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Human Remove Human filter Veterinary (160) Apply Veterinary filter

Medicine name

Active substance / international non-proprietary name (INN) / common name

Medicine

Summaries of opinion Remove Summaries of opinion filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter European public assessment reports (EPAR) (1700) Apply European public assessment reports (EPAR) filter Withdrawn applications (286) Apply Withdrawn applications filter Paediatric investigation plans (2437) Apply Paediatric investigation plans filter Periodic safety update report single assessments (2396) Apply Periodic safety update report single assessments filter Shortages (39) Apply Shortages filter Direct healthcare professional communication (85) Apply Direct healthcare professional communication filter Opinions on medicines for use outside EU (15) Apply Opinions on medicines for use outside EU filter

Product number

Opinion status

Negative (2) Apply Negative filter Positive (46) Apply Positive filter

Application type

Initial authorisation (15) Apply Initial authorisation filter Post-authorisation (33) Apply Post-authorisation filter

Date of opinion

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Orphan designation – intended use

Decision date

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Orphan decision number

Orphan designation status

Expired (68) Apply Expired filter Negative (36) Apply Negative filter Positive (1949) Apply Positive filter Withdrawn (703) Apply Withdrawn filter

Referral name

Referral status

European Commission final decision (414) Apply European Commission final decision filter CMDh final position (18) Apply CMDh final position filter Opinion provided by Committee for Medicinal Products for Human Use (4) Apply Opinion provided by Committee for Medicinal Products for Human Use filter

Referral safety status

Yes (97) Apply Yes filter

Referral type

Article 29(4) referrals (121) Apply Article 29(4) referrals filter Article 31 referrals (121) Apply Article 31 referrals filter Article 30 referrals (95) Apply Article 30 referrals filter Article 20 procedures (26) Apply Article 20 procedures filter Article 6(12) referrals (prior to January 2010) (21) Apply Article 6(12) referrals (prior to January 2010) filter Article 107 procedures (prior to July 2012) (15) Apply Article 107 procedures (prior to July 2012) filter Article 29 paediatrics (9) Apply Article 29 paediatrics filter Article 36 referrals (prior to July 2012) (9) Apply Article 36 referrals (prior to July 2012) filter Article 107i procedures (9) Apply Article 107i procedures filter Article 13 referrals (6) Apply Article 13 referrals filter Article 6(13) referrals (prior to January 2010) (5) Apply Article 6(13) referrals (prior to January 2010) filter Article 5(11) referrals (prior to January 2010) (2) Apply Article 5(11) referrals (prior to January 2010) filter

Referral reference number

Referral decision making model

PRAC-CAT-CHMP-EC (1) Apply PRAC-CAT-CHMP-EC filter PRAC-CHMP-EC (31) Apply PRAC-CHMP-EC filter PRAC-CMDh (37) Apply PRAC-CMDh filter

Referral authorisation model

Centrally and nationally authorised products (mixed) (12) Apply Centrally and nationally authorised products (mixed) filter Centrally authorised product(s) (24) Apply Centrally authorised product(s) filter Nationally authorised product(s) (63) Apply Nationally authorised product(s) filter

Referral PRAC recommendation

No further action (1) Apply No further action filter Revocation (4) Apply Revocation filter Risk minimisation measures (35) Apply Risk minimisation measures filter Suspension (9) Apply Suspension filter Variation (14) Apply Variation filter

Referral procedure start date

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Referral PRAC recommendation date

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Medicine type

Accelerated assessment (25) Apply Accelerated assessment filter Additional monitoring (157) Apply Additional monitoring filter Biosimilar (2) Apply Biosimilar filter Conditional approval (35) Apply Conditional approval filter Exceptional circumstances (24) Apply Exceptional circumstances filter Generic (8) Apply Generic filter Orphan medicine (265) Apply Orphan medicine filter

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