(systemic formulations) List of nationally authorised medicinal ...

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Mar 8, 2018 - number. National Authorisation Number. MAH of product in the member state. Member State where product is a
8 March 2018 EMA/154217/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: ketorolac (systemic formulations)

Procedure no.: PSUSA/00001811/201707

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ERRKES 20 mg/5 ml

not available

S01102

VERISFIELD (UK) LTD

CY

not available

97411/11-11-2014

VERISFIELD (UK) LTD

GR

not available

027253032

RECORDATI INDUSTRIA

IT

πόσιμο διάλυμα ERRKES 20 mg/5 ml πόσιμο διάλυμα Tora-Dol 10 mg compresse rivestite con

CHIMICA E FARMACEUTICA

film

S.P.A.

Tora-Dol 10 mg/ml

not available

027253018

soluzione iniettabile

RECORDATI INDUSTRIA

IT

CHIMICA E FARMACEUTICA S.P.A.

Tora-Dol 20 mg/ml gocce

not available

027253069

orali, soluzione

RECORDATI INDUSTRIA

IT

CHIMICA E FARMACEUTICA S.P.A.

Tora-Dol 30 mg/ml

not available

soluzione iniettabile

027253020

RECORDATI INDUSTRIA

IT

CHIMICA E FARMACEUTICA S.P.A.

List of nationally authorised medicinal products EMA/154217/2018

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