol
ManufacturerJanssen-Cilag International NV

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, 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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