SmPC- Tadalafil 10mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Tadalafil 10mg 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.
SmPC Sections updated: 2, 4.1, 4.2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
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.
SmPC Sections updated: 2, 4.1, 4.2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
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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.
SmPC Sections updated: 2, 4.1, 4.2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.
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Changes: (Updated: 03 Feb 2023)
Type IB (C.I.2.a) To update section 4.4, 4.5, 4.8, 5.1 & 5.2 of SmPC information in-line with the product information of the reference product (CIALIS 2.5 mg, 5 mg, 10 mg & 20 mg film-coated tablets, EU procedure number: EU/1/02/237, MAH; Eli Lilly Nederland B.V., The Netherland)
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Changes: (Updated: 22 Sep 2022)
initial upload