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6.3.7. Desogestrel, ethinylestradiol (NAP) - PSUSA/00000967/201509<br />
Applicant: various<br />
PRAC Lead: Kimmo Jaakkola<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.8. Diclofenac (systemic formulations) (NAP) - PSUSA/00001048/201509<br />
Applicant: various<br />
PRAC Lead: Doris Stenver<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.9. Diclofenac (topical formulations) (NAP) - PSUSA/00010342/201509<br />
Applicant: various<br />
PRAC Lead: Doris Stenver<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.10. Fenoterol (obstetric indications) (NAP) - PSUSA/00010001/201509<br />
Applicant: various<br />
PRAC Lead: Marina Dimov Di Giusti<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.11. Glycopyrronium (all indications except for chronic obstructive pulmonary disease)<br />
(NAP) - PSUSA/00001556/201509<br />
Applicant: various<br />
PRAC Lead: Almath Spooner<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.12. Glycopyrronium, neostigmine (NAP) - PSUSA/00001557/201509<br />
Applicant: various<br />
PRAC Lead: Almath Spooner<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: For adoption of recommendation to CMDh<br />
6.3.13. Ketoprofen (topical use only) (NAP) - PSUSA/00009205/201509<br />
Applicant: various<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/325452/2016 Page 35/52
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