English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Telmisartan Teva Pharma (telmisartan) – Conditions or restrictions regarding supply and use - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Teva Pharma
ATC CodeC09CA07
Substancetelmisartan
ManufacturerTeva 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 Pharmaceutical Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

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 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

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed