Annex II ESSENTIAL MEDICAL USES

Quota of controlled substances of Group I that may be used in the production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs) are allocated to:

• Chiesi Farmaceutici SpA (IT)

• Valeas SpA Pharmaceuticals (IT)

• (VARI) SpA — LINDAL Group Italia (IT)