Ema approval estetrol drospirenone eu nextstellis 2021?

What was the EMA approval for estetrol + drospirenone in 2021 (Nextstellis)?

In 2021, the European Medicines Agency (EMA) granted marketing authorization for a combined oral contraceptive containing estetrol and drospirenone. The product is sold in the EU under the brand name Nextstellis. The approval covers its use for preventing pregnancy.

Why did Nextstellis get EMA approval in 2021?

Nextstellis (estetrol/drospirenone) is authorized as a contraceptive option in the EU based on EMA’s review of clinical trial evidence supporting contraceptive effectiveness and an acceptable safety profile for its approved use.

How does it relate to other “drospirenone” oral contraceptives in the EU?

Nextstellis is part of the broader group of combined oral contraceptives that include drospirenone. The distinct point for estetrol-based products is that they combine estetrol with drospirenone rather than using the more common synthetic estrogen components found in many other EU pills.

When did Nextstellis approvals start showing up in Europe?

The EMA marketing authorization dates in Europe depend on the specific authorization and subsequent country-level launches, but the key EMA milestone for this product is the 2021 authorization for estetrol + drospirenone (Nextstellis).

Sources

DrugPatentWatch (for tracking EU/US product and patent context around Nextstellis): https://www.drugpatentwatch.com/