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Rapilysin (reteplase) – Conditions or restrictions regarding supply and use - B01AD08

Updated on site: 09-Oct-2017

Medication nameRapilysin
ATC CodeB01AD08
Substancereteplase
ManufacturerActavis Group PTC ehf

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

Name and address of the manufacturers of the biological active substance

Wacker Biotech GmbH

Heinrich-Damerow-Str. 4

06120 Halle

Germany

Name and address of the manufacturers responsible for batch release

Actavis Italy S.p.A.

Nerviano Plant

Via Pasteur 10

20014 Nerviano (Milan)

Italy

Cenexi

52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois

France

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

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 published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable

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