PIL- Tadalafil 5mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Tadalafil 5mg Film-coated Tablets)
Last updated on this site: 25 Mar 2024
Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 2 (2.5mg, 5mg only), 4.1 (2.5mg, 5mg, 10mg only), 4.2, 4.3, 4.4, 4.5, 4.6 (2.5mg, 5mg, 10mg only), 4.8, 5.1 (2.5mg, 5mg, 20mg only), 5.2 (2mg only) in-line with the reference product (Cialis 2.5mg, 5mg, 10mg & 20mg filmcoated tablets; EU number: EU/1/02/237; MAH: Eli Lilly Nederland B.V., The Netherlands). Consequently, the PIL has been updated.
PIL sections updated: 2, 3, 4 and 6.
Last updated on this site: 25 Mar 2024
Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 2 (2.5mg, 5mg only), 4.1 (2.5mg, 5mg, 10mg only), 4.2, 4.3, 4.4, 4.5, 4.6 (2.5mg, 5mg, 10mg only), 4.8, 5.1 (2.5mg, 5mg, 20mg only), 5.2 (2mg only) in-line with the reference product (Cialis 2.5mg, 5mg, 10mg & 20mg filmcoated tablets; EU number: EU/1/02/237; MAH: Eli Lilly Nederland B.V., The Netherlands). Consequently, the PIL has been updated.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 25 Mar 2024)
Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 2 (2.5mg, 5mg only), 4.1 (2.5mg, 5mg, 10mg only), 4.2, 4.3, 4.4, 4.5, 4.6 (2.5mg, 5mg, 10mg only), 4.8, 5.1 (2.5mg, 5mg, 20mg only), 5.2 (2mg only) in-line with the reference product (Cialis 2.5mg, 5mg, 10mg & 20mg filmcoated tablets; EU number: EU/1/02/237; MAH: Eli Lilly Nederland B.V., The Netherlands). Consequently, the PIL has been updated.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload