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Approval and labeling information
Download the approved EU product label
The EU product label for Tarceva is available in all of the languages listed below. Click to download a version in the language of your choice.
To see if Tarceva has been approved in your country, see Countries with regulatory approval.
Download the product label with the new indication for pancreatic cancer.
Translated versions of the EU product label
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Countries with regulatory approval
[Product may not be commercially available in all markets]
Country |
NSCLC approval date |
Albania |
|
Argentina |
November 8, 2005 |
Armenia |
July 14, 2005 |
Aruba |
September 19, 2005 |
| Australia |
January 30, 2006 |
| Austria |
September 19, 2005 |
Azerbaijan |
|
| Bahrain |
June 13, 2006 |
Bangladesh |
October 2, 2005 |
| Belgium |
September 19, 2005 |
Bosnia-Herzegovina |
|
Brazil |
April 10, 2006 |
| Bulgaria |
November 1, 2005 |
Cambodia |
February 2, 2006 |
| Canada |
July 7, 2005 |
Chile |
July 27, 2005 |
China |
April 6, 2006 |
Colombia |
February 2, 2006 |
Costa Rica |
September 13, 2005 |
Curacao |
March 21, 2006 |
| Cyprus |
September 19, 2005 |
| Czech Republic |
September 19, 2005 |
| Denmark |
September 19, 2005 |
Dominican Republic |
May 31, 2005 |
Country |
NSCLC approval date |
Ecuador |
August 30, 2005 |
| Egypt |
March 12, 2006 |
El Salvador |
|
| Estonia |
September 19, 2005 |
| EU |
September 19, 2005 |
| Finland |
September 19, 2005 |
| France |
September 19, 2005 |
| Germany |
September 19, 2005 |
| Greece |
September 19, 2005 |
Guatemala |
September 16, 2005 |
Honduras |
August 17, 2005 |
Hong Kong |
May 3, 2006 |
| Hungary |
September 19, 2005 |
Country |
NSCLC approval date |
| Iceland |
|
India |
February 27, 2006 |
Indonesia |
|
| Ireland |
September 19, 2005 |
Israel |
September 21, 2005 |
| Italy |
September 19, 2005 |
| Jamaica |
November 23, 2005 |
| Kuwait |
July 5, 2005 |
| Latvia |
September 19, 2005 |
| Lithuania |
September 19, 2005 |
| Luxemburg |
September 19, 2005 |
Country |
NSCLC approval date |
Macao |
|
Macedonia |
|
Malaysia |
|
| Malta |
September 19, 2005 |
| Mexico |
June 20, 2006 |
Moldova |
|
Nepal |
|
| Netherlands |
September 19, 2005 |
| New Zealand |
March 23, 2006 |
Pakistan |
March 22, 2006 |
Panama |
|
Peru |
May 31, 2005 |
Philippines |
November 23, 2005 |
| Poland |
September 19, 2005 |
| Portugal |
September 19, 2005 |
Country |
NSCLC approval date |
| Qatar |
May 30, 2006 |
| Romania |
December 30, 2005 |
| Russia |
|
| Serbia & Montenegro |
January 26, 2006 |
| Singapore |
Febuary 10, 2006 |
| Slovakia |
September 19, 2005 |
| Slovenia |
September 19, 2005 |
| Spain |
September 19, 2005 |
| South Korea |
July 29, 2005 (100 mg)
October 24, 2005 (150 mg)
|
| Sweden |
September 19, 2005 |
| Switzerland |
March 21, 2005 |
| Taiwan |
March 14, 2006 |
| Thailand |
August 1, 2005 |
| Trinidad/Tobago |
November 30, 2005 |
| Ukraine |
|
| United Kingdom |
September 19, 2005 |
| Uruguay |
February 17, 2006 |
| US |
November 18, 2004 |
| Venezuela |
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