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(1)Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen Module 1.2, Annex 5.19

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(1)

Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen Module 1.2, Annex 5.19

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List of Proposed (invented) names and Marketing Authorisation Holder in the Concerned Member States

Teriparatide 20 µg / 80 µl solution for injection in pre-filled pen Procedure No.:

RMS Product name MAH

DE Teriparatide Welding 20 µg/ 80µl Injektionslösung in einem vorgefüllten Injektor

Welding GmbH & Co. KG Esplanade 39 20354 Hamburg

Germany

CMS Product name MAH

LU Teriparatide Welding 20 microgrammes/80 microlitres solution injectable en stylo prérempli

Welding GmbH & Co. KG Esplanade 39 20354 Hamburg

Germany

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1.3 Product Information 1.3.6 Braille

Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen

‘Teriparatide 20 µg/80 µl’ or ‘[INVENTED NAME]’ (as place holder in the proposed PIL) are used synonymously.

The only difference between the European reference product Forsteo, Terrosa and Teriparatide 20 µg/80 µl is the pen device used for subcutaneous administration of the solution

1 LABELLING Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen Module 1.3.1. ________________________________________________________________________________________________

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN.. Keep out of the sight and reach

1 LABELLING Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen Module 1.3.1. ________________________________________________________________________________________________

Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen Module 1.3.1... Teriparatide 20 µg/80 µl, solution for injection in pre-filled pen

Scientific Advice given by Member States Teriparatide 20 µg / 80 µl solution for injection in pre-filled pen

equivalence of reference product Forsteo and Teriparatide 20 µg/80 µl formulation can be assumed and a BE waiver can be granted taking into account the parental administration

Concerned Member State Comments on Day 180 Assessment Report to be sent at Day 195 at the latest

For DE/H/6160/001/DC, the proposed product name “TERIPARATIDE BIOGARAN 20 microgrammes / 80 microlitres, solution injectable en stylo prérempli” is acceptable in France.