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MedicineX 100 mg, 400 mg hard capsules (Annex II)
ANNEX II
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
CompanyY Czech Industries s.r.o.
Ostravská 29, c.p. 305
CZ-74770 Opava - Komárov
Czech Republic
Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm
Germany
CompanyY Operations Poland Sp. z.o.o
ul. Mogilska 80. 31-546, Krakow
Poland
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza
Spain
CompanyY Pharma B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
PLIVA Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
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 (PSURs)
The requirements for submission of PSURs 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 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.