Zalecenia dla podmiotów odpowiedzialnych | Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

ZALECENIA DLA PODMIOTÓW ODPOWIEDZIALNYCH

Substancja czynna	Zalecenia	Podstawa prawna	Termin złożenia zmiany	Klasyfikacja zmiany
17-alpha-oestradiol (topical)	PSUR worksharing	-	06/06/2017	IB nr C.I.3 z)
5 fluorouracil	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
99mTc-human albumin macro-aggregates	PSUR worksharing	-	06/05/2014	IB nr C.I.3 z)
Acitretin	Stanowisko CMDh	-	05/10/2016	IA_IN nr C.I.3 a)
Aksytynib	Pojedyncze sygnały	-	11/06/2016	IA_INnr C.I.z
Alprostadil (erectile dysfunction)	Stanowisko CMDh	-	25/01/2017	IA_IN nr C.I.3 a)
Altizide, Spironolactone	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Amiodarone	Stanowisko CMDh	-	04/11/2015	IA_IN nr C.I.3 a)
Amitriptyline	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Amitriptyline/perphenazine	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Amlodipine + Atorvastatine	PSUR worksharing	-	11/09/2016	IB nr C.I.3 z)
Amlodipine besilate / Ramipril	Stanowisko CMDh	-	30/03/2016	IA_IN nr C.I.3 a)
Ampicillin-sulbactam	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Anakinra	Pojedyncze sygnały	-	03/01/2016	IA_INnr C.I.z
Antithrombin III	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Apomorphine	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Apomorphine	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Argatroban	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Asparaginase	Stanowisko CMDh	-	10/08/2016	IA_IN nr C.I.3 a)
Atenolol / Chlortalidone	Stanowisko CMDh	-	20/08/2015	IA_IN nr C.I.3 a)
Azathioprine	Pojedyncze sygnały	-	11/06/2016	IA_INnr C.I.z
Bazedoksyfen + Estrogen	Pojedyncze sygnały	-	06/04/2016	IA_INnr C.I.z
Bemetizide / Triamterene	Stanowisko CMDh	-	08/06/2016	IA_IN nr C.I.3 a)
Benazepril	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Bendamustine/hydrochloride	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Benzydamine	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Bilastine	Stanowisko CMDh	-	24/01/2017	IA_IN nr C.I.3 a)
Bismuth subcitrate potassium / Metronidazole / Tetracycline	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Botulinum neurotoxin type a (150 d) free from complexing proteins	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Botulinum toxin a - haemagglutinin complex	Stanowisko CMDh	-	18/12/2016	IA_IN nr C.I.3 a)
Botulinum toxin a	Stanowisko CMDh	-	18/12/2016	IA_IN nr C.I.3 a)
Brotizolam	PSUR worksharing	-	-	IB nr C.I.3 z)
Budesonide	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Budesonide	PSUR worksharing	-	-	IB nr C.I.3 z)
Budesonide + Formoterol	PSUR worksharing	-	-	IB nr C.I.3 z)
Buflomedil hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Buprenorphine	PSUR worksharing	-	11/04/2017	IB nr C.I.3 z)
Bupropion	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Cabergoline	PSUR worksharing	-	-	IB nr C.I.3 z)
Calcium carbonate, Famotidine, Magnesium hydroxide	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Calcium carbonate + Cholecalciferol	PSUR worksharing	-	-	IB nr C.I.3 z)
Calcium valproate	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Candesartan/Candesartan+ Hydrochlorothiazide	PSUR worksharing	-	-	IB nr C.I.3 z)
Captopril / Hydrochlorothiazide	Stanowisko CMDh	-	23/03/2017	IA_IN nr C.I.3 a)
Captopril + Hydrochlorothiazide	PSUR worksharing	-	-	IB nr C.I.3 z)
Carboplatin	Stanowisko CMDh	-	25/01/2017	IA_IN nr C.I.3 a)
Carmustine (powder and solvent for solution for infusion)	Stanowisko CMDh	-	30/03/2016	IA_IN nr C.I.3 a)
Carteolol	PSUR worksharing	-	-	IB nr C.I.3 z)
Cefepime	PSUR worksharing	-	-	IB nr C.I.3 z)
Cefoperazone/sulbactam	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Cefoperazone	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Cefotaxime	PSUR worksharing	-	-	IB nr C.I.3 z)
Ceftazidime	PSUR worksharing	-	-	IB nr C.I.3 z)
Cetirizine	PSUR worksharing	-	-	IB nr C.I.3 z)
Chloroquine	Stanowisko CMDh	-	14/07/2016	IA_IN nr C.I.3 a)
Chlorpromazine	PSUR worksharing	-	11/04/2017	IB nr C.I.3 z)
Chlorprothixene hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Cholekalcyferol	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Ciclosporin	PSUR worksharing	-	-	IB nr C.I.3 z)
Cilostazol	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Ciprofloxacin	PSUR worksharing	-	-	IB nr C.I.3 z)
Ciprofloxacin hydrochloride + Dexamethasone acetate (ear drops, suspension)	PSUR worksharing	-	-	IB nr C.I.3 z)
Clarithromycin	PSUR worksharing	-	11/09/2016	IB nr C.I.3 z)
Clebopride	PSUR worksharing	-	-	IB nr C.I.3 z)
Clevidipine	PSUR worksharing	-	-	IB nr C.I.3 z)
Clodronate	PSUR worksharing	-	-	IB nr C.I.3 z)
Clostridium botulinium neurotoxin type A haemagglutinin complex	PSUR worksharing	-	-	IB nr C.I.3 z)
Codeine	Stanowisko CMDh	Art. 31	20/07/2015	IB nr C.I.1 a) lub IB nr C.I.1 b)
Corticorelin	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Cyproheptadine	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Cyproterone acetate/Ethinylestradiol	PSUR worksharing	-	-	IB nr C.I.3 z)
Daklataswir	Pojedyncze sygnały	-	13/06/2015	IA_INnr C.I.z
Danaparoid	PSUR worksharing	-	-	IB nr C.I.3 z)
Daunorubicin	Stanowisko CMDh	-	08/06/2016	IA_IN nr C.I.3 a)
Dazatynib	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Dekslanzoprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Delapril	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Deoxyribonuclease human (dornase alpha)	PSUR worksharing	-	-	IB nr C.I.3 z)
Desogestrel	PSUR worksharing	-	-	IB nr C.I.3 z)
Dexamethasone (apart from centrally authorised products)	Stanowisko CMDh	-	02/02/2017	IA_IN nr C.I.3 a)
Dexibuprofen	PSUR worksharing	-	-	IB nr C.I.3 z)
Dexketoprofen	PSUR worksharing	-	-	IB nr C.I.3 z)
Dextromethorphan	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Diclofenac (systemic formulations)	Stanowisko CMDh	-	07/09/2016	IA_IN nr C.I.3 a)
Didanosine	PSUR worksharing	-	-	IB nr C.I.3 z)
Dinoprostone	PSUR worksharing	-	-	IB nr C.I.3 z)
Domperidone	PSUR worksharing	-	-	IB nr C.I.3 z)
Donepezil	Pojedyncze sygnały	-	07/10/2015	IA_INnr C.I.z
Dorzolamide	Stanowisko CMDh	-	22/02/2017	IA_IN nr C.I.3 a)
Dorzolamide + Timolol	PSUR worksharing	-	-	IB nr C.I.3 z)
Doxazosin	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Doxylamine	PSUR worksharing	-	-	IB nr C.I.3 z)
Drospirenone and Ethinylestradiol	PSUR worksharing	-	-	IB nr C.I.3 z)
Dutasteride	PSUR worksharing	-	-	IB nr C.I.3 z)
Ebastine	PSUR worksharing	-	-	IB nr C.I.3 z)
Econazole	PSUR worksharing	-	-	IB nr C.I.3 z)
Enalapril	PSUR worksharing	-	-	IB nr C.I.3 z)
Epinastine hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Epirubicin	PSUR worksharing	-	-	IB nr C.I.3 z)
Estradiol valerate + Dienogest	PSUR worksharing	-	-	IB nr C.I.3 z)
Estradiol + Norethisterone	PSUR worksharing	-	-	IB nr C.I.3 z)
Estrogen	Pojedyncze sygnały	-	06/04/2016	IA_INnr C.I.z
Estrogen + Progestagen	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Estrogen + Progestagen	Pojedyncze sygnały	-	06/04/2016	IA_INnr C.I.z
Ethinylestradiol + Dienogest	PSUR worksharing	-	-	IB nr C.I.3 z)
Ethinylestradiol + Levonorgestrel	PSUR worksharing	-	-	IB nr C.I.3 z)
Etrogen	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Everolimus (indicated for rejection of transplanted organs)	Stanowisko CMDh	-	14/07/2016	IA_IN nr C.I.3 a)
Ezetimibe	PSUR worksharing	-	-	IB nr C.I.3 z)
Ezomeprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Famotidine	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Felbamate	PSUR worksharing	-	-	IB nr C.I.3 z)
Felodipine + Ramipril	PSUR worksharing	-	-	IB nr C.I.3 z)
Fenoterol hydrobromide + Ipratropium bromide	PSUR worksharing	-	-	IB nr C.I.3 z)
Fentanyl	PSUR worksharing	-	-	IB nr C.I.3 z)
Ferumoxsil	PSUR worksharing	-	-	IB nr C.I.3 z)
Finasteride	PSUR worksharing	-	-	IB nr C.I.3 z)
Finasteride	Stanowisko CMDh	-	03/08/2017	IA_IN nr C.I.3 a)
Fingolimod	Pojedyncze sygnały	-	01/08/2015	IA_INnr C.I.z
Fixed combination containing: Dimethyl sulfoxide,Camphor, Tterebinthini aetheroleum,Benzyl nicotinate, Nonivamide	PSUR worksharing	-	-	IB nr C.I.3 z)
Fluconazole	PSUR worksharing	-	-	IB nr C.I.3 z)
Flumazenil	PSUR worksharing	-	-	IB nr C.I.3 z)
Fluoxetine	PSUR worksharing	-	-	IB nr C.I.3 z)
Fluticasone	PSUR worksharing	-	-	IB nr C.I.3 z)
Folinic acid / (di)sodium folinate / Calcium folinate / Calcium levofolinate	PSUR worksharing	-	-	IB nr C.I.3 z)
Formoterol	PSUR worksharing	-	-	IB nr C.I.3 z)
Furosemide/Spironolactone	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Furosemide	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Fusidic acid and Sodium fusidate	PSUR worksharing	-	-	IB nr C.I.3 z)
Gabapentin	Stanowisko CMDh	-	25/01/2017	IA_IN nr C.I.3 a)
Gabapentin	PSUR worksharing	-	-	IB nr C.I.3 z)
Gadobenic acid	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadobutrol	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadodiamid	PSUR worksharing	-	-	IB nr C.I.3 z)
Gadodiamide	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadopentetic acid dimeglumine	PSUR worksharing	-	-	IB nr C.I.3 z)
Gadopentetic acid	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadoteric acid (IV and intravascular formulations)	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadoteridol	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gadoteridol	PSUR worksharing	-	-	IB nr C.I.3 z)
Gadoxetic acid disodium	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Gilnacipran	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Glatiramer	PSUR worksharing	-	-	IB nr C.I.3 z)
Glibenclamide / Metformin hydrochloride	Stanowisko CMDh	-	08/06/2016	IA_IN nr C.I.3 a)
Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease)	Stanowisko CMDh	-	07/09/2016	IA_IN nr C.I.3 a)
Glycopyrronium / Neostigmine	Stanowisko CMDh	-	07/09/2016	IA_IN nr C.I.3 a)
Granisetron (other formulations except for transdermal patch)	Stanowisko CMDh	-	22//02/2017	IA_IN nr C.I.3 a)
Human coagulation factor VII	PSUR worksharing	-	-	IB nr C.I.3 z)
Human coagulation factor VIII inhibitor bypassing fraction	PSUR worksharing	-	18/01/2017	IB nr C.I.3 z)
Human coagulation factor VIII inhibitor bypassing fraction	PSUR worksharing	-	-	IB nr C.I.3 z)
Hydrochlorothiazide, Spironolactone	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Hydromorphone	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Hydroquinidine	PSUR worksharing	-	-	IB nr C.I.3 z)
Hydroxyzine	Stanowisko CMDh	Art. 31	19/06/2015	IB nr C.I.1 a) lub IB nr C.I.1 b)
Ibuprofen- and dexibuprofen	Stanowisko CMDh	Art. 31	16/10/2015	IB nr C.I.1 a) lub IB nr C.I.1 b)
Ibutilide	PSUR worksharing	-	-	IB nr C.I.3 z)
Idarubicin	PSUR worksharing	-	-	IB nr C.I.3 z)
Imatynib	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Imipenem/cilastatin	PSUR worksharing	-	-	IB nr C.I.3 z)
Inactivated influenza split trivalent vaccine	PSUR worksharing	-	-	IB nr C.I.3 z)
Indium (In-111) chloride solution	PSUR worksharing	-	-	IB nr C.I.3 z)
Indobufen	PSUR worksharing	-	-	IB nr C.I.3 z)
Influenza vaccine (surface antigen, inactivated)	Stanowisko CMDh	-	-	IA_IN nr C.I.3 a)
Interferon alfa-2a	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Interferon alfa-2a	PSUR worksharing	-	-	IB nr C.I.3 z)
Interferon alfa-2b	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Interferon beta-1a	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Interferon beta-1b	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Iobitridol	PSUR worksharing	-	-	IB nr C.I.3 z)
Iodine (131i) Iobenguane	Stanowisko CMDh	-	07/09/2016	IA_IN nr C.I.3 a)
Ipratropium	PSUR worksharing	-	-	IB nr C.I.3 z)
Ipratropium + Salbutamol	PSUR worksharing	-	-	IB nr C.I.3 z)
Isoniazid	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Isradipine	PSUR worksharing	-	-	IB nr C.I.3 z)
Ivermectin	PSUR worksharing	-	-	IB nr C.I.3 z)
Ivermectin (topical use)	Stanowisko CMDh	-	29/03/2017	IA_IN nr C.I.3 a)
Karbidopa	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Ketoprofen (except topical use)	PSUR worksharing	-	-	IB nr C.I.3 z)
Ketoprofen for topical use	PSUR worksharing	-	-	IB nr C.I.3 z)
Kwas alendronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas etydronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas ibandronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas klodronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas nerydronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas pamidronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas ryzedronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas tioktynowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas tyludronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Kwas zoledronowy	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Labetalol	PSUR worksharing	-	-	IB nr C.I.3 z)
Lamotrigine	PSUR worksharing	-	-	IB nr C.I.3 z)
Lanzoprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Latanoprost	Pojedyncze sygnały	-	01/08/2015	IA_INnr C.I.z
Latanoprost/Timolol	PSUR worksharing	-	-	IB nr C.I.3 z)
Ledipaswir	Pojedyncze sygnały	-	13/06/2015	IA_INnr C.I.z
Leflunomid	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Leflunomid	Pojedyncze sygnały	-	01/08/2015	IA_INnr C.I.z
Lenograstim	PSUR worksharing	-	-	IB nr C.I.3 z)
Levobupivacaine	PSUR worksharing	-	-	IB nr C.I.3 z)
Levocetirizine	PSUR worksharing	-	05/09/2017	IB nr C.I.3 z)
Levosimendan	PSUR worksharing	-	-	IB nr C.I.3 z)
Lewodopa	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Lomustine	PSUR worksharing	-	-	IB nr C.I.3 z)
Loratidine	PSUR worksharing	-	-	IB nr C.I.3 z)
Lormetazepam	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Losartan + Hydrochlorothiazide	PSUR worksharing	-	-	IB nr C.I.3 z)
Lovastatin	PSUR worksharing	-	-	IB nr C.I.3 z)
Lubiprostone	PSUR worksharing	-	-	IB nr C.I.3 z)
Macrogol 4000	PSUR worksharing	-	-	IB nr C.I.3 z)
Macrogol 4000 and combinations	PSUR worksharing	-	-	IB nr C.I.3 z)
Mefloquine	PSUR worksharing	-	-	IB nr C.I.3 z)
Meloxicam	Stanowisko CMDh	-	05/07/2017	IA_IN nr C.I.3 a)
Mepivacaine, mepivacaine/adrenaline, mepivacaine hydrochloride/dextrose monohydrate	PSUR worksharing	-	-	IB nr C.I.3 z)
Merkaptopuryna	Pojedyncze sygnały	-	11/06/2016	IA_INnr C.I.z
Meropenem	Stanowisko CMDh	-	10/08/2016	IA_IN nr C.I.3 a)
Mesalazine	PSUR worksharing	-	-	IB nr C.I.3 z)
Methylphenidate hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Methylprednisolone	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Metoclopramide	Stanowisko CMDh	-	05/10/2016	IA_IN nr C.I.3 a)
Miconazole / Hydrocortisone, miconazole nitrate /Miconazole nitrate, zinc oxide	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Milnacipran	PSUR worksharing	-	-	IB nr C.I.3 z)
Milnacipran	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Minoxidil (topical fprmulation)	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Mirtazapine	PSUR worksharing	-	-	IB nr C.I.3 z)
Misoprostol (gynaecological indication - labour induction)	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Misoprostol (gynaecological indication)	PSUR worksharing	-	-	IB nr C.I.3 z)
Moclobemide	PSUR worksharing	-	-	IB nr C.I.3 z)
Modafinil	PSUR worksharing	-	-	IB nr C.I.3 z)
Mometasone+salicylic acid	PSUR worksharing	-	-	IB nr C.I.3 z)
Moxifloxacin (systemic use)	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Mycophenolic acid	PSUR worksharing	-	-	IB nr C.I.3 z)
Nabumetone	PSUR worksharing	-	-	IB nr C.I.3 z)
Nadifloxacin	Stanowisko CMDh		10/05/2017	IA_IN nr C.I.3 a)
Nafarelin	PSUR worksharing	-	-	IB nr C.I.3 z)
Natalizumab	Pojedyncze sygnały	-	01/08/2015	IA_INnr C.I.z
Nebivolol	PSUR worksharing	-	-	IB nr C.I.3 z)
Nedocromil	PSUR worksharing	-	-	IB nr C.I.3 z)
Nefopam	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Nicardipine	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Nicardipine hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Nifedipine	Stanowisko CMDh	-	10/08/2016	IA_IN nr C.I.3 a)
Nifuroxazide	PSUR worksharing	-	-	IB nr C.I.3 z)
Nilotynib	Pojedyncze sygnały	-	07/05/2016	IA_INnr C.I.z
Nilvadipine	PSUR worksharing	-	-	IB nr C.I.3 z)
Nortriptyline	PSUR worksharing	-	-	IB nr C.I.3 z)
Octreotide	PSUR worksharing	-	-	IB nr C.I.3 z)
Ofloxacin	PSUR worksharing	-	-	IB nr C.I.3 z)
Ofloxacin (systemic use)	Stanowisko CMDh	-	30/03/2016	IA_IN nr C.I.3 a)
Ofloxacin (topical use)	Stanowisko CMDh	-	30/03/2016	IA_IN nr C.I.3 a)
Oksybutynina	Pojedyncze sygnały	-	08/04/2016	IA_INnr C.I.z
Omeprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Ondansetron	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Oxaliplatin	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Oxaliplatin	PSUR worksharing	-	-	IB nr C.I.3 z)
Oxatomide	PSUR worksharing	-	-	IB nr C.I.3 z)
Oxcarbazepine	PSUR worksharing	-	-	IB nr C.I.3 z)
Oxybutynin hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Paclitaxel	Stanowisko CMDh	-	18/12/2016	IA_IN nr C.I.3 a)
Paclitaxel	PSUR worksharing	-	-	IB nr C.I.3 z)
Pamidronate	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Pantoprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Paracetamol / Tramadol	Stanowisko CMDh	-	14/07/2016	IA_IN nr C.I.3 a)
Paracetamol/Tramadol	PSUR worksharing	-	11/09/2016	IB nr C.I.3 z)
Paracetamol for infusion	PSUR worksharing	-	-	IB nr C.I.3 z)
Paricalcitol	PSUR worksharing	-	-	IB nr C.I.3 z)
Paroxetine	PSUR worksharing	-	-	IB nr C.I.3 z)
Peginterferon alfa-2a	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Peginterferon alfa-2b	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Peginterferon beta-1a	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Penciclovir (topical use only)	PSUR worksharing	-	-	IB nr C.I.3 z)
Perindopril	Stanowisko CMDh	-	05/10/2016	IA_IN nr C.I.3 a)
Perphenazine	Stanowisko CMDh	-	03/02/2016	IA_IN nr C.I.3 a)
Phenylephrine	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Pimecrolimus	PSUR worksharing	-	-	IB nr C.I.3 z)
Piretanide	PSUR worksharing	-	-	IB nr C.I.3 z)
Pramiracetam	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Pravastatin	PSUR worksharing	-	-	IB nr C.I.3 z)
Pravastatin sodium + buffered aspirin	PSUR worksharing	-	01/01/2017	IB nr C.I.3 z)
Praziquantel	PSUR worksharing	-	-	IB nr C.I.3 z)
Propofol	PSUR worksharing	-	-	IB nr C.I.3 z)
Prulifloxacin	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Quetiapine fumarate	PSUR worksharing	-	-	IB nr C.I.3 z)
Rabbit anti-human thymocyte (powder for solution for infusion)	Stanowisko CMDh	-	04/11/2015	IA_IN nr C.I.3 a)
Rabbit anti-human thymocyte immunoglobulin	PSUR worksharing	-	-	IB nr C.I.3 z)
Rabeprazol	Pojedyncze sygnały	-	07/11/2015	IA_INnr C.I.z
Rabies vaccine	Stanowisko CMDh	-	22/02/2017	IA_IN nr C.I.3 a)
Ramipril	PSUR worksharing	-	-	IB nr C.I.3 z)
Ranitidine	PSUR worksharing	-	-	IB nr C.I.3 z)
Recombinant human interferon gamma-1b	PSUR worksharing	-	-	IB nr C.I.3 z)
Rilmenidine	Stanowisko CMDh	-	10/08/2016	IA_IN nr C.I.3 a)
Risperidone	PSUR worksharing	-	-	IB nr C.I.3 z)
Rizatriptan benzoate	PSUR worksharing	-	-	IB nr C.I.3 z)
Ropinirole	Stanowisko CMDh	-	05/07/2017	IA_IN nr C.I.3 a)
Ropivacaine	PSUR worksharing	-	-	IB nr C.I.3 z)
Rupatadine	PSUR worksharing	-	-	IB nr C.I.3 z)
Rupatadine fumarate	PSUR worksharing	-	-	IB nr C.I.3 z)
Sertindole	PSUR worksharing	-	-	IB nr C.I.3 z)
Simvastatin	PSUR worksharing	-	-	IB nr C.I.3 z)
Sodium iodine (123I)	PSUR worksharing	-	-	IB nr C.I.3 z)
Sodium valproate	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Sofosbuwir	Pojedyncze sygnały	-	13/06/2015	IA_INnr C.I.z
Solifenacin	PSUR worksharing	-	-	IB nr C.I.3 z)
Solifenacin/tamsulosin	PSUR worksharing	-	-	IB nr C.I.3 z)
Spironolactone	Stanowisko CMDh	-	02/03/2016	IA_IN nr C.I.3 a)
Strontium (89Sr) Chloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Sufentanil citrate	PSUR worksharing	-	-	IB nr C.I.3 z)
Sulbactam	PSUR worksharing	-	-	IB nr C.I.3 z)
Sulprostone	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Sulproston	PSUR worksharing	-	-	IB nr C.I.3 z)
Technetium (99mTc)	PSUR worksharing	-	-	IB nr C.I.3 z)
Technetium (99mTc) exametazime	PSUR worksharing	-	-	IB nr C.I.3 z)
Technetium (Tc-99m) bicisate	PSUR worksharing	-	-	IB nr C.I.3 z)
Technetium (99mtc) mebrofenin	Stanowisko CMDh	-	02/11/2016	IA_IN nr C.I.3 a)
Tenoxicam	Stanowisko CMDh	-	03/03/2016	IA_IN nr C.I.3 a)
Testosterone	Stanowisko CMDh	Art. 31	20/02/2015	IB nr C.I.1 a) lub IB nr C.I.1 b)
Testosterone (all formulations apart from topical use and testosterone undecanoate injection)	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Testosterone (topical use)	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Testosterone undecanoate (injection)	Stanowisko CMDh	-	28/12/2016	IA_IN nr C.I.3 a)
Testosterone undecylate (injection)	Stanowisko CMDh	-	04/11/2015	IA_IN nr C.I.3 a)
Tetrabenazine	Stanowisko CMDh	-	07/10/2015	IA_IN nr C.I.3 a)
Thiocolchicoside	Stanowisko CMDh	-	30/06/2016	IA_IN nr C.I.3 a)
Thiopental	Stanowisko CMDh	-	29/03/2017	IA_IN nr C.I.3 a)
Tiagabine (hydrochloride)	PSUR worksharing	-	-	IB nr C.I.3 z)
Tianeptine	PSUR worksharing	-	-	IB nr C.I.3 z)
Tiapride	PSUR worksharing	-	-	IB nr C.I.3 z)
Tibolone	PSUR worksharing	-	-	IB nr C.I.3 z)
Tick-borne encephalitis vaccine (inactivated)	PSUR worksharing	-	-	IB nr C.I.3 z)
Ticlopidine	Stanowisko CMDh	-	11/05/2016	IA_IN nr C.I.3 a)
Tioconazole	PSUR worksharing	-	-	IB nr C.I.3 z)
Tirofiban hydrochloride	PSUR worksharing	-	-	IB nr C.I.3 z)
Tixocortol, Tixocortol/Chlorhexidine	PSUR worksharing	-	-	IB nr C.I.3 z)
Tizanidine	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Tolterodine	PSUR worksharing	-	-	IB nr C.I.3 z)
Trabektedyna	Pojedyncze sygnały	-	06/12/2015	IA_INnr C.I.z
Trabektedyna	Pojedyncze sygnały	-	13/07/2015	IA_INnr C.I.z
Trandolapril + Verapamil	Stanowisko CMDh	-	02/03/2016	IA_IN nr C.I.3 a)
Trandolapril + Verapamil	PSUR worksharing	-	-	IB nr C.I.3 z)
Treprostinil	Stanowisko CMDh	-	10/05/2017	IA_IN nr C.I.3 a)
Triamcinolone (intraocular formulations)	Stanowisko CMDh	-	24/02/2017	IA_IN nr C.I.3 a)
Trimetazidine	Stanowisko CMDh	-	05/07/2017	IA_IN nr C.I.3 a)
Tybolon	Pojedyncze sygnały	-	06/04/2016	IA_INnr C.I.z
Tygecyklina	Pojedyncze sygnały	-	11/06/2016	IA_INnr C.I.z
Valaciclovir	PSUR worksharing	-	-	IB nr C.I.3 z)
Valproate	Stanowisko CMDh	Art. 31	-	IB nr C.I.3 z)
Valproate bismuth	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valproate magnesium	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valproate pivoxil	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valproate semisodium	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valproic acid	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valpromide	Stanowisko CMDh	-	06/01/2016	IA_IN nr C.I.3 a)
Valsartan	PSUR worksharing	-	-	IB nr C.I.3 z)
Varicella Vaccine (live)	PSUR worksharing	-	01/07/2016	IB nr C.I.3 z)
Vecuronium bromide	PSUR worksharing	-	-	IB nr C.I.3 z)
Zafirlukast	PSUR worksharing	-	-	IB nr C.I.3 z)
Zolmitriptan	PSUR worksharing	-	-	IB nr C.I.3 z)