List of medicines for which protection against trade diversion is granted under. Regulation 953/2003

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List of medicines for which protection against trade diversion is granted under Regulation 953/2003 List of medicines EPIVIR ORAL SOLUTION 10 mg/ml x 240 ml... 2 TRIZIVIR 750 mg x 60... 3 EPIVIR 150 mg x 60... 4 RETROVIR 250 mg x 40... 5 RETROVIR 300 mg x 60... 6 RETROVIR 100 mg x 100... 7 COMBIVIR 300/150 mg x 60... 8 ZIAGEN 300 mg x 60... 9 RETROVIR ORAL SOLUTION 10 mg/ml 200 ml... 10 Reference documents: Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines Commission Regulation (EC) No 1876/2004 of 28 October 2004 amending Annex I of Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines Commission Regulation (EC) No 1662/2005 of 11 October 2005 amending Annex I of Council Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines

EPIVIR ORAL SOLUTION 10 mg/ml x 240 ml Product Name: GSK/HIV/2004/001 EPIVIR ORAL SOLUTION 10 mg/ml x 240 ml BANGLADESH - BENIN - BHUTAN - BOTSWANA - BURKINA FASO - BURUNDI - CAMBODIA - CAMEROON - CAPE VERDE - CENTRAL AFRICAN REPUBLIC - CHAD - COMOROS - CONGO - COTE IVOIRE - DEM REP OF THE CONGO - DJIBOUTI - EAST TIMOR - EQUATORIAL GUINEA - ETHIOPIA - GAMBIA - GHANA - GUINEA - GUINEA-BISSAU - HAITI - INDIA - INDONESIA - KENYA - KIRIBATI - KOREA - KYRGYZ REPUBLIC - LAO PEOPLS DEMOCRATIC REPUBLIC - LESOTHO - MADAGASCAR - MALAWI - MALDIVES - MALI - MAURITANIA - MOLDOVA - MONGOLIA - MOZAMBIQUE - MYANMAR - NAMIBIA - NEPAL - NICARAGUA - NIGER - NIGERIA - PAKISTAN - RWANDA - SAMOA - SAO TOME AND PRINCIPE - SENEGAL - SIERRA LEONE - SOMALIA - SOUTH AFRICA - SUDAN - SWAZILAND - TAJIKISTAN - TANZANIA - TOGO - TUVALU - UGANDA - VANUATU - YEMEN - ZAMBIA - ZIMBABWE - Distinctive access pack Trilingual text Approval Date: 2004-04-19 CN/ Taric 3004 9019 Documents gsk-hiv-2004-001.pdf Epivir Oral Solution 10 mg/ml 240 ml

TRIZIVIR 750 mg x 60 GSK/HIV/2003/001 Product Name: TRIZIVIR 750 mg x 60 distinctive access pack tri-lingual text Approval Date: 2004-04-19 CN/ Taric 3004 9019 Documents gsk-hiv-2003-001.pdf - Trizivir 750 mg x 60

EPIVIR 150 mg x 60 GSK/HIV/2003/002 Product Name: EPIVIR 150 mg x 60 Distinctive access pack - tri-lingual text - red tablets Approval Date: 2005-10-11 CN/ Taric 3004 9019 HIV infection

RETROVIR 250 mg x 40 GSK/HIV/2003/004 Product Name: RETROVIR 250 mg x 40 General export pack - not used in Europe French hospital pack - Francophone markets Approval Date: 2004-04-19 CN/ Taric 3004 9019

RETROVIR 300 mg x 60 GSK/HIV/2003/005 Product Name: RETROVIR 300 mg x 60 General export pack - not used in Europe French hospital pack - Francophone countries Approval Date: 2004-04-19 CN/ Taric 3004 9019 Documents gsk-hiv-2003-005.pdf - Retrovir 300 mg x 60

RETROVIR 100 mg x 100 GSK/HIV/2003/006 Product Name: RETROVIR 100 mg x 100 General export pack - not used in Europe French hospital pack - Francophone countries Approval Date: 2004-04-19 CN/ Taric 3004 9019

COMBIVIR 300/150 mg x 60 GSK/HIV/2003/007 Product Name: COMBIVIR 300/150 mg x 60 Distinctive access pack- tri-lingual text bottle (rather than blister pack ) "A22" embossed red tablets Approval Date: 2005-10-11 CN/ Taric 3004 9019

ZIAGEN 300 mg x 60 GSK/HIV/2004/002 Product Name: ZIAGEN 300 mg x 60 AFGHANISTAN - ANGOLA - ARMENIA - AZERBAIJAN - BANGLADESH - BENIN - BHUTAN - BOTSWANA - BURKINA FASO - BURUNDI - CAMBODIA - CAMEROON - CAPE VERDE - CENTRAL AFRICAN REPUBLIC - CHAD - COMOROS - CONGO - COTE IVOIRE - DEM REP OF THE CONGO - DJIBOUTI - EAST TIMOR - EQUATORIAL GUINEA - ERITREA - ETHIOPIA - GAMBIA - GHANA - GUINEA - GUINEA-BISSAU - HAITI - HONDURAS - INDIA - INDONESIA - KENYA - KIRIBATI - KOREA - KYRGYZ REPUBLIC - LAO PEOPLS DEMOCRATIC REPUBLIC - LESOTHO - LIBERIA - MADAGASCAR - MALAWI - MALDIVES - MALI - MAURITANIA - MOLDOVA - MONGOLIA - MOZAMBIQUE - MYANMAR - NAMIBIA - NEPAL - NICARAGUA - NIGER - NIGERIA - PAKISTAN - RWANDA - SAMOA - SAO TOME AND PRINCIPE - SENEGAL - SIERRA LEONE - SOLOMON ISLANDS - SOMALIA - SOUTH General export pack - Not used in EU French hospital pack - Francophone countries Approval Date: 2004-09-20 CN/ Taric 3004 9019 Documents gsk-hiv-2004-002.pdf - ZIAGEN 300 mg x 60

RETROVIR ORAL SOLUTION 10 mg/ml 200 ml Product Name: GSK/HIV/2004/003 RETROVIR ORAL SOLUTION 10 mg/ml 200 ml AFGHANISTAN - ANGOLA - ARMENIA - AZERBAIJAN - BANGLADESH - BENIN - BHUTAN - BOTSWANA - BURKINA FASO - BURUNDI - CAMBODIA - CAMEROON - CAPE VERDE - CENTRAL AFRICAN REPUBLIC - CHAD - COMOROS - CONGO - COTE IVOIRE - DEM REP OF THE CONGO - DJIBOUTI - EAST TIMOR - EQUATORIAL GUINEA - ERITREA - ETHIOPIA - GAMBIA - GHANA - GUINEA - GUINEA-BISSAU - HAITI - HONDURAS - INDIA - INDONESIA - KENYA - KIRIBATI - KOREA - KYRGYZ REPUBLIC - LAO PEOPLS DEMOCRATIC REPUBLIC - LESOTHO - LIBERIA - MADAGASCAR - MALAWI - MALDIVES - MALI - MAURITANIA - MOLDOVA - MONGOLIA - MOZAMBIQUE - MYANMAR - NAMIBIA - NEPAL - NICARAGUA - NIGER - NIGERIA - PAKISTAN - RWANDA - SAMOA - SAO TOME AND PRINCIPE - SENEGAL - SIERRA LEONE - SOLOMON ISLANDS - SOMALIA - SOUTH Distinctive access pack, tri-lingual text Approval Date: 2004-09-20 CN/ Taric 3004 9019 Documents gsk-hiv-2004-003.pdf RETROVIR ORAL SOLUTION 10 mg/ml 200 ml

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