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Agence nationale de securite du medicament et des produits de sante (ANSM) 143/147, boulevard Anatole France

FR-93285 SAINT-DENIS CEDEX France

Buenos Aires, September 191\ 2016

LETTER OF ACCESS TO OUR EUROPEAN DMF FOR TRA VOPROST (Internal DMF reference number TV/05/2015-07)

National Reference Number 2014-148

Number of Active Substance Master File: Travoprost TV /05/2015/07

Manufacturing site:

Delta Biotech

S.A. -Armenia 3881, Munro, Vicente Lopez - Pcia. Buenos Aires - Argentina

Active Substance Master File holder:

Delta Biotech S.A.

- Armenia 3881, Munro, Vicente Lopez - Pcia. Buenos Aires- Argentina

The aforementioned Active Substance Master File holder hereby authorizes the ANSM, to refer to and review the above mentioned Active Substance Master File in support of the following Marketing Authorization Application submitted by Horus Pharma for:

Travoprost-Timolol Horus Pharma 40micrograms/mL+5mg/mL

DC: DK/H/2708/00 1/DC

MA number:-

HORUSPHARMA

148 A venue Georges Guynemer Cap Var D2

06700 Saint Laurent du Var France

(2)

AEMPS

Agencia Espanola de Medicamentos y Productos Sanitarios Parque Empresarial Las Mercedes

C/ Campezo 28022 Madrid

SPAIN

10 ..

Buenos Aires, september 19th, 2016 '

LETTER OF ACCESS TO OUR EUROPEAN DMF FOR TRA YO PROST (Internal DMF reference number TV/05/2015-07)

National Reference Number 09/01/2015 AA/0004/ 15

Number of Active Substance Master File: Travoprost TV /05/2015/07

Manufacturing site: Delta Biotech S.A.- Armenia 3881, Munro, Vicente Lopez- Pcia. Buenos Aires- Argentina

Active Substance Master File holder: Delta Biotech S.A.- Armenia 3881, Munro, Vicente Lopez - Pcia. Buenos Aires - Argentina

The aforementioned Active Substance Master File holder hereby authorizes the Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS), to refer to and review the above mentioned Active Substance Master File in support of the following Marketing Authorization Application submitted by Horus Pharma for:

Travoprost-Timolol Horus Pharma 40micrograms/mL+5mg/mL

DC: DK/H/2708/001/DC

MA number:-

HORUS PHARMA

148 A venue Georges Guynemer Cap Var D2

06700 Saint Laurent du Var France

•

Delta J3iotech S.A.

Armenia 3881- (B1605CE1)- munro Pcia. de Buenos A1res - Argentina Tei./Fax: (5411) 4700-8025 (rotativas ) info@deltabiotech. com. ar - www .deltabiotech. com .ar

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The af orementioned Active Substance Master File holder hereby authorizes the ANSM, to refer to and review the above mentioned Active Substance Master File in

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