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.

1 Download the product label with the new indication for pancreatic cancer.

Translated versions of the EU product label

Language

Product Label

Package Leaflet

Czech

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Danish

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Dutch

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English

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Estonian

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Finnish

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French

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German

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Greek

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Hungarian (Magyar)

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Italian

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Latvian

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Lithuanian

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Polish

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Portuguese

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Slovak

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Slovenian

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Spanish

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Swedish

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Countries with regulatory approval
[Product may not be commercially available in all markets]
A-D   E-H   I-L   M-P   Q-Z

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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