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Ibandronic Acid Teva (ibandronic acid) – Conditions or restrictions regarding supply and use - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic Acid Teva
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerTeva Pharma B.V.

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

HU-4042 Debrecen

Hungary

TEVA UK Ltd

Brampton Road, Hampden Park

Eastbourne, East Sussex,

BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

Teva Czech Industries s.r.o. Ostravska 29/305

747 70 Opava-Komarov Czech Republic

Teva Operations Poland Sp.z.o.o ul. Mogilska 80

31-546 Krakow Poland

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

Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

Ibandronic Acid Teva 150 mg: Medicinal product subject to medical prescription.

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 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.

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