Adcirca (previously Tadalafil Lilly)
Opinion
On 15 December 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Adcirca. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.
The CHMP adopted a new indication for the treatment of patients aged 2 years and above with pulmonary arterial hypertension. For information, the full indication will be as follows:1
Adults
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Paediatric population
Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
Key facts
| Name |
Adcirca (previously Tadalafil Lilly) |
| Agency product number |
EMEA/H/C/001021 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Hypertension, Pulmonary
|
| Date opinion adopted |
16/12/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |