Lenis & Mikro+Polo registrations.... Agency for medicinal...

Lenis & Mikro+Polo registrations....

Agency for medicinal products and medical devices of the Republic of Slovenia
Union Format for Registration of Manufacturer, Importer or Distributor of Active Substances to be used as Starting Materials in Medicinal Products for Human Use

1. Registration Number: 805-25/2017-4
2. Name or corporate name of registrant: LENIS farmacevtika d.o.o.
3. Permanent or legal address of registrant: Litostrojska cesta 52, Ljubljana, 1000, Slovenia
4. Address(es) of site(s) where registered activities take place: Cesta na Brdo 100, Ljubljana, 1000, Slovenia
5. National legal basis of registration: Medicinal product act (ZZdr-2, UL No. 17/2014), Republic of Slovenia
6. Name of responsible officer of the competent authority of the member state validating the registration: Confidential
7. Signature:

8. Date: 2017-09-27


This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in the Union database or with the validating authority.

The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.


SCOPE OF REGISTRATION

Name and address of the site: Kemofarmacija d.d., Cesta na Brdo 100, Ljubljana, 1000, Slovenia


2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution

Cannabidiol (extracts from Cannabis Sativa L.) (JAZMP20)

Tetrahydrocannabinol (synthetic) (JAZMP18)

Tetrahydrocannabinol (extracts from Cannabis Sativa L.) (JAZMP19)

Cannabis flower (JAZMP91)


-----------------------------------------------------------------------------------------------------------


Agency for medicinal products and medical devices of the Republic of Slovenia
Union Format for Registration of Manufacturer, Importer or Distributor of Active Substances to be used as Starting Materials in Medicinal Products for Human Use

1. Registration Number: 805-12/2017-13
2. Name or corporate name of registrant: MIKRO+POLO, družba za inženiring, proizvodnjo in trgovino d.o.o.
3. Permanent or legal address of registrant: Zagrebška cesta 22, Maribor, 2000, Slovenia
4. Address(es) of site(s) where registered activities take place: Zagrebška cesta 22, Maribor, 2000, Slovenia
5. National legal basis of registration: Medicinal product act (ZZdr-2, UL No. 17/2014), Republic of Slovenia
6. Name of responsible officer of the competent authority of the member state validating the registration: Confidential
7. Signature:
  
8. Date: 2017-11-08


This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in the Union database or with the validating authority.

The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.


SCOPE OF REGISTRATION

Name and address of the site: MIKRO+POLO, družba za inženiring, proizvodnjo in trgovino, d.o.o., Zagrebška cesta 22, Maribor, 2000, Slovenia


2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution

ACETYLCYSTEINE ()

ACETYLSALICYLIC ACID ()

ACICLOVIR ()

all-rac-α-Tocopheryl acetate (JAZMP47)

ALPRAZOLAM ()

AMFETAMINE SULFATE ()

ARNICA FLOWER ()

ASCORBIC ACID ()

ATROPINE SULFATE ()

BACITRACIN ()

BARBITAL SODIUM ()

Bearberry leaf (JAZMP54)

BENZALKONIUM CHLORIDE ()

BENZOCAINE ()

BENZOYL PEROXIDE, HYDROUS ()

BENZYL BENZOATE ()

BETACAROTENE ()

BISMUTH SUBGALLATE ()

BISMUTH SUBNITRATE, HEAVY ()

BLACK COHOSH ()

BOLDO LEAF ()

BORAX ()

BORIC ACID ()

BUPIVACAINE HYDROCHLORIDE ()

CAFFEINE ()

CALCIUM CARBONATE ()

CALCIUM PANTOTHENATE ()

CAMPHOR, RACEMIC ()

Cannabidiol (extracts from Cannabis Sativa L.) (JAZMP20)

CAPSAICIN ()

CARBACHOL ()

CARBAMAZEPINE ()

CARBOPLATIN ()

CHARCOAL ACTIVATED ()

CHLORAL HYDRATE ()

CHLORHEXIDINE DIACETATE ()

CHLORHEXIDINE DIGLUCONATE SOLUTION ()

CHOLECALCIFEROL ()

CLINDAMYCIN HYDROCHLORIDE ()

CLOBETASOL PROPIONATE ()

CLOTRIMAZOLE ()

CLOVE OIL ()

COCAINE HYDROCHLORIDE ()

CODEINE ()

CODEINE PHOSPHATE HEMIHYDRATE ()

CODEINE PHOSPHATE SESQUIHYDRATE ()

DEXAMETHASONE ()

DEXAMETHASONE SODIUM PHOSPHATE ()

DEXPANTHENOL ()

DIAZEPAM ()

DICLOFENAC SODIUM ()

DIMETHYL FUMARATE ()

DIPHENHYDRAMINE HYDROCHLORIDE ()

DISODIUM PHOSPHATE DIHYDRATE ()

DITHRANOL ()

CHLORAMPHENICOL ()

DRONABINOL ()

EPHEDRINE HYDROCHLORIDE ()

ERYTHROMYCIN ()

ESTRIOL ()

ETHACRIDINE LACTATE MONOHYDRATE ()

ETHAMBUTOL HYDROCHLORIDE ()

ETHINYLESTRADIOL ()

EUCALYPTUS OIL ()

FENTANYL CITRATE ()

FOLIC ACID ()

Frangula bark (JAZMP63)

FUROSEMIDE ()

GENTAMICIN SULFATE ()

GINKGO LEAF ()

GLYCOPYRRONIUM BROMIDE ()

GRAMICIDIN ()

GREATER CELANDINE ()

HAWTHORN BERRIES ()

HEPARIN SODIUM ()

HOMATROPINE HYDROBROMIDE ()

HYDROCORTISONE ACETATE ()

HYOSCINE HYDROBROMIDE ()

IBUPROFEN ()

ICHTHAMMOL ()

ISONIAZID ()

IVY LEAF ()

JUNIPER ()

KETOCONAZOLE ()

KETOPROFEN ()

LACTIC ACID ()

LEVOMENTHOL ()

LIDOCAINE ()

LIDOCAINE HYDROCHLORIDE ()

LITHIUM CARBONATE ()

CLUB MOSS (LYCOPODIUM CLAVATUM) (JAZMP102)

MELATONIN ()

MELILOT ()

METHACHOLINE CHLORIDE ()

METHADONE HYDROCHLORIDE ()

METHENAMINE ()

METHOTREXATE ()

METHOXSALEN ()

METHYL NICOTINATE ()

METHYL SALICYLATE ()

METRONIDAZOLE ()

MINOXIDIL ()

Mistletoe (JAZMP71)

MORPHINE HYDROCHLORIDE ()

MYRRH ()

NAPHAZOLINE HYDROCHLORIDE ()

NAPROXEN ()

NICOTINAMIDE ()

NIFEDIPINE ()

NYSTATIN ()

OMEPRAZOLE ()

OXYCODONE HYDROCHLORIDE ()

OXYMETAZOLINE HYDROCHLORIDE ()

OXYTETRACYCLINE HYDROCHLORIDE ()

PAPAVERINE HYDROCHLORIDE ()

PARACETAMOL ()

PEPPERMINT OIL ()

PHENOBARBITAL SODIUM ()

PHENYLEPHRINE HYDROCHLORIDE ()

PILOCARPINE HYDROCHLORIDE ()

PIRACETAM ()

PODOPHYLLUM RESIN ()

POLYMYXIN B SULFATE ()

POTASSIUM CHLORIDE ()

POTASSIUM PERMANGANATE ()

PRILOCAINE HYDROCHLORIDE ()

PROCAINE HYDROCHLORIDE ()

PROGESTERONE ()

PROPYPHENAZONE ()

PYRAZINAMIDE ()

PYRIDOXINE HYDROCHLORIDE ()

QUININE HYDROCHLORIDE ()

RANITIDINE HYDROCHLORIDE ()

RED POPPY PETALS ()

RESORCINOL ()

RHUBARB ()

RIBOFLAVIN SODIUM PHOSPHATE ()

RIFAMPICIN ()

Rupturewort (JAZMP81)

SALICYLIC ACID ()

SANDY EVERLASTING (JAZMP103)

Saw palmetto fruit (JAZMP83)

SILVER NITRATE ()

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE ()

SODIUM HYDROGEN CARBONATE ()

SPIRONOLACTONE ()

St.John's wort (JAZMP86)

SULFADIAZINE ()

Sulfur for external use (JAZMP37)

TANNIC ACID ()

TAURINE ()

TEA TREE OIL ()

TESTOSTERONE PROPIONATE ()

TETRACAINE HYDROCHLORIDE ()

Tetrahydrocannabinol (extracts from Cannabis Sativa L.) (JAZMP19)

THEOPHYLLINE ()

THYMOL ()

TRETINOIN ()

TRIAMCINOLONE ACETONIDE ()

TRIMETHOPRIM ()

VALERIAN ROOT (JAZMP104)

VANCOMYCIN HYDROCHLORIDE ()

WILD CHESTNUT SEED (JAZMP105)

OPIUM TINCTURE, STANDARDISED (JAZMP106)